MITA warns the FDA of risks of ignoring OEM disinfectant guidelines, urges immediate action

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MITA warns the FDA of risks of ignoring OEM disinfectant guidelines, urges immediate action

Press releases may be edited for formatting or style | September 15, 2020 HTM
Washington, D.C. – The Medical Imaging & Technology Alliance (MITA) sent a letter to the U.S. Food and Drug Administration (FDA) calling attention to recent reports of inappropriate cleaning agents and disinfectants being used on medical imaging devices amid the COVID-19 pandemic. The letter urged the agency to issue a clear communication to the public about the importance of following the original equipment manufacturer (OEM) guidelines regarding the use of cleaning agents and disinfectants on medical imaging devices.

“Imaging devices include manufacturer guidelines for proper cleaning and disinfection,” said Patrick Hope, Executive Director of MITA. “It is essential – especially in the context of a viral pandemic – to follow these expert guidelines to ensure patient safety and the ongoing performance of these devices.”

Failure to follow manufacturer guidelines may cause damage to the product, leading to otherwise unnecessary repairs, irreversible damage, or downtime for the machine, potentially leading to delayed care. To underscore this problem, MITA highlighted a recent example of an ultrasound probe that was cleaned with a non-OEM approved disinfectant, resulting in significant damage to the lens material and necessitating replacement of the part.

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The letter also raised concerns that certain cleaning products are being marketed as effective against COVID- 19, leading to the use of these products without proper verification and validation.

“Given the public health emergency, it is incumbent on the government, manufacturers, and users to prevent imaging devices from becoming vectors of COVID-19 disease transmission. As patients return to care, we want them to trust that imaging devices have been appropriately cleaned and disinfected according to OEM processes each time and every time,” said Hope.

The letter concluded with an urgent request that the FDA take immediate action to communicate to the public the importance of following manufacturer guidelines for cleaning and disinfecting medical imaging devices.

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