Guidance Article Investigating Device-Related “Burns”

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December 2005, Volume 34, Number 12

Also in This Issue

Guidance Article

Conducting an Electrosurgical Safety Audit

Evaluation Update

Baxter Colleague CX and 3CX Infusion Pumps

Note of Thanks

Thank You to All Our Clinical Reviewers

Problem Reports

■ Hazard: Fire Risk with Defibrillators

■ Incorrect Use Can Damage Medcare Lifts

Talk to the Specialist

Ventilator Gas Supply Inlet Filters

Guidance Article

InvestigatingDevice-Related “Burns”

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391

392 Executive Summary

Guidance Article393 Investigating Device-Related “Burns”394 Identifying the Cause of an Accidental Skin Injury

394 Separating Fact from Fiction

394 Building Blocks for a Thorough Investigation

395 The Investigation Process

397 The Investigation Format

398 In Summary

400 Investigation Questionnaire: Accidental Skin Injuries

400 Instructions

400 Collecting and Analyzing the Data

404 Form: Accidental Skin Injury Investigation Questionnaire

412 Selected Bibliography

Supplementary Articles395 Routine Steps That Can Facilitate Future Skin-Injury Investigations

399 Etiologies of Accidental Skin Injuries

Guidance Article414 Electrosurgical Safety: Conducting a Safety Audit415 10 Key Questions to Ask during an Electrosurgical Safety Audit

418 Developing an Electrosurgical Safety Checklist

Evaluation Update421 General-Purpose Infusion Pumps:

Baxter Colleague CX and 3CX Infusion PumpsRated NOT RECOMMENDED for Purchase

Note of Thanks422 Thank You to All Our Clinical Reviewers

ECRI Problem Reporting SystemHazard Report

423 Using External Defibrillators in Oxygen-Enriched Atmospheres CanCause Fires

User Experience Network426 U-Brackets on Medcare Total Support Lifts May Suffer Damage

through Incorrect Use

Talk to the Specialist425 Ventilator Gas Supply Inlet Filters

December 2005, Volume 34, Number 12

PUBLISHING STAFFRobert W. Schluth, BA, Editorial Director,Health Devices GroupGarrett J. Hayner, BA, EditorGeoffrey C. Keston, BA, Associate Editor

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392 HEALTH DEVICES December 2005 ■ www.ecri.org ©2005 ECRI. Duplication of this page by any means for any purpose is prohibited.

ExecutiveSummary

Featured in This Issue

Investigating Burnsand Other Skin InjuriesSkin injuries sustained—or suspected of having beensustained—by patients in the operating room or special careareas of the hospital are often initially mistaken for thermalor electrical burns, with medical devices immediatelyblamed as the cause. However, such a hasty conclusion canoverlook the actual cause of the injury and delay the imple-mentation of measures to prevent future occurrences. In thismonth’s feature article (page 393), we describe a thoroughinvestigation process to help heathcare facilities uncover thereal cause of an accidental skin injury.

Identifying the CauseAlthough certain medical procedures, such as electrosur-gery, are known to present the risk of burns, it is importantthat staff not rush to judgment about the nature or cause ofany injuries that do occur. Skin injuries are not alwayswhat they seem: What appears to be a device burn may in-stead be an abnormal or idiosyncratic physiologic responseto otherwise normal conditions of device use and perfor-mance, or it may be due to pressure necrosis, an adversedrug reaction, or a disease process that happens to developin the area where a device was applied.

Thus, when an accidental skin injury is suspected,healthcare facilities should initiate an investigation to de-termine both the nature and the cause of the injury. Thefollowing steps, as detailed in our Guidance Article, willfacilitate the investigation process if an injury occurs:

■ Always perform a preprocedure skin check, noting thegeneral condition of the patient’s skin and any unusualconditions, and a postoperative check, noting anychanges or abnormalities.

■ If a device-related injury is suspected, preserve anddocument the evidence, especially all disposables andpackaging.

■ Ensure that relevant staff complete an incident report.The report should include only facts (e.g., “postopera-tive skin check revealed lesions on the patient’s heel”)and not speculation or supposition (e.g., “patient re-ceived electrosurgical burns on heel”).

■ Discuss the issue honestly, but cautiously, with the pa-tient and family. Again, stick to the facts as they areknown at that time, and avoid speculation.

The article also offers specific guidance on how to con-duct an investigation, including how to assess an injury todetermine its cause and what device-specific factors mostcommonly contribute to such injuries.

ECRI’s Investigation Questionnaire

The questionnaire on pages 404 through 411 can be usedby investigators to collect information during staff inter-views and to summarize the baseline patient and equip-ment data that will be needed for the investigation.

Electrosurgical Safety AuditThis month, we follow up our August 2005 articles onelectrosurgical safety with guidance on conducting asafety audit. The article identifies 10 key questions to askof your facility as part of a safety audit. It also provides astarter list that facilities can employ to create a customizedchecklist for clinicians to use each time they performelectrosurgery. The article begins on page 414.

Also in This IssueEvaluation Update: Baxter Colleague infusion pumps.

ECRI evaluated the Baxter Colleague CX and 3CX gen-eral-purpose infusion pumps in October 2002 and foundthe models to be Acceptable. Since that time, however,ECRI’s criteria have evolved to reflect the increasingly so-phisticated capabilities of dose error reduction systemsnow on the market, and the two Baxter pumps have notkept up with advances in the technology. As a result,ECRI now rates these pumps Not Recommended for newpurchases. See page 421 for details.

Thank you. In our annual Note of Thanks (page 422), weacknowledge some of the individuals outside ECRI whohelp us do what we do.

Problem reports. Fires that result during the use of exter-nal defibrillators in oxygen-enriched environments con-tinue to occur, despite warnings from ECRI and otherorganizations. The Hazard Report on page 423 describesthe problem and how hospitals should address it. Also thismonth, we describe how maneuvering Medcare Model400001 and 400003 lifts in certain ways can damage thedevices over time—a consequence that is not mentioned inthe original training manual (see page 426 for details). ◆

©2005 ECRI. Member hospitals may reproduce this page for internal distribution only. www.ecri.org ■ HEALTH DEVICES December 2005 393

GuidanceArticle

InvestigatingDevice-Related “Burns”

Summary. Skin injuries sustained—or suspected of having been sustained—bypatients in the operating room or special care areas of the hospital have manypotential causes. Such injuries are often initially mistaken for thermal or electricalburns, with medical devices immediately blamed as the cause. However, such ahasty conclusion can overlook the actual cause of the injury and delay the imple-mentation of measures to prevent future occurrences.

In this article, we describe a thorough investigation process to help healthcarefacilities uncover the real cause of an accidental skin injury. Included is a detailedquestionnaire to facilitate the investigation. We also present a list of potentialcauses of accidental skin injuries; these causes must be considered in a thoroughinvestigation.

Identifying the Cause of an AccidentalSkin Injury

Despite a great deal of care and concern by medical, nurs-ing, surgical, and engineering personnel, patients do occa-sionally suffer inadvertent burns and other skin injuries inoperating rooms (ORs) and in special care areas of thehospital—including recovery rooms, intensive care units(ICUs), and cardiac care units (CCUs). Such injuries canprolong morbidity and extend hospitalization, appreciablyincreasing medical costs to the patient and hospital; also,the hospital and surgical team may face liability costs ifthe injured patient brings suit.

Although certain medical procedures (e.g., electrosur-gical procedures) are known to present the risk of causingdevice-related burns or other accidental skin injuries, it isimportant that staff not rush to judgment about the natureor cause of any such injuries that do occur. In its 35 yearsof investigating patient injuries and deaths from errors andaccidents involving healthcare technology, instruments,devices, and systems, ECRI has observed that skin injuriesare not always what they seem. The guidelines presentedin this article will help healthcare personnel organize andconduct a thorough skin-injury investigation to identify thecause of an accidental skin injury. The questionnaire thataccompanies this article facilitates the investigation pro-cess (see page 404).

Separating Fact from FictionWhen an accidental skin injury is suspected, healthcare fa-cilities should initiate an investigation to determine boththe nature of the injury and the cause. While these may ap-pear obvious in particular cases, the seemingly obvious ex-planation for a skin injury is not always the correct one.

Medical devices are frequently blamed for accidentalskin injuries, particularly for those that have the appear-ance of a full- or partial-thickness burn. However, thermalor electrical sources are not always involved. In manycases, the injury may be an abnormal or idiosyncraticphysiologic response to otherwise normal conditions ofdevice use and performance. Alternatively, the injury maybe due to pressure necrosis, an adverse drug reaction, or adisease process that happens to develop in the area wherea device was applied. (See “Etiologies of Accidental SkinInjuries,” on page 399.) It is therefore misleading—and inmany cases inaccurate—to refer to such an injury as a

“burn.” For these injuries, “lesion” is a more appropriateterm because it allows the consideration of other causes.

When approaching the problem of skin injury, the fol-lowing questions need to be addressed:

■ What are the various kinds of skin injury, and where inthe hospital do they occur?

■ What procedures should be followed immediately afterdiscovery of an injury?

■ Who should be involved in an investigation?

■ What information should be gathered?

■ What measures should be implemented to prevent fu-ture occurrences?

■ How and when should the hospital communicate withthe manufacturer of implicated devices?

An understanding of the possible causes and effects ofskin injury, combined with an effective investigation pro-cedure, enables investigators to identify the actual cause ofa particular injury and recommend precautions, therebyhelping to minimize future risks to patients and to thehospital.

Building Blocks for a ThoroughInvestigation

FOR ALL SURGICAL PROCEDURES . . .Be prepared. As described in the inset on page 395, stepstaken before a surgical procedure can greatly facilitate theinvestigation of any skin injury that develops afterward.For example, information obtained during a preprocedureskin check—in which staff thoroughly examine the pa-tient’s skin and note any unusual conditions—will allowstaff to identify changes that might have occurred duringor after the procedure.

Perform a postoperative skin check. As soon as possi-ble following a surgical procedure, personnel should ex-amine the patient’s skin and record any observed changesor abnormalities. In some cases, the patient’s physical con-dition may not permit an immediate and thorough postop-erative skin check, but accessible areas (e.g., buttocks,heels, thighs, elbows, head, electrode sites) should bechecked. The nursing staff should check other areas assoon as possible.

394 HEALTH DEVICES December 2005 ■ www.ecri.org ©2005 ECRI. Member hospitals may reproduce this page for internal distribution only.

GuidanceArticle


GuidanceArticle

IF AN INJURY IS DISCOVERED . . .Preserve and document the evidence. When a sus-pected device-related lesion is discovered, personnelshould preserve and thoroughly document the evidence,especially all disposables and packaging. Contaminateddisposables or other instruments should be stored in appro-priate biohazard containers. When practicable, color pho-tos of the skin injury should be taken immediately afterdiscovery and 24 and 48 hours afterward (permission fromthe patient or family may be necessary). Photographsshould provide some indication of the scale of the lesion(e.g., using a coin or ruler).

If possible, surgical and medical personnel should notmove or disconnect the equipment, except as necessary tocare for the patient or to prevent further injury or equip-ment damage. When it is not possible to preserve thephysical setup of the involved equipment and devices,personnel should record the scene with photographs orsketches. Color photographs should be taken before in-spection of devices that may be damaged when examined,such as a disposable dispersive electrode for use with anelectrosurgical unit (ESU).

Ensure that no involved materials or devices are re-leased to the manufacturer until completion of the internalincident investigation or until approval has been given byrisk management or administration. Note, however, thatfacilities in the United States may be required to submit atimely report to the manufacturer in compliance with U.S.Food and Drug Administration (FDA) regulations.

Complete an incident report. The head nurse of the de-partment in which the injury occurred should fill out an in-cident report and record the immediate observations of allinvolved personnel. To avoid premature or inaccurate con-clusions, the incident report should include only facts, notspeculation or supposition. For example:

■ Incorrect: “Patient received electrosurgical burns onright buttock and heel.”

■ Correct: “Postoperative skin check revealed lesions onthe patient’s right buttock and heel.”

The head nurse should make sure that all personnel in-volved in the incident complete incident reports as well.

Discuss the injury honestly, but cautiously, with the

patient and family. Discussion with the patient and fam-ily about the injury should be honest and cautiously diplo-matic. The actual cause of the injury probably will not beknown before the incident is discussed with the patient. Assuch, offering specific theories can be misleading andprovoke litigation.

