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INSIDE THE CURRENT ISSUE May 2015

2015 CS/SPD Equipment & Technology Guide

Current Issue ­ June 2015Featured advertisers:

AHRMM

Angelini Pharma

Avadim Technologies

Boston Scientific

Cardinal Health

Clorox Healthcare

Contec Inc.

Covidien

Crosstex/SPS Medical

CS Medical

Data Solutions Corp.

Dial Corp.

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Ethicon

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Fashion Seal Healthcare,a brand of Superior Uniform Group

Hanel Storage Systems

Healthmark Industries

HealthTrust Purchasing Group

Hygie

Steam builds behind progress and relief ofprocessing pressures

by Valerie J. Dimond

After a recent string of incidentslinking contaminatedduodenoscopes to serious bacterialinfections and deaths amonghospital patients across thecountry, medical devicemanufacturers, Central Service(CS)/Sterile ProcessingDepartments (SPDs) and even the regulating bodies that govern them,are under the scope now too. The scrutiny isn’t likely to let up any timesoon and, according to some, that’s exactly what’s needed to drivechanges that will keep patients safer and healthcare facilities more cost­effective and efficient.

Speaking on behalf of Crosstex/SPSmedical, which makes sterilityassurance and other related products, Chuck Hughes, Vice President,Infection Prevention Consulting Services, Cantel Medical, says adverseevents are likely to continue unless SPD personnel receive the properresources and education. "Complex devices, such as flexible endoscopes,ophthalmic instruments, dental hand pieces and orthopedic sets to namea few, require a substantial amount of training and education for staff tocomply with very detailed reprocessing steps," said Hughes. "In addition,special equipment and supplies are commonly needed, along withextensive flushing and thorough rinsing with copious amounts of treatedwater. Not knowing and not having the necessary resources to properlyreprocess complex devices is a contributing factor to this problem forsure."

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Tamara Hinceman, RN, BSN, CGRN, Clinical Education Consultant andField Trainer, ASP, says today’s instrumentation is indeed becomingincreasingly complex. "Physicians want the latest technology available toimprove diagnosis rates for certain disease states, but at what cost?"declared Hinceman. "They want the instruments to be small but performmore complex tasks. The smaller the instrument, the smaller thediameter will be of the internal components of the scope, which increasesthe complexity of the device and the risk of both improper cleaning andspreading healthcare­associated infections. The smaller the lumens, theharder it is to perfuse cleaning agents and high­level disinfectants (HLDs)through the lumens, which can lead to ineffective cleaning and HLD."

Although currently working with manufacturers to tackle these problems,the Food and Drug Administration (FDA), in a March safety alert, statedthat "effective cleaning of all areas of the duodenoscope may not bepossible … even when manufacturer reprocessing instructions arefollowed correctly."

SPDs lack education, time, even IFUs

Dan Gusanders, President, Pure Processing, says the challenge ofcleaning rests on the shoulders of both hospitals and devicemanufacturers. "Yes, there are many devices that are difficult to cleanbut that is not going to change any time soon so hospitals shoulddiscontinue use or ensure that its clean," he said. "I also think thatsurgery departments need to get into the habit of asking before theypurchase devices ‘how do you clean it?’ If hospitals start creating theexpectations they will force manufacturers to make device changes. Ithink we are seeing this shift already but it’s important to continue withthe expectation that cleaning is going to be an important question in thefuture. Also, companies need to collaborate more. Pure Processing hasmany relationships with device manufacturers. We have learned a lotabout device design through our relationship with Richard Wolf, whichenabled us to integrate features into our flushing system that protectdelicate devices from expensive repairs. I would like to think that ourcollaboration has also provoked more thought into their designs that allowfor easy cleaning."

Patricia Fritz, Senior Clinical Education Consultant, ASP, agrees thateducation should start with the vendor and continue with the provider. "Iam a true believer in vendor­led or sponsored training, and I think if acompany is selling a product, they should provide the training. With thatsaid, I also believe that facilities should have nurse educators on staff,"asserted Fritz. "All of the initial trainings should be vendor­led until thestaff is comfortable, and at that point, companies should be able to workwith an educator, or key department lead, to develop ‘train the trainer’­based education for relevant products."

