Guidelines for reprocessing medical devices

Some devices in hospitals and offices are made for one-time use. These are used and then thrown away. But many of the high-price items are used repeatedly and for multiple patients. There are specific safety measures involved to ensure that such devices remain safe for use with multiple patients. Perhaps these measures include cleaning guidelines for protective covers. Whatever the specific case, there are countless devices that require users to closely follow instructions for reprocessing.

The U.S. Food and Drug Administration (FDA) recently made changes to their guidelines on reprocessing used medical devices. The final guidance clarifies testing protocols and which data should be submitted to the agency for a pre-market submission.

The six criteria for communicating reprocessing instructions to manufacturers are:

  1. Labeling should reflect the intended use of the device.
  2. Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
  3. Reprocessing instructions should indicate the appropriate microbicidal process for the device.
  4. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
  5. Reprocessing instructions should be comprehensive.
  6. Reprocessing instructions should be understandable.

While Medical Device Depot does not sell used or pre-owned devices, a leasing program is available to offer a more affordable option. Leasing arrangements range from 24 months, where the equipment is generally depreciated, to up to 60 months, where the monthly payment is generally deducted as an operating expense. You can work with confidence knowing that you are using the best equipment available at a more affordable price.

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