For example, if a patient develops a palm-sized lesionover the sacrum on the day following a lengthy cardio-vascular surgical procedure, pressure necrosis is theprobable cause. But we know of many cases like this inwhich the nursing, medical, or surgical staff told the pa-tient, “The electrosurgical machine accidentally burnedyou during the surgery.” Such statements frequently leadthe patient to seek legal counsel, sometimes even beforeleaving the hospital. A more productive and factual ap-proach is to tell the patient that there is “an injury” or “anarea of skin breakdown” and that it will be treated. Insome cases, it may be suitable to mention that the causeis being investigated.

The Investigation ProcessAn investigation need not be a threatening experiencefor anyone. The goal of the investigation is to determinewhat happened and recommend appropriate preventivemeasures—not to assign blame. This should be explainedto all personnel involved in the incident.

Routine Steps That CanFacilitate Future Skin-Injury

Investigations

Steps taken before a surgical procedure will facili-tate the investigation of any skin injury that developsafterward. Before a procedure, surgical nursingand/or medical personnel should thoroughly exam-ine the patient’s skin. A description of the generalskin condition, as well as any unusual conditions—rashes, reddened or discolored areas, contusions,cuts, abrasions, or other abnormalities—should berecorded in the patient history, perioperative record,or surgical notes.

Ideally, the surgical notes for each patient wouldalso include information on the manufacturer, lotnumbers, and expiration (or “use before”) dates ofprepping solutions, electrodes, and electrode gels, aswell as information on manufacturers, models, hos-pital control numbers, and serial numbers of equip-ment. However, because it is impractical to expectoperating room personnel to record all this informa-tion, the available information should be collected atthe first sign of a skin injury. ◆


GuidanceArticle

ASSEMBLING THE INVESTIGATION TEAMThe investigation team should include staff members whoare familiar with the equipment used and the environmentin which the incident occurred. The team might include aclinical engineer, an OR or critical care nurse (frequentlythe supervisor for one of these departments), a physician,an equipment technician, and the risk manager. The riskmanager will help ensure that proper steps are taken topreserve confidentiality and maintain legal compliance.

The chosen coordinator should understand the variousmechanisms of skin injury and the investigative process. Toensure objectivity, no one who had primary responsibilityfor the patient before or after the injury should be includedon the team. Also, the team must be careful to fairly repre-sent different interpretations of the incident: what one per-son calls operator error may be interpreted by someone elseas inadequate equipment design or a device failure.

It may be beneficial to deploy qualified, independentexternal investigators in some cases. For example, the hos-pital may lack the in-house expertise to investigate the in-cident; also, the potential for bias or concealment exists inany in-house investigation. External investigators can behelpful in exploring both technical and legal issues, espe-cially when litigation is likely. Because they have no pre-conceived notions, external investigators are usuallyobjective and cooperative, rather than defensive or ad-versarial. With in-house investigators, there may be therisk of damaging long-term working relationships.

IDENTIFYING THE CAUSEWhen trying to ascertain the cause of an accident, ECRIhas historically considered the five broad categories listedbelow. Within each of these categories, we have listed therelevant subcategories that should be considered when in-vestigating suspected device-related burns. To ensure thor-oughness and accuracy, each of these must be consideredin any investigation.

1. Device Factors

— Device failure

— Device interaction

— Design/labeling error

— Failure of an accessory

— Improper maintenance, testing, or repair

— Manufacturing error

2. User or Use Error

— Abuse of the device

— Accidental misconnections

— Improper (“bad”) connection

— Device misassembly

— Failure to monitor

— Failure to heed labeling

— Inappropriate reliance on an automated feature

— Incorrect clinical use

— Incorrect control settings

— Maintenance or incoming inspection error

— Failure to perform pre-use inspection

3. Facilities Factors

— Water supply (especially temperature)

4. Tampering/Sabotage

— Device user (clinician)

— Device user (patient)

— Family member or enemy

— Random act

5. Support System Failure

— Poor prepurchase evaluation

— Poor incident/recall reporting systems

— Failure to impound incident-related devices

— Lack of competent accident investigation

— Failure to train and credential

— Use of inappropriate devices

— Lack of incoming inspections

— Improper cleaning, sterilization, or storage

In addition, it must be remembered that a patient mayhave specific physiologic sensitivities, abnormalities, ordiseases. As such, a patient’s suspected “burn” injury mayultimately be determined to be an abnormal or idiosyn-cratic physiologic response to otherwise normal conditionsof use and performance for that device. It may also be de-termined that a technology was not involved at all.

ACTING QUICKLYTime is a significant factor in starting and completing aninvestigation. The longer it takes to mount and completean investigation, the greater the probability that the causewill grow elusive as evidence is lost, memories dim, de-fensive rationalizations crystallize, and speculation cloudsthe process. In addition, if there is a reason to suspectmedical-device-related injuries, there is a limited timetablefor submission of a report to the manufacturer (e.g., tomeet FDA regulations) or to appropriate regulatory bodies.


GuidanceArticle

The Investigation FormatA thorough investigation of accidental skin injury shouldinclude the following:

■ Consideration of the incident report and collected evi-dence, such as photographs

■ Collection of baseline patient and equipment informa-tion

■ Documentation and assessment of the lesion’s appear-ance and progression

■ Inspection and testing of equipment used

■ Interviews with involved personnel

Before performing equipment inspections and inter-views, the investigation team should review and be famil-iar with the clinical and surgical procedures and conditionssurrounding the incident, as well as understand the lesion’sclinical appearance and collect the baseline information.

BASELINE INFORMATION

Baseline information on both the patient and the equip-ment is required for the investigation. Much of the patientbaseline information will come from the patient’s chart.Before any interviews are conducted, the patient’s chartshould be thoroughly reviewed because it will indicate thehospital personnel most appropriate to be interviewed.

The investigation team should make sure that equip-ment information is recorded for all devices involved inthe incident, including disposables. For devices that areroutinely inspected, the date of the “last” inspection andthe “due” date must be recorded. If available, the equip-ment performance history should also be reviewed.

LESION ASSESSMENT

Details about a lesion’s clinical appearance and progres-sion are important to determining its cause. A guide forcollecting critical information about the lesion can be re-membered by using the mnemonic OPALSS—Onset,Progression, Appearance, Location, Shape, and Size.These six descriptive criteria are central to assessingthe cause of a lesion and the potential involvement of amedical device. For example, pressure necrosis injuries(decubitus ulcers) from intraoperative pressure may showup several days after the insulting event, whereas electro-surgical burns are visible immediately at the end of sur-gery and do not suddenly appear days later.

The following list illustrates how the OPALSS criteriacan be applied to obtain needed details about a lesion. The

list is not intended to be all-inclusive, but rather to stimu-late thinking during the investigation.

■ Onset

— When was the lesion discovered? Get the precisetime and date.

— When did surgery occur?

— How long was the patient immobile in the recoveryroom or ICU after surgery?

— At what time was the last heat-therapy device orheated product used on the patient, and how longwas it applied?

— Where was discovery made and by whom?

■ Progression

— After discovery, did the lesion get larger, deeper?

— Did blisters form? When?

— Did an eschar form?

■ Appearance

— What did the lesion look like upon discovery?

— Note the color and texture of both the central areaand the surrounding areas.

■ Location

— Where on the body was the lesion?

— Record its location in relation to electrodes, high-pressure areas of contact, and positioning devices.

— Is there a clearly definable electrical current paththrough the area of injury? Specify the validity ofthe alleged current path in collaboration with engi-neering staff.

■ Shape

— Note the geometry of the lesion.

— Are there patterns of devices or electrodes within thelesion?

— Does the shape correspond to heat-therapy devicesor electrodes?

■ Size

— Measure the injury dimensions.

— What is the area of the injury, including all affectedtissue area (e.g., perimeter halos)?

— If there are multiple lesions, what is the combinedarea?

Changes in the lesion should be noted as the injury pro-gresses or heals. Color photographs are the best way todocument changes in the condition of the injury. The time,

date, and scale should be recorded for each photograph.The same lighting conditions should be maintained whentaking photographs.

EQUIPMENT INSPECTIONAfter discovery of a suspected device-related skin injury,all equipment that may be involved, including disposables,should be sequestered until it has been inspected. Mostequipment can be immediately returned to service becauseit will be obvious that it played no role in the injury. How-ever, no suspect device should be returned to service untilit has been eliminated as a possible cause of the injury.

The manufacturer should not be permitted to removeequipment or disposables from the hospital becausethe hospital then loses all access to them. The hospitalshould not send such devices to their suppliers withoutapproval from risk management or administration, norshould suppliers be permitted unwitnessed access tothe devices for inspection or repair. In many cases,evidence that might protect the hospital could be lostor compromised.

Depending on the nature and location of the injury, theequipment, devices, and solutions that may have to be in-spected might include the following:

■ ESUs and accessories, such as active electrodes,dispersive electrodes, cables, and electrode gels

■ Hypo/hyperthermia units, with associated blankets andpatient temperature probes

■ Blanket and solution warming cabinets

■ Heat lamps and heating pads

■ Lasers and laser fibers

■ Radiant warmers

■ Diathermy units

■ Endoscopes, with their light sources

■ Transilluminators

■ Pulse oximeters and pulse oximeter probes

■ Nerve stimulators and stimulator electrodes

■ Intra-aortic balloon pumps

■ Tourniquets

■ Monitors such as ECG, EEG, and temperature, withassociated cables, electrodes, and probes

■ Cardiopulmonary bypass equipment

■ Beds

■ OR tables

■ Anesthesia masks and tubing

■ Prepping and degreasing agents

■ Ointments

■ Linens

Personnel who are normally responsible for maintain-ing and inspecting the incident equipment should not in-spect it following an incident, as such individuals may notrecognize past errors or may even try to conceal them. Ifalternate technical personnel are not available, an outside,independent examination of equipment may be most effec-tive. The manufacturer may want to witness equipment in-spections, and it is usually in everyone’s best interest thatthis be permitted. Inspections are best undertaken by thehospital’s risk manager and clinical engineer, an outsideinvestigator, and the manufacturer simultaneously.

INTERVIEWS AND DATA COLLECTION:USING ECRI’S QUESTIONNAIRE

The questionnaire on pages 404 through 411 is a guide forcollecting information during interviews, as well as forsummarizing baseline patient data and recording necessarydetails about each device involved in the investigation.One copy should be completed for each person involved inthe incident. Relevant questions should be directed to allappropriate people because multiple responses will helpcorroborate data on the time and sequence of events. Al-though it is unlikely that any one person will be able toanswer all the questions, everyone can provide useful in-formation based on his or her general observations anddiscussions with other personnel involved in the incident.

In Summary . . .A thorough investigation of a skin injury includes con-sideration of all possible device and/or solution interac-tions. It must also consider the possibility that the injurywas an allergic reaction, a disease, or an idiosyncratic re-sponse. While it is easy to assume that a certain device orsolution caused the injury simply because it was used,such assumptions are often incorrect and may precludeconsiderations of other possibilities. Hasty conclusionsthat a device or an operator was at fault may bias the in-vestigation, mislead the patient into bringing suit, andunjustly impugn personnel, equipment, service organiza-tions, or manufacturers.

The investigation team must make sure that all possibil-ities are explored and that everyone involved in the inci-dent is questioned. Only then will it be possible to developeffective preventive measures.


