When medical devices fail and death or serious injury occurs, your department is required to report it. This article tells you how.
First responders arriving at a cardiac arrest powered on their AED, attached the pads to their patient and pressed the AED analyze button, expecting it to assess the rhythm. Instead, the AED shut off. The patient did not survive. Was this an isolated incident?
In 2016, several patients with implanted cardioverter defibrillators (ICDs) experienced sudden, unexpected battery failure of their devices. Two patients died after their pacemaker-defibrillators failed to shock lethal arrhythmias. An investigation found that the pacemaker batteries short-circuited, leading to rapid failure. In all, the manufacturer recalled 251,346 ICDs.
In 1976, the U.S. Congress directed the Food and Drug Administration to begin regulating medical devices. The Safe Medical Devices Act of 1990 gave the FDA expanded authority, and in 1992, medical-device amendments established a single reporting standard for medical-device user facilities, manufacturers and importers. Unlike in many federal laws, fire and EMS were specifically named as medical-device user facilities (under the category “Outpatient Treatment Facility,” 20 C.F.R. 803.3[u]).
Ambulance providers and rescue services are all included, regardless of whether they’re licensed or accredited, independent or under the control of a larger medical entity. If an event meets certain criteria for reporting, the user facility must report it, regardless of where, when or how it occurred. The adverse-event reports are referred to as medical-device reports (MDRs).
Bottom line: if your department owns or uses any medical or patient-care equipment, you are a user facility and mandated under federal law to report adverse events.
What is a medical device?
The simplest definition is any object used in patient care that is not a drug. The fire and EMS list is endless: defibrillators, suctions units, stretchers, bandages, splints and even patient-care compartments of ambulances.
What constitutes an adverse event?
By strict definition, any occurrence that a user facility becomes aware of that reasonably suggests a medical device has or may have caused or contributed to a death or serious injury is an adverse event.
Operator error that may have contributed to the event is inconsequential and may actually identify design flaws. The definition of serious injury can be simplified to any injury requiring medical treatment.
Adverse events don’t have to involve patients. A firefighter or civilian injured or killed by a medical device would constitute a reportable adverse event.
When and how do you report an adverse event?
Since July 31, 1996, user facilities have been required to file MDRs within 10 working days of learning about an adverse event. Deaths must be reported to both the FDA and the device manufacturer. Serious injuries need only be reported to the product manufacturer or, if the manufacturer is unknown, to the FDA.
Reporting device malfunctions that don’t result in death or serious injury is encouraged, but not required. Any user facility submitting an MDR (to either the FDA or a manufacturer) in the 12 months before January 1 must also file an annual report with the FDA, compiling all of the previous year’s MDRs. Copies of MDRs and annual reports must be maintained for two years. Fire/EMS departments are required to have written procedures in place to identify, evaluate, submit, and maintain MDR reports.
Reporting adverse events can follow two tracks: voluntary and mandatory. Healthcare providers and consumers can voluntarily report any adverse event or safety issue by completing FDA form 3500 electronically at the FDA’s MedWatch website.
Mandatory reports are more easily submitted on paper by downloading and completing a PDF version of FDA form 3500. Mandatory MDRs can be done online, but require a very complex registration and vetting process. Both form 3500 and the annual user-facility report (form 3419) must be mailed to
FDA
Medical Device Reporting
PO Box 3002
Rockville MD 20847-3002
This is an address not easily located.
The Importance of Reporting
Regulation of medical devices protects the public. Required reporting of adverse events brings important information to manufacturers and the FDA about serious problems with medical devices—if those required to report actually do.
Many studies have documented significant underreporting. A U.S. government study in 1986 concluded that hospitals reported less than 1% of medical-device problems; the more serious the event, the less likely that it was reported.
A search of the MAUDE (Manufacturer, User facility, Distributor Experience network) database using an AED brand name will produce hundreds of adverse-event reports. In fact, the adverse AED event at the start of this column was more than an isolated incident.
Reporting equipment failures helps to ensure the safety of the public and your fire/EMS colleagues throughout the world. Through adverse-event reporting, the days you’ll remember as the worst of your fire/EMS career can become the best days for the future of medical care.