The patient safety organization ECRI has named the federal government's authorization of certain medical devices during the COVID-19 public health emergency the top technology hazard this year.
The Food and Drug Administration since February of last year has issued emergency use authorizations for some medical devices the industry can use to respond to COVID-19. Emergency use authorization allows the FDA to approve devices for uses that haven't gone through the agency's usual approval process, but it's determined the potential benefits of the device outweigh potential risks.
ECRI said the emergency use authorization presents safety risks for patients and liability challenges for providers because the FDA can revoke authorization of a device at any time.
Some of the devices the FDA has approved for emergency use authorization during the pandemic are decontamination systems to clean respirator masks; ventilators and surgical masks.
ECRI is concerned providers are using devices under emergency use authorization but don't have systems in place to monitor their impact on patient safety, how the devices are being used and when the FDA removes authorization, said Dr. Marcus Schabacker, CEO of the organization.
To avoid safety risks and liability challenges with the use of these devices, ECRI suggests providers set up a committee headed by a C-suite level executive that lays out guidelines for how and where the device can be used as well as monitor its impact on patients, Schabacker said. The committee should also keep track of its authorization by the FDA.
ECRI also recommends providers reach out directly to the manufacturer of the device to ask if they have done safety testing on the product and if they plan to receive permanent FDA approval after the public health emergency ends.
In response, the FDA said devices approved through emergency use authorization are still subject to adverse event reporting, which involves manufacturers submitting such reports to the FDA within 30 days after becoming aware of the adverse event, according to a statement emailed Friday evening.
The FDA's Center for Devices and Radiological Health also alerts the public and stakeholders of any revisions to emergency use authorizations.
"The Center for Devices and Radiological Health is developing guidance for transitioning EUA authorized devices to traditional premarket clearance or approval," the FDA added.
Each year ECRI releases a list of the top 10 health technology hazards. ECRI staff, which includes engineers, clinicians and patient safety analysts, help compile the list. The top 10 hazards aren't necessarily the most frequent or severe problems in the industry but rather what ECRI determines warrants attention immediately. "We try to identify areas where people are not currently paying attention," Schabacker said.
The second hazard ECRI selected this year was medication errors that occur when the wrong drug is selected using entry systems. To make drug ordering easier, some systems auto-populate a list of drugs to choose from when entering the first few letters of the drug. The auto-populate feature causes some to order the wrong drug by mistake. The Institute for Safe Medication Practices, which is part of ECRI, has received reports of such mistakes leading to severe harm and even death.
ECRI suggests entering in more letters to avoid this error. ECRI found in an analysis of drug names that 92% of FDA-approved drugs have the same first three letters as another drug. By comparison, 58% of drugs have the same first five letters as another drug.
The third hazard named by ECRI stems from the safety and cybersecurity risks that result from rapid adoption of telehealth. Many healthcare organizations quickly stood up telehealth services or expanded them in 2020 due to stay-at-home orders and to conserve personal protective equipment.
In the report, ECRI said telehealth can increase the risk for errors, lead to poorer treatment and exacerbate inequities in access to care. Additionally, rushed adoption of telehealth can be vulnerable to cybersecurity oversights.
ECRI suggests healthcare organizations thoroughly review their telehealth platforms to ensure the service complements in-person care well, integrates into the workflow for providers and is offered to the best candidates for telehealth. A risk assessment for cybersecurity should also be conducted.
The full report is available to ECRI members.
