FDA medical device regulations, safety controls challenged by ethics journal AMA

The AMA Journal of Ethics has taken an in-depth look at US medical device regulation, raising the question of whether the FDA strikes the right balance between supporting innovation and protecting patients.

In creating the problem, Ariel Wampler, a plastic and reconstructive surgery physician at Lahey Hospital and Medical Center in Massachusetts, shared data on the regulation, use and impact of medical devices. Most of the statistics go back years, but still provide a snapshot of the case against the current approach. Wampler notes that less than 1% of medical devices have gone through two major clinical trials, as is the standard for pharmaceuticals, from 2003 to 2007.

Since it is generally easier and safer to stop using a drug than an implant, Wampler suggests that it “might be reasonable” to expect some devices to be subject to safety standards. higher safety than pharmaceuticals.

Serious safety issues reported are extremely rare – less than 1% of devices authorized or approved between 2004 and 2009 were subject to a Class I recall, although the recall system itself has also been criticized as being fragmentary and not exhaustive. Clinical trials of implants can be more complex, expensive, and ethically problematic than drug studies.

Wampler and Anna Pisac and Natalia Wilson, the authors of an article in the journal issue, all echoed criticisms of the use of the 510 (k) route. Pisac and Wilson cited a study which found that between 1992 and 2012, 510 (k) certified devices were 11.5 times more likely to be subject to recalls than products that received pre-market approval.

“In addition, devices or materials were cleared on the basis of their substantial equivalence with predicates that were recalled due to adverse events, as was the case for 16% of surgical mesh cleaned between 2013 and 2015” , wrote Pisac and Wilson.

Surgical mesh products have a troubled history, leading to increased FDA scrutiny, an agency advisory panel, and a call for more studies, amid tens of thousands of reports of serious and adverse events. of some deaths.

In 2019, The FDA on Tuesday ordered Boston Scientific and Danish device maker Coloplast to immediately stop the sale of surgical mesh products indicated for transvaginal repair of pelvic organ prolapse after an agency advisory committee said ‘there was not enough evidence that the products were safe.

The use of substantial equivalency, rather than evidence of safety and efficacy, to support authorization of devices via 510 (k) has been a long-standing target of criticism of U.S. medical technology regulations. While the 510 (k) pathway remains a key pathway to market, including for some implants, the FDA has made changes in recent years, as Pisac and Wilson note in their article. Notably, the FDA restricted the use of the route, introduced a “refuse to accept” policy, and eliminated approximately 1,500 predicate devices.

Beatrice Brown and Aaron Kesselheim of Harvard Medical School suggest a different approach to how to handle questions about the safety and efficacy of 510 (k) approved devices. Brown and Kesselheim make the case that hospitals should halt bulk purchases of certain devices and have clinicians discuss the benefits and risks with patients on a case-by-case basis.

“While hospitals may incur higher costs by not purchasing devices in bulk, purchasing on a case-by-case basis can help avoid side costs – such as using hospital beds for additional procedures. – if the device turns out to be worse. patient outcomes, ”wrote Brown and Kesselheim.

Women can benefit disproportionately from a new approach to devices. From breast implants to surgical nets, many of the biggest device-related health issues of recent years have affected women. In an article titled “Is the FDA Failing Women?” Madris Kinard and Rita Redberg identify areas of weak enforcement and compliance, such as a series of delays in completing post-market surveillance studies for breast implants.

Kinard, a former FDA staff member, and Redberg, a former FDA expert panelist, want better enforcement of post-market surveillance, as well as the creation of a reporting mechanism. more accessible and user-friendly adverse events to ensure transparency. .


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