Resterilizing Single Use Items

[Guest]

My hospital resterilizes opened, but unused single use blades, bits, and burs. We have a letter from 2 of the companies stating that their products may be sterilized if opened and unused. Do we need more documentation than that? They did not provide us with sterilization instructions.
Thank you.

[Craig Nitschke]

One who is the letter from? Your sales rep on company letterhead, or from their scientific experts. Does the letter specifically state the burrs, bits, and blades by product number. What dioes the outside of the package say? What does the package literature say that is in a full case. Does the letter say they will assume full liability if the item fails. If you are comparing this to unused screws, implants, that is okay as the companies have the necessarey data to support this. However, if a package is put up and sold with the understanding and statement single use device or "one time use only" it is not approoved by the FDA to re-process this item by your facility unless your facility has gone through the necessary steps to be able to be a third party reprocessor of SUD's

so in short the answer to your question is no, but I thought you would like to know why?

[MFennel]

That reply is correct. FDA regulations would require an official letter from the manufacturer that gives detail instructions on cleaning and resterilization of a one time use product. I have already run into a few facilities that interpretted this information incorrectly and found themselves with major fines for not following correct recommendations. Never rely on a sales reps letter (no offense but they will say what they think you want to hear) It must be an official letter from a scientific recommendations with detail instructions. These letters are to be kept on file with copies that the staff can check if they need them for reference.
Hope that helps. If I can be of more help please feel free to contact me at mike.fennel@cardinal.com

[ladyj]

FDA has specific guidelines for reprocessing of SUD(single use devices)
I think the devices are classified as I,II orIII and this determines what must be in place for reprocessing of a device. It must meet the same standards after reprocessing as original, be cleaned and sterilized adequately. The biggest challenge would be to assure meeting FDA standards and keeping up with any changes.
Companies that do nothing but reprocessing have a large volume of paper to start and also stay current with onging regulations