U.K. warns on reusable probes following patient death

June 28, 2012 by MassDevice staff

The U.K.'s Medicines & Healthcare products Regulatory Agency warns of contamination risks for all transoesophageal echocardiography, transvaginal and transrectal probes after a patient dies from a hepatitis B infection.

ultrasound probe

The U.K.'s Medicines & Healthcare products Regulatory Agency today issued a contamination warning on all makes and models of reusable transoesophageal echocardiography, transvaginal and transrectal probes after receiving reports of a single patient death from hepatitis B.

The death wasn't definitively tied to infection from a contaminated probe, but the cautious regulators advised healthcare providers to take extra care when cleaning the devices between patients.

MHRA advised medical providers to review and update their decontamination procedures in accordance with the agency's "Managing Medical Devices" guidance, which lists proper decontamination as one of the 3 "core standards" relating to the use of medical devices.

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Contamination in reusable medical devices has also gotten the attention of U.S. regulators.

Earlier this year the FDA renewed its focus on reusable medical devices after receiving reports that patients were exposed to infection when the instruments weren't properly cleaned.

Infection risks resulted from improper "reprocessing," the multi-step process for cleaning and disinfecting or sterilizing durable medical devices.

Inadequate reprocessing could mean that blood, tissue or other biological debris may remain stuck on the device, allowing microbes to survive further disinfection or sterilization measures.

The FDA noted that unclear, incomplete, difficult-to-obtain or impractical cleaning instructions provided by some device makers may contribute to the problem, but early studies conducted with the University of Michigan found that problem debris remained on some devices even when instructions were followed.

"Transmission of infection was extremely rare, but the potential for becoming infected by an inadequately processed device was there," according to the FDA consumer update.

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