eNews Sep. 15, 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.

 

Rethink EUAs, says ECRI president

Since the beginning of the pandemic, the FDA has approved more than 1,000 Emergency Use Authorizations (EUAs) for medical devices, therapies, drugs and other consumables, but has only revoked a handful of them since. That’s a problem, says Marcus Schabacker, M.D., PhD., president and CEO of ECRI. “We’re not arguing for universal revocation of emergency use authorizations,” Schabacker was quoted as saying in HealthLeaders Media. “We are saying there are risks associated with EUAs. We believe the FDA, definitely, but also the hospital, has an obligation to manage this proactively.” In 2020, the FDA listed numerous categories of device EUAs, including blood purification devices, continuous renal replacement therapy and hemodialysis devices, respiratory assist devices and ventilators and ventilator accessories. The devices went through an abbreviated authorization process instead of the more rigorous 510(k) Premarket Notification and Premarket Approval programs.

Relief fund for respiratory therapists

The American Association for Respiratory Care is activating its Disaster Relief Fund for AARC members in Oregon and California who have been affected by the recent wildfires, and in Louisiana, Mississippi, Tennessee, New York, and New Jersey for those impacted by Hurricane Ida. Members living in federally declared disaster areas in these states may apply for a grant of up to $500. The AARC Disaster Relief Fund was established in 1992 and has been used following hurricanes in Florida and Hawaii, earthquakes and fires in California, flooding in the Midwestern states, tornadoes in numerous areas of the country, and in the aftermath of Hurricane Katrina. The Disaster Fund is open for six months from the date of the disaster.

Renal failure device is designated a Breakthrough

Carlsbad, California-based ImpediMed Limited announced that its SOZO® Digital Health Platform has been designated a Breakthrough Device by the U.S. Food and Drug Administration. Using bioimpedance spectroscopy — a noninvasive technology that can measure a patient’s total body water, extracellular and intracellular fluid volumes in a clinical setting – the system aims to provide clinicians with a more precise measure of fluid volume to be removed from a renal failure patient during dialysis. The current standard-of-care method to measure the accumulation of fluid in kidney failure patients uses weight scales.

Blood loss monitored during surgery

Stryker completed its acquisition of Gauss Surgical, Menlo Park, California, developer of Triton™, an artificial-intelligence-enabled platform for real-time monitoring of blood loss during surgery. Triton has demonstrated improvements in maternal and surgical care through earlier recognition of hemorrhage leading to earlier intervention. Up to 5 percent of mothers experience a post-partum hemorrhage,, which is the leading cause of maternal death globally, said Stryker. Studies suggest that 70 percent of these are preventable.

Endoscopic spinal surgery

Joimax®, a German-based spinal surgery company, received FDA clearance to market the EndoLIF® Delta-Cage and EndoLIF® DoubleWedge-Cage in the United States. The cages are intended for intervertebral body fusion procedures for various diseases of the lumbar spine, such as degenerative disc disease. “With FDA clearance of two of our cages, our EndoLIF® platform gets more complete,” joimax® Founder and CEO Wolfgang Ries was quoted as saying. “The next major step in endoscopic spinal surgery is endoscopically assisted fusion.”

Pediatric Pandemic Network formed

Five children’s hospitals have created the Regional Pediatric Pandemic Network, intended to prepare for caring for children in disasters and global health threats. The HHS Health Resources and Services Administration awarded $9.7 million per year to fund a five-year grant for the program, which includes UH Rainbow Babies and Children’s Hospital (Cleveland), University of California San Francisco-Benioff Children’s Hospital, University of Louisville School of Medicine-Norton Children’s Hospital, University of Utah Primary Children’s, and Saint Louis University-Cardinal Glennon Children’s Hospital.

Amazon Cares

Amazon is planning to expand its primary care service to 20 additional metros this year and in 2022, reports MedCity News. Called Amazon Care, the program consists of an app with virtual visits and the ability to chat with a registered nurse. If a clinician recommends an in-person visit, a mobile care nurse is dispatched to that person’s home to collect lab samples, administer vaccines, and test for strep and other common conditions. The telehealth service is available in a handful of states, including Washington state, California, Virginia, Texas, Ohio, Michigan, Maryland and Washington D.C. But access to in-person services is currently limited to Washington state, Washington D.C., and Baltimore. The company reportedly plans to expand the in-person services to Philadelphia, Chicago, Dallas and Boston.