Aaron Liang For repairs down at the OEM site for example, the process should ensure that the customer either provides evidence of cleaning and sterilization accompanying the package (e.g. a sterilization strip) or in the absence of such the package is automatically directed to a third party or qualified internal team for cleaning/sterilization. Essentially if you don't have assurance for bio-hazard, you don't begin servicing until its ready.

If you are providing servicing in a bio-hazardous area, the obvious first choice is to remove the material from that area, decontaminate it and then perform servicing. If that is not possible, then the service staff should wear the necessary protective equipment and take the necessary precautions for safety in the bio-hazardous area. Either you physically remove the source of harm or you equip them to mitigate the source of harm in the area.

Ee Bin Liew Hi Andrew - there're (supposed to be) hospital and technical servicing protocols that specifically addresses this. Adherence is another matter altogether, due to habits, or capacity issues .. but it's true that it's not often that there're verbal or written assurance that returned equipment is bio-hazard free, or at least has temporary packaging that protects it from contaminating the supply chain and its personnel.

I guess you many on-site repair jobs(?) usually the site is considered 'decontaminated' per protocol, so usually the technician takes the hospital's word for it and just performs the service. once we start asking for proof, there'll be a lot of pushback as it affects service durations and turnaround time, added costs etc.

Cheers,
Ee Bin

Robert Poyser Even when a device has, so called been decontaminated, I've found that they are not decontaminated (despite certificates) or done badly, I always assume the device is contaminated and treat the device accordingly before the device goes anywhere in a repair/service centre. Manufacturers of re-usable devices could help when designing by not having crevices and materials that can harbour germs! I've seen leather handles, rib designs on flat surfaces, sticky labels - over time lift, product case joints you could push a credit card into ect ect.

Andrew Kyle Just a thought, but a single contaminated device could be a risk to an entire building since the chain-of-custody starts when the package arrives. As I recall, technical staff working inside hospitals are required? to have vaccinations against a number of diseases when working in biohazard areas But such safeguards are not in place when a device is returned. Seems like a huge risk - we sold urodynamics equipment and it was often dirty when returned.

When I worked in failure analysis, we developed a return kit that was sent out to the clinical reps in the field, they would call in for a RMA number wrote it on the shipping box, dropped the defective device in the plastic bags provided in the kit. Put the bag in the shipping box and returned it to the main office. When the receiving clerk saw a kit returned their action was not to open but bring directly to the Failure Analysis office. Where the contaminated product could be decontaminated and investigated. ASTM Standards also give warnings that nothing is decontaminated 100% take proper precautions

We had this same issue semiconductor equipment with chemical contamination on RMA's that were not cleaned by the customer. We had to put protocol in place to test the returned equipment in a fume hood or glove box with chemical swabs. It was time consuming and added cost but deferred other regulatory issues.

Dr. Patrick Druggan Our lab had a clean-down procedure and a signed document that the work was carried out.

An equipment bio Decon service such as Bioquell's EBDS or RBDS solution can assist in many circumstances. I no longer work there but assisted many Pharma and hospital teams needing equipment decontamination prior to return to manufacturer. Fast, effective, save, validated 6log g.stearothermophilus kill. http://www.bioquell.com/en-uk/