Furthermore, Hughes says oftentimes SPD personnel aren’t given the timethey require to do the job correctly. "Many healthcare facilities strugglewith enough instruments and are unable or unwilling to reduce their caseload to accommodate proper reprocessing of complex instrumentsregardless of whether the instruments are owned or borrowed," saidHughes. "Borrowed instruments (loaners) routinely arrive late to SPDeven when the healthcare facility’s policy requires them to arrive 24, 48or even 72 hours in advance of their scheduled use. In many cases, theinstruments come without a validated instructions for use (IFU) whichmeans SPD must delay reprocessing until the IFUs are provided. Withoutthe IFU, the SPD personnel have to guess how to properly reprocess thedevices, which is a patient safety issue. Many SPD Managers have sharedstories with me about how they were pressured to reprocess complexdevices without the IFU, only to find out later the IFU required resourcesthey did not have. "

Shawn M. Flynn, Senior Vice President, Customer Operations, RestoreMedical Solutions Inc., shares a similar sentiment. "Since many of thedevices are becoming more complex, many of the SPD departments have

Hy­Tape Corp.

IAHCSMM

Innovative Sterilization Technologies

Ivera Medical

Jump Technologies Inc.

Maquet Medical Systems USA

Masimo

Metrex Research Corp.

Multisorb Technologies

One Source

Palmero Health Care

Parker Labs Inc.

PCI Medical

PDI

Ruhof Corporation

Sage Products

Spectra254

Thermomedics

Tronex Healthcare Industries

TRU­D SmartUVC

Tuttnauer USA Co. Ltd.

Viscot Medical/OP­Marks

Xenex

Healthmark Industries' Flexible Inspection Scope

Summit Medical's InstruSafe Tray

to take more and more time to reprocess these devices. These devicesrequire the technician to have the critical thinking capabilities coupledwith vital attention to detail. The margin for error is becomingincreasingly smaller and it’s challenging when some departments areunderpaid, overworked and understaffed," he said. "SPD is one of themost important departments in the entire hospital as they are the firstline of defense for disease prevention. As many hospitals consolidateservices to include HLD within SPD, it’s absolutely imperative thatadequate resources aren’t spared when building, staffing, and operating asterile processing department."

Cleaner, safer, more efficient

To assist staff in evaluatinghow clean instruments areafter processing them —and to catch any remainingdebris that may have beenmissed — HealthmarkIndustries recently releasedits Flexible InspectionScope. It’s designed withtechnology that allows SPDprofessionals to visuallyinspect the inside oflumened instruments, takepictures and video recordimages for effective recordkeeping. "We also offer theEndoCheck, which checksthe cleanliness of thebiopsy channel of theflexible endoscope,"explained Matt Smith,Marketing Manager."Simply swab the biopsychannel of the scope withthe included soft­tippedlong probe, clip off theswab into the vial, mix theactivating agent, shake vigorously, wait and then check for a colorchange. Depending on the type of test used, a color change indicates thatblood residue or protein residue remains in the channel, and should bereprocessed. EndoCheck complies with ASTM Guide D7225. We offerenzyme­based tests, like our 10­minute gram­negative HangTimeKit. Itutilizes a unique enzyme detection method, the easy to read fluorometerchecks for possible colony formation by reading telltale fluorescence inthe recaptured water. If the fluorometer reading is positive for gram­negative bacteria (which includes organisms such as CRE) reprocess theendoscope prior to use. Our innovative cleaning verification products helpour customers streamline operations process and stay compliant. Bystaying compliant, they are also ensuring that their products andequipment are safe to use on their patients."

Healthmark also makes SPD education available in a way that’s fun andmotivating. "We introduced our SP Dollars program to help departmentsearn points that can be redeemed toward educational materials andprograms," said Ralph Basile, Vice President, Marketing. "Further, ourCrazy4Clean.com CEU games provide a fun and free method for gainingvaluable education and earning CEU credits from IAHCSMM and CBSPD."

Having worked insterile processingfor 13 years,Marcus Super,Director ofInstruSafe, Salesand Marketing,Summit Medical,says somefacilities routinelyspend large sumsof money oninstrument repairsand replacements— costs that couldbe contained usingSummit’sInstruSafe Tray products, which are designed to protect delicateinstruments. "At my former job, surgical services spent nearly $300,000 ayear on repair and replacement of instruments. Much of this stems fromnot properly organizing instrument sets with adequate trays," said Super."The upfront expense to properly protect and organize instruments caneasily be justified by the reduction of instrument repair and replacementwithin the first year. As you start to add up the expense of needing torepair or replace instruments in these sets it becomes obvious for theneed to keep them protected from damage. Through the use of InstruSafeTrays we can start to reduce these problems from day one.