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Etiologies of Accidental Skin Injuries

Electrical

■ Radio frequency (RF)—electrosurgery, magneticresonance imaging (MRI) RF coils

■ DC—batteries, circuit continuity monitors, pace-makers, nerve and muscle stimulators

■ AC—60 Hz line voltage

Thermal

■ Direct contact—heating pads, electrocautery, dia-thermy, heated irrigation solution bag, excessivelyheated cotton blanket, unlubricated surgical drillshank, flash-sterilized surgical instruments, heatedprobes

■ Irradiant—radiant warmers, exam and operatinglights, fiberoptic light cables, lasers

■ Exothermic chemical reaction—Merthiolate on alu-minum electrode

Chemical

■ Povidone-iodine prep solutions—problems withlot-specific formulation, solution pooled under a pa-tient that reacts with other solutions or with residuallaundry chemicals in linens, mixing with alcohol orhydrogen peroxide

■ Ethylene oxide (EtO)—improper aeration ofEtO-sterilized devices

■ Improper electrode plating components reacting withconductive paste

Mechanical

■ Constant high pressure in excess of two to threehours (e.g., caused by positioning contours, sup-ports, straps, pinching); time required may be shorterwith very high pressure

■ Pneumatic tourniquets

■ Tenacious electrode adhesive

Radiation

■ Diagnostic imaging

■ Therapeutic treatment

Pharmacologic

■ Warfarin therapy (e.g., Coumadin)

■ Intra-arterial injection of Bicillin (penicillin G)

■ Drug infiltration at a catheterization site

■ High-dose injected barbiturates injection in subcuta-neous or fat layer

Physiologic/Medical

■ Allergic reaction (e.g., to adhesives, electrode gel,ointment, or skin prep solution)

■ Aplasia cutis (neonates)

■ Chronic chilblain (pernio)

■ Ecthyma gangrenosum

■ DIC (disseminated intravascular coagulopathy)

■ Lesions secondary to lupus erythematosus or Hodg-kin’s disease

■ Lichen sclerosus et atrophicus

■ Livedo reticularis (including idiopathica)

■ Purpura fulminans

■ Necrotizing fasciitis (“flesh-eating bacteria”)

■ Ischemic lesions resulting from:

— Peripheral vascular disease

— Venous stasis

— Diabetes mellitus

— Cryoglobulinemia

— Arterial emboli of atherosclerotic plaque (bluetoe syndrome)—iatrogenic, intraoperative, orotherwise

— Anterior compartment syndrome ◆

Investigation QuestionnaireAccidental Skin Injuries

ECRI developed the questionnaire presented on pages 404through 411 to help investigators gather information aboutaccidental skin injuries. The form serves as a guide forcollecting information during interviews, as well as forsummarizing baseline patient data and recording necessarydetails about each device involved in the investigation. Al-though the questionnaire is designed for skin injuries thatoccur in the OR, it may also be used to investigate skin in-juries that occur in the recovery room and special care ar-eas or skin injuries noticed on any patient exposed toheating and illumination devices, tenacious tape orelectrode adhesives, or prepping and degreasing agents.

The questionnaire is divided into five main sections:

A. Baseline Patient Information

B. Baseline Equipment Information

C. The Surgical Procedure

D. The Injury

E. The Equipment

These sections are discussed below. Additional sectionsfor the interviewer’s and the interviewee’s summary com-ments are also provided.

Instructions■ Record the baseline patient and equipment information

(Sections A and B).

■ Make a separate copy of the partially completed ques-tionnaire for each person who is to be interviewed.

Note: Each person involved in the incident should beinterviewed. Relevant questions should be directed toall appropriate people because multiple responses willhelp corroborate data on the time and sequence ofevents. Although it is unlikely that any one person willbe able to answer all the questions, everyone can pro-vide useful information based on his or her generalobservations and discussions with other personnelinvolved in the incident.

■ Record the interviewee’s answers to all relevant ques-tions in Sections C through E.

Note: Most information can be recorded directly onthe questionnaire form. If needed, lengthy answers to

questions or device identification details can be re-corded on a separate sheet of paper with the numberscorresponding to the questions. Be sure to record the in-terviewee’s name and your name on all attached sheets.

■ File the completed questionnaires with the incident re-port. The questionnaires should not be filed with the pa-tient’s record.

Collecting and Analyzingthe Data

A. BASELINE PATIENT INFORMATIONThe need for baseline patient information is self-evident.

B. BASELINE EQUIPMENT INFORMATIONInformation about each involved device, including dispos-ables, will also be needed for a thorough investigation tobe conducted.

C. THE SURGICAL PROCEDUREPatient surgical and medical records typically provide in-formation that is only marginally useful in determining thecause of a suspected device-related injury. The investiga-tion team must interview all surgical, medical, and nursingstaff involved in the procedure and in the postoperativecare of the patient. It may also be necessary to questiontechnicians and other personnel responsible for cleaning,sterilizing, inspecting, or maintaining the equipment andsupplies used for the injured patient.

Investigators should pay special attention to informa-tion concerning any unusual occurrences during the proce-dure. For example, they should ask about occurrences suchas the following:

■ Changes in device performance

■ Unattended devices

■ Peculiar sounds, monitor displays, smells, or alarms

■ Sudden changes in the patient’s condition or physicalposition

Investigators must also determine how solutions, degrea-sers, and prepping agents were applied during the proce-dure. During routine surgery, there is usually enough timeto apply these substances carefully. During emergency


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surgery, however, sometimes not enough care is taken, andtoo much prepping agent is applied. This can result inpooling beneath the patient. After exposure for severalhours to these substances, a sensitive patient may de-velop lesions. A patient may be sensitive to the preppingagent itself, and the application of heat from a hyper-thermia blanket, for instance, may increase that sensitiv-ity. Even the wetness alone can compromise skin toneand make it more susceptible to developing pressurenecrosis.

D. THE INJURY

The anatomical drawing on the questionnaire enables in-vestigators to locate lesions in relation to the incision site,dispersive electrodes, stimulation electrodes, ECG elec-trodes, and all associated cables. Any contact between thepatient and metal (e.g., drape supports on the side of theoperating table, mechanical supporting instruments such asretractors) or conductive tubing and masks should also berecorded.

Lesion patterns can help identify the causes. When anESU is used, incomplete contact of an electrosurgicaldispersive electrode with the patient may produce a lesionidentical to a section of the electrode’s perimeter. Or whena hypo/hyperthermia blanket is used, lesions that conformto the blanket’s ridges may appear on the sacral areas,while no other area of the skin that was touching the blan-ket shows any injury. In this case, the blanket was proba-bly not hot enough to cause thermal injury from simplecontact; possible causes are pressure necrosis (perhaps incombination with mild heat) and ethylene oxide (EtO) res-idue (in a reusable hyperthermia blanket).

The investigation team should pay attention to whenthe injury was discovered and to any subsequent changes.While a lesion on the patient’s back or sacral area mayhave been discovered several hours postoperatively in therecovery room or intensive care area, it may have actu-ally occurred in the OR, but was aggravated by the pa-tient’s position during postoperative care. The patient’streatment and medication and other comments regardingthe progression and prognosis of the lesion should alsobe recorded.

Determining the etiology of an injury may be aided byhistological examination of skin or tissue pathology speci-mens. Such specimens may have been taken duringdebridement. Pathology findings may be able to revealwhether the injury was caused by a disease, by electrosur-gical current, or by thermal injury.

E. THE EQUIPMENTElectrodes. Care should be taken when handling elec-trodes (e.g., electrosurgical, nerve stimulation, and EEGelectrodes) used during a procedure in which an injurymay have been sustained. For example, suspect electrodeswith adhesive borders or conductive adhesive should notbe folded over on themselves. Rather, they should be ap-plied to a nonstick material, such as the backing materialwith which the electrode was packaged. If necessary, anew electrode can be opened and its nonstick backing canbe applied to the suspect electrode. Doing so will help pre-vent the electrode from drying out and makes subsequenttesting easier and more likely to produce useful results.

ESUs and accessories. Information obtained from inter-views about the performance and control settings of theESU should be compared with the results from equipmentinspections. If the unit meets proper performance specifi-cations (e.g., the manufacturer’s specifications), it can bereturned to service.

In most cases of skin injury involving ESUs, the causeof the injury is related to the electrodes, cables, or otheraccessories, rather than improper functioning of the unit it-self. For example:

■ Insufficient contact, improper electrode placement orsize, an inadequate amount of gel, pressure on the pad,or a defective electrode can contribute to lesions be-neath the dispersive electrode.

■ Defective cables and connectors may causeelectrosurgical currents to seek alternate return path-ways through the patient, resulting in injuries at loca-tions other than the incision or return electrode sites.

Poor electrical continuity in either the return electrode orthe cables can lead to difficulty achieving the desired surgi-cal effect, which in turn can lead the surgeon to requestmore power. However, increasing the power setting underconditions of poor continuity usually does not result in theexpected increase in ESU performance, and the surgeonmay again request more power if poor continuity is not rec-ognized as the cause of the problem. Continued use of theESU in this manner increases the likelihood of a burn eitherat the site of the return electrode or at an alternate site. Staffeducation that emphasizes intraoperative checking of ESUelectrodes and cables if a problem is suspected and the useof a return-electrode contact-quality monitor (RECQM) canminimize the risk of injury from a partially or fully detachedreturn electrode or a damaged cable.

If a lesion is found beneath the electrosurgical disper-sive electrode (also called the ground plate or patient


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plate), surgical personnel should inspect the electrode im-mediately for discoloration, obvious damage, wetness ofthe gel, evidence of contact with fluids, and those othercharacteristics listed in the questionnaire. Comparisonwith a new electrode is helpful in determining subtle dif-ferences with the suspect electrode. The investigatorshould also observe whether the entire conductive or ca-pacitively coupled surface had been in contact with the pa-tient’s skin. It should also be noted whether straps wereplaced over the electrode or whether a member of the sur-gical team leaned on it or stepped on its cable and causedpartial dislodgment. Pressure on a disposable return elec-trode or partial dislodgment may cause localized high cur-rent densities, which can cause burns. Later inspectionsshould be performed to determine whether there are anydiscontinuities or separations of the connector and/or ofthe conductive substrate (usually made of foil) or whethera part of the electrode is missing.

The type of ESU can be a factor in the cause of alter-nate-site burns. Typically, ground-referenced ESUs willmore likely be associated with an alternate-site burn thanisolated-output units. However, the investigator should beaware that isolation can fail and that, under certain operat-ing conditions (e.g., open-circuit activation), a properlyoperating isolated-output unit could cause an alternate-siteburn from current originating at the return electrode.

Hand-switched active electrodes, both disposable andreusable, must also be inspected. A defective switchingmechanism of a hand-switched active electrode can causeinadvertent activation of the ESU and result in burns. Insu-lation failure can also cause a burn where the section ofthe electrode with missing or poor insulation contacted thepatient. Determine where the active electrode was placedbetween uses. Injury from inadvertent activation wouldbe more likely if the electrode was not placed in a well-insulated safety holster.

➤ For more information about managing burn risks dur-ing electrosurgical procedures, especially those involvinghigh-current electrosurgery, refer to the collection of arti-cles on electrosurgical safety in the August 2005 HealthDevices. Also refer to the discussion of electrosurgicalsafety audits on page 414 of the current issue.

Hypo/hyperthermia units and radiant warmers. In mostcases of intraoperative skin injury attributed to hypo/hyperthermia blankets, the unit proves to be operatingproperly; other causative mechanisms (e.g., pressure

necrosis) must then be considered. Lesions resulting fromexposure to radiant warmers are commonly caused by op-erator error, device malfunction, or poor device design.With both blankets and warmers, it is important to inspectthe units in all possible operating modes, both with andwithout the actual temperature probe used on the patientplugged into the machine. Primary and redundant thermo-stat failure, misadjustment, or faulty calibration may notbe discovered except under very specific, abnormal oper-ating conditions.

In addition to general information on the use of theequipment, the team should review cleaning and steriliza-tion procedures for the hypo/hyperthermia blanket. Itshould also review the placement of the temperature probeon the patient. A blanket that has been sterilized with EtOand not aerated adequately can cause a chemical lesionduring prolonged contact.

Manipulation or repositioning of the patient after inser-tion or placement of the temperature probe (rectal, esopha-geal, or skin) can dislodge the probe. Depending on theoperating mode, this may cause a hypo/hyperthermia unitto heat even though it was set to cool the patient. A dis-lodged probe on a radiant warmer can cause it to con-stantly heat, even if it was set to cycle on and off.

Blanket and solution warming cabinets. Warming cab-inets are used to heat blankets and solutions (e.g., for sur-gical irrigation, for intravenous infusions) for patientcomfort. Warmed blankets are often placed on patients tomake them feel more comfortable in cool ambient temper-atures or when sedation or anesthesia has disturbed thebody’s thermal regulation. Warmed solutions are used toprevent hypothermia caused by infusion of lower-tempera-ture liquids into a patient’s body. Most warming cabinetshave separate compartments and temperature settings forblankets and solutions.

In response to customer demands, suppliers have de-signed some cabinets so that they can be set to a widerange of temperatures. Unfortunately, this allows the cabi-nets to heat blankets and solutions to temperatures that cancause contact burns to patients’ skin.

Patients have received burns during surgery becausewarmed blankets or solutions were too hot. Such thermalinjuries typically occur with patients who are unconsciousor who have been given regional (e.g., spinal) anesthesiaand are therefore insensate to temperature. Many incidentshave involved solution containers (e.g., IV bags) that havebeen heated to unsafe temperatures and then used as posi-tioning aids during surgery or as “hot water bottles” to


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provide local heat. In other incidents, overheated solutionshave been used for surgical irrigation, causing severe in-ternal injury. And blankets that have been excessivelyheated and placed on or under the patient have causedburns; in some cases, the blankets were folded in layers.

