eNews October 6, 2020

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

How is COVID-19 affecting your business, your people, your customers? IMDA is a membership organization, and in times like these, we can all use some camaraderie. If you have a COVID story to share, advice to offer, or a warning to sound, send it to Mark Thill, IMDA’s communications director, at mdthill1913@gmail.com, with the subject line “IMDA COVID story.” We’ll compile them and send them back out to you.

EtO regulations still pending

The final federal rule limiting ethylene oxide emissions from commercial medical sterilization plants is now set to come out in 2021, reports Medical Design & Outsourcing. Before the COVID-19 pandemic struck, the Environmental Protection Agency had expected to issue the proposed rule in the spring of 2020. The agency considers EtO a carcinogen, and EtO emissions have attracted national scrutiny since Illinois state officials closed a Sterigenics plant in Willowbrook, Ill., in February 2019. Because nearly one-third of the commercial sterilizers the rule could affect are small businesses, the EPA is required by law to convene a Small Business Advocacy Review Panel. The panel met in June and will meet again this fall to understand the potential impacts of the rule on small businesses.

For frontline providers, remote programming and monitoring

Remote programming and monitoring of medical devices have become paramount features, in part due to COVID-19, reports MedTech Dive. Given FDA regulatory flexibility, Medtronic, Philips, ResMed and others have modified existing products so frontline providers could reduce virus exposure. Medtronic worked with Intel to create a remote management capability for its Puritan Bennett 980 ventilator, allowing providers to adjust the breathing machine’s settings outside of hospital ICUs. ResMed developed cloud-based remote monitoring software for ventilators across Europe, providing clinicians with access to respiratory information using their smartphones. And the FDA issued guidance in April expanding the remote monitoring and manual control of infusion pumps.

Better system needed to report adverse events

The Food and Drug Administration needs to do a better job tracking and identifying adverse events related to medical devices, conclude the authors of a study in JAMA Internal Medicine. “An efficient modern surveillance system would require automatic collection and continuous analysis of real-time, real-world data from multiple electronic sources (such as anonymized electronic patient records),” the authors wrote, according to MedTech Dive. Madris Tomes, a former FDA analyst who now runs a safety-focused company, recommends that physicians be required to report adverse events directly to the FDA, and that the collection of reports via a third-party mobile app be permitted.

Bleed monitoring system wins GPO contract

Saranas, Inc., developer of the Early Bird® Bleed Monitoring System for early detection of internal bleed complications during endovascular procedures, was awarded a group purchasing agreement with Premier Inc., as part of Premier’s Technology Breakthroughs program. The agreement, effective November 1, allows Premier’s network of over 4,100 U.S. hospitals and health systems to receive special pricing and access to the Early Bird.