Investigators also highlighted long-standing concerns that modified devices may bear little resemblance to the device originally FDA-approved.

Katie Hobbins | Apr 19, 2023

Recently, a study published in JAMA Network Open reported that high-risk medical devices whose manufacturers file supplements to the FDA so modifications can be made to PMA-approved products are 30% more likely to be the subject of any recall and high-risk Class I recall.

Makers of Class III PMA devices are offered five different types of supplements to allow for product improvements. Only one of the supplements — namely, panel track supplements — actually require clinical evidence for implementation and, as such, are the least-used type of the five, (approximately 1%). In contrast, the most used supplement type is a 30-day notice. A 30-day notice is used when a company makes changes to a manufacturing procedure or the way it makes a device.

In the study, investigators analyzed devices approved through the PMA pathway from January 2008 through December 2021 — a total of 373 PMA products with 10,776 supplements — and obtained recall data. Explanatory variables used were the number of supplements, number of panel track supplements, and cardiovascular devices.

Of the devices and associated supplements, a median of 2.5 supplements per device were approved annually. Investigators wrote that multivariable analysis demonstrated that “each increase of one supplement per year was associated with increased risk of recall (HR, 1.28 [95% CI, 1.15-1.44]; P < 0.001). For class 1 recall, increased number of supplements (HR, 1.32 [95% CI, 1.06-1.64]; P = 0.01) and cardiovascular vs noncardiovascular classification of devices (HR, 3.51 [95% CI, 1.15-10.72]; P = 0.03) were significantly associated with an increased risk of recall.”

Additionally, they noted that there are long-standing concerns that modified devices may bear little resemblance to the device originally approved by FDA. Pointing to cardiac defibrillator leads made by Medtronic and St. Jude Medical — the Sprint Fidelis and the Riata, respectively — the study wrote that the products “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,” they wrote. “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.”

The study urged FDA to reconsider processes around PMA supplement approval and suggested additional physician awareness, improved preapproval testing, and post-market surveillance strategies to mitigate risks to patient safety and public health.

PMAs are not the only pathway under scrutiny, however. Two studies published by JAMA in January also linked the recall of 510(k)-cleared medical devices to problematic predicate products. 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.

PMA study authors Hope Caughron and Sanket Dhurva argue that there may be a solution to these problems — Unique Device Identifiers (UDIs) on Medicare claims forms. In commentary that ran alongside the study, they discussed how UDIs on administrative claims forms would ensure better data surrounding clinical outcomes for specific device.

To do this, health systems would integrate UDIs into electronic health records, meaning a device identifier would need to be submitted to receive payment.

“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.”

A proposal for CMS to add UDI information on claims forms came in 2022 from X12, a United States accreditation body that set standards for healthcare transaction. As of now, the suggestion is unable to move forward until it is ratified by the National Committee on Vital and Health Statistics.