➤ For more information on preventing burns from over-heated solutions and blankets, see the Hazard Report onpage 168 of the May 2005 Health Devices.

Endoscopes and accessories. Endoscopes (e.g., laparo-scopes) and their accessories, such as trocars and sleeves,are frequently used in combination with electrosurgery.The use of monopolar electrosurgery during minimally in-vasive procedures, such as laparoscopy, introduces risksthat are not typically encountered during open procedures.For example:

■ Current can become concentrated within narrow inter-nal pathways, leading to excessive heating of internalstructures.

■ Contact between an activated electrode tip and otherconductive instruments within the patient can causethose instruments to become energized, possibly lead-ing to a burn.

■ Stray electrosurgical energy (leakage current) from theshaft of the active electrode can pass through gaps inthe insulating material or across the intact insulation bymeans of capacitance to other instruments or internaltissues.

Any of these events can create burns within the body,and some of these burns, such as those that lead to bowelperforations, can be fatal. Laparoscopic electrosurgicalhandpieces should be inspected for any damage or deterio-ration of the insulation from repeated sterilization orphysical abuse.

➤ For more information about managing burn risks dur-ing laparoscopic electrosurgical procedures, see “SafetyTechnologies for Laparoscopic Monopolar Electrosur-gery” in the August 2005 Health Devices.

Another issue to consider with endoscopes is the use ofhigh-powered light sources, which generate a significantamount of heat and can lead to burn hazards such as thefollowing:

■ Burns from the light itself. For example, when thefiberoptic cable is disconnected from the light source,the beam of light freely streaming from the light sourcecan generate enough heat to burn objects in close range,or even start a fire.

■ Burns from heat conducted to metal connectors on thecable. This can happen if the size of the light cable ispoorly matched with the instrument’s light post and/orthe receptacle on the light source or if too many of thecable’s fibers are broken and thus won’t carry light.The generated heat has to go somewhere, and usually itis transferred to the metal connectors. While the result-ing heat isn’t typically enough to start a fire, it can defi-nitely cause serious burns to patients and operators.

The investigation team should determine whether thelight cable was removed from the light source or whetherthe instrument (e.g., laparoscope) was removed from thelight cable while the light source was still turned on. Theteam should further note the placement of the light sourceand light cable in relation to the patient. Light cablesshould be inspected to make sure that they are appropri-ately matched to the light source and that there is not anexcessive number of broken fibers in the cable.

➤ For more information on preventing burns and firescaused by high-powered light sources, refer to the HazardReport on page 325 of the September 2005 Health Devices.

Pulse oximeters. Burns and other skin injuries havebeen associated with the use of pulse oximeters. Pulseoximeters are used during most surgical procedures,including electrosurgery, and pulse oximeter probeshave provided alternate pathways for electrosurgical cur-rents. Also, skin injuries have occurred at pulse oximeterprobe sites from pressure necrosis, and mismatchingof pulse oximeter probes and monitors has resulted inexcessive heating of the probe LEDs. Burns have alsooccurred during magnetic resonance imaging (MRI)procedures.

If pulse oximeter involvement is suspected, carefullyinspect the probe and its cabling, note the location of theprobe and how the cable was draped, and note whether theprobe site was changed during the procedure. Becausepulse oximeter and probe compatibility is a potential causeof injury, note whether the probe was used with the appro-priate pulse oximeter monitor.


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Accidental Skin InjuryInvestigation Questionnaire

Date of Interview: _______________________________________________________________________

Interviewee:

Name ____________________________________________________________________________________

Title/department____________________________________________________________________________

Job function during incident __________________________________________________________________

Interviewer:

Name ____________________________________________________________________________________

Department________________________________________________________________________________

A. Baseline Patient Information

1. Name __________________________________________________________________________________

2. Hospital ID No. __________________________________________________________________________

3. Sex ____________________________________________________________________________________

4. Age ____________________________________

5. Race ___________________________________

6. Skin color and skin description (e.g., mottled)

__________________________________________

__________________________________________

__________________________________________

7. Weight _________________________________

8. Diagnosis _______________________________

__________________________________________

__________________________________________

9. Known allergies __________________________

__________________________________________

10. Known circulatory problems _______________

__________________________________________

Instructions

Record the baseline patient information (Section A) andbaseline equipment information (Section B). Note that Sec-tion B will need to be completed for each involved device,including disposables; thus, it may be necessary to makemultiple copies of that page.

Make a separate copy of the partially completed question-naire for each person who is to be interviewed.

Record the answers to all relevant questions in the remain-ing sections. Attach additional sheets, if needed; be sure torecord the interviewee’s name and your name on all at-tached sheets.

File the completed questionnaires with the incident report.The questionnaires should not be filed with the patient’srecord.

Source. This form was developed by ECRI. A detailed dis-cussion of how to use this questionnaire is included in theDecember 2005 issue of ECRI’s monthly journal HealthDevices. ◆


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B. Baseline Equipment InformationCopy this page and record the following information for each involved device (including disposables). Attach allcompleted copies to the questionnaire.

* Members can search ECRI’s Health Devices Alerts database for Action Items and other information about device hazards and recalls. To accessthis database, visit www.ecri.org, log in as a member, go to your membership home page, and select the Health Devices Alerts option.

1. Device type __________________________

2. Manufacturer _________________________

3. Model ______________________________

4. Serial and/or Lot No.___________________

5. Hospital Equipment Control No.__________

6. Expiration date or “use before” date ___________________________________________

7. “Last” and “due” inspection dates_____________________________________________

8. Any outstanding recalls or Action Itemsregarding this device* ______________________________________________________

9. If reusable, method of sterilization orcleaning _____________________________

10. For endoscopes and endoscopic instruments,also record the following:

a. Generic type (e.g., laparoscope orlaparoscopic forceps, resectoscope,colonoscope) _______________________

b. Endoscope type

i. Operating or diagnostic (circle one)

ii. Direct viewing or video (circle oneor both)

c. Trocar sleeve type—metal, plastic,other________________________________________________________________

d. Light source and fiberoptic cableused ________________________________________________________________

e. Special connectors oradapters _____________________________________________________________

1. Device type __________________________

2. Manufacturer _________________________

3. Model ______________________________

4. Serial and/or Lot No.___________________

5. Hospital Equipment Control No.__________

6. Expiration date or “use before” date ___________________________________________

7. “Last” and “due” inspection dates_____________________________________________

8. Any outstanding recalls or Action Itemsregarding this device* ______________________________________________________

9. If reusable, method of sterilization orcleaning _____________________________

10. For endoscopes and endoscopic instruments,also record the following:

a. Generic type (e.g., laparoscope orlaparoscopic forceps, resectoscope,colonoscope) _______________________

b. Endoscope type

i. Operating or diagnostic (circle one)

ii. Direct viewing or video (circle oneor both)

c. Trocar sleeve type—metal, plastic,other________________________________________________________________

d. Light source and fiberoptic cableused ________________________________________________________________

e. Special connectors oradapters _____________________________________________________________


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C. The Surgical Procedure

1. Procedure ________________________________________________________________________________

2. Date performed and OR No. _________________________________________________________________

3. Time duration_____________________________________________________________________________

4. How many procedures of this type are performed per month? _______________________________________

5. Was this an elective or emergency procedure? ___________________________________________________________________________________________________________________________________________

6. Who was present during the procedure? ________________________________________________________________________________________________________________________________________________

7. Who performed the following tasks? When?

a. Applied degreasing and prepping agents _____________________________________________________

b. Applied ESU dispersive electrode ___________________________________________________________

c. Applied surgical drapes ___________________________________________________________________

d. Inserted hypo/hyperthermia temperature probe ________________________________________________

e. Set up ESU and connected cables ___________________________________________________________

f. Set up endoscope and accessories ___________________________________________________________

g. Applied any other electrodes, temperature probes, etc. __________________________________________

8. Was a skin check performed before the procedure? By whom? Results? _______________________________________________________________________________________________________________________

9. Was the patient wearing jewelry or any other items during the procedure? _____________________________

10. What degreasers, prepping agents, and ointments were used?________________________________________________________________________________________________________________________________

11. How were they applied to the patient? Were they poured onto the skin? _______________________________________________________________________________________________________________________

12. Was there pooling of fluids beneath the patient? __________________________________________________

13. Were prepping agents dry before draping? ______________________________________________________

14. What was the patient’s initial position on the operating table? For how long? ___________________________________________________________________________________________________________________

15. In what position(s) was the patient placed for surgery? For recovery? _________________________________________________________________________________________________________________________

16. Were any changes made in the patient’s position during surgery? Describe. ____________________________________________________________________________________________________________________


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17. What types of restraint straps or positioning pads were used to position the patient?Describe their location. _____________________________________________________________________________________________________________________________________________________________

18. What, if anything, occurred during the procedure that was out of the ordinary? Any alarms or unusual noises?

________________________________________________________________________________________

________________________________________________________________________________________

19. How well does the user understand the equipment controls, functions, and safety features? ________________________________________________________________________________________________________

D. The Injury1. Mark on the anatomical drawing the position and shape of the following items:

a. Skin injuries

b. ESU dispersive electrode

c. ECG electrodes and cables

d. Extent of prepping

e. Incision (or site of active electrode)

f. Restraint straps

g. Patient/metal contacts

h. Conductive masks and tubing

2. When and where was the lesion noticed(e.g., during surgery, postop, or recov-ery; in the patient’s room)?By whom? ___________________________________________________________________________________________________________________

3. Did the lesion correspond to the positionof an electrode, a cable, or patient/metalcontacts?_______________________________________________________

4. Does the patient have any metal implants (e.g., hip, knee)? __________________________________________

5. Sketch the shape of the lesion in the space provided.


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6. Give the dimensions. _______________________________________________________________________

7. Extent: Full or partial thickness? First degree? Second? Third? ______________________________________

8. Describe lesion tissue color, texture, size, and location when first noticedand as healing progressed. ___________________________________________________________________________________________________________________________________________________________

9. Were photographs taken? Record the dates and times, and note the scale. ______________________________________________________________________________________________________________________

10. Were skin or tissue specimens from the injury retained? Pathology findings? ___________________________________________________________________________________________________________________________________________________________________________________________________________

11. Describe the treatment and medication applied to the injury. ________________________________________________________________________________________________________________________________________________________________________________________________________________________

12. Did infection of the lesion occur? How soon? ____________________________________________________________________________________________________________________________________________

13. Comments by patient regarding the level of pain at the injury site. ___________________________________________________________________________________________________________________________

E. The Equipment1. Sketch the positions of equipment, cables, and leads relative to the patient. Do this for operative, recovery room,

and general care settings, as appropriate. Use separate sheets if needed, and attach them to the questionnaire. Ifknown, indicate where equipment was plugged in and the relative distance from the patient and otherequipment.

