Dive Brief:
- An industry group made up of GE Healthcare, Medtronic and others, in collaboration with FDA device officials, has developed emergency use guidance for the remote control of medical devices during the coronavirus pandemic.
- The standards-based document, put together by the Association for the Advancement of Medical Instrumentation and others, seeks to give practical consensus guidelines for adding remote-controlled capabilities to hospital devices including ventilators and infusion pumps.
- Using unprecedented regulatory flexibility during the pandemic, medtechs such as GE Healthcare, Medtronic, Philips, and ResMed, all members of AAMI's response team, have modified products with remote control capabilities to create safe physical distances between providers and COVID-19 patients. The guidance highlights common system elements and safety and risk control measures device makers and caretakers should consider in implementing remote technology.
Dive Insight:
Prior to the pandemic, remote programming and monitoring of a wide swath of medical devices was already gaining momentum. However, these features have become critical for creating safe physical distance between frontline healthcare workers and COVID-19 patients to prevent virus transmission and reduce the need for limited personal protective equipment.
"The FDA has recognized the clinical benefits and the reduction of PPE consumption," said Julian Goldman, co-chair of AAMI's COVID-19 Response Team and Mass General Brigham's medical director of biomedical engineering, noting medtechs have several pathways during the public health emergency for getting remote control devices out to hospitals.
When it comes to remote-controlled ventilators, infusion pumps and physiological monitors, Goldman contends "it's a no-brainer" for medtechs looking to leverage the broad regulatory flexibilities put in place earlier this year.
FDA in March first issued an enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the public health emergency, and began granting emergency use authorizations for certain remote or wearable patient monitoring devices.
The AAMI document offers an overview of key safety issues to consider for remote control capabilities for medical devices using an "auxiliary Human Machine Interface" under the scope of an EUA or the FDA's enforcement policy, providing design considerations "to guide the regulatory review of these devices."
Sandy Weininger, a senior electrical/biomedical engineer at the FDA's Center for Devices and Radiological Health, also serves as co-chair of the AAMI COVID-19 Response Team that developed the guidelines with the input of six other members from CDRH.
While a disclaimer in AAMI's guidance emphasizes that participation by FDA representatives "does not constitute endorsement" by the agency, Weininger believes this is the time for medtechs to innovate.
"The FDA has paved the way for innovation with very low overhead because the clinical need is recognized," Weininger said in a written statement, noting that early in the pandemic there was some "uncertainty" about how to implement remote control for some critical medical devices, particularly among non-medtech companies.
"You had this perfect storm of scarcity of parts, testers who aren't in labs, and constructors trying to innovate in spaces they’re not entirely familiar with. So, we’ve leveraged existing device standards while narrowing the scope, slicing up the apple and only taking the immediately useful parts," Weininger added.
Goldman, an anesthesiologist at Mass General, advises medtech manufacturers to act quickly, take advantage of the FDA's regulatory flexibilities during the pandemic to improve their products, and get much-needed remote-controlled devices out to hospitals.
"This is their chance to get real-world evidence" with an eye towards future regulatory submissions to the FDA once the pandemic ends, Goldman said. "They should not squander this opportunity."
Lessons learned from Goldman's work on the remote control of medical devices during the 2014 Ebola outbreak helped to inform the guidance from AAMI's COVID-19 Response Team. However, he sees remote-controlled devices as permanent parts of the healthcare landscape after the current public health crisis ends beyond just infectious disease.
"Remote control is a capability that if present in medical devices and done in a thoughtful, safe way, hopefully following interface standards, will be a key enabler to develop next-generation healthcare environments," Goldman said. "The horse is out of the barn. As you change expectations of the clinical community for their medical equipment and how they can best serve patient care, it's very hard to go back."
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December 02, 2020 at 11:30PM
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Medtechs, working with FDA, offer guidance for remote control of medical devices during pandemic - MedTech Dive
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