eNews Aug 17, 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.

‘Get better about cybersecurity or get out of the way’

Medical technology companies must design and develop devices that “have far more robust security built in” to keep pace with emerging cybersecurity threats and vulnerabilities, Suzanne Schwartz, director of CDRH’s Office of Strategic Partnerships and Technology Innovation said during a presentation at the recent HIMSS21 conference, reports MedTech Dive. To do that, device developers need better threat models, which lay out what hackers might do to target a device and how to protect it, she said. Schwartz is the latest CDRH official in recent months to warn about lackluster threat models from medical technology companies. Kevin Fu, CDRH’s acting director of medical device cybersecurity, in May told the Food & Drug Law Institute conference that companies must do a better job and that FDA “has denied premarket clearance based solely on cybersecurity concerns for medical devices.”

Novel technology manufacturers look to the U.S. market

Based on an 87% response rate from companies contacted about novel technology devices between 2018 and 2020, 62% of companies said they intended to bring their devices to the United States first or in parallel with other major markets by December 31, 2020, reports the FDA’s Center for Devices and Radiological Health. Between January 2018 and December 2020, CDRH identified 1,090 manufacturers of novel technology. As of May 2021, more than 900 of these manufacturers shared with CDRH their plans for bringing their device to market.

Hyperbaric oxygen therapy: Get the facts

Hyperbaric oxygen therapy (HBOT) is used to treat a variety of health problems, including carbon monoxide poisoning and diabetic foot ulcers. But the FDA warns users to be skeptical about claims of HBOT’s capabilities  – e.g., that it can cure cancer, Lyme disease, autism or Alzheimer’s disease. As of July 2021, the FDA has cleared hyperbaric chambers for the following disorders:

  • Air and gas bubbles in blood vessels
  • Anemia (severe anemia when blood transfusions cannot be used)
  • Burns (severe and large burns treated at a specialized burn center)
  • Carbon monoxide poisoning
  • Crush injury
  • Decompression sickness (diving risk)
  • Gas gangrene
  • Hearing loss (complete hearing loss that occurs suddenly and without any known cause)
  • Infection of the skin and bone (severe)
  • Radiation injury
  • Skin graft flap at risk of tissue death
  • Vision loss (when sudden and painless in one eye due to blockage of blood flow)
  • Wounds (non-healing, diabetic foot ulcers)

HBOT is being studied for other conditions, including COVID-19. However, at this time, the FDA has not cleared or authorized the use of any HBOT device to treat COVID-19.

Try us. You’ll like us.

You don’t have to be an IMDA member to attend the IMDA/HIRA Annual Conference, Sep. 27-29 in suburban Chicago. But you might want to join by the time it’s over. Non-members pay more to attend the Conference than members, but if you join IMDA within 90 days after Sept. 29, 2021, IMDA will deduct the non-member portion you paid from your first annual dues. That’s how sure we are that once you try us, you’ll like us.