The Pulse | Friday, March 20, 2020
Medical Device Adverse Event Reporting for User Facilities and Voluntary Reporting
Medical device reporting (MDR) is a process used by the Food and Drug Administration (FDA) to collect mandatory reports from manufacturers, importers, and user facilities for post-market device-related events1. Voluntary reporting is also available via the MedWatch Program as a separate pathway for receiving device-related information primarily from healthcare professionals and patients/caregivers, which may involve malfunctions (product problems) and adverse events (serious injuries and deaths).
MDR plays a critical role in the promotion and protection of public health as a tool for post- market surveillance and monitoring of device performance and safety. MDR facilitates identification and evaluation of emerging trends and potential device-associated issues that might impact public health. A redacted version of these reports is publicly available, hence increasing public awareness of device-associated events. There are two types of post-market reports that may be used by hospitals: the mandatory user facility report2 and the voluntary MedWatch report3 for healthcare professionals and consumers.
User facilities are required to report MDRs according to 21 CFR 803.30. User facilities include hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, and outpatient treatment facilities. User facilities must report device-related deaths to both the FDA and the manufacturer within 10 work days of becoming aware, and they must report device-related serious injuries to the manufacturer or to the FDA (if the medical device manufacturer is unknown) within 10 work days of becoming aware.
Voluntary reports are those submitted from healthcare professionals and consumers (including patients/caregivers) who don’t have mandatory reporting requirements. Both user facility and voluntary reports are especially valuable, given that the information is often submitted by first-line users, such as nurses, health care providers, and technicians and includes the perspective of real-time use experience. Because the manufacturer might not be aware of the event, these reports may be the only source of information available to FDA for specific device-associated scenarios concerning device performance and patient safety.
Voluntary reports are easy to complete online at FDA’s MedWatch website. The MedWatch site is secure and confidential, and there is a help button located in each section of the form. After submitting a report, the submitter will receive a confirmation e-mail from the FDA. Please refer to the links in the footnotes of this article for post-market reporting.
If you have any MDR-related questions, you may contact the MDR Policy Help Desk via telephone at 301-796-6670 or via email at MDRPolicy@fda.hhs.gov.
1 (reportable malfunctions, serious injuries and deaths), as set forth in the Medical Device Regulation per 21 CFR 803 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803
2 For mandatory reporting (FDA Form 3500A)
3 For voluntary reporting: (FDA Form 3500) https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home