eNews May 25, 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.

Medline and Teleflex

Medline announced its intention to acquire a significant portion of the Hudson RCI® brand of respiratory products from Teleflex. Medline will add the brand’s oxygen and aerosol therapy, active humidification, and pulmonary hygiene products to its respiratory division. As part of the acquisition, Medline will gain two manufacturing facilities – a respiratory sterile water products manufacturing plant in suburban Chicago, and a facility producing respiratory consumables in Nuevo Laredo, Mexico. In the U.S., more than 30 sales specialists and clinical specialists will join Medline’s Acute Care Specialty Sales group. The company’s announcement comes one month after The Wall Street Journal reported that Medline had hired Goldman Sachs Group to explore a sale of the company.

Cybersecurity risk: Your customers want to know

Given the growing incidence of cybercrime in healthcare, equipment suppliers would be well-advised to talk to their customers about cybersecurity, advises ECRI’s Marc Schlessinger in a recent AARC e-newsletter. With the ever-increasing digitization of healthcare, including EMR and more connected devices, there are more inherent cybersecurity risks, he writes. Many early medical devices designed to communicate with the hospital network lacked robust cybersecurity features, as do today’s devices. And while medical devices may have a long life, the security environment is constantly changing, with new vulnerabilities, threats, and exploits exposed every few months. For these reasons and more, IMDA members should expect customers to request the device’s MDS2 (Manufacturer Disclosure Statement for Medical Device Security) form prior to purchasing. This standardized form contains details of the device’s security features and functionality.

Supply chain looking at the next pandemic

A bill introduced May 19 in the U.S. Senate would strengthen America’s medical supply chain and improve the nation’s ability to respond to future pandemics, reports the Health Industry Distributors Association. The Medical Supplies for Pandemics Act would allow the Strategic National Stockpile to 1) partner with commercial distributors to manage inventory and prevent expiration of critical pandemic supplies, 2) work with manufacturers to geographically diversify production sources of medical supplies, and 3) work with manufacturers to ensure there can be enhanced production of supplies during emergencies.

Software bill of materials

The Biden administration signed an Executive Order on May 12 requiring that medical equipment and device manufacturers provide customers a Software Bill of Materials, that is, an electronically readable inventory of third-party components in devices, reports MedTech Dive. At the recent Food & Drug Law Institute annual conference, Zach Rothstein, AdvaMed’s vice president for technology and regulatory affairs, said the medical industry is very supportive of the concept but wants to see uniform standards to ensure that device manufacturers “don’t have to create 10 different versions of the same document.”

Back-end approach to oxygenation

Scientists are hopeful about a procedure that could one day be used to treat people with low oxygen, without risking the lung damage that can be caused by mechanical ventilators. Reporting in The Scientist, researchers introduced into mice – through the anus — an oxygenated liquid known as perfluorocarbon. (In previous clinical studies, perfluorocarbons carrying dissolved oxygen have been administered directly into human eyes and blood vessels, as well as to the airways of premature infants to help reduce lung injuries.) The mice showed improvements in the oxygen pressure in their blood and were more active after their infusion than were control mice that received saline. Then the team tested the strategy in anesthetized pigs. They used a ventilator only five or six times per minute to induce nonlethal respiratory failure and then rescued the pigs from hypoxia with an enema-like administration of oxygen-loaded perfluorocarbon. No obvious side effects were observed. To further test safety, they infused perfluorocarbon into the intestines of rats. The rats were not dehydrated, did not experience diarrhea, and the levels of organ toxicity markers were the same or less than those observed in the saline control.

You’re Worth It

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!