FDA Turns Down Industry Call for Regulatory Controls on Third-Party Medical Device Servicers
IV Pump News May 24, 2018
In a long-awaited report, the FDA states it does not believe there is a safety problem with the servicing, manufacturing, and repair of medical devices by third-party organizations or the original equipment manufacturers.
Each year the FDA receives hundreds of Medical Device Reports (MDRs) of suspected device-associated deaths, serious injuries, or malfunctions. From this information, the FDA determined it was unable to establish a conclusive relationship between a device’s third-party entity’s servicing and subsequent adverse events. The report did find that there is persistent under-reporting of patient safety events, device malfunctions, and service histories which impeded root-cause analysis.
Currently, only original equipment manufacturers are FDA regulated when it comes to medical device servicing. The topic has been a top priority at several industry associations such as the Medical Imaging Technology Association and the Association for the Advancement of Medical Instrumentation. Both organizations are developing and revising standards on the matter. According to the FDA Reauthorization Act, third-party services include anyone who refurbishes, reconditions, rebuilds, remarkets, repairs, remanufactures, or performs other servicing on the device.
A full review of the report is encouraged, especially the portions where the FDA has stated its intention to clarify the difference between servicing and remanufacturing; as well as, the strengthening of cybersecurity practices. View the FDA’s full report.
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