Devices

GAO Probing FDA Ventilator Recall Actions

At the request of Sens. Dick Durbin (R-IL) and Richard Blumenthal (D-CT), the Government Accountability Office (GAO) will look into FDA’s role and actions in oversight of medical device recalls, and especially the Philips Respironics recall of breathing machines. The Pittsburgh Post-Gazette, which worked with ProPublica on reports detailing FDA’s work during the Respironics recall, says the senators cited those reports in their request to GAO.

In a statement last week, FDA said it “welcomes the opportunity for GAO review of the agency’s oversight of medical device recalls.” GAO told the Post-Gazette it had accepted the senators’ request for an inquiry.

“It’s clear from the Philips case that information about patient harm was known for years and not properly shared or addressed,” Durbin said in a statement. “We must ensure there is adequate oversight on medical device manufacturers so that Americans know the potential risks and can make informed decisions with their healthcare providers.”

Durbin and Blumenthal told GAO they need more information about FDA’s oversight of the medical device industry, including how it ensures that companies initiate recalls and what happens when manufacturers fail to comply. A similar GAO probe in 2011 called for changes to better protect patients, the story says. It says safety advocates have said a new investigation is badly needed and long overdue.

In 2022, the Post-Gazette says, FDA received three million reports about malfunctioning devices, about 30 times more than in 2005. Nearly one-third described injuries and deaths, it says.

The story says device safety advocates say GAO should review whether FDA is regularly using information in health records, insurance claims, medical device registries, and other sources to improve its ability to track dangerous products.

Former FDA public health analyst Madris Kinard told the newspaper FDA should do more to ensure the safety of medical devices before they are marketed and sold. She pointed to the 510(k) approval pathway and said FDA should investigate whether the products that are already on the market have had any safety issues before they can be cited as predicates in 510(k) approvals. “Simply getting a new device to market to me isn’t innovation,” she said. “Innovation is only good if it’s helping the patient.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome