The FDA acknowledged interruptions with notifications from recalling firms during the pandemic, while regulatory experts point to fewer inspections and fewer procedures.
FDA medical device product recalls dropped last year to their lowest level since 2013, according to a Medical Design & Outsourcing analysis of recall data from the regulatory agency.
Medtech regulatory experts said the COVID-19 pandemic showed room for improvement in FDA oversight and postmarket surveillance of medical devices.
Device products recalled in fiscal year 2021 (ended Sept. 30, 2021) totaled 2,607, a 14.3% decrease from the 3,042 recalls reported in fiscal 2020.
The drop in device recalls occurred at the same time the FDA put more emphasis on fighting the COVID-19 pandemic and improving device safety protocols, according to FDA’s Center for Devices and Radiological Health (CDRH) annual report. CDRH Director Dr. Jeff Shuren said in September that the agency was “starting to turn the corner” on catching up on premarket approval applications and 510(k) clearance submissions, after having focused on the pandemic and issuing emergency use authorizations (EUA) in record time.
The 2,607 product recalls from last year are the fewest since fiscal 2013, when device companies had 2,304 recalls. Fiscal 2013 was the first full year for which the FDA made these tallies public. The agency reported its highest number of recalls, at 3,285, in fiscal 2018.
In fiscal 2021, Class I recalls dipped 1.2% to 169, Class II recalls decreased 15% to 2,389 and Class III recalls dropped 19.7% to 49.
The largest year-over-year change of any year and any class since FDA started reporting these numbers was in fiscal 2019 — the last full year before the COVID-19 pandemic — when Class I recalls more than tripled. That year, there were 370 Class I recalls (up 216.24%), 2,376 Class II recalls (down 23.5%) and 97 Class III recalls (up 43%).
Medical device recalls may have been down last year. But the time period also saw one of the most serious industry recalls in years: Class I recalls involved millions of Philips Respironics ventilators, CPAPs and BiPAPs with dangerous sound abatement foam. The FDA received more than 21,000 medical device reports and 124 reports of deaths between April 2021 and April 30, 2022. The agency ordered the Amsterdam-based company to submit a plan for repairs, replacements or refunds of respiratory devices with the faulty foam. After inspecting a manufacturing facility connected to the recall, the FDA said Philips has known about problems with the foam since 2015. Philips is no longer taking orders of the sleep therapy systems and said it is cooperating with the FDA as well as the U.S. Department of Justice, which subpoenaed the company for information related to the recall.
FDA spokesperson Jim McKinney told MDO that the FDA could not say with certainty what’s behind the reduction in device recalls and recall events in fiscal 2021.
“The number of devices recalled in a year is not an indicator of the safety of marketed devices generally and is not a metric that can be analyzed as a trend,” he said in an email.
McKinney said the pandemic “has not changed the FDA’s critical oversight role to protect and promote public health by ensuring medical devices are safe and effective,” but acknowledged COVID disruption.
“We have seen some interruptions with notification and reporting to the FDA and implementation of mitigation efforts on behalf of some firms with active recalls,” McKinney said. “The FDA continues to actively work with these firms to address such recalls and implement mitigation efforts as soon as possible.”
FDA regulates over 190,000 different devices manufactured by more than 18,000 firms across the world. Since the beginning of the pandemic, the FDA’s CDRH granted EUA or full marketing authorization for more than 2,000 medical devices specifically designed for COVID-19 treatment, detection and diagnosis.
With a greater focus on the pandemic, there were fewer inspections, and those that took place were virtual, for the most part.
“This leads to potentially all kinds of issues on the manufacturing, reliability and quality side,” said Michael Drues, a regulatory consultant for medical device companies and the FDA.
He warned against drawing conclusions from the low recall numbers — or celebrating them.
“Just because people are not reporting doesn’t necessarily mean that there aren’t problems,” Drues said. “Lawsuits against medical device companies is probably a much better surrogate biomarker or prognostic indicator of how this industry is doing.”
‘Maybe we just had a good year’
Starting in March 2020, the Centers for Medicare and Medicaid Services (CMS) recommended postponing elective procedures to preserve personal protective equipment. CMS later relaxed the guidelines, but critical care for patients in the delta and omicron variant waves further delayed scheduled procedures and hurt sales of many medical devices.
That could have contributed to fewer recalls, said Canyon Labs Chief Clinical Research Officer Dr. David Locke, a regulatory science program instructor at Johns Hopkins University who was previously a regulatory affairs professional at Johnson & Johnson.
“Maybe we just had a good year where products functioned well,” Locke said. “Or maybe not as many were used.”
Device manufacturers, physicians and patients are responsible for reporting issues to the FDA. If an issue is severe enough for a company to initiate a recall, the agency will collaborate with the recalling firm to weigh the risk of a device against the benefits. It’s not always an easy call.
“It’s up to the FDA as well as the company, the product liability attorneys and the physicians and the patients, and everybody else to try to figure out where that compromise is,” said Drues.
Making the difficult call
Some devices may have stayed on the market longer than they should have due to a fear of shortages in healthcare facilities during the pandemic, said Madris Kinard, the founder and CEO of Device Events and a former unique device identification (UDI) external program manager and adverse events SME for medical devices at the FDA.
“The companies are making these decisions, and then the FDA might review them, but isn’t necessarily taking an active enough approach,” Kinard said.
BD’s Alaris infusion pump and vital signs monitoring system is designed to deliver controlled amounts of fluid, medication, blood and blood products. Photo courtesy of BD.
One example of a device that would have likely caused shortages in hospitals if recalled is BD’s Alaris pumps. In March 2020, the FDA called for a comprehensive 510(k) submission after BD recalled hundreds of thousands of Alaris pumps due to system-, software- and use-related errors. The pumps continued to face a series of Class I recalls until April 2021. As of publication, BD still had new shipments of the pumps on hold in the U.S. as it awaits the results of a required 510(k) clearance submission it made to FDA last year.
“They didn’t want to pull them for the software update if they were being used on a patient. And of course, with COVID going on, they probably were all in use,” Kinard said.
In another serious device recall last year, Medtronic’s HeartWare Ventricular Assist Device (HVAD) system was designed as a bridge to cardiac transplants in patients who were at risk of death from end-stage left ventricular heart failure, for heart tissue recovery or as destination therapy in patients who cannot receive heart transplants.
The Fridley, Minnesota-based medtech giant began recalling the HVAD pump implant kits in March 2021 and later stopped sales and implantations of the device altogether due to an increased risk of serious injury or death, yielding the market to Abbott’s competing technology.
When Medtronic stopped selling the HVAD in June 2021, it reported over 100 complaints involving a delay or failure to restart the HVAD internal pump, which led to 14 deaths and 13 pump removals. The medtech giant continues this year to work through Class I level recalls related to the device.
“I think the BD Alaris pumps and the HVAD are good examples of why recalls should be mandatory, because they postponed them,” Kinard said. “And if the FDA agrees because of COVID reasons, or if there’s something else, if it’s going to cause a market shortage. Of course, with the HVAD, it didn’t because there was another company that was better able to service those patients anyway.”