Preventing Medical Device Shortages by Ensuring Safe and Effective Sterilization in Manufacturing
Device Shortages Update: The FDA Announces Two New Innovation Challenges on Device Sterilization
FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies
I just stumbled upon the Elsmar Cove website and tried to post the following , but it won’t post, so I am trying to reach out to you with the following:
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?
Hi, in fact you did post on Elsmar – https://elsmar.com/elsmarqualityforum/threads/sterilization-of-a-custom-medical-device.77061/, please follow to see if anyone can help.