Innovative Sterilization Technologies’ ONE TRAY sterilization container technology

"This begins with initial use in the operating room and continues all theway through decontamination and sterilization," Super continued."Surgical instruments are completely protected throughout the use cyclewith medical­grade silicone instrument holders configured in the coverand base of our InstruSafe Trays. The base holders are molded to holdinstruments in place while minimizing contact points to improve sterilantpenetration of each individual instrument. Sterilization is furtherimproved with aluminum construction for optimal heat transfer and largeamounts of perforation that provide superior penetration and drainage.This provides 360 degrees of protection superior to any product on themarket."

Scott Cohen, CEO,InnovativeSterilizationTechnologies LLC(IST) also providestray solutions thatimproveefficiencies. "Oneof the biggestchallenges we hearin the field is thecost and resourcesit is taking toprocess OEMloaner andconsignmentinstrumentationand implants.Some of the kneeand hip revisionswe have seen involve over 30 pans for one surgery, one had over 52different pans needing processing. There is a tremendous cost to thehospitals to process these and in the world of DRG (diagnosis­relatedgroups) payments these costs hit directly on the bottom line," said Cohen."Our ONE TRAY sterilization container technology becomes so important inreducing preparation and processing terminal sterilization times by 75percent compared to the existing technologies. With ONE TRAY’spreparation/processing speed and efficiency we offer facilities costsavings of over 40­plus percent versus blue wrap and no torn wraps orwet paks to worry about. Our savings come from much less neededpersonnel, less energy and water used, and 95 percent less waste."

Sterilization Container technology has not changed in over 40 years;value or savings needs to be obvious, traceable, and significant for wideacceptance from supply chain," Cohen continued. "Implementing a smallamount of ONE TRAY containers can completely change the way an SPDmanages instrumentation and situations. ONE TRAY allows for all of theunforeseen changes that occur to be reacted to in a very quick timeframe. Prior to ONE TRAY there was a three­plus hour terminalprocessing time needed or IUSS (immediate­use steam sterilization) wasinvolved in reacting to these situations. This efficiency, at its simplestconcept, will reduce if not eliminate the SPD’s/OR’s need for redundantinstrument/set/power purchases."

Flynn (Restore) describes a typical SPD challenge and how his companyhas also come up with a unique solution. "If you have ever worked in anoperating room or sterile processing, you are already familiar with thejumbled basket of dirty surgical instruments that find their way from theOR to SPD for decontamination, prep and pack, and sterilization followingevery surgical procedure," he said. "Any SPD employee can tell you thechallenges of reprocessing and sterilizing thousands of surgicalinstruments. When instruments, such as rigid scopes, light sources, andflexible scopes, are piled into a basket and baskets are in turn stackedupon each other, immediate deterioration of quality and functionalityoccur. Since instruments have to be manually cleaned individually andthen mechanically cleaned as a set, it can literally take 15 to 20 minutesto manually decontaminate a set of instruments using proper procedures.On occasion, residual bio­burden can find its way on the prep and packside, which triggers re­work. The frequency of this re­work is amanifestation of inefficient processes. When people feel rushed forquicker OR turnovers and SPD is being called to expedite reprocessing ofcertain sets, sharps can find their way to SPD thereby becoming aworkplace injury. Depending on how long that case cart sat idle, it maybe impossible to determine which set was used on which patient. This isan unnecessary risk that no employee should endure."

Flynn saysrestringing andspraying theinstruments withenzymatic solutionat the point of usein the OR can helpsolve thoseproblems. "Thissolitary action

Restore Medical Solutions' iQ

Pure Station FlexiPump System by Pure Processing

makes it easier torecountinstruments on theback table andaccurately accountfor them. It alsoenables a quickerand saferinspection in SPD,which in turndelivers cleanerinstruments to theOR in a moreefficient manner,"he explained. Flynnalso noted thatalthough the FDA and the Association for the Advancement of MedicalInstrumentation (AAMI) recommend that instruments be placed inside thewasher in an upright position, doing so was difficult. "Prior to Restorethere was not a product on the market that facilitated an organizationalelement in­situ the containment device," said Flynn about the company’sIntelligent Modular Sterilization Tray System. In early March, Restore alsolaunched its Restore iQ as an extension of the tray system, which wasdesigned to be used in conjunction with a hospital’s current surgicalbaskets, enabling safer and faster reassembly and organization of ringed­handled instruments for more effective point­of­use cleaning anddecontamination and increased productivity. "With the instruments in anopen and upright fashion, it is easier for the SPD tech to inspect andreassemble instruments, thereby lessening the touch points within thesurgical sterilization continuum," Flynn said. "Fewer touch points translateinto fewer sharps­related accidents for staff, reduced capital budget forrepairs and replacements, decreased assembly time, and increased focuson inspection and functionality. The bottom line is consistent cleaning withfewer touch points translates into fewer delays associated with missing orcontaminated instrumentation and better quality healthcare for patients."

