Fewer Medical Device Testing Labs are Being Inspected, Consumer Watchdog Group Alleges

The U.S. Food and Drug Administration has drastically cut back on enforcement of safety regulations and inspections of facilities for testing pacemakers, stents, and other medical devices before they are implanted in patients, according to an independent consumer watchdog group.

The reduction in enforcement of federal rules for the pre-market testing of medical devices has put millions of consumers directly at risk of suffering death or devastating injuries from defective or ineffective medical devices, according to the Project on Government Oversight.

In 2005, the FDA conducted 33 inspections of medical device testing laboratories, but that number dropped to just seven in 2007, then to just one in 2008, according to the group. There are no inspections planned for 2009, the group said.

The FDA inspections are supposed to ensure that initial testing of medical devices on lab animals or specialized machinery is being conducted properly. It is not known how many, if any, patient injuries or deaths can be attributed to the cut back in inspections.

FDA Division Rocked by Scandal

A division of the FDA called the Center for Devices and Radiological Health is charged with overseeing medical device makers. The enforcement division has been rocked by various scandals in recent years, most notably recent accusations by scientists who claimed managers hushed debate about how to improve medical devices and allowed devices to be approved even when they were potentially unsafe or ineffective.

In 2006, it was revealed that FDA scientists had objected to reducing the number of inspections at medical device testing laboratories, but that their superiors made the cuts over their objections and without public input.

FDA Defends Reduction in Inspections

The FDA said medical device testing firms are still required to abide by the agency’s lab standards and must certify in writing that they are in compliance with federal rules. Detailed specifications for medical device laboratories were adopted in the 1970s after it was learned a leading medical device lab had falsified testing data submitted to the government for approval.

By focusing its declining resources on enforcement of clinical trials on people rather than preliminary testing of devices on machines or lab animals, the FDA said it can still effectively protect the public health.

The Fox is Watching the Hen House

Allowing medical device makers to conduct their own preliminary testing of products outside the watchful eye of the FDA sets a dangerous precedent. As we have recently seen with the cut back in FDA inspections of food-processing plants leading to the deadly outbreak of salmonella bacteria linked to tainted peanut butter and other products, allowing manufacturers to police themselves without close FDA oversight can have fatal consequences. Medical device makers who are allowed to conduct initial testing of their products without having to answer to FDA inspections are more likely to churn out unsafe, defective, or unnecessary medical devices, which can down the road cause untold patient injuries and deaths.

The FDA has to find a way to maintain strict oversight of medical device testing laboratories.

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