Study: Recall Risk Tied To Device Modifications
Executive Summary
A study by University of Missouri-Kansas City scientists found that high-risk devices that have been modified via the US FDA’s PMA supplement process are about 30% more likely to be recalled than devices marketed under original PMAs, with the recall rate climbing as supplements mounted up.
High-risk devices that have been modified since their original approval are more likely to be recalled than similar products that have not been altered, researchers from the University of Missouri-Kansas City reported in a study published in JAMA Network Open on 11 April.
The US Food and Drug Administration allows developers of class III devices to modify their products post-approval by filing one of six types of PMA supplements.
However, the only one of these supplements that calls for additional clinical testing is the relatively rare panel-track supplement, used for substantial changes to a device’s design or indication for use. Other supplement types – including 80-day, real-time, special, and 30-day notice or 135-day supplement – call for either preclinical data or proof of GMP compliance or have no specific data requirements at all.
The study looked at recall data for 373 devices that the FDA approved via PMA between 2008 and 2019, as well as 10,776 associated supplements. The analysis found that each additional supplement per year increased the overall recall risk by 28% and risk of a class I recall 32%.
Cardiovascular devices and devices with a high number of total supplements were the most likely to be the subject of a class I recall, the paper states.
The increased recall risk was smaller for panel-track supplements than for the other types. However, panel-track supplements made up only about 1.2% of supplements in the study. The most common type of supplement was the 30-day notice, accounting for 67.3% of the total.
A total of 97 devices included in the study were recalled during the relevant period in 193 separate recalls. Sixty-six devices were recalled more than once, with one device – Medtronic’s HeartWare ventricular assist system – the subject of an eye-popping 26 recalls. Medtronic stopped selling the device in 2021 after a series of injuries and deaths. (Also see "Medtronic Issues Another Recall For The HeartWare VAD System" - Medtech Insight, 1 Dec, 2022.)
Authors Call For More Physician Awareness
The 43 class I recalls of devices included in the study involved 20 devices. Of these, 15 – 75% – were cardiovascular devices.
The study’s authors, led by orthopedist Jonathan Durbin, take care to note that it is an observational analysis and cannot prove causation. But it found a few interesting correlations. For example, Cordis issued a sterility-related 2013 recall on Exoseal vascular closure devices just six weeks after the FDA passed a 30-day supplement for “alternate sterilization minimum dose.” (Also see "FDA Recalls List – Feb. 06, 2013" - Medtech Insight, 18 Feb, 2013.)
“Our results should not be misconstrued to imply that the regulatory process is intrinsically flawed,” Durbin et. al. wrote. “The supplement process is critical in expediting delivery of incremental device changes with potentially greater safety and effectiveness profiles. Rather, we believe physicians should be aware of the risks associated with modified devices for their practices.”
The authors also endorsed a range of measures to strengthen premarket surveillance, including integrating Unique Device Identifiers (UDIs) into medical records, improving registry participation, and asking the FDA and manufacturers for more detailed recall reports that explain how and why a device or process failed.
Related Commentary Points To More Examples
JAMA Network Open also published an editorial by Hope Caughron and Sankey Dhruva of the University of California San Francisco discussing the study.
Caughron and Dhruva noted that prior research focused on ophthalmic devices also found a higher rate of recalls in devices with more PMA supplements per year. They also point to St. Jude Medical’s high-profile 2011 recall of Riata and Riata ST implantable cardioverter-defibrillator leads, which had reached market through a real-time PMA supplement.
In total, Caughron and Dhruva say, Riata leads were the subject of 78 supplements between their 1996 approval and 2012. (Also see "St Jude's Riata recall gets most serious classification from FDA" - Medtech Insight, 16 Dec, 2011.)
“Improved clinical outcomes for patients must be at the center of medical device innovation, and PMA supplements offer an efficient pathway for approval of device modifications that could achieve this goal. Ensuring that these device alterations do not inadvertently introduce risk to patients requires important, coordinated steps to protect patient safety.”— Hope Caughron and Sankey Dhruva
Caughron and Dhruva urge the FDA to take steps ensuring alterations to PMA devices are submitted and processed through the correct supplemental pathways.
“[N]early half of changes in device indication for orthopedic PMA devices were not approved through panel-track supplements, which is the typical pathway for new device indications due to the requirement for new clinical data,” they wrote.
“Use of a less stringent pathway means that devices may be modified without adequate rigor of regulatory review and evidence generation, both of which could uncover possible safety risks before PMA supplements are approved.”
Additionally, the article says that the FDA should limit the number of PMA supplements that can be approved per device without new clinical safety data, with the threshold varying based on device class, mechanism of action, intended use, and device changes over time.
“If manufacturers were not allowed future PMA supplements without clinical evidence generation, manufacturers would be strongly incentivized to proactively collect evidence from device use over time,” they explained.
And like Durbin, Caughron and Dhruva press for additional use of UDIs to better track device function over time.
“Improved clinical outcomes for patients must be at the center of medical device innovation, and PMA supplements offer an efficient pathway for approval of device modifications that could achieve this goal,” they wrote. “Ensuring that these device alterations do not inadvertently introduce risk to patients requires important, coordinated steps to protect patient safety.”