Important Facts about the Medical Device Adverse Event Reporting Law

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In the United States, the Food and Drug Administration (FDA) makes large efforts to manage and oversee the safety of medical devices used by today’s health care professionals. In our health care system, large numbers of cases pertaining to ill-desired outcomes potentially caused by medical devices are reported each year. The FDA has developed a database for collecting these submissions, known as the Manufacturer and User Facility Device Experience (MAUDE) database.
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In February 2014, the FDA released mandates requiring medical device manufacturers and importers to submit medical device reports (MDRs) to the FDA to track and resolve medical device problems and avoid resulting adverse events. These mandates were put into effect August 14, 2015, according to the FDA’s official online documentation. Because medical device malfunctions could result in costly, life-threatening or even fatal problems in potentially millions of cases per year, the FDA’s revamp of its reporting requirements could help save countless lives.

Medical Device Reports in Review

Before the 2015 Medical Device Reporting (MDR) regulation (21 CFR 803) was finalized, the previous rules for reporting adverse events linked to medical devices had been in place since 1997. Updates were necessary. The number of MDR reports submitted in 2015 outnumbered those submitted the previous year by 109,198, or 8 percent, according to the MedTech Insight article, “Adverse Events Stack Up at FDA.” Specific medical devices seemed to trend as causing significant percentages of the total number of reports submitted in 2015, among them were uterine power morcellators, duodenoscopes, transvaginal mesh and birth control devices. Medical devices with high incident rates were not being fixed or taken off the market quickly enough to avoid large numbers of adverse events, some of which included fatalities.

FDA’s Current Reporting Mandate

The important elements of the August 2015 regulations are relatively straightforward: Those who either domestically manufacture or import medical products must submit reports to the FDA when “they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur,” according to the FDA website. The current rules also impose a strict timeline for submitting reports. Manufacturers are required to submit an MDR report within 30 days of becoming aware of the event or issue. In the case of the FDA bringing a circumstance or issue to light and requiring a report from the manufacturer, the manufacturer has five days to submit a report. For importers, the time requirement in both cases is 30 days from becoming aware of the incident. These timelines will promote fast action and could help limit the number of people affected by a medical device malfunction.

The regulations also issue requirements for device user facilities, described by the FDA as “a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility or outpatient treatment facility, which is not a physician’s office.” These regulations state that “user facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.”

In the case of malfunctions that occur within device user facilities that do not result in death, device users are not required to submit MDR reports to the FDA or to the device manufacturer. They are, however, highly encouraged to keep records of the events should the FDA make a future investigation. In addition, device users are encouraged to submit voluntary reports of malfunctioning medical devices to MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program. These submissions can be made online through the FDA website and can be submitted either by health professionals or by consumers.

What Types of Occurrences Require Submissions?

The FDA has outlined specific guidelines for when an MDR report should be made, as summarized by “According to FDA, a medical device may be considered to have ‘caused or contributed’ [to] a death or serious injury, or to have played as a factor in these adverse events, as a result of either: device failure; malfunction; improper or inadequate design; manufacture; labeling; or user error. Any of these reasons may constitute an MDR reportable event, for which manufacturers should submit an MDR report using appropriate FDA forms.” Though in some cases the negative results could be attributed to device misuse, the problem may have been caused by insufficient or incorrect labeling, instructions or documentation.

The FDA’s latest updates to its Medical Device Reporting mandates reveal a concerted effort to stem the rising number of reported incidents involving, or caused by, medical device problems that occur in the United States. As the FDA continues to make reporting a priority for manufacturers and device users, the United States health care community hopes to benefit from a decrease in the time required for the FDA to address complaints and fix or remove potentially dangerous products before they affect American lives. Legal professionals who work in areas such as medical malpractice should pay careful attention to the FDA’s rulings to stay apprised of current legal landscapes.

Recommended Readings:
Cybersecurity and Hacked Medical Devices
7 Landmark Bioethical Cases Throughout History
Important Food and Drug Administration Regulations Throughout History

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