FDA green-lights new device sterilization chemical

3M via AP

The Food and Drug Administration this month officially said that vaporized hydrogen peroxide could be used to sterilize devices as part of the manufacturing process. As STAT's Lizzy Lawrence reports, half of devices in the United States are sterilized using ethylene oxide, a chemical that's known to cause cancer. In March, the Environmental Protection Agency will finalize restrictions on ethylene oxide, giving manufacturers 18 months to comply.

Communities impacted by the dangerous chemical — which wafts into the neighborhoods near sterilizing facilities that use it — have urged the FDA to more aggressively push manufacturers toward safer alternatives. Nevertheless, industry has resisted saying that there is no appropriate substitute for ethylene oxide and that restrictions could lead to device shortages.

Policy

Telehealth bill kickstarts year of debate

On Wednesday, Sens. Bill Cassidy, M.D. (R-LA), Tina Smith (D-MN), John Thune (R-SD), and Ben Cardin (D-MD) introduced a rejiggered version of the Telemental Health Care Access Act floated last year. If passed, the bill would eliminate the requirement that Medicare enrollees be seen in person for an initial visit within six months of receiving mental health treatment over telehealth. While telehealth access to behavioral health care is now permanent, the in-person requirement will be reinstated at the end of this year.

The bill highlights how many of the pandemic-era regulatory flexibilities designed to streamline access to virtual care are on borrowed time. They were temporarily extended at the end of the official public health emergency but will expire at the end of 2024 if Congress does not move to either extend them again or make them permanent. Strap in, it's gonna be a wild ride.

Crime

Prison for man who faked FDA approval for surgical drill

The Department of Justice announced that Peter Stoll, a former regulatory affairs specialist at Aesculap was sentenced to one year in prison and one year of supervised release after admitting to faking Food and Drug Administration approvals for a surgical drill and sterilization container. Based on his forgeries and false statements, Aesculap sold $140,000 worth of devices until the ruse was discovered, according to court documents.

In the sentencing memorandum, Stoll is portrayed as a man of established good character whose serious crime was motivated by his desire to keep his job despite being in over his head. It notes no one was harmed by the devices.

Cybersecurity

HHS issues cybersecurity guidance for hospitals

Amid rising data breaches and ransomware attacks impacting hospitals and other critical health care infrastructure, the Department of Health and Human Services on Wednesday released new voluntary cybersecurity performance goals aimed at helping avoid costly and potentially deadly disruptions in service. The list is split into "essential" and "enhanced" goals, many of which might seem common sense to individuals who've got their computer up to date and two-factor authentication turned on for their bank accounts. Implementing the same at hospitals with thousands of employees and endless workstations and medical devices, however, is a much more challenging task. Crucially, the goals give busy IT leaders a concrete standard that will help secure systems from the most common attack vectors.

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