eNews July 14, 2021

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.

Backlog at ports must be addressed: AdvaMed

Medtech trade group AdvaMed wants the Biden administration to put the transport of medical supplies at the top of its list to address supply chain problems at ports worldwide, reports Medical Design and Outsourcing. On his first day in office, President Biden issued an executive order promising to secure the pandemic supply chain and create a U.S. manufacturing base to fill the strategic national stockpile. Medical technology companies answered the call to produce PPE, diagnostic tests, vaccines, needles and syringes, but were frustrated by materials shortages and distribution snafus, says AdvaMed. The more recent backlog of ships unable to unload their cargo at U.S. and other ports has further exacerbated the supply chain problem, according to AdvaMed.

EMS device for deep stab wounds

When someone is suffering from a deep stab wound, it’s important to apply pressure within the wound, not just down onto it. A student-designed device is intended to let first responders do just that, reports New Atlas. At the scene of a stabbing, if the knife or other implement is still inside the wound, it’s typically left in place until an ambulance arrives. This is because it acts somewhat like a cork, with the pressure that it’s applying actually helping to limit internal bleeding. In many cases, however, police arrive to find an open stab wound that urgently needs to be “plugged.” For that purpose, Joseph Bentley – a final-year Product Design and Technology student at Britain’s Loughborough University – created the REACT tool, short for “rapid emergency activating tamponade.” The handheld device consists of two parts. One of these parts – the tamponade – is a medical-grade silicone sleeve that’s initially inserted into the wound. The other part, called the actuator, is then coupled to a valve on the tamponade and used to inflate it.

Medicare coverage for breakthrough devices

Bipartisan legislation would require Medicare to cover breakthrough medical devices cleared by the FDA, reports Fierce Healthcare. The legislation, introduced in the House on June 23, would require Medicare to cover all breakthrough products approved by FDA for four years. During that time, the Centers for Medicare & Medicaid Services (CMS) would determine whether coverage should be permanent. Sometimes it can take CMS up to three years after a device is approved to grant a national coverage determination that ensures Medicare reimbursement. The Ensuring Patient Access to Critical Breakthrough Products Act would also give temporary coverage for any breakthrough devices that did not exist or were not considered when Medicare was first created, including digital therapeutics

FDA is working overtime this year

Premarket approval applications (PMAs) are on track to hit a record high in 2021, according to Wells Fargo analysts, reports MedTech Dive. The applications are adding to FDA’s workload at a time when the agency is warning review times are slowing because of the volume of work. Despite the pressures, FDA is on track to issue record numbers of safety communications and letters to healthcare providers in 2021, as well as to conduct more advisory committee meetings than in recent years.

Do not hoard!

The Department of Health and Human Services extended until Nov. 15, 2021, its “no hoarding” policy, which forbids the “excessive accumulation by people or entities not needing excess supplies” of several materials deemed essential during the pandemic, including N-95 filtering facepiece respirators; powered air purifying respirators; portable ventilators; and ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators.

Feds draw the line on imported respirators

The U.S. Food and Drug Administration is revoking Emergency Use Authorizations (EUAs) of all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, which includes imported disposable respirators such as KN95s, along with revoking EUAs for decontamination and bioburden reduction systems. Since the beginning of the pandemic, NIOSH has approved more than 875 respirator models or configurations, with some of these manufactured by approximately 20 new, domestic NIOSH-approval holders. In addition, as of today, there are more than 6,400 total respirator models or configurations on the NIOSH-certified equipment list that have met the NIOSH-approved EUA criteria and thus are FDA-authorized.

Think ROI … because your customers are

Learn how to clarify and articulate your return-on-investment for your manufacturers and customers at this fall’s 2021 IMDA/HIRA Annual Conference, “ROI: It’s More Than Just Money,” Sept. 27-29, in suburban Chicago. You know you’re worth it. Now let everyone else know it too!