2. Describe the condition of all cables, leads, and connectors. _________________________________________________________________________________________________________________________________________________________________________________________________________________________

3. Document all switch, control, and indicator settings on all devices used. Were these settings typicalfor the procedure? _________________________________________________________________________________________________________________________________________________________________

4. If a device that was EtO sterilized was touching the lesion, how was the device aerated? __________________________________________________________________________________________________________

5. Who had contact with the suspect equipment after the incident? _____________________________________________________________________________________________________________________________

6. Were any inspections or repairs performed? Results? ______________________________________________________________________________________________________________________________________


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7. Have there been any recent malfunctions of devices used in this procedure or similar procedures?Does the injury possibly relate to device malfunctions recently experienced? Were there anymalfunctions during the procedure? (Review equipment service records for possible information.) __________________________________________________________________________________________________________________________________________________________________________________________

8. Was the packaging from suspect disposables saved? ______________________________________________

9. Electrosurgery

a. Determine the following:

i. What was the mode of operation (cut, coag, blend, bipolar)? ___________________________________

ii. What were the control settings for each mode? ________________________________________________________________________________________________________________________________

iii. What electrode adapters were used? _________________________________________________________________________________________________________________________________________

iv. Does the ESU have a ground-referenced or isolated output? ___________________________________

v. Does the ESU have a return-electrode contact-quality monitor(e.g., return electrode monitor)? If so, was it used? _____________________________________________________________________________________________________________________________

b. Was the condition of the ESU cables and connectors checked before surgery? ________________________

c. Was electrosurgery effective at normal settings? _______________________________________________

d. Were ESU settings changed during the procedure? To what? When?Why? By whom? ______________________________________________________________________________________________________________________________________________________________

e. Describe the condition of dispersive and active ESU electrodes after the procedure.Discolored? Charred? Evidence of fluid contact? _____________________________________________________________________________________________________________________________________

10. ESU Dispersive Electrode

a. Describe the gel condition before and after use. Dry to touch? Viscous or runny? Color? Odor? ________________________________________________________________________________________________

b. When was the dispersive electrode package opened? ____________________________________________

c. At the time of removal, was the entire electrode surface in contact with the patient? __________________________________________________________________________________________________________

d. Were there separations or discontinuities in the foil substrate? __________________________________________________________________________________________________________________________

e. Was the electrode checked for proper placement after patient repositioning or checked atany other time during the procedure? ______________________________________________________________________________________________________________________________________________

f. Did anyone lean on the dispersive electrode or put tension on the associated cable during theprocedure? ___________________________________________________________________________________________________________________________________________________________________

g. If injury occurred beneath the dispersive electrode, was the electrode saved? _________________________


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11. ESU Active Electrode

a. Where was the active electrode placed when not in use during the procedure? Was it placed in asafety holster? ________________________________________________________________________________________________________________________________________________________________

b. Was the active cable draped next to any other cables, leads, or conductive tubingor across the patient? Was it clamped to the drapes? How? _____________________________________________________________________________________________________________________________

12. Hypo/Hyperthermia Units and Radiant Warmers

a. Record the following:

i. Placement of temperature probes (rectal, esophageal, skin) _______________________________________________________________________________________________________________________

ii. Times unit was turned on and off ___________________________________________________________________________________________________________________________________________

iii. Set temperatures and times ________________________________________________________________________________________________________________________________________________

iv. Mode of operation (manual, automatic, warm-up) ___________________________________________

b. Was the temperature of the unit routinely checked? How? Results? ______________________________________________________________________________________________________________________

c. Was the patient’s temperature routinely checked? How? Results? ________________________________________________________________________________________________________________________

d. Describe the cleaning/sterilization procedure for the hypo/hyperthermia blanket. ___________________________________________________________________________________________________________

13. Blanket and Solution Warming Cabinets

a. Were blankets that were warmed in a warming cabinet placed on the patient? Where were they placed? __________________________________________________________________________________________

b. Were irrigation solution bags taken from a warming cabinet and placed on or under the patient?Where were they placed? _______________________________________________________________________________________________________________________________________________________

c. What was the set temperature on the warming cabinet for both the blanket and the solution chambers?Was it above 110°F? _____________________________________________________________________

14. Endoscopes and Accessories

a. Is there visible damage to or deterioration of the insulation of the electrosurgical handpiece? __________________________________________________________________________________________________

b. Describe the method of cleaning and sterilization of the endoscope and its accessories. _______________________________________________________________________________________________________

c. Is the fiberoptic cable appropriately matched to the light source? __________________________________

d. Are there damaged fibers within the fiberoptic cable? ___________________________________________

e. Was the fiberoptic cable or endoscope removed while the light source was still powered on? __________________________________________________________________________________________________

f. Note the placement of the light source and fiberoptic cable in relation to the patient. _________________________________________________________________________________________________________


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15. Pulse Oximeters

a. Describe the condition of the pulse oximeter probe and cable. ___________________________________________________________________________________________________________________________

b. Was the probe used with the correct pulse oximeter? ____________________________________________

c. Was the probe moved during the procedure? __________________________________________________

16. Other Equipment

a. Could other equipment have contributed to the problem? Describe. ______________________________________________________________________________________________________________________

b. Were difficulties experienced with other devices used? Describe. ________________________________________________________________________________________________________________________

F. Summary (Interviewee)1. Other comments?

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

2. Given your observations, how do you think the injury occurred?

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

G. Summary (Interviewer)1. Highlight salient points gained from the interview.

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

Selected Bibliography

A full bibliography is available upon request; for details,contact the Health Devices Group at [email protected].

ECRI CitationsThe following Health Devices articles, listed in reversechronological order, relate to skin injury in the surgical orintensive care setting:

Preventing burns and fires caused by high-powered light sources [hazardreport]. Health Devices 2005 Sep;34(9):325-6.

Safety technologies for laparoscopic monopolar electrosurgery: devicesfor managing burn risks [evaluation]. Health Devices 2005Aug;34(8):259-72.

Higher currents, greater risks: preventing patient burns at the return-elec-trode site during high-current electrosurgical procedures. Health De-vices 2005 Aug;34(8):273-9.

Return-electrode-site burns associated with Rita Medical Systems Model1500 and 1500X radio-frequency generators [hazard report]. HealthDevices 2005 Aug;34(8):280-2.

Skin burns resulting from the use of conductive distention/irrigation me-dia during electrosurgery with a rollerablation electrode [hazard re-port]. Health Devices 2005 Aug;34(8):283-4.

Improper return-electrode selection and placement contribute to patientburn with the Smith & Nephew Vulcan ElectroThermal ArthroscopySystem (EAS) [hazard report]. Health Devices 2005 Aug;34(8):284-6.

Improperly connected cord leads to patient burns on Advanced SurfacesCool/Heat mattresses [hazard report]. Health Devices 2005 Jun;34(6):219-20.

Limiting temperature settings on blanket and solution warming cabinetscan prevent patient burns [hazard report]. Health Devices 2005May;34(5):168-71.

Overheating relays in Mallinckrodt WarmTouch patient warmers couldcause patient burns or surgical fires [hazard report]. Health Devices2004 Nov;33(11):409-10.

Heating of a cerebral oximeter’s in-line amplifier illustrates that hot elec-tronics in bed can burn patients [hazard report]. Health Devices 2004Oct;33(10):371-2.

Common flashlights can cause burns when used for transillumination[hazard report]. Health Devices 2003 Jul;32(7):273-4.

Exposed connections in pulse oximeter sensors can cause electrochemicalburns [hazard report]. Health Devices 2001 Dec;30(12):456-7.

Alternate-site burns from improperly seated electrosurgical pencil activeelectrodes [hazard report]. Health Devices 2000 Jan;29(1):24-7.

Misusing forced-air hyperthermia units can burn patients [hazard report].Health Devices 1999 May-Jun;28(5-6):229-30.

Minimizing the risk of skin burns when using disposable defibrillation/pacing electrodes [User Experience NetworkTM]. Health Devices1999 Apr;28(4):169, 171.

Lesions and shocks during iontophoresis [hazard report]. Health Devices1997 Mar;26(3):123-5.

Scleral and corneal burns during phacoemulsification [hazard update].Health Devices 1996 Nov;25(11):426-31.

Are spark-gap electrosurgical units safe to use? [User ExperienceNetworkTM]. Health Devices 1995 Jul;24(7):293.

The risks of laparoscopic electrosurgery [clinical perspective]. Health De-vices 1995 Jan;24(1):4.

Misconnection of bipolar electrosurgical electrodes [hazard report].Health Devices 1995 Jan;24(1):34-5.

Patient burn caused by excessive illumination during surgical microscopy[hazard report]. Health Devices 1994 Aug-Sep;23(8-9):372-3.

Risk of electrosurgical burns at needle electrode sites [hazard report].Health Devices 1994 Aug-Sep;23(8-9):373-4.

Burns and fires from electrosurgical active electrodes [hazard update].Health Devices 1993 Aug-Sep;22(8-9):421-2.

ESU burns from poor dispersive electrode site preparation [hazard up-date]. Health Devices 1993 Aug-Sep;22(8-9):422-3.

Thermal injuries and patient monitoring during MRI studies [hazard re-port]. Health Devices 1991 Sep;20(9):362-3.

Controlling the risks of electrosurgery [risk analysis]. Health Devices1989 Dec;18(12):430-6.

Hypo/hyperthermia machines [evaluation]. Health Devices 1988Nov;17(11):320-33.

Electrosurgical units [evaluation]. Health Devices 1987 Sep-Oct;16(9-10):323-34.

Skin injury in the OR and elsewhere [hazard report]. Health Devices 1980Oct;9(12):312-7.

Citations from OtherPublicationsThe following articles are listed in alphabetical order byauthor:Andersen K. Safe use of lasers in the operating room: what perioperative

nurses should know. AORN J 2004 Jan;79(1):171-88. Review.

Association of periOperative Registered Nurses. Recommended PracticesCommittee. Recommended practices for electrosurgery. AORN J2005 Mar;81(3):616-8, 621-6, 629-32.

Becker CM, Malhotra IV, Hedley-Whyte J. The distribution of radiofre-quency current and burns. Anesthesiology 1973 Feb;38(2):106-21.

Britt BA, Joy N, Mackay MB. Positioning trauma. In: Orkin FK,Cooperman LH, eds. Complications in anesthesiology. Philadelphia:J.B. Lippincott; 1983:646-70.

Bruley ME. Accident and forensic investigation. In: van Gruting CWD,ed. Medical devices: international perspectives on health and safety.Amsterdam: Elsevier; 1994.

Does alcohol interfere with the effect of the iodophor? (The expertsresearch: Q & A). AORN J 1982 Mar;35:646.

Doyle JE. All leg ulcers are not alike: managing and preventing arterialand venous ulcers. Nursing 1983 Jan;13(1):58-63.

Faraci PA, Deterling RA Jr, Stein AM, et al. Warfarin induced necrosis ofthe skin. Surg Gynecol Obstet 1978 May;146(5):695-700.


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Foster CG, Mukai G, Breckenridge JF, et al. Effects of surgical position-ing. AORN J 1979 Aug;30(2):219-32.

Gale P, Adeyemi B, Ferrer K, et al. Histologic characteristics of laparo-scopic argon beam coagulation. J Am Assoc Gynecol Laparosc 1998Feb;5(1):19-22.

Geddes LA. Handbook of electrical hazards and accidents. Boca Raton(FL): CRC Press; 1995.

Gendron FG. “Burns” occurring during lengthy surgical procedures.J Clin Eng 1980 Jan-Mar;5(1):19-26.

Gillette MK, Caruso CC. Intraoperative tissue injury: major causes andpreventive measures. AORN J 1989 Jul;50(1):66-78.

Gozal D, Ziser A, Shupak A, et al. Necrotizing fasciitis. Arch Surg 1986Feb;121(2):233-5.

Jacob JR, Weisman MH, Rosenblatt SI, et al. Chronic pernio: a historicalperspective of cold-induced vascular disease. Arch Intern Med 1986Aug;146(8):1589-92.

Jelenko C 3rd, Wheeler ML. Production of the experimental burn—a crit-ical technical evaluation. J Surg Res 1969 Mar;9(3):159-65.

Katcher ML. Scald burns from hot tap water. JAMA 1981 Sep;246(11):1219-22.

Keatinge WR, Cannon P. Freezing-point of human skin. Lancet 1960 Jan2;1:11-4.

Kempczinski RF. Lower-extremity arterial emboli from ulceratingatherosclerotic plaques. JAMA 1979 Feb;241(8):807-10.

Kosiak M. Etiology of decubitus ulcers. Arch Phys Med Rehabil 1961Jan;42:19-29.

Leeming MN, Ray C, Howland WS. Low-voltage, direct-current burns.JAMA 1970 Nov 30;214(9):1681-4.

Morgan-Hughes J, Bray RA. Iodine and acetone-containing plastic spraydressings. Br Med J 1978 Aug 26;2(6137):639.

Moritz AR, Henriques FC. Studies of thermal injury, II: the relative im-portance of time and surface temperature in the causation of cutane-ous burns. Am J Pathol 1947;23:695-720.

Okun MR, Edelstein LM, Fisher BK. Gross and microscopic pathology ofthe skin. Canton (MA): Dermatopathology Foundation Press; 1988.

Phippen ML. OR nurse’s guide to preventing pressure sores. AORN J1982 Aug;36(2):205-12.

Schanzer H, Jacobson JH 2nd. Tissue damage caused by the intramuscu-lar injection of long-acting penicillin. Pediatrics 1985 Apr;75(4):741-4.

Schultz A, Bien M, Dumond K, et al. Etiology and incidence of pressureulcers in surgical patients. AORN J 1999 Sep;70(3):434, 437-40,443-9.

Shroff AP, Jones JK. Reactions to povidone-iodine preparation. JAMA1980 Jan 18;243(3):230-1.

Stoll AM, Greene LC. Relationship between pain and tissue damage dueto thermal radiation. J Appl Physiol 1959 May;14(3):373-82.

Tucker RD, Platz CE, Landas SK. Histologic characteristics ofelectrosurgical injuries. J Am Assoc Gynecol Laparosc 1997Feb;4(2):201-6.

Tulikangas PK, Smith T, Falcone T, et al. Gross and histologic character-istics of laparoscopic injuries with four different energy sources.Fertil Steril 2001 Apr;75(4):806-10.

