Updated March 7, 2016
When medical devices fail, you may be required to report it so manufacturers and regulators understand the consequences.
Reporting problems is the only way that manufacturers and regulators can understand the “big picture” consequences of medical equipment failures on users and patients. When medical devices fail, you or your service may be required to report it. This column will tell you how.
Case 1: Defibrillator fails to charge
In May 2004, paramedics in Clifton Park, New York used a biphasic monitor-defibrillator to shock a patient in cardiac arrest. They successfully achieved return of spontaneous circulation and began packaging for transport when the patient fibrillated again. While charging their defibrillator, the screen went blank and then displayed a message, “bridge test failed.” A defibrillator from another ALS unit on scene was retrieved to treat the patient. Was this an isolated incident?
Case 2: Frequent IV pump alarms
During 2006 at several Albany, New York hospitals, nurses noted frequent IV pump alarms suggesting the tubing had occluded. Their initial complaints resulted in a recommendation from clinical engineering personnel that users be more attentive to proper alignment of the tubing in the pump channel.
When alarms persisted, a report was filed with the Food and Drug Administration. Investigators discovered that the manufacturer had recently outsourced production of the IV tubing. The new production plant had produced tubing with external diameters outside the contracted specification. The defect resulted in the recall of tens of thousands of IV tubing sets from across the United States.
Background on medical device safety
The United States Congress first decided to regulate medical devices in 1976 by placing them under the watchful eyes of the FDA. The Safe Medical Devices Act of 1990 expanded the authority of the FDA. In 1992 Medical Device Amendments to the Act established a single reporting standard for medical device user facilities, manufacturers, and importers.
While prehospital providers and services are largely ignored in federal legislation, EMS is specifically named as a medical device user facility under the category “Outpatient Treatment Facility” (21 C.F.R. 803.3(u)(1)). The law expressly refers to ambulance providers and rescue services, regardless of whether they are licensed or accredited and whether they are independent or under the control of a larger medical entity.
The law dictates that if an event meets certain criteria for reporting, the user facility must report it, regardless of where, when, or how it occurred. Adverse event reports are referred to as Medical Device Reports. Bottom line: If your department has any medical or patient care equipment, you are a user facility and mandated under federal law to report adverse events.
Changes to the reporting requirements have redefined manufacturers and importers to ensure that foreign manufacturers who ship devices into the United States are required reporters, but requirements for device users have not changed.
Definitions of medical devices
So what is a medical device? The simplest definition of a medical device is any object used in patient care that is not a drug. The prehospital list of devices is seemingly endless:
- Defibrillators
- Suctions units
- Stretchers
- Bandages
- Splints
- Ambulance patient care compartments
What constitutes an adverse event? By strict definition, an adverse event is 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. Operator error that may have contributed to an adverse event is inconsequential and may actually identify design flaws.
Serious injury also has a complex definition that can be simplified to any injury requiring medical treatment. It is important to note that adverse events do not have to involve patients. A paramedic or civilian injured or killed by a medical device would constitute a reportable adverse event.
The FDA is empowered to extend the reporting requirements to other adverse experiences beyond those involving deaths, serious injuries, and serious illnesses, but has not yet done so.
Since 1996 user facilities including fire and EMS departments, rescue services, and air medical and ground transport services 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, while serious injuries need only be reported to the product manufacturer. If the manufacturer is unknown, serious injuries must be reported to the FDA.
Reporting device malfunctions that do not result in death or serious injury is encouraged, but not required. Any user facility submitting a medical device report — to either the FDA or a manufacturer — in the 12 months prior to 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 2 years. Fire/EMS departments are required to have written procedures in place to identify, evaluate, submit, and maintain MDR reports.
Reporting routes for adverse events
Reporting adverse events can follow two tracks: voluntary and mandatory. Health care 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, such as those required by fire/EMS departments and other user facilities, cannot be done online at the present time. FDA form 3500 is used to file mandatory reports, and can be downloaded with instructions from the FDA MedWatch website.
Both form 3500 and the annual user facility report (form 3419) must be mailed to the FDA, Medical Device Reporting, PO Box 3002, Rockville MD 20847-3002, an address not too easily located.
A slightly out of date, but otherwise excellent, instructional manual on Medical Device Reporting for User Facilities can be found online. A change from semi-annual to annual reporting came after the manual was published.
Why report medical device errors?
Reporting adverse events brings important information to manufacturers and the FDA about serious problems with medical devices — if those required to report actually do. Numerous studies have documented significant under-reporting. A US government study in 1986 concluded that hospitals reported less than 1 percent of medical device problems, and the more serious the event, the less likely it was reported.
The FDA maintains two searchable databases, including MAUDE (Manufacturer, User facility, Distributor Experience network), that are invaluable resources for researching equipment histories and user experience. MAUDE contains all adverse device reports, both voluntary and mandatory, filed by users, manufacturers and distributors in recent years. The precursor to MAUDE maintains Medical Device Reports filed prior to 1996.
You can search the MDR Database using free text queries, while MAUDE lets you pick product types. EMS services should scrutinize these databases whenever considering equipment purchases or investigating safety records of equipment in use.
Reporting equipment failures assures the safety of patients and your EMS colleagues throughout the world. Required or not, it is a moral and ethical imperative you owe to those you care for, the manufacturing industry, regulators, and your colleagues.
Reference
U.S. Food and Drug Administration. Medical Device Reporting. April 2013. On-Line at: www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. Accessed October 26, 2013.
