eNews June 8, 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.

‘Everything is hackable’

Cyber threats to the medical device industry, including ransomware and other malware, are growing in sophistication and putting patient safety at risk, according to Kevin Fu, acting director of medical device cybersecurity at the FDA’s Center for Devices and Radiological Health, reports Medtech Dive. “It’s not just a kid in their basement causing trouble. These are financially motivated intruders who are going after the low-hanging fruit,” Fu told the Food & Drug Law Institute annual conference recently. Sophisticated cybercriminals are targeting medical devices, and as manufacturers increasingly use and depend on the cloud for real-time functions, the industry will likely see patient safety issues arise, he says. “Everything is hackable.”

Graduation Day for Advanced Practice RTs

The first class of students to earn the Master of Respiratory Care, Advanced Practice degree, graduated in May from Ohio State University, reports the American Association for Respiratory Care. The degree is said to be the first in the country designed to prepare respiratory therapists as advanced care providers (APRTs) at the master’s degree level. Ohio State received provisional accreditation from the Commission on Accreditation for Respiratory Care, or CoARC, in December 2019.

Most master’s degree programs for RTs currently available are focused on advanced education in leadership, research, education, and administration, said Associate Professor and Director of Clinical Education Sarah Varekojis, PhD, RRT, FAARC. “This is a clinical practice Master of Respiratory Therapy, which leads to a role as a cardiopulmonary advanced practice provider.” Students must complete 1,000 hours of clinical experience within the curriculum.

AARC published a scope of practice for APRTs in February 2020. It states that an APRT may perform medical acts, tasks, or functions in accordance with state licensing laws that are:

  • Related to the care of persons with problems affecting the cardiovascular and/or cardiopulmonary systems.
  • Delegated by a supervising physician to an APRT.
  • Within the scope of practice identified in collaboration with the supervising physician.
  • Appropriate to the APRT’s education, experience, and level of competence.
  • Related to the prescribing, ordering, procuring, dispensing, and administering of drugs, medical care, and medical devices related to the cardiovascular and/or cardiopulmonary systems.

MDR goes into effect in Europe

If your manufacturer partners – particularly those who sell in the European market – seem distracted these days, it is with good reason. On May 26, the Medical Device Regulation (MDR) went into effect. The MDR places more emphasis on a life-cycle approach to safety, backed up by clinical data than prior directives, according to the European Commission. The MDR:

  • Brings more stringent requirements for the designation of Notified Bodies (independent organizations responsible for assessing and recertifying most medical devices).
  • Reclassifies certain devices and has a wider scope. For instance, the MDR explicitly covers all devices for cleaning, sterilizing or disinfecting other medical devices, and reprocessed single-use medical devices.
  • Covers Internet sales of medical devices.
  • Introduces a new Unique Device Identification system, intended to “significantly enhance the traceability and the effectiveness of post-market safety-related activities.”
  • Provides increased transparency, with information on devices and studies being made public.

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!