eNews May 13, 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.

Surgeries reopening for business

North American cardiovascular societies have crafted joint guidance on the safe reintroduction of invasive procedures and diagnostic tests, as more U.S. states ease restrictions on elective medical care, reports MedTech Dive. The guidance, published in the Journal of the American College of Cardiology, discusses how surgeons should make decisions on restarting invasive cardiovascular care caseloads, including transcatheter aortic valve replacement (TAVR) and mitral valve repair. The plan details the schedule for restarting procedures involving devices from medical technology firms.

ECMO life support: Last hope for COVID-19 recovery

When conventional treatments have failed, extracorporeal membrane oxygenation, or ECMO, can be a COVID-19 patient’s last hope for recovery, according to an article in HealthLeaders. The ECMO machine is connected to a patient through plastic tubes that are placed in large veins and arteries in the legs, neck, or chest, according to the American Thoracic Society. Blood flows through the machine, which adds oxygen to the blood and removes carbon dioxide, then the blood is returned to the patient. ECMO technology has advanced significantly since it was developed in the early 1970s, but it remains a high-risk intervention.

Hospital consolidation: The downside.

The founders of Hoag Memorial Hospital Presbyterian, a two-hospital system in Southern California, filed suit against Providence Health seeking to dissolve its affiliation with Providence. Speaking with HealthLeaders Media, Hoag President and CEO Robert Braithwaite talked about what he called a “paradox of scale” for smaller hospitals and health systems. “On the one hand, everybody oftentimes just thinks of the upside of scale, where maybe [organizations] need a brand lift, financial help, or access to more physicians,” he said. “[However], there is the other side, where, at times, scale is too big and does constrain, or it’s not efficient and nimble for the communities that healthcare organizations are trying to serve. When [leaders] examine both sides of that paradox, they’ve got to keep what the community needs front and center.”

Manufacturers’ responsibilities in public health emergencies

IMDA members: Let your manufacturers know about a recent FDA guidance document that offers instructions on how to notify the agency of product shortages or discontinuations during public health emergencies, such as COVID-19. Of special interest to the FDA are “devices that are critical to public health during a public health emergency, including those that are life-supporting, life-sustaining or intended for use in emergency medical care or during surgery,” and “devices for which FDA determines information on potential meaningful supply disruptions is needed during a public health emergency.”