Vermillion C. Operating room acquired pressure ulcers. Decubitus 1990Feb;3(1):26-30. ◆


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ECRI Reprint Policy

All material in ECRI publications is protected by copyrightlaw. Readers may not copy, resell, or quote this material inpromotional literature.

ECRI does make reprints of individual articles or com-plete publications available for educational purposes. Forfurther information, contact the Communications Depart-ment by phone at +1 (610) 825-6000, ext. 5888, or throughe-mail at [email protected].


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Electrosurgical SafetyConducting a Safety Audit

UMDNS terms. Electrosurgical Units [11-490] ■ Electrosurgical Units,Monopolar [18-229] ■ Electrodes, Electrosurgical, Active [16-860] ■ Electrodes,Electrosurgical, Return [11-500] ■ Radiofrequency Therapy Systems [18-800]

Summary. ECRI detailed some of the lesser-known risks of electrosurgery ina collection of articles published in the August 2005 Health Devices. However,it’s also important to recognize that even hazards that are well understood byclinical personnel can lead to injury if appropriate safety measures aren’t appliedconsistently.

In this follow-up to our August 2005 articles, we offer guidance to helphealthcare facilities conduct a safety audit that examines critical aspects of thefacility’s use of electrosurgical technology. ECRI recommends that healthcarefacilities periodically conduct such an audit to ensure that the appropriate equip-ment and procedures are in place to protect patients and staff from injury. Thisarticle reviews some of the key questions to ask during a safety audit, and itincludes detailed guidance for developing an electrosurgical safety checklist.

10 Key Questions to Ask during anElectrosurgical Safety Audit

To help healthcare facilities conduct an effective audit,we examine below the critical safety measures that facili-ties should take to avoid some of the most commonelectrosurgery-related adverse incidents. While most ofthese measures are basic, ECRI has found that too oftenthey are misunderstood, forgotten, or ignored. In addition,some users may be unfamiliar with the special risks asso-ciated with laparoscopic monopolar electrosurgery andhigh-current, long-duration activations (e.g., as used fortissue ablation).

The audit might be conducted by members of a safetycommittee; by clinical engineering, risk management, orsurgical staff; or by some combination of personnel fromthese groups. Periodic reexamination of the issues coveredin the safety audit is advised.

1. Are safe practices emphasized in user training andreinforced in daily practice?

The safety of electrosurgery depends largely on cliniciansand their adherence to good practices. Ensuring that surgi-cal staff members are properly trained in these practiceswill significantly improve safety.

Verify that user training covers the following (many ofthese topics are described in subsequent items):

■ The operating principles of electrosurgical units(ESUs), including devices used for argon-enhancedelectrosurgery (where relevant)

■ The causes of return-electrode-site, active-electrode-site, and alternate-site injuries and the preventive mea-sures that can be taken to minimize associated risks

■ Fire safety

■ Surgical smoke evacuation

■ The unique causes of injuries during laparoscopicelectrosurgery and high-current ablation and the preven-tive measures that can be taken to minimize the risks

2. Have you developed an electrosurgical safetychecklist to reinforce safe practices?

Using a checklist will reinforce safe practices by remind-ing clinical staff of each safety step while they are prepar-ing for or performing electrosurgery. In the next section,Developing an Electrosurgical Safety Checklist, we pres-ent a starter list with safety practices that you can use to

create a checklist that addresses your facility’s specificneeds.

3. Is RECQM technology used to prevent return-electrode-site injuries?

Return-electrode contact-quality monitor (RECQM) tech-nology has proven to be an effective tool for helping toprevent patient burns at the site of the return electrode dur-ing most electrosurgical procedures.

Ensure that RECQM capability is provided on allgeneral-purpose ESUs in your inventory. In addition, youshould verify that dual-foil return electrodes, which areneeded to enable contact-quality monitoring, are availableand are being used. (Note that RECQM is unnecessarywhen large-area capacitive return electrodes are used in-stead of adhesive return electrodes. For a discussion, referto the December 2000 Health Devices Evaluation of theMegadyne Mega 2000 Return Electrode.)

4. Are safeguards in place and followed to protectagainst active-electrode-site injuries?

For all ESUs in your inventory, verify, at minimum, thatvisual activation indicators illuminate and that audible ac-tivation indicators are clearly audible. Also ensure thatduring surgical procedures, all active electrodes are insafety holsters (see the photos on the bottom of page 419)or otherwise placed safely away from the surgical fieldand patient when they are not in active use.

5. Are reusable accessories replaced on time?

If your hospital employs reusable cables or active elec-trodes, ensure that a replacement policy has been estab-lished and is followed for these accessories to minimizethe risk of failure during use. Internal failure of a cable’sconductor may cause sparking and fires, and employingreusable active electrodes until they fail may result inpatient injury (e.g., tonsillectomy burns inside apatient’s mouth).

Because cable and electrode failures are not easilydetected by normal inspections, ECRI recommends peri-odically replacing these reusable accessories. If the equip-ment manufacturer does not publish a recommendedreplacement schedule, consider replacing the devices afterone year of use.


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6. Is surgical smoke evacuated to ensure safety andcomfort?

Ensure that a policy is established and followed regardingsurgical smoke evacuation. ECRI recommends that, atminimum, surgical smoke be evacuated in the followingcircumstances: (1) when tissue is being ablated in patientsinfected with human papillomavirus (HPV), (2) whenthere is expected to be enough smoke to obscure visionand therefore diminish staff performance, or (3) whensmoke causes staff discomfort. For more information, referto “Should You Evacuate Surgical Smoke?” in the March2001 Health Devices. More detailed discussions can alsobe found in the following articles: “Technology Manage-ment Guide: Clearing the Air—Should Surgical Smoke BeEvacuated?” (Health Devices April 1997) and “Should

Surgical Smoke Be Evacuated? (Revisited)” (HealthDevices September 1999).

7. Is equipment standardization used to minimizeuser error?

Determine your facility’s level of standardization regard-ing ESUs and accessories, and then consider whether yourpurchasing practices need to be altered to increase equip-ment standardization. A lack of standardization increasesthe chance of error during the use of these devices. If yourfacility uses multiple product models for the same proce-dures, provide adequate training to ensure correct use ofeach model.

8. Are policies in place and followed to prevent surgi-cal fires?

Ensure that safe practices are followed and that preventivemeasures are implemented to minimize surgical fires. Al-though surgical fires—fires on or in the surgical patient—are rare, they do occur, and their consequences can bedevastating. ECRI’s investigations and research show thatelectrosurgical equipment is a common ignition source inthese fires.

Key preventive measures include minimizing the risksassociated with oxygen and nitrous oxide enrichment nearthe surgical site, especially in head and neck surgery, andnot draping the patient until all flammable prepping agentshave fully dried. Also, keep a 5 lb carbon dioxide fire ex-tinguisher in every room used for electrosurgery. Refer tothe January 2003 Health Devices for more information onsurgical fire safety. Health Devices will publish updatedguidance on this topic in 2006.

9. Are policies in place and followed to minimize thespecial risks during laparoscopic monopolarelectrosurgery?

Ensure that policies are in place and followed to minimizethe special risks associated with the use of monopolarelectrosurgery during minimally invasive procedures, suchas laparoscopy. Some of the resulting burns may lead tobowel perforations, which can be fatal.

For instance, during such procedures, electrical cur-rent can become concentrated within narrow internalpathways, leading to excessive heating of internal struc-tures. Also, contact between an activated electrode tipand other conductive instruments within the patient cancause those instruments to become energized, possiblyleading to a burn.

Consider whether any technology solutions should beused to minimize the risks of stray electrosurgical energy

For More Information onElectrosurgical Safety

ECRI dedicated the August 2005 issue of HealthDevices to special topics in electrosurgical safety,focusing on the particular hazards associated withlaparoscopic monopolar electrosurgery and proce-dures—such as tissue ablation—that require high-current, long-duration electrosurgical unit activations.

Steps that all hospitals should be following tominimize risks associated with laparoscopic proce-dures are described in the supplementary article“General Risks and Protective Measures during Lap-aroscopic Monopolar Electrosurgery.” In addition toenacting the measures discussed in that article, somefacilities may wish to implement the supplementalprotection that can be offered by active-electrodeshielding and some other technologies. In the Evalu-ation “Safety Technologies for LaparoscopicMonopolar Electrosurgery,” we review four productsdesigned to reduce the risk of leakage-current burnsduring laparoscopic monopolar electrosurgery.

In the Guidance Article “Higher Currents,Greater Risks,” we detail the hazards associated withhigh-current, long-activation-time electrosurgicalprocedures and describe the factors that can increasethe risks of return-electrode-site skin injuries for agiven procedure. We also provide recommendationsto help healthcare facilities and clinicians minimizethose risks. ◆


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(leakage current) from the shaft of the active electrodepassing through gaps in the insulating material or acrossthe intact insulation by means of capacitance to otherinstruments or internal tissues. ECRI discussed this topicin detail in the August 2005 Health Devices. (See the inseton page 416 for more information.)

10. Are policies in place and followed to minimizethe special risks associated with tumor ablation andother high-current ESU procedures?

During high-current, long-duration activations, a singleconventional return electrode may be inadequate to safelydisperse high currents; consequently, a patient may beburned at the site of the return electrode. Ensure that clini-cians are aware of this often unrecognized electrosurgicalhazard—which has developed as a result of newer tech-niques that require the continuous application of high cur-rent for a prolonged period of time—and verify thatappropriate practices are followed to minimize the

associated risks. For example, some generator manufactur-ers recommend that for high-current procedures, facilitiesuse either multiple return electrodes or return electrodesthat are no smaller than a specified size.

A specialty electrosurgical generator may increasethe risk of injury if it does not offer RECQM, return-electrode-fault monitoring, or other measures to minimizethe possibility of return-electrode-site burns. In addition,the likelihood of overwhelming the return electrode canincrease if a conductive solution—such as saline or lactatedRinger’s solution—is used as a distention/irrigationmedium. Such solutions can conduct and disperse electro-surgical current away from the surgical site, causing a lossof surgical effect that can lead an operator to increase thepower settings of the ESU. Conductive solutions also lowerelectrical impedance at the active electrode, which furtherelevates current. ECRI also addressed these topics in theAugust 2005 issue. (See the inset on page 416.)

Developing an Electrosurgical Safety Checklist

The information presented below can be used as a guidefor developing a checklist that clinical staff will employ toensure that safe practices are followed before, during, andafter electrosurgical procedures. This is designed as astarter list; facilities should modify or add to it as appropri-ate to meet their particular needs.

Preoperative Precautions andProcedures

1. ESU condition

1.1 Examine the electrosurgical unit (ESU) and itsaccessories for defects. Do not use cables or ac-cessories with damaged (e.g., cracked, burned,taped) insulation or connectors.

1.2 When the ESU goes through its self-test modeafter being powered on, or when it is first acti-vated during surgery, do the following:

1.2.1 Verify that the audible activation tone isloud enough to be heard over other noisesin the operating room.

1.2.2 Verify that the visual activation indicatorilluminates.

1.3 Before connecting the return electrode, verifythat the unit will not activate and that it soundsan alarm if a user attempts to activate the unitwhile the return electrode is disconnected.

1.4 Verify operation of any additional alarms orsafety features, if applicable.

2. Return-electrode integrity and application*

2.1 Clean, shave (if applicable), and dry the applica-tion site.

2.2 If the ESU incorporates a return-electrodecontact-quality monitor (RECQM), verify thata dual-foil-surface return electrode is being usedto enable contact-quality monitoring. (Notethat an RECQM is unnecessary when large-area

capacitive return electrodes are used instead ofadhesive return electrodes.)

2.3 Confirm that the electrode’s expiration date hasnot passed.

2.4 Before placement, inspect the electrode for anyflaws or damage (e.g., discoloration, areas thatappear dry, lack of tackiness).

2.5 Follow the manufacturer’s recommendations forreturn-electrode application, and ensure that theelectrode is firmly attached to the skin.

2.6 Ensure that the electrode is not applied to aweight-bearing surface (e.g., underneath the pa-tient, on bony prominences).

2.7 Ensure that no sections of the electrode overlap.In particular, verify that no electrode is appliedcircumferentially around a small limb becausethis placement increases the likelihood of anoverlap and might cut off circulation.

2.8 If possible, apply the return electrode so thatone of its long edges (one without the cableconnection) is positioned closest to the surgicalsite.

