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FDA allows for parallel, confidential reporting of medical device failures

Posted Monday, April 8, 2019 by Carl-Erich Kruse

Medical device manufacturers have been taking advantage of so-called “alternative summary reporting” to secretly report device related injuries and malfunctions to the FDA. The system is functionally “secret” in that the reports are often sent directly to the FDA without opportunity for the public, including medical providers, to later read.

The FDA has long required medical device manufacturers to report adverse device events, like malfunctions, so the events are available for public scrutiny on the Manufacturer and Used Facility Device Experience (“MAUDE”). The alternative reporting system, however, allows adverse events on exempted devices to be reported en masse, often hundreds or thousands at a time. What’s worse, getting details of these incidents is exceedingly difficult once the reports have been filed. The system appears specifically designed to omit details of device malfunctions.

Kaiser Health News discovered that since 2016, there have been 1.1 million incidents, and hundreds of thousands of injuries, from hundreds of exempted medical devices. Such exempted devices include certain models of the near-ubiquitous surgical stapler, da Vinci surgical robots, mitral valve clips, and SAPIEN 3 artificial heart valves.

This hidden reporting scheme has caused untold headaches for many actually involved in care, and those injured as a result of device malfunction. Hospitals and clinics may be relying on incorrect device failure information when making purchasing decisions on medical devices. Likewise, providers may be using devices with far higher failure rates than they have been made aware of.

In our arena, this scheme may cause medical providers to be incorrectly blamed for negligence when in fact the device, with a history of repeated, similar, failures, gets defended as “safe.” Additionally, burying this information leads to incorrect opinions from expert witnesses on device safety.

The FDA defends the obscure system as meant to streamline the reporting requirements, perhaps to improve efficiency and save cost, but as consumers we are troubled by the health and safety costs passed to the providers and consumers of medical care.

Read the entire investigative piece from Kaiser Health News here.

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