Guidelines for Reuse of Medical Devices
FDA to Increase Regulation of Hospitals and Reprocessing Companies
Because of the increased practice of reusing medical devices, the Food and Drug Administration is taking steps to more rigorously regulate the practice. A recent report by the General Accounting Office estimated that 20% to 30% of U.S. hospitals reuse devices such as surgical saw blades, drills, catheters, and forceps in order to cut the cost of the devices. While the devices are cleaned, sterilized and repackaged, there have been a number of reports of patients being harmed by such devices. Under the new guidelines, hospitals that reuse devices and the independent companies that sterilize and repackage them will be regulated in the same manner as the device makers. This will mean that hospitals and reprocessing companies will now have to submit information to the FDA indicating the safety and effectiveness of a device used more than once. Additional rules also call for the registration of businesses that reuse or reprocess medical devices as well as the submission of "adverse event reports." While the new guidelines only apply to hospitals, the FDA said that they might later be applied to all healthcare facilities. For more information and the latest updates, visit the Food and Drug Administration web site at www.fda.gov.
Beyond the Surface: Rethinking Environmental Hygiene Validation at Exchange25
June 30th 2025Environmental hygiene is about more than just shiny surfaces. At Exchange25, infection prevention experts urged the field to look deeper, rethink blame, and validate cleaning efforts across the entire care environment, not just EVS tasks.
A Controversial Reboot: New Vaccine Panel Faces Scrutiny, Support, and Sharp Divides
June 26th 2025As the newly appointed Advisory Committee on Immunization Practices (ACIP) met for the first time under sweeping changes by HHS Secretary Robert F. Kennedy Jr, the national spotlight turned to the panel’s legitimacy, vaccine guidance, and whether science or ideology would steer public health policy in a polarized era.
Getting Down and Dirty With PPE: Presentations at HSPA by Jill Holdsworth and Katie Belski
June 26th 2025In the heart of the hospital, decontamination technicians tackle one of health care’s dirtiest—and most vital—jobs. At HSPA 2025, 6 packed workshops led by experts Jill Holdsworth and Katie Belski spotlighted the crucial, often-overlooked art of PPE removal. The message was clear: proper doffing saves lives, starting with your own.