3. Precautions for patients with a pacemakeror ICD

Take appropriate precautions for patients with pace-makers or implantable cardioverter-defibrillators(ICDs). Follow recommendations from the pace-maker or ICD manufacturer or from your facility’scardiology department. When developing a policy forsuch patients, consider including the following steps:

3.1 Use a safer pacing mode (e.g., fixed-rate single-chamber mode), or deactivate the ICD ifappropriate.

3.2 Ensure that the following are readily available: apacemaker or ICD programmer, external defib-rillator, external pacemaker, and cardiac drugs.

3.3 Ensure that the return electrode is not placednear the pacemaker or ICD.

3.4 Ensure that the return electrode is not placed sothat the pacemaker, ICD, or leads are in the pathof the ESU current.


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* The items in this section apply specifically to the use of adhesive returnelectrodes. Although most of these measures (e.g., the use of an RECQM)are not applicable when large-area capacitive return electrodes are used,appropriate measures, such as checking the position and condition of elec-trodes, should be substituted.


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3.5 Ensure that the return- and active-electrode ca-bles are not placed near the pacemaker, ICD, orleads.

4. Safeguarding against alternate-site injuries

4.1 Eliminate patient contact with grounded objects.

4.2 Ensure that the active electrode is properlyseated in the electrosurgical handpiece. (See thephotos above.)

4.3 If feasible, remove nonvital monitoring elec-trodes (e.g., esophageal probes, rectal probes)from the patient.

4.4 Keep ECG and other monitoring electrodes asfar as possible from the surgical site and fromthe active- and return-electrode cables.

4.5 If possible, do not use needle electrodes formonitoring or other nonelectrosurgical pur-poses. Needle electrodes increase the risk of al-ternate-site burns because stray current can flowthrough the small contact area of the needle,particularly when monopolar delivery is used.The risk cannot always be avoided by discon-necting the monitoring cable at the monitor end.If using needle electrodes is deemed necessary,avoid using monopolar electrosurgery followingneedle placement. Instead, consider using ascalpel, a laser, or bipolar electrosurgery.

5. Drying time for prepping agents

Verify that flammable prepping solutions and tinc-tures (if used) have fully dried before draping the pa-tient or activating the ESU.

6. Use of safety holstersPosition an insulated safety holster (see the photosbelow) for each active electrode; the safety holstersshould be in convenient locations.

7. Sparking the active electrodeEnsure that no one sparks the active electrode toground or to the return electrode to test the ESU. Un-der some circumstances, sparking the active electrodethis way can create a current path that passes througha point where the patient is touching grounded metal;consequently, the patient may be burned at this point.

Intraoperative Precautions andProcedures

8. Minimizing oxygen buildup

8.1 Minimize the buildup of oxygen and nitrous ox-ide beneath drapes and, during oropharyngealsurgery, in the oropharynx.

8.2 Verify that electrosurgery is not used around theopen tracheobronchial tree.

9. Activation and deactivation

9.1 Activate the unit only when ready to deliverelectrosurgical current and only when the activetip is in view. This consideration is especiallyimportant when a surgeon is viewing through amicroscope or endoscope.

9.2 Allow only the user of the active electrode toactivate the device, regardless of the activationmechanism (e.g., footswitch) used.

9.3 Keep the active electrode clean; do not, how-ever, wipe the electrode on drapes.

When active electrodes are not in use, place them insafety holsters. Never rest them on beds or patients.

The picture on the left shows an improperly seatedactive electrode in an electrosurgical handpiece. Thepicture on the right shows proper seating.

9.4 Deactivate the unit before the tip leaves the sur-gical site.

9.5 Place the active electrode in a safety holster whennot in use. (See the photos on the bottom of page419.) When long electrodes (e.g., for endoscopicinstruments) are used, store them at a locationaway from the patient.

10. Power settings

10.1 Use the lowest possible power settings and min-imum activation times necessary to achieve thedesired surgical effect at the target-tissue site.

10.2 When a surgical effect is not evident or is lessthan expected for the surgical circumstance,look for other problems (e.g., confirm adequateplacement of the return electrode, check all ca-ble connections) before increasing the genera-tor’s power setting.

11. Repositioning a patientCheck contact and adherence of the return electrodeeach time the patient is repositioned.

12. Patients with a pacemaker or ICD

12.1 Do not use the active electrode in the immediatevicinity (within approximately 6 in [15 cm]) ofa pacemaker, ICD, or the associated leads.

12.2 When possible, use bipolar electrosurgery or al-ternative methods (scalpel or laser) for patientswith pacemakers or ICDs.

12.3 If monopolar electrosurgery is needed, to theextent possible use short intermittent burstsof activation, which will allow the heart to bepaced between activations in the event of

inhibiting interference; these bursts should be atthe lowest output level needed to achieve thedesired surgical effect.

Documentation andPostoperative Procedures

13. Inspecting the patient

When removing the return electrode, inspect the pa-tient for injuries at the return-electrode site and atother sites (e.g., the sacral area). In virtually all cases,electrosurgical injuries are immediately visiblefollowing a procedure; pressure injuries may notshow up for as long as one or two days following sur-gery, however.

14. Documenting all findings

Ensure that procedure documentation includes:

14.1 The ESU identification number

14.2 The ESU settings used (e.g., monopolar orbipolar, cutting or coagulation)

14.3 The location of the return electrode

14.4 The condition of the skin at the return-electrodesite before and after the procedure

14.5 The use and position of any other equipment(e.g., hypo-/hyperthermia units, temperatureprobes) employed during the procedure, includ-ing identification numbers

15. Saving items associated with an incident

If any problems are noted during or after the proce-dure, save all disposable items and their packages(e.g., so that expiration dates can be confirmed). ◆


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©2005 ECRI. Duplication of this page by any means for any purpose is prohibited. www.ecri.org ■ HEALTH DEVICES December 2005 421

General-Purpose Infusion PumpsBaxter Colleague CX and 3CX Infusion Pumps

Rated NOT RECOMMENDED for Purchase

In the past three years, Health Devices haspublished three Evaluations of general-purposeinfusion pumps equipped with dose error re-duction systems (October 2002, October 2003,and December 2004). In those Evaluations, theBaxter Colleague CX (shown in the photo) and3CX pumps were rated Acceptable.

Since our 2002 Evaluation, however, wehave updated our criteria for dose error re-duction systems to reflect the increasingly sophisticatedcapabilities of such systems.* Unfortunately, the Guard-ian dose error reduction software provided on the Col-league pumps has not kept up with advances in thetechnology, and it no longer compares favorably with thesystems on other general-purpose pumps. Guardian’sprincipal drawbacks are these:

■ Setting up the drug library in the pump is laborious.Drug names, dose units, concentrations, and doselimits must be entered directly on the pump’s keypad(rather than on a laptop computer)—there is no spread-sheet function for listing and reviewing any of thisinformation.

■ The drug library is small, and most of the drugs are pre-assigned by Baxter rather than being programmable bythe user, preventing a facility from tailoring the druglibrary to meet its specific needs.

■ The pump does not default to the dose error reductionsystem on power-up—the user must specifically selectthis function.

■ Drug names cannot be displayed using TALLman let-tering (e.g., DoBUTamine, DOPamine).

■ There is still no dedicated log for storing (1) program-med doses that trigger alerts or (2) the subsequent pro-gramming that activates in response to the alerts by eithersetting a dose that is within limits or enabling a limit“override.” The lack of such logs makes it impossible tomeasure the effectiveness of the dose error reduction sys-tem and to use logged data to improve clinical practice.

Because these pumps no longer meet many of our doseerror reduction criteria, we are changing their rating: They

are now rated Thismeans that, while the pumps’ performanceand safety are adequate, and pumps in in-ventory are still suitable for use, we no lon-ger recommend them for new purchases.There are better choices available.

In addition, while not a direct factor inour rerating of these pumps, the number ofrecalls and other corrective actions affect-

ing these pumps concerns us.** These recalls, which in-clude two U.S. Food and Drug Administration (FDA)Class I recalls—one in February and one in July—later re-sulted in FDA’s seizure of Colleague pumps that Baxterintended to use to replace pumps sent to the company forrepair. This is a troubling number of problems for pumpsthat have been around as long as the Colleague pumps have.The impact on users has been extremely burdensome.

It’s not clear what will happen from here. Baxter hasnot been able to ship Colleague pumps to new accountssince summer 2005. Shipments will not resume untilBaxter receives clearance for two FDA 510(k) regulatoryfilings covering intended fixes for the pumps. One filingwas submitted on November 19, 2005; Baxter anticipatessubmitting the second filing in January 2006.

If Baxter resolves the many reliability issues involvingthe Colleague pumps and upgrades the capabilities of theGuardian software to keep up with the advances in tech-nology, we will revisit our rating of these pumps.

UMDNS term. Infusion Pumps, General-Purpose [13-215]

Supplier. Baxter Healthcare Corp., Medication Delivery/Infusion Systems [393248], Round Lake, Illinois (USA); +1(888) 229-0001, +1 (847) 948-2000; www.baxter.com ◆

* These criteria are summarized in a checklist available in the membersarea of our Web site. Log onto www.ecri.org, go to your membership page,click on the Health Devices Journal option, scroll to the December 2004 is-sue, click “(Overview),” and click “Infusion Pump Checklist.”** In the past year alone, the Colleague CX and 3CX have been the subjectof 11 Action Items published in Health Devices Alerts, some of them cov-ering more than one problem. See Accession Nos. A6077, A6188, A6216,A6238, A6434, A6520, A6652, A6683, A6703, A6756, and A6943.

Thank YouTo All Our Clinical Reviewers

We deeply appreciate the contributions made by the following clinicians and otherhealthcare professionals, who donated their time and shared their expertise as review-ers of the Evaluations and Guidance Articles published in Health Devices during thepast year. We would also like to thank the countless others—too numerous to mentionhere—who have helped us inform the healthcare community about medical-device-related problems through our Problem Reporting System.

Thomas Bauld, PhD

Bob Baxter

Linda Bell

Richard Bielen

Jeffrey D. Burke

Jocelyn Chalquist

Mike Churchman

Richard Cummins, MD

Dale R. Cyr

Jeff DeToro

Eugene Ditullio

Michael Fraai

Manny Furst

Paddy Gilligan

Steven L. Grimes

Tony Hall

Janet Henderson

Emanuel Kanal, MD

Bruce Kavanaugh

Kristopher Kusche

Joseph Lewandowski

Alan Lipschultz

Todd Malora

Jane McCaffrey

Michele Morris, AuD

Kenneth D. Olbrish

Joseph Ornato, MD

Charles Platt

Katharine C. Rathbun, MD

Linda Reino

Steven Rubino

Kimberly Ryan

Joyce Sensmeier

Frank G. Shellock, PhD

Nat Sims, MD

Matt Soroush, MD

Diane Stockdale

Stephen M. Walker

Steve Wexler

Karl R. White, PhD

Roger White, MD

Barbara Wintraub

Terry O. Woods, PhD

The end of the year is also a good time for us to thank you, our members, for your support of theHealth Devices program. We wish you all a safe and happy New Year.

422 HEALTH DEVICES December 2005 ■ www.ecri.org ©2005 ECRI

Note ofThanks


ECRI ProblemReporting System

Problem Reports

Policy statement. ECRI encourages members, healthcare providers, patients,and suppliers to report all medical-device-related incidents and deficiencies to usso that we can determine whether a report reflects a random failure or one that islikely to recur and cause harm. Reports can be generic or model specific. Weadd all reports to our internal confidential databases to track trends of devicefailure or lot-specific defects. Although many reports do not result in a publishedarticle, we inform the reporting party of our findings or opinions when appropri-ate. As soon as we become aware of device hazards and problems, we informthe suppliers and invite them to respond constructively.

If our investigations yield information that should be communicated to thehealthcare community, we publish the information in Health Devices as eithera Hazard Report or a User Experience Network™ (UEN™) article, dependingon the level of risk associated with the problem. Member hospitals may repro-duce these reports for internal distribution only. This policy does not apply toother articles in Health Devices, unless otherwise noted.

Submitting a report. Please report problems to us by mailing or faxing oneof the problem reporting forms in your Health Devices binder, by sending us aletter, by completing the online form available at www.ecri.org/problemreport, orby calling +1 (610) 825-6000. The identity of the reporting individual orinstitution is never revealed without permission.

