eNews July 12, 2022

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

Cybersecurity of medical devices

The American Hospital Associated voiced support for the Protecting and Transforming Cyber Health Care Act (S. 3983/H.R. 7084), which would require medical device manufacturers to meet certain cybersecurity requirements when seeking approval for devices that are internet-connected or that include software. The association made the announcement in a June 27 email. For example, the bill would require medical device manufacturers to monitor and identify post-market vulnerabilities in a timely manner, develop a plan for coordinated vulnerability disclosure, and provide lifetime cybersecurity support of the device. It also would provide a “software bill of materials” for all software contained in the device, including third-party software.

 

Recall classified as most serious

The FDA labeled its May 2 recall of the Getinge Flow-c and Flow-e Anesthesia Systems a class 1 recall, the most serious type. Use of these devices may cause serious injuries or death, the FDA said on July 6. Getinge is recalling the systems after receiving reports of cracked or broken on/off switches on the system’s suction unit. If the switch breaks, the suction unit will not work to remove fluids such as phlegm, blood, or stomach (gastric) content from the patient’s mouth and/or airways.

 

Semiconductor shortage worries device makers

Medical technology manufacturers have become more pessimistic about the semiconductor shortage, with respondents to a Deloitte survey predicting the disruption to continue into next year, reports MedTech Dive. Commissioned by AdvaMed, Deloitte surveyed the industry in July 2021 and again in April 2022. The second survey found almost 80% of respondents are experiencing extended lead times. Faced with the supply constraints, all respondents are pursuing alternative sources, having often relied on single semiconductor providers in the past, and 70% have increased inventory levels.

 

Pulse oximeter discrepancies outside the ICU

Studies have shown that Black patients in the ICU are more likely than White patients to have low oxygen levels that were missed by pulse oximeters, Now research in BMJ indicates that discrepancies exist in general-care inpatient settings as well. Researchers reported that in such settings in the Veterans Health Administration, where paired readings of arterial blood gas (SaO2) and pulse oximetry (SpO2) were obtained, Black patients had higher odds than White patients of having occult hypoxemia noted on arterial blood gas but not detected by pulse oximetry. This difference could limit access to supplemental oxygen and other more intensive support and treatments for Black patients.

 

Cardiomyopathy in U.S. expected to grow

The United States will have the highest number of diagnosed prevalent cases of cardiomyopathies in 2031, at over 2.3 million, according to healthcare market research firm GlobalData. This represents 83% of the total cases in the seven major market countries, with the next closest countries being Germany (5.7%) and Spain (2.9%). Cardiomyopathy is a general term for a collection of diseases that affect the heart muscle. The walls of the heart are thickened or stretched, reducing its ability to pump blood around the body and can lead to heart attack. Risk factors range from family history to diabetes, alcohol consumption, obesity and high blood pressure.

 

It’s on us!

Not a member of IMDA or HIRA? On Monday, July 25, at 3:30 p.m. Central, you’re invited to attend FREE OF CHARGE the electrifying opening session of the IMDA/HIRA Conference, “Materials management and value analysis: A live-wire discussion.” The conference will be held at the Eaglewood Resort in Itasca, Illinois. At the session, you will learn from, question, challenge and inform two highly regarded experts on healthcare materials management and value analysis – Barbara Strain and Dee Donatelli. If you consider Materials Management and Value Analysis to be barriers to providing your customers and their patients with life-saving medical technologies, it may be time to change your approach. Register now to attend the opening session on us and experience the knowledge exchange that IMDA and HIRA members have come to know.