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 personnel  Deaths of patients and hospital personnel  Environmental damage  Lawsuits by patients or their families  New expenses for repair or retraining  Abandonment of a product and loss of the investment

The Causes of Medical-Device-Related Incidents  Device failure  Device interaction  User error  Maintenance error  Packaging error  Tampering  Support system failure  Environmental factor  Idiosyncratic patient reaction

Typical Causes of Device Failure  Design/labeling error  Manufacturing error  Software deficiency  Random component failure  Power-supply failure  Failure of accessory

Mechanisms of Device Related Injury & Death  Overdose  Suffocation/barotrauma  Infection  Embolism (gas/particulate)  Skin lesion (puncture/cut/burn  Electrocution  Fire  Performance failure  Crushing  Exsanguination

Most Frequently Reported Harmful Devices  Anesthesia machines  Cardiac interventional catheters  Cardiopulmonary bypass systems  Defibrillators  Dialysis systems  Electrosurgical (surgical diathermy) units  Disposable surgical trocars  IV pumps  Surgical staplers  Ventilators

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 –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 fire  The 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 information  How to use SFDA-ECRI supplied databases to improve selection and procurement of medical devices

Thank You or Questions