Medical Device Problem Reporting

A Saudi Food & Drug Authority Program

3 3

Experienced

Pioneering

Independent

Evidence-based

Medical Device Reporting

January 2008

Joel J. Nobel, MD. Founder & President Emeritus

Reporting Medical Device Problems

Why?

Who?When?How?

Why Report Medical Device Problems?

Health professionals have a moral and ethical obligation to minimize harm to patients, improve their skills and support their hospital’s pursuit of patient safety and quality of care

Reporting medical device failures and related adverse effects helps identify and prevent similar events in the future

Reporting allows analysis of cause and focused corrective action

Why Report Medical Device Problems?

Without reporting and sharing information health professionals, biomedical engineers, materials managers and procurement personnel are handicapped in selecting and purchasing medical products

Without reporting health professionals may not be able to identify the need for additional training of physicians and nurses

Without reporting the Saudi Food and Drug Authority cannot identify deficient products and prevent their import or sale and this increases the probability that hospitals will harm patients, waste time and money

Why Report Medical Device Problems?

Health professionals and hospitals need to minimize the risk of lawsuits by patients and families and loss of reputation caused by injuries and deaths related to medical devices

Saudi suppliers and manufacturers need organized feedback to improve their judgment about products, processes, components and materials so they can deliver safer and higher quality products to hospitals and device users

What Types of Adverse Events Are Caused by Medical Devices?

Injuries to patients and hospital personnelDeaths of patients and hospital personnelEnvironmental damageLawsuits by patients or their familiesNew expenses for repair or retraining Abandonment of a product and loss of the investment

The Causes of Medical-Device-Related Incidents

Device failureDevice interactionUser errorMaintenance errorPackaging error

TamperingSupport system failureEnvironmental factorIdiosyncratic patient

reaction

Typical Causes of Device Failure

Design/labeling errorManufacturing errorSoftware deficiencyRandom component failurePower-supply failureFailure of accessory

Mechanisms of Device Related Injury & Death

OverdoseSuffocation/barotraumaInfectionEmbolism (gas/particulate)Skin lesion

(puncture/cut/burn

ElectrocutionFirePerformance failureCrushingExsanguination

Most Frequently Reported Harmful Devices

Anesthesia machinesCardiac interventional

cathetersCardiopulmonary bypass

systemsDefibrillatorsDialysis systems

Electrosurgical (surgical diathermy) units

Disposable surgical trocarsIV pumpsSurgical staplersVentilators

Observation

Of these top 10 harmful devices, half (5) are used only in the operating theatre.

3 additional ones may be used in the operating theatre.3 are used in almost all areas of the hospital.The most frequently reported problem device is the infusion pump.3 of the 10 devices are highly dependent on physician technique with

very simple devices (i.e., interventional catheters, trocars, and staplers)

Conclusion 7 of these 10 devices require main voltage electrical energy. But in 6 of these 7 devices, almost all reported problems are

mechanical. One device, the defibrillator, has frequently reported battery- and

power-supply problems (i.e., too little rather than too much electricity).

Focus attention on mechanical problems because the electrical safety issues are highly exaggerated.

Maintenance error or failure to inspect is rarely a cause of harm. Focus attention on training because most harm involving devices is

caused by operator error.

What Inhibits Reporting of Medical Device Adverse Events?

Perception of the event Information-sharing culture Fear of authoritarian superiors Fear of blame and punishment Lack of a general incident reporting system, (critical to risk management) Failure to investigate the event and incorporate what was learned into

training, revised clinical procedures and more effective selection and procurement of medical devices

Educate Device Users

Have them:– Explore www.mdsr.ecri.org– Read case histories of deaths and injuries caused by devices

they use in their specialty and why they occurred – Download and publicize safety posters for specific devices

Who Should Report?

It depends on the incident reporting system and reporting channels in your hospital

In most Western hospitals reporting is done by the nursing staff through the incident reporting system and the incident comes to the attention of the risk management department and biomedical engineering department

Typically the risk manger or biomedical engineer reports the incident to the device regulatory agency

When?

As quickly as possible before memories fade While the scene of the incident and evidence is preserved so

the risk manager and biomedical engineer can examine the device, take notes and if appropriate take photographs and try to determine the cause

Protect the Patient & Staff, But Preserve the Evidence!

The first priority is to prevent further harm to patient or staff The next highest priority is to protect the physical environment

e.g. from fireThe last critical priority is to preserve the evidence so cause

can be determined

Preserve the Evidence for Analysis

Do not move equipment, or accessories unless needed to project patient or staff from harm

Treat the location of the event as if it were a crime scene Do not changes control settings on any equipment Do not detach or dispose of any accessories or consumables or single use

products such as cables, catheters, electrodes. tubes, humidifiers, etc. Their presence, juxtaposition and connections may prove critical in understanding the event

Make sketches or take photographs as appropriate Document who was there, who did what, what happened. etc.

Things Not To Do

Never, ever send or release implicated devices to suppliers or manufacturers until the analysis is complete and cause is determined. Once the device is out of your control it can be altered or be lost

Do not assume that suppliers are on your side. If investigation requires the help of the supplier be sure it is done in the hospital with your risk manager, biomedical engineer and involved health professionals and, if you wish, a representative of the SFDA present

Do not assume, once you have completed your investigation, that nothing else need be done. If litigation is possible lock the device and its accessories in an area with controlled access and preserve it and related documentation and photographs as if it will undergo additional analysis and be introduced as evidence in court

Things to Do

Prevent adverse events by carefully selecting and purchasing medical devices. You now have immediate access to the most comprehensive up-to-date information in the world on the quality, safety and cost-effectiveness of such products via SFDA and ECRI

When choosing equipment give special attention to ergonomics and human factors design (aviation examples)

Emphasize training and retraining Share information openly

How?

We will now demonstrate: How to report a medical device event to the Saudi Food & Drug

Authority How to search SFDA-ECRI supplied databases for adverse

event informationHow to use SFDA-ECRI supplied databases to improve

selection and procurement of medical devices

Thank You

or Questions