eNews April 6, 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.

Respiratory Award

Tell your customers that July 31 is the deadline for submitting a nomination for the National Respiratory Patient Advocacy Award, a collaboration of the American Association for Respiratory Care and The FACES Foundation. Among the qualifications is evidence that the nominee sets an exemplary level of professionalism and clearly demonstrates advocacy for the profession. Click here for more information about the award and nomination process.

Hire this kid

After juicing dozens of them, Dasia Taylor, a 17-year-old high school senior in Iowa City, Iowa, discovered beets provide the perfect dye for her invention — suture thread that changes color (from bright red to dark purple) when a surgical wound becomes infected, reports Smithsonian Magazine. Taylor had read about sutures coated with a conductive material that can sense the status of a wound by changes in electrical resistance, and relay that information to the smartphones or computers of patients and doctors. While these “smart” sutures could help in the United States, they are of lesser value in developing countries, where internet access and mobile technology is sometimes lacking.

Portable gamma ray camera

Scientists in the UK have developed a handheld imaging device – a portable gamma ray camera – said to offer 3D images of cancerous growths beneath the skin, reports New Atlas. The idea is to leverage the technology currently found in large, complex gamma ray imaging systems, which can take up entire rooms. These systems involve injecting a patient with low levels of radioactive tracer particles, which are taken up by cancer cells and which show up in subsequent scans, forming images that reveal the size and shape of cancerous growths.

GPO gobbles GPO

Vizient completed its acquisition of the purchasing group Intalere from the latter’s parent company, Intermountain Healthcare. Vizient says the acquisition will help it increase its presence in smaller and/or rural acute-care facilities. Vizient plans to bring the Intalere business fully under the Vizient brand by the end of 2021.

FDA warns about reprocessing urological scopes

The U.S. Food and Drug Administration has warned healthcare providers about the risk of infections associated with reprocessed urological endoscopes, including cystoscopes, ureteroscopes, and cystourethroscopes. The agency said it has received numerous Medical Device Reports (MDRs) describing patient infections post-procedure or other possible contamination issues associated with reprocessing these devices. While some reports point to inadequate reprocessing or maintenance issues (for example, device failed leak testing), the FDA is also evaluating other issues, including reprocessing instructions in the labeling and device design.

Barriers to new market entrants?

Want to know who’s NOT in favor of expanding Americans’ access to innovative medical devices? Some medical device companies, that’s who. In January, the FDA posted a proposal to exempt certain Class II medical devices from 510(k) premarket notification requirements. The agency says the average total cost ($31 million) for participants to bring a low-to-moderate-risk product from concept to clearance, as well as the time (average 10 months) companies typically spend from first filing to clearance for a 510(K) device, are barriers to new market entrants. The Medical Imaging & Technology Alliance (MITA) argued against exempting multiple CT and X-ray products from 510(k) requirements, because doing so “may erode the public’s confidence in the safety and efficacy of the devices in question.” Baxter, AliveCor and Pear Therapeutics also were reported to have expressed opposition to the proposal.

Orthopedic practice announces invention

A New York-based orthopedic practice has invented a bone and joint implant device that has the potential to counteract the effects of osteoarthritis, diminishing the need for joint replacement surgery. The invention from New York Bone & Joint Specialists is an anchor that increases blood circulation to soft tissue. It features a network of channels designed to maximize blood flow and rejuvenate vital structures, such as the meniscus, in a degenerating knee.