FDA, in fact, has compiled a list of single-use medical devices that could be reprocessed safely. They include non-invasive, skin-contacting devices such as pulse oximetry probes, non-electrical invasive externally communicating devices such as bisectors and graspers, and electrical invasive externally communicating devices such as electrophysiology catheters.
The agency recommends following guidance in the Medical Device User Fee and Modernization Act of 2002, as well as “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals” and “Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals,” according to Nelson Labs.
Here are 5 consideration Nelson Labs officials say should be kept in mind when reprocessing SUDs:
- Understand the families in which medical device manufacturers group their products. In each family, the worst-case device is chosen for validation – making it the master product in the family for validation testing.
- There are a whole series of questions that must be answered when it comes to the level of cleaning needed for the device. (e.g. How much organic soil or bodily fluid comes in contact with the device?)
- It is important to know how an original equipment manufacturer initially marketed a device, as well as how it is used in a clinical setting, because not every device requires disinfection and sterilization.
- Many cleaning processes are water based, so water system design, validation and monitoring is crucial.
- It is important to follow applicable current good manufacturing standards (cGMP) and requirements specified in ISO 13485, which governs quality management systems in the manufacturing of medical devices.
Find out more in the full Nelson Labs whitepaper.
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