February 02, 2010 | | Comments 2
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A 24-hour reporting period for medical device injuries is a good approach

I was asked by a hospital about its policy for reporting patient injury or death related to medical equipment use. The policy states that the reporting time frame for an incident is within 24 hours of the occurrence.

I looked at information posted on the FDA’s Web site. On page 2 of this document (page 12 of the PDF), there is an indication of an expectation that deaths or serious injury are reported within 10 working days.

So an internal policy is fine with a 24-hour timeframe because it helps to ensure that if you need to go the external reporting route, you won’t be behind the eight ball.

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Steve MacArthur About the Author: Steve MacArthur is a safety consultant with The Greeley Company in Danvers, Mass. He brings more than 30 years of healthcare management and consulting experience to his work with hospitals, physician offices, and ambulatory care facilities across the country. He is the author of HCPro's Hospital Safety Director's Handbook and is contributing editor for Briefings on Hospital Safety. Contact Steve at stevemacsafetyspace@gmail.com.

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  1. I think that there may be some inconsistencies within the FDA’s own website… I was under the impression that the medical-device related death of a patient was to be reported by the caregiver directly to the FDA within 24 hours.

    By contrast, the other two criteria under the Medical Device Reporting (MDR) regulations are ‘serious injury’ and ‘unreasonable risk of death or serious injury’. Incidents that fall under one of these two criteria, may be reported by the provider directly to the FDA, but the ‘standard’ way is to report the event to the device manufacturer who, in turn, is to report the event to the FDA.

    I think that the time frame for that little two-step is 10 days from the event for the provider to report to the manufacturer, and then the manufacturer has 30 days (from receipt) to report it to the FDA.

    I may be working from bad information… God knows that the MDR information on the FDA’s website isn’t exactly easy to navigate!

  2. The sooner the better. The faster the incident gets reported the more convincing your case will be if it gets brought up in court.

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