Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo Especially for content not in the forum
Such as files in the Cove "Members" Directory

Safe Handling of Non-Device Refurbished Medical Equipment

C

Cerengr

#1
We are a service facility for refurbished PC equipment and have been approached to service non-device medical equipment. The equipment is a chart cart (trolley) with integrated PC that would be used in healthcare facilities to manage chart records. It is not classified by the FDA as a medical device, however, it will be used in areas that have the potential for exposure to contaminants. As such, are there any guidelines or recommendations as to safe handling of such equipment that is to be sent to a repair/refurbish facility in terms of who is responsible for what aspects of cleaning. This is a bit of a grey area for the FDA and OSHA but i prefer to do due diligence in determining if there is any risk that needs to be addressed.

An feedback on similar scenarios would be appreciated.

Cheers
 

Stijloor

Staff member
Super Moderator
#2
We are a service facility for refurbished PC equipment and have been approached to service non-device medical equipment. The equipment is a chart cart (trolley) with integrated PC that would be used in health care facilities to manage chart records. It is not classified by the FDA as a medical device, however, it will be used in areas that have the potential for exposure to contaminants. As such, are there any guidelines or recommendations as to safe handling of such equipment that is to be sent to a repair/refurbish facility in terms of who is responsible for what aspects of cleaning. This is a bit of a gray area for the FDA and OSHA but I prefer to do due diligence in determining if there is any risk that needs to be addressed.

An feedback on similar scenarios would be appreciated.

Cheers
Can someone help with this?

Thank you!!

Stijloor.
 
M

MIREGMGR

#3
We are a service facility for refurbished PC equipment and have been approached to service non-device medical equipment. The equipment is a chart cart (trolley) with integrated PC that would be used in healthcare facilities to manage chart records. It is not classified by the FDA as a medical device, however, it will be used in areas that have the potential for exposure to contaminants. As such, are there any guidelines or recommendations as to safe handling of such equipment that is to be sent to a repair/refurbish facility in terms of who is responsible for what aspects of cleaning.
I don't know of any FDA reg or guidance requiring that stuff sent out of a user facility, for whatever reason, be safety-disinfected or even minimally cleaned. Hospitals send durable devices back to us all the time for repair without it being cleaned at all, where it's perfectly obvious that the contamination is potentially high-level-hazardous.

You can however establish whatever contractural-agreement requirements you choose, except that you probably cannot disclaim responsibility for contamination that's still present when you return-ship the product. If someone is harmed from that point until some indeterminate time thereafter, my guess would be that you'd end up with at least shared liability even if you attempted to disclaim it.

Do you have the ability to set up a separate hazardous-receiving location, where incoming items are handled using comprehensive PPE and the items go straight into a hazardous-decontamination/cleaning operation?

What you definitely don't want to do is receive non-medical stuff and medical stuff across the same dock, with the same people opening the boxes.
 
C

Cerengr

#4
I don't know of any FDA reg or guidance requiring that stuff sent out of a user facility, for whatever reason, be safety-disinfected or even minimally cleaned. Hospitals send durable devices back to us all the time for repair without it being cleaned at all, where it's perfectly obvious that the contamination is potentially high-level-hazardous.

You can however establish whatever contractural-agreement requirements you choose, except that you probably cannot disclaim responsibility for contamination that's still present when you return-ship the product. If someone is harmed from that point until some indeterminate time thereafter, my guess would be that you'd end up with at least shared liability even if you attempted to disclaim it.

Do you have the ability to set up a separate hazardous-receiving location, where incoming items are handled using comprehensive PPE and the items go straight into a hazardous-decontamination/cleaning operation?

What you definitely don't want to do is receive non-medical stuff and medical stuff across the same dock, with the same people opening the boxes.
Thanks for the response. That seems to be the consensus among some of our sister sites as well. As a result we have created a CoC (certificate of compliance) to be sent along with the equipment that essentially states that the returner has met the cleaning/disinfecting requirements as outlined by the OEM. We have also decided to not cross-dock any return equipment of this type and will first verify the CoC is present before processing as a minimum safeguard.

It may all be a bit of overkill, but the liability issues with personnel and exposure risks seem to warrant a minimal investment in procedure changes.
 
Top Bottom