eNews August 23, 2022

30 minutes to remove heart tumor

Interventional cardiologists at the University of Washington in July used a catheter-delivered retrieval device to remove a benign tumor from a patient’s heart, reports Cardiovascular Business. The 30-minute procedure is reported to be the first time such a device has been used to remove a heart tumor. The catheter-delivered device in question, the ŌNŌ retrieval system, gained FDA clearance in May. It was designed and developed by Onocor, a U.S. healthcare startup with roots in the Penn Center for Innovation.

Alarming rise in medical device reports

The Food and Drug Administration will carry out an in-depth review to determine why it received more than twice as many medical device reports (MDRs) from May to July 2022 than it did from April 2021 to April 2022, reports MedTech Dive. Medical Device Reporting is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. From May 1 to July 31, 2022, the agency received more than 48,000 MDRs – and reports of 44 deaths — related to the breakdown or suspected breakdown of foam in Philips respiratory devices, including certain ventilators and sleep apnea machines.

National RC Week Oct. 23-29

National Respiratory Care Week is coming up Oct. 23-29. The American Association for Respiratory Care offers an RC Week Planning Guide with suggestions on how hospitals and health systems can make the week special, including tips on notifying local media about RC Week and a link to the AARC Store and RC Week merchandise.

23 commercial EtO sterilizers present risk

The Environmental Protection Agency is expecting to propose an air pollution regulation later this year to address ethylene oxide (EtO) emissions at commercial sterilizers. (Long-term exposure to high concentrations of EtO can increase the lifetime risk of getting cancer.) Recently, the agency collected information from almost 100 commercial sterilizers and found elevated risks in residential areas among 23 of them. The agency will also release proposed limits on how EtO can be used within sterilization facilities with the goal of reducing risks to workers who handle it and those who are exposed in other ways, like working or attending school near a facility.

From the 2022 IMDA/HIRA Conference

Strategic accounts demand strategic selling

Now we know what it takes to change the course of the ocean freighter known as the American healthcare system: A pandemic. Specialty dealers and reps have to adapt.

Speaking at the 2022 IMDA/HIRA annual conference in Itasca, Illinois, Maria Hames, partner, Healthcare Links, listed for specialty dealers and reps just some of the changes that COVID-19 has accelerated among supply chain executives, including:

• A more serious look at “made in USA” technologies (while balancing cost with risk mitigation).
• Concern about sole-source or limited-source relationships. (Given the product shortages of the past two years, providers are wary of getting burned again.)
• Redefinition of the traditional relationship between sales rep and customer. (Zoom calls are probably here to stay, and reps must hone their on-screen skills. That said, it’s unlikely virtual calls will occur as frequently as they did at the height of COVID-19.)
• Labor shortages among clinical and non-clinical workers alike, which are taxing processes and people – i.e., customers and potential customers — in the health system.
• Skepticism about “just-in-time” programs, which is leading supply chain executives to take another look at consolidated service centers.
• A serious look at taking inhouse some of the “non-core services” providers outsourced over the past decade.
• Continued emphasis on reducing variance in the medical procedures their clinicians perform and the supplies and equipment they use for them.

As providers reconsider their mission and focus on their potential role in the prevention of disease, wellness, and disease management, suppliers need to step up, said Hames. But they must produce evidence to prove the value of their products and services. For reps, it’s an opportunity to distinguish themselves through strategic selling.

Watch future issues of IMDA eNews for more reporting from this summer’s IMDA/HIRA conference.