The FDA's emergency use authorizations in early 2020 remain mostly in effect, creating potential risks to patient safety.
The COVID-19 pandemic is well over 18 months old, yet medical devices that the U.S. Food and Drug Administration (FDA) temporarily authorized for use remain, for the most part, still in use under that emergency edict.
That is a big problem, says Marcus Schabacker, MD, PhD, president and CEO of ECRI.
Early this year, ECRI named "complexity of managing medical devices with COVID-19 emergency use authorization" (EUA) at the top of its annual list of health technology hazards for 2021.
"We're not arguing for universal revocation of emergency use authorizations," Schabacker says. "We are saying there are risks associated with EUAs. We believe the FDA definitely, but also the hospital, has an obligation to manage this proactively."
Marcus Schabacker, MD, PhD, is the president and CEO of ECRI. Photo courtesy of ECRI.
The FDA granted emergency device EUAs at a time when many essential devices needed to treat the pandemic, such as ventilators, were in short supply. Inventors stepped forward, devising makeshift ventilators and related devices to address the shortage.
And yet, these devices have gone through a massively abbreviated authorization process, not having had to demonstrate safety and efficacy in the same rigor as the FDA's two main authorization mechanism, the 510(k) Premarket Notification, and the Premarket Approval (PMA).
EUAs are not new. "It hasn't been used very often," Schabacker says. But since the beginning of the pandemic, the FDA has approved more than 1,000 EUAs for medical devices, therapies, drugs, and other consumables, he says.
But the FDA's 510(k) and PMA approval process ultimately does not end up covering all devices in use in healthcare. For instance, Class III devices already on the market in 1976 or before are not subject to PMAs.
In 2020, the FDA listed numerous categories of device EUAs that were covered during the COVID-19 pandemic:
- Blood purification devices
- Continuous renal replacement therapy and hemodialysis devices
- In vitro diagnostic devices (IVD) for molecular diagnostic tests, antigen diagnostic tests, and serology tests for SARS-CoV-2, and IVDs for management of COVID-19 patients
- Infusion pumps
- Personal protective equipment
- Remote or wearable patient monitoring devices
- Respiratory assist devices
- Ventilators and ventilator accessories
- Other medical devices
"So far, the FDA has gone one by one and only revoked two handfuls—only nine of the many hundreds have been revoked so far," Schabacker says.
ECRI urges the FDA and hospitals that are using those EUA-authorized devices " to assess the necessity of maintaining the EUA," he says.
"We have a process for a reason in the United States, to ensure the safety and efficacy of medical devices, therapies, and therapeutics," Schabacker says. "For good reason, that can be shortcutted, which the FDA did in 2020, but there's an obligation to protect the public, and the patients in particular, that these EUAs now get reviewed and revoked."
There is also a burden on the healthcare suppliers to withdraw such devices until they have been proven safe and effective, he says. Hospitals should be seeking alternative products that have ordinary 510(k) or PMA approval, and substitute them, wherever possible, for devices currently in use under the FDA's EUA process, he adds.
In addition, the surge in EUA-approved devices is causing further delays in the already-lengthy process of submitting any device for 510(k) or PMA approval, Schabacker says. "It's just exaggerating the problem," he says.
In addition, hospitals need to be vigilant to know when a device has had its EUA revoked, Schabacker says.
"If these EUAs get revoked, and [hospitals] continue to use these devices with an EUA, they're out of compliance," he says. "They're seeing liability risks. They're essentially using a non-approved, non-authorized device. And if anything happens to the patient, their liability risk would go dramatically up."
ECRI believes that its tools, also instrumental in helping providers manage medical device product recalls, help providers manage these risks, Schabacker says.
ECRI is urging its customers to have a plan in place to ensure continued operation in the event that devices they are using have their EUAs revoked, he says.
"Once the EUA has been revoked, you cannot continue to use the device," Schabacker says. The one exception to this is devices currently in use with a patient, such as a ventilator, but even those ventilators would need to be removed, once that patient is off that ventilator.
So far, ECRI is not aware of any adverse events happening to patients that can be ascribed to a medical device that only has EUA authorization, Schabacker says. But this might also be due to delays in device-related adverse event reporting due to COVID-19.
"What we did see is that during the height of the pandemic, the likelihood of reporting any events went down," Schabacker says. "I think healthcare providers were simply overwhelmed and did not have the time and the focus to report potential events."
Asked if organizations such as the American Hospital Association or AdvaMed, the Advanced Medical Technology Association, have expressed concerns about the lingering device EUAs, Schabacker says neither organization had been in touch with ECRI with concerns.
“If these EUAs get revoked, and [hospitals] continue to use these devices with an EUA, they're out of compliance. They're seeing liability risks. They're essentially using a non-approved, non-authorized device. And if anything happens to the patient, their liability risk would go dramatically up.”
Marcus Schabacker, MD, PhD, president & CEO, ECRI
Scott Mace is a contributing writer for HealthLeaders.
Normal 510(k) and premarket device approval processes were bypassed, and only nine devices have had Emergency Use Authorization (EUA) revoked so far.
Traditional approval confirms the safety and efficacy of medical devices.
Hospitals should have plans in place to remove devices that have EUA approvals revoked, says ECRI.