Ed,
adding the perspective of a class III AIMD manufacturer who also investigates returned (explanted) devices after inhouse disinfection:
Occupational safety is not the core focus of ISO 13485, but product /patient safety. Don't get me wrong: your employees' health is very important and you should take all measures to protect your employees from exposure to infectious material. It should just no be in the main focus of your ISO auditor.
Anyway, validating your disinfection process is quite simple:
- You need a microbiological lab that inoculates your product with a defined number of a representative microorganism. The number depends on your desired log reduction, e.g. 10exp3 up to 10exp6.
- You provide them with your disinfection procedure, which contains detailed step-wise instructions
- The microbiology labs performs the disinfection procedufre based on your instructions
- The microbiology lab performs a bioburden test on both the positive inoculated controls as well as on the disinfected devices.
- Comparing these results will retunf the log-reduction power of your disinfection process
In addition to establishingh this validated disinfection procedure at your site, you should take additional safety measure measure, such as mandatory wearing of gloves/goggles, disinfection procedures for equipment as as well as hands of personnel; establish also emergency procedures in case of contamination/contact with potential infectuous material or disinfection media.
HTH,
Gerhard