Gusanders (PureProcessing) saysit’s not uncommonfor SPD to bemisinformed aboutthe importance ofpre­cleaning,which can beoverlooked whensonic irrigators areused. "Many SPDsdon’t understandsonic irrigators donot allow you toskip pre­cleaning,"he said. "Thesepre­cleaning stepsare still requiredby equipmentmanufacturers aswell as instrumentmanufacturers. The FlexiPump Independent Flushing System is a cost­effective automated alternative that helps assure compliant, high qualityflushing, provides much greater workflow capacity, and supports workerand patient safety. The FlexiPump is used on all types of reusablelumened devices, including rigid and flexible scopes, robotic instruments,minimally invasive surgical devices, ocular devices and suction tips,which must be flushed thoroughly and consistently to assure completeremoval of debris and soils during pre­cleaning."

Protecting the health and well­being of SPD workers is also criticallyimportant, says Gusanders, noting that traditional manual flushingprocesses with syringes can lead to repetitive motion injuries. "Imagine atech standing at the sink manually flushing a single endoscope channelover and over again with her 60 ml syringe. Now, imagine a departmentwith three FlexiPump systems at that same sink (two on the wall and oneon the counter), each pump with three tubes connected to a device,automatically flushing nine lumens at the same time, each in 60 seconds!It’s not hard to see that having these compact, cost­effective systems atyour sink can save time and greatly reduce manual labor, which can freeup your technicians for other duties in the workflow. National andinternational regulating bodies have been calling for more robustreprocessing quality systems in the wake of infection outbreaks aroundthe world. They have flagged the need for standardized, consistent andrepeatable processes, which can be enhanced by using automatedsystems where appropriate. The FlexiPump system injects consistent,repeatable flushing into the pre­cleaning process, with simple, intuitiveoperation that is easy to train and a system that’s easy to maintain."

Dependable chemistries and sterilizers

For dependable and effective

Henry Schein's Maxicide OPA28

TSO3 VP4 sterilizer

disinfectant chemistries, speaking onbehalf of the Henry Schein SPD productline, Matt Beauchaine, ChannelManager, Crosstex/SPSmedical, saysHenry Schein brands have gained areputation of improving existingproducts with proprietary technologies— and MaxiCide OPA28 is a perfectexample. "OPA chemistries have beenon the market for some time now;MaxiCide OPA28 improves on thistechnology by offering a longer reuseperiod and faster disinfection timethrough its proprietary formula,"explained Beauchaine. "MaxiCideOPA28 is an ortho­phthalaldehyde­based high­level disinfectant that lastslonger and works faster than competingchemistries. MaxiCide OPA28 has areuse period of 28 days (two timeslonger than 14­day chemistries) savingfacilities significant dollars. The productalso has a reduced 10 minute manualsoak time, compared to 12 minuteswith competing OPA products. Theresult is an additional reprocessingcycle every hour! Maxima Sterilizationpouches are another good example. These pouches use Sure­Checktechnology, a patent pending technology, where every pouch includes amulti­variable internal chemical indicator. Additional internal indicatorsare not needed, thus saving departments time, money and reducing thechance for errors. For facilities using Class 5 integrating indicators, theinternal indicator serves as a back­up should staff forget to include anintegrator in a pouch."

Jim Wetzel, Vice President, Salesand Marketing, TSO3, says theSTERIZONE VP4 sterilizationtechnology is the only dual sterilant,low­temperature sterilizationproduct on the market thatprocesses heavy, mixed loads inone cycle with vaporized hydrogenperoxide and ozone. "Because ourSTERIZONE VP4 sterilizationtechnology is able to process amixed load of up to 75 poundscontaining flexible scopes, rigidscopes, cameras, cables, etc., thisefficiency allows us a 3:1 ratio inprocessing capability per load overcompetitive equipment," Wetzelasserted. "This translates to animmediate cost savings of a nearequal ratio while increasingefficiency and equipment inventoryturns. Also, because of our singlecycle capability, it removes thepotential for operator error in cycleselection. As the complexity ofsurgical technology increases moreand more, items are being broughtinto the OR that require sterilization or reprocessing, including morescopes. Often times these items include electronics or are lensed andunable to withstand classic steam sterilization. This increases the needfor a more device friendly, low temperature process. Couple this with adesired more rapid turnaround time and environmental concerns and itdrives the need for more productive and efficient processes such asoxidizing processes."