Hazard ReportUsing External Defibrillators in Oxygen-Enriched

Atmospheres Can Cause Fires

PROBLEMECRI continues to receive reports of fires starting whenexternal defibrillators are used with oxygen administra-tion devices (e.g., oxygen masks, manual resuscitators,ventilators), which can create oxygen-enriched areasaround a patient’s head, neck, and chest. These fires of-ten spread through surface-fiber flame propagation, inwhich flames travel across body hairs or fabric fibers,typically toward an oxygen source. In many cases, thesefires do not burn skin or underlying fabric; sometimes,however, they can burn people or spread to bedding,clothing, supply tubing, or medical devices, includingoxygen administration devices themselves (Bruley andLavanchy 1989).

DISCUSSIONExternal defibrillation normally doesn’t create a firerisk, but it may do so when (1) there is an oxygen-enriched atmosphere and (2) an electric arc formsbetween two conducting sources.

Oxygen administration devices can raise the oxygenconcentration around a patient’s head, neck, and chest.The exact concentration depends on factors such as thedevice’s oxygen flow rate, the position and directionof the oxygen outflow, the amount of time oxygen hasbeen flowing, the position of the patient, and themovement of nearby people and equipment. In mostcases, the area will extend less than 30 cm (12 in) in

any direction from the outflow point, and the concentra-tion will quickly return to ambient levels when thesource of enrichment is turned off or removed.

An electric arc in an oxygen-enriched atmosphere canignite body hairs or the surface nap fibers on most fabrics.Two of the common ways these fires can occur duringdefibrillation are when a paddle or defibrillation electrodeis placed close to an ECG electrode, or when there is poorcontact between a patient’s skin and the defibrillator pad-dles or disposable defibrillation electrodes being used.Poor contact can be caused by any of the following:

■ Insufficient force during paddle application.

■ Use of the wrong amount or wrong type of gel (e.g., ul-trasound gel); or, when gel pads are used instead, use ofpads that are the wrong size or that have passed theirexpiration date.

■ Application of paddles or defibrillation electrodes on ir-regular surfaces (e.g., bony prominences, wires, ECGelectrodes).

■ Misapplication of paddles (e.g., the metal surface of thepaddle is not completely on the conductive pad).

■ Improper patient surface preparation (e.g., not shavingareas where paddles or electrodes will be applied).

■ Use of defective disposable defibrillation electrodes(e.g., a fold in the electrode, an expired electrode, a dryelectrode).

ECRI has discussed this problem in Health Devices sev-eral times (December 1979, March-April 1987, July 1994).

Also, the medical literature includes numerous references tothis hazard, starting as early as 1972. Furthermore, theAmerican Heart Association recently proposed updating thedefibrillation guidelines it offers to healthcare providers toinclude a description of this problem. However, despitewidespread awareness, fires during defibrillation in oxy-gen-enriched atmospheres continue to occur.

RECOMMENDATIONS

1. Alert clinicians to the problem and to this report. Thisdanger must be periodically reemphasized so that itwill not be ignored or forgotten.

2. If possible, remove all sources of supplemental oxygenfrom the area around the patient before defibrillation.This includes all manual and gas-powered resuscitators,breathing circuits, masks, and nasal cannulae that pro-vide oxygen at concentrations above 21% (i.e., abovenormal ambient concentration).

If it isn’t possible to remove such oxygen sources,they should be turned off a few seconds before defibril-lation to reduce the localized oxygen concentration. Asan added precaution, oxygen sources shouldn’t beplaced on a bed or patient, and they shouldn’t be drapedover a siderail, because a clinician could forget to turnoff the device or the device could leak oxygen.

3. To reduce the risk of arcing during defibrillation:

A. If defibrillator paddles are used:

— Apply the defibrillator paddles firmly, and ensurethat there is unobstructed, even contact with thepatient’s skin.

— Do not place defibrillator paddles on an ECGelectrode or wire.

— When gel pads are used in place of conductinggel, use pads that are larger than the metal sur-face of the paddle; that have not reached theirexpiration date; and that are sticky, flexible,and wet.

B. If disposable defibrillation electrodes are used:

— Ensure that the electrodes have not reached theirexpiration date and that they are sticky, flexible,and wet.

— Ensure that electrodes properly adhere to the pa-tient and are flat against the skin. Do not placepads over bony prominences, excessively hairyareas, electrode leads, or wires.

— Do not place the electrodes on an ECG electrodeor wire.



ECRI’s Hazard Reports

A Hazard Report describes a possible source of peril, danger,or difficulty. We publish reports about those units in whichwe have identified a fault or design feature that might, un-der certain circumstances, place patients or users at risk.These reports describe the problem and ECRI’s recom-mendations on how to correct or avoid it. Publication of areport on a specific brand name and model of device in noway implies that competitive devices lack hazardouscharacteristics.

When deciding whether to discontinue using a devicethat ECRI believes poses a risk, staff should balance theneeds of individual patients, the clinical priorities, and theavailability of safer or superior products against the infor-mation we provide. Clinical judgment is more significantthan an administrative, engineering, or liability decision.Users can often take precautions to reduce the possibilityof injury while waiting for equipment to be modified orreplaced.

4. Ensure that defibrillation protocols include steps, suchas those above, to reduce the risk of arcing in an oxy-gen-enriched atmosphere. However, preventive mea-sures must not interfere with resuscitation attempts.

Reference

Bruley ME, Lavanchy C. Oxygen-enriched fires during surgery of thehead and neck. In: Stoltzfus J, Benz FJ, Stradling JS, eds. Symposiumon flammability and sensitivity of materials in oxygen-enriched

atmospheres: fourth volume, ASTM STP 1040. Philadelphia:American Society for Testing and Materials; 1989.

UMDNS terms. Defibrillators [11-132] ■ Resuscitators[13-360] ■ Oxygen Administration Kits [12-855] ■ Breath-ing Circuits, Ventilator [15-003] ■ Breathing Circuits, Oxy-gen Administration [16-987] ■ Cannulae, Nasal, OxygenAdministration [12-700] ■ Masks, Air-Oxygen [12-448]

Suppliers. These devices are available from a variety ofsources; consult ECRI’s Health Devices Sourcebook orHealth Devices International Sourcebase for suppliers. ◆



Talk to the SpecialistVentilator Gas Supply Inlet Filters

Question. Should a ventilator’s gas supply inlets havefilters?

Answer. Yes. Most ventilators have a particulate filter,which is encased in a water trap, on both the air and theoxygen inlet. (On some ventilator models, the oxygenfilter and trap are inside the unit.) Although medical gassystems are supposed to be constructed—and tanks aresupposed to be filled—so that no water or particles en-ter the gas, ECRI has seen numerous systems in whichthis problem occurred. These contaminants can damageventilators by corroding metal and clogging small pas-sages, and they can also harm patients. Filters reducethe likelihood of these problems and are therefore im-portant to use; note, however, that they cannot preventall risks because they do not trap very small particles.*

Inlet filters need to be checked regularly to improvepatient safety, protect ventilators, and identify anyproblems with the medical gas system. (For example,the presence of green particles in the filters or trapswould indicate that copper pipes in the gas system

might be corroding.) If the filters or water traps containparticles or water, then the entire system needs to be in-spected and its problems fixed.

UMDNS terms. Filters, Gas [15-649] ■ Ventilators,Intensive Care [17-429] ◆

Talk to the Specialist

In this column, we provide answers to questions fre-quently asked of ECRI’s specialists. Members of eitherthe Health Devices System or the SELECTplus™ Programare encouraged to contact ECRI’s experts to pose ques-tions such as these or to seek assistance on healthcaretechnology issues. This type of direct, personal assis-tance—which can save you valuable time, effort, andmoney—is a membership benefit available to all individu-als at subscribing healthcare facilities.

ECRI’s specialists can be reached by telephone at+1 (610) 825-6000; by fax at +1 (610) 834-1275; bymail at 5200 Butler Pike, Plymouth Meeting, PA 19462,USA; or through e-mail at [email protected].

*For more information on very small particles in medical gassystems, see the October 17, 2003, Health Devices Alerts Special Re-port “Medical Compressed Air: Is It Clean Enough?” (Accession No.S0027).

User Experience NetworkU-Brackets on Medcare Total Support LiftsMay Suffer Damage through Incorrect Use

HOSPITALCracks have formed on the U-brackets of our MedcareTotal Support Lifts. The U-bracket is welded to the topof the device’s mast, attaching the boom to the mast. Ineach case, the cracks were noticed after a patient waslifted; we later learned that this resulted from operatorstrying to maneuver the lift by pushing the boom insteadof the handlebar, which is located at the backend of thelift. Although no injuries occurred, we believe that if theproblem goes unnoticed, it could lead to patient or staffinjuries. Medcare said it will replace the U-brackets at nocost under warranty, perform an in-service training ses-sion for our operators, and send us warning stickers to beplaced on the side of the boom.

ECRIThe problem described by the reporting hospital affectsMedcare Model 400001 (Figure 1) and 400003 TotalSupport Lifts. These lifts are designed to be maneuveredonly from the unit’s backend—using the designatedhandlebar (Figure 2a)—and the boom is designed to

move only vertically, either up or down. Operatorsshould not try to position patients by pushing or pullingthe boom (Figure 2b) or by pushing a suspended patient(Figure 2c); these actions, when performed repeatedly,may cause the U-bracket to crack, bend, or twist overtime. Furthermore, pushing the boom or a suspended pa-tient may cause the lift to tip over.

SUPPLIER’S CORRECTIVE ACTIONMedcare is aware of the problem. In October 2002, thecompany doubled the U-bracket’s thickness to make it lessprone to cracking, bending, and twisting. Despite thischange, the company strongly encourages users to maneu-ver the lift only from its backend, using the handlebar(Figure 2a), because other ways of maneuvering the liftcan still damage the U-bracket if enough force is applied.Although Medcare didn’t initiate a recall, it is now proac-tively inspecting all known units in the field and providingin-service training.

An explicit warning against improperly maneuveringthe device is not included in the current version of the op-erator’s manual, but Medcare is incorporating such a state-ment into the manual’s next edition. The company alsofreely provides labels—to be affixed to the boom—thatwarn users against improperly operating its lifts.

RECOMMENDATIONS

1. Visually inspect all Medcare 400001 and 400003 liftsto identify any cracking, bending, or twisting of theU-bracket (see Figure 1 for identification of theU-bracket). If damage is found, remove the unit from



ECRI’sUser Experience Network

User Experience Network™ (UEN™) articles describe prob-lems that ECRI believes are unlikely to pose a significant riskof harm. Most describe common or nuisance problems thatcan be corrected with an available modification or revisedoperating or maintenance procedures. Typically, they in-clude the hospital’s report and ECRI’s comment. When ap-propriate, they also include the supplier’s response andrecommendations for corrective action.

Figure 1. Medcare 400001 lift components dis-cussed in this article. Reprinted with permissionfrom Medcare. (Labeling by ECRI.)

service until a new U-bracket has been installed and awarning label has been affixed. The U-bracket will bereplaced at no charge if the device is still under war-ranty (i.e., within five years of the purchase date). Thewarning labels are available free of charge regardlessof the warranty status. If the part is not under warrantyand there are no signs of damage, routinely monitorthe U-bracket for problems and replace the part only ifdamage is visible.

2. Ensure that the visual inspection described in Recom-mendation 1 is included in your inspection and pre-ventive maintenance procedure. This inspection shouldbe performed at least annually.

3. Train clinicians to maneuver the lift only fromthe unit’s backend, using the handlebar, and makethem aware of the consequences of maneuvering thedevice incorrectly. (Contact Medcare to obtain trainingvideos or to schedule an in-service session.) Documentwhich users receive the training, and repeat trainingperiodically.

UMDNS term. Lifts, Patient Transfer [12-330]

Supplier. Medcare Products [370363], Burnsville, Minne-sota (USA); +1 (800) 695-4479, +1 (952) 894-7076;www.medcarelifts.com ◆



Figure 2a.Correct operation

Figure 2b.Incorrect—Do not push or pull the boom

Figure 2c.Incorrect—Do not push the patient

ALTHDEVICES

HESYSTEM

A Publication of the

Health Devices SystemObjectives

To improve the effectiveness, safety, andeconomy of health services by:

1. Providing independent, objective judg-ment for selecting, purchasing, managing,and using medical devices, equipment, andsystems.

2. Functioning as an information clearing-house for hazards and deficiencies inmedical devices.

3. Encouraging the improvement of medicaldevices through an informed marketplace.

www.ecri.org5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

Telephone +1 (610) 825-6000 ■ Fax +1 (610) 834-1275 ■ E-mail [email protected]

Guidance Article Investigating Device-Related “Burns”

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Transcript of Guidance Article Investigating Device-Related “Burns”