Higher recall risk for PMA-approved devices with supplements, study suggests

High-risk medical devices whose manufacturers file supplements to the US Food and Drug Administration (FDA) so modifications can be made to the PMA-approved products are more likely to be the subject of a recall, according to a recent study published in JAMA Network Open.

“PMA supplements are associated with an approximately 30% increased risk of any recall and [high-risk] Class I recall,” the study’s authors wrote, adding that “the FDA processes for approving modifications to high-risk medical devices should be reevaluated to optimize patient safety and public health.”

The agency offers makers of Class III PMA devices six types of supplements to allow for product improvements, but only one—panel track supplements—requires clinical evidence. Panel track supplements are the least-used of the bunch. The study found that the most-used supplement type is a 30-day notice, used when a company makes changes to a manufacturing procedure or the way it makes a device.

For their study, the authors looked at devices approved via the FDA’s PMA pathway from January 2008 through December 2021; a total of 373 PMA products with 10,776 supplements were reviewed. “Multivariable analysis demonstrated that each increase of one supplement per year was associated with increased risk of recall,” they wrote. “For Class I recall, increased number of supplements … and cardiovascular vs. noncardiovascular classification of devices … were significantly associated with an increased risk of recall.”

The authors further noted that “previous investigators have expressed concerns that modified devices may bear little resemblance to the device originally approved.” As an example, they pointed to cardiac defibrillator leads made by Medtronic and St. Jude Medical—the Sprint Fidelis and the Riata, respectively—that “were recalled after being approved by supplements due to high rates of lead failure.”

“The accrual of supplements over time has raised concerns that the modern device may bear little resemblance to its approved predecessor,” wrote the authors, who found that roughly 2.5 supplements per PMA device are approved each year. “Both the Sprint Fidelis and Riata cardiac leads were approved through supplements … to devices originally approved in the mid-1990s that each had 80 or more supplements through 2012. These devices were linked to multiple patient deaths and were recalled in 2007 and 2011, respectively, after implantation in hundreds of thousands of patients worldwide.”

Aside from calling on the FDA to reconsider its processes around PMA supplement approvals, the study authors suggested that “physician awareness, improved preapproval testing, and postmarket surveillance strategies should be used to mitigate risks to patient safety and public health.”

Of note, the study pointed out that “devices approved via PMA harbor three times the risk of any recall and seven times the risk of a Class I … recall when compared with those devices cleared through the less-stringent 510(k) pathway used for nearly all moderate-risk devices.”

Interestingly, JAMA published two studies in January that linked the recall of 510(k)-cleared medical devices to problematic predicate products. The authors of one of the studies reported that roughly 11% of 35,176 devices granted 510(k) clearance between 2003 and 2018 underwent a Class I or moderate-risk Class II recall. (RELATED: Expert: Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’ for manufacturers, Regulatory Focus 17 January 2023)

Most devices—more than 3,000 a year—enter the US market as 510(k)s, which means they were shown to be substantially equivalent to already-authorized and marketed products.

UDIs on Medicare claims forms a solution?

In commentary that ran alongside the 12 April study, authors Hope Caughron and Sanket Dhruva argued that wider use of Unique Device Identifiers (UDIs) on administrative claims forms would ensure better data around clinical outcomes for specific devices.

They are optimistic that a proposal for the US Centers for Medicare & Medicaid Services (CMS) to add UDI information on claims forms will be a huge leap forward. The proposal came last year from X12, a US accreditation body that sets standards for healthcare transactions, but that suggestion cannot move forward for Medicare until it is ratified by the National Committee on Vital and Health Statistics (NCVHS).

“If this [proposal] is ultimately adopted as a requirement by the United States’ largest payer, [CMS], health systems would need to integrate this information into electronic health records so that they could transmit the device identifier to receive payment,” Caughron and Dhruva wrote. “This process would entail linking each medical device to a patient and, therefore, would enable tracking clinical outcomes associated with medical devices in both electronic health records and claims data.”

This, they explain, would provide better visibility to device problems in the field and allow for greater identification of safety concerns.

“More timely notification could also be provided to patients who had been treated with a recalled device, thereby mitigating harm,” Caughron and Dhruva wrote. In any event, they say, “ensuring device alterations do not inadvertently introduce risk to patients requires important, coordinated steps to protect patient safety.”

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Higher recall risk for PMA-approved devices with supplements, study suggests

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