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A question of safety

Medical Design Technology

August 2012


How has news questioning the safety of medical devices misled the public about testing protocols?

PA's Answer

A recent article about medical device testing in Newsday incorrectly asserts: “Many widely used medical devices have never been tested for safety and manufacturers are only required to file paperwork and pay a small fee.” While such hyperbole makes for good press, articles like this are misleading and inaccurate.

In reality, the “paperwork” includes the entire device development documentation, running to thousands of pages of testing.  Developers test materials’ compatibility with human tissue, test the function and malfunction of the device to mitigate failures. The “small fee” is not small and is necessitated by funding cuts over the last decade in Congressional budgets for the Food and Drug Administration (FDA).

The FDA Quality System Requirements (21 CFR 820) outline a rigorous design control and validation process. Clinical trials are mandatory for any Class III device and most companies conduct testing of Class II devices. In addition, the FDA and international regulators issue specific guidance for high-risk devices like artificial joints, coronary stents, in-dwelling catheters, pacer/defibrillators, and very extensive requirements for inhalers, patient monitors, infant incubators, prosthetic limbs and wheelchairs. No device gets cleared for sale without satisfying the regulators that they have addressed these requirements.

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