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Sterilization of a custom medical device

I am new to this site and was just about to start a new thread when I saw your post. I am a Biomedical Engineer working in research at an orthopedic hospital. On rare occasions I need to modify an existing medical device or fabricate it in house or have it fabricated by a medical device manufacturer. In order to comply with JCOH/FDA regulations, our sterile processing department will not sterilize anything that does not have an Information for Use (IFU) that specifies the sterilization method. I am trying to find any documentation that will allow us to sterilize any custom medical devices. A similar problem is this: A foot surgeon wishes to use a goniometer (protractor) during a surgery. I have found one that is made of stainless steel and either steam or gamma radiation will be suitable; however, it does not come with an IFU, so our sterile processing department will not sterilize it and gamma sterilization provider such as Steris require large volumes and it is expensive. Does anyone know of a way to do this?


Bill Pierce

I see two items in your request:

1) By modifying /building medical devices, you actually become the legal medical-device manufacturer with _sole_ responsibility for sterilization (validation) - and BTW, a miriad of other things, such as e.g. risk management. So it will be upon you to develop a sterilization cycle that is safe and effective according to FDA-recognized consensus standards. Except for steam, these cycles are typically not standardized but device-/manufacturer-specific and and thus, developing them from scratch may be difficult. One easier way might be to co-operate with the manufacturer of the predicate unchanged device and have him built the changed (sterile) device within his established quality system and controls in place.

2) If you are supplied with a medical device that is intended to be (re-) processed at the healthcare facility, but lacks the specific instructions how to do so, then this is an unacceptable non-conformity. File a complaint with the legal manufacturer and if this does not resolve the issue, contact FDA.

HTH, Gerhard
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