In the News: FDA to strengthen medical device cybersecurity, infusion pump issues in Europe, and more
As medical devices are increasingly connected to the internet or other healthcare facility networks, the importance of medical device security protocols cannot be overstated as a hacker attack can have costly repercussions, including reputational damage and increased risk to patients.
With cybersecurity top of mind for many healthcare leaders right now, senators recently introduced a Bill that would require the FDA to update medical device security guidelines every two years. According to coverage by HealthITSecurity, this Bill is important because “...it sets out requirements to update the guidance on a more frequent and regular basis, thereby recognizing the dynamic and changing nature of the threat and it lays out responsibility for regularly updating information for improving cybersecurity of medical devices both before and after manufacturing.”
In other healthcare news, Smiths Medical issued an urgent field safety notice in Europe regarding its Medfusion 3500 and 4000 infusion pumps, and the Surgeon General released guidance to help healthcare organizations strategically mitigate the risk of burnout. Plus, learn how Elite is partnering with the AAMI to help the next generation of BMETs.
The Strengthening Cybersecurity for Medical Devices Act calls on the US Food and Drug Administration (FDA) to regularly update its security guidelines for medical devices.
It would also require the FDA to work with the Cybersecurity and Infrastructure Security Agency (CISA) to review industry guidance, make appropriate updates every two years, and provide the industry with new information on improving the cybersecurity of medical devices.
This new information should include guidance on identifying and addressing medical device security vulnerabilities and how providers, health systems, and medical device manufacturers can effectively get support from CISA, HHS, and other government entities.
Smiths Medical issued an urgent field safety notice in Europe regarding its Medfusion 3500 and 4000 infusion pumps. The company issued the letter to notify on eight potential issues with its pumps. The issues include false alarms, unanticipated depleted battery alarms and abnormal circuit board behavior causing internal clock system failure.
Across all eight potential issues, Smiths Medical has received seven reports of serious injury and one death.
The U.S. surgeon general released a report that provides ways to reduce healthcare worker burnout. According to the report, more than half a million registered nurses plan to retire by the end of the year, and a shortage of more than 3 million low-wage health workers is projected over the next five years. The Association of American Medical Colleges has also projected a shortage of 139,000 physicians by 2033.
To solve this, they suggest giving healthcare workers a living wage, paid sick and family leave, and evaluating their workloads and hours.
A U.S. national BMET Apprenticeship Program organized by AAMI has gained a valuable new employer partner. Elite Biomedical Solutions (Elite) will be expanding their training opportunities with program support. They expect to take on 2 apprentices within the year, with plans to train additional talent as needed.
“With the launch of our own training program last year, this opportunity only seemed fitting,” said Amy Ward, Director of Customer Support Services at Elite. “We look forward to helping the next generation of BMETs.”