Inadequate or Onerous Device Cleaning Instructions Endanger Patients

January 29, 2024 | Evaluations & Guidance


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Failure to properly clean and disinfect or sterilize reusable medical devices between uses can lead to the spread of infection, device damage, and other forms of harm. Successful reprocessing is made more challenging, however, by the wide variation in the content, quality, and feasibility of the reprocessing instructions provided by vendors of medical devices and reusable healthcare items.

FDA's guidance states that device manufacturers should provide reprocessing instructions that are validated, complete and understandable, and reasonable to implement. (1) Nevertheless, ECRI is aware of numerous reusable medical devices and healthcare items that have incomplete, impractical, or onerous reprocessing instructions. As a result, healthcare workers who perform reprocessing may find it difficult or impossible to complete this task effectively.

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