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Medical Device Reporting Requirements

Medical Device Reporting Requirements

Last week’s blog covered the U.S. Senate’s release a report on the outbreak of deadly bacterial infections linked to contaminated medical scopes.  According to the report, Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients, the duodenoscope-related infections, which StayAlert! covered extensively in 2015, were significant and wide-spread.  The report is the result of an investigation initiated by Senator Patty Murray, Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions.

Today’s blog reviews 21 C.F.R. § 803.30(a)(1) in detail.

Under the Medical Device Reporting (MDR) regulation, 21 CFR 803, device user facilities are required to report certain device-related adverse events and product problems to the U.S. Food and Drug Administration (FDA).  A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. User facilities must report suspected medical device-related deaths 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.

Specifically, medical device reporting requirements for user facilities (21 C.F.R. § 803.30(a)(1)) are as follows:

  • As soon as practicable, but no more than 10 working days after the day a user facility becomes aware of information, from any source, that that reasonably suggests that a device has or may have caused or contributed to the death of a patient of that facility. The facility must also submit the report to the device manufacturer, if known. The information reported should include all information required by 803.32 on FDA Form 3500A or an electronic equivalent approved under 803.14.
  • A user facility must submit a report to the manufacturer of the device no later than 10 work days after the day that it becomes aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of the facility. If the manufacturer is not known, the facility must submit the report to the FDA. The information reported should include all information required by 803.32 on FDA Form 3500A or an electronic equivalent approved under 803.14.

“Reasonably known” information includes all of the data elements listed in 21 CFR 803.32.  This includes information found in documents that the facility possesses and any information that becomes available as a results of the follow-up within the facility.

Compliance officers must ensure that hospital staff understands their reporting requirements.  Hospitals should have a written policy that outlines the reporting process and all appropriate staff should receive training on the reporting requirements.  Training on medical device reporting requirements and the hospital’s process for such reporting should be included in new employee orientation (as appropriate) and then reviewed at regular intervals thereafter.

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