According to Joney de Souza, Group Product Director, InfectionPrevention, ASP, the STERRAD 100NX System delivers innovativehydrogen gas plasma technology that is safe for patients, instruments,health care workers and the environment.

"The STERRAD 100NX Systemprovides unsurpassed productivitywith extensive IFU endorsementsfrom the medical devicemanufacturers for low­temperaturesterilization, easy­to­use featuresand functionality and shorter cycletimes to increase throughput andefficiency," said de Souza."Compared to steam sterilization,STERRAD technology reducesinstrument damage that can save atypical hospital one­third of its

STERRAD 100NX System by ASP

STERRAD 100NX System by ASP

annual repair costs orapproximately $18 for each scopeprocessed. Our proprietarytechnologies and services such asour hydrogen peroxide monitor thatmeasures sterilant concentrationduring cycle and gas plasmatechnology appeal to SPD customersas they are unique to ASP." ASPalso developed the STERRADSterility Guide (SSG), availableonline and as a mobile app, to helpusers comply with IFUs in real timeand quickly and easily identifywhich devices fall within STERRADSystem sterility claims. "Anotherkey feature is the system’s abilityto adapt to new technology, such asSTERRAD 100NX Systemexpandability and STERRAD SterilityGuide validations," said de Souza."This increases the value of theinvestment for a facility."

Sterilization product manufacturer Tuttnauer USA recently launched a newhealthcare sterilizer model that easily fits into very small spaces, makingit an ideal choice for operating rooms and small­ to mid­sized outpatientclinics. Jake Miller, Sales and Marketing Manager, says the new 5075HSGmodel has a 19.5­inch diameter and 29.5­inch deep chamber with a built­in steam generator, pre/post vacuum cycle capability, and vacuum pumpfor efficient air removal and low water usage. Furthermore, Miller saysTuttnauer sterilizers’ non­proprietary components make their machineseasier to maintain since replacement parts can be obtained more readilythrough the years — an advantage that "lowers the total cost ofownership compared to other manufacturers," he said.

Tracking and accountability

As more facilities make instrument identification and traceability apriority, new products and services are available to help in that efforttoo.

Censitrac, Censis’ customizable instrument tracking system is oneexample. David Craig, Director of Clinical Initiatives, says Censitrac’smain features include tray and instrument level tracking, patient careequipment tracking, full­scale electronic sterilization documentation, casecart tracking, effective tracking for flexible endoscopes, and specialtraceability options for vendor loaner sets.

"Censitrac generates a unique load number for every sterilization cyclefor which it is used and is forever associated with the specific items inthe sterilizer load," said Craig. "The load numbers contain specificinformation about the items, the parameters of the sterilization cycle, thebiological indicator (BI) and chemical indicator (CI) results of theprocessed cycle. The BI interface "monitors" the correct format for lotnumbers, avoiding data entry errors. The interface prevents a BI’s results(positive or negative) from being saved if the determined incubationperiod is not fully met. An efficiency aspect includes tying the results ofthe BI to the Censitrac generated sterilizer load number.

"Censitrac alsooffers personal

Censitrac Surgical Instrument Management System

accountability in allaspects of itsfunctions,"continued Craig."Who assembled aset, how long did ittake, who wasresponsible forsterilizing the load,who checked thecycle for correctsterilizationparameters, whopicked a case cart,where was theinstrument set’slast location scanand who put itthere?Management hasfull capability tosee whateverdetail he/shewants to see for accurate and efficient location of items. Censitrac offers‘alerts’ or ‘warnings’ and documents the technician’s response to thewarning."

The system also has a preventative maintenance feature that Craig sayscan provide a measurable ROI by stopping unnecessary instrumentrepairs before they occur. "Prevention of a costly and delicate flexibleendoscope being inadvertently placed into a steam sterilizer can result incostly repair or replacement," he said, adding that Censitrac even assistsin improving work flow and staff scheduling. "The extensive reports thatare available allow the manager to trend work load and work flow, justifythe need for more staff, reallocating hours worked for the staff — puttingthem where the volume of work is, versus a traditional shift."

View the 2015 CS Technology Guide Vendor Listings