Glossary Building Post
Medical device reporting (MDR), according to the FDA website, is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Medical device reports are achieved by mandatory reporters following the MDR regulation that requires them to submit certain types of reports for adverse events and product problems about medical devices to the FDA. Mandatory reports to the FDA are required from manufacturers, importers, and device user facilities.
A medical device report submitted a medical professional, patient, caregiver, or consumer about the pernicious effects of a defective medical device is called voluntary medical device reporting and this specific group of reporters are called voluntary reporters. Voluntary medical reports are not required by the FDA, but strongly encouraged. Voluntary reporters can also report usage errors, product futilities and quality issues, treatment ineffectualities, and equipment failures. I wasn’t aware of the MDR surveillance tool and now that I looked into it, I think it is important that more consumers are made aware of it.
The MDR system is important because it encourages and helps achieve maximum consumer safety by providing critical information that can aid in the improvement of a medical device. Mandatory reporters play a vital role in MDR. Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. If the imported devices have malfunctioned and could likely be the cause of or contribute to death or serious injury, the importer must report only to the manufacturer. A device user facility is any facility that provides patient care, which is not a physician’s office. These user facilities are hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, or outpatient treatment facilities. Device user facilities are required, per MDR regulations, to report any and all suspected medical device-related death(s) to both the FDA and the manufacturer. User facilities are also required to report any serious medical device injury to the manufacturer, or if the manufacturer is unknown, to the FDA. Once the manufacturer is informed by the importer or device user facility of the adverse events or faults of a medical device, they then must report to the FDA.
I believe this system of communication is important, not only for the mandatory reporters and the FDA, but for the consumers as well. It can help provide peace of mind, ensures the safety and wellbeing of the consumers and can provide assurance that the medical device will benefit consumer health and safety. I also think voluntary reports are extremely useful, providing a voluntary report can help your patients, those you care about and can benefit the safety of strangers as well. I think everyone should participate in voluntary reporting. All reporters, whether voluntary or mandatory, play an important part of consumer health.
- Medical device reporting: one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
- Mandatory reporters: manufacturers, device user facilities, and importers of medical devices.
- Manufacturers: Required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury and 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.
- Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury.
- Device User Facilities: A hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office.
- Voluntary Reporter: A medical professional, patient, caregiver, or consumer that chooses to submit a medical device report to the FDA about pernicious effects of a defective medical device.
Sources
Center for Devices and Radiological Health. “Medical Device Reporting (MDR): How to Report Medical Device Problems.” U.S. Food and Drug Administration, FDA, 2020, www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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