Hello Anon
If you decide to do it yourself, OSHA's model plans are very helpful.
https://www.osha.gov/sites/default/files/publications/bbfact01.pdf
https://www.osha.gov/sites/default/files/publications/osha3186.pdf
If the device is serviceable, I infer it's reusable, so you probably already have validated cleaning and disinfection instructions for the hospital staff to use, which would be a good basis for the in-house decontamination process.
https://array.aami.org/content/news/aami-st98-2022-06-10-first-cleaning-validation-standard-medical-device-manufacturers
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/reprocessing-reusable-medical-devices-information-manufacturers
https://health.ec.europa.eu/system/files/2020-07/md_checklists-iso-17664-14937_en_0.pdf
https://www.cdc.gov/infectioncontrol/guidelines/disinfection/disinfection-methods/index.html
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Anne LeBlanc
United States
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Original Message:
Sent: 21-Dec-2023 09:31
From: Anonymous Member
Subject: OSHA Bloodborne Pathogen
This message was posted by a user wishing to remain anonymous
We are a small device manufacturer. Our devices are used in the operating room. Occasionally, we receive returned medical devices, either for service or for complaint investigation. The returned devices have the potential of being contaminated with blood or tissue. Can anyone recommend any resources (preferably in Massachusetts) that can help with the implementation of an exposure control plan and decontamination process?