Who is responsible for cleaning medical devices before return for repairs?

ScottK

Not out of the crisis
Staff member
Super Moderator
#11
Jerome

If you have a medical device, then decontamination is part of the design control process if the device has bodily fluid contact.
Is it that cut and dry?
Because I know a lot of Class I makers that don't do this. Especially if bodily fluid contact is not part of the normal use of the device.
 
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Statistical Steven

Statistician
Staff member
Super Moderator
#12
Is it that cut and dry?
Because I know a lot of Class I makers that don't do this. Especially if bodily fluid contact is not part of the normal use of the device.
A class I device that is reusable? If you are going to design a resuable device, the IFU includes solvents that can be used to clean/disinfect the device for reuse. Of course this does not include single use devices (the need for santization procedures).
 
T

Trackerii

#14
It's common for our facility to receive product from the field that obviously has not been cleaned, even perfunctorily. I'd say that is more common than to receive cleaned items.

And, even if a returned item appeared clean and came with a certification of sanitation, how do you know that the sanitization was effective?

What are the consequences to your business operations if it's determined that your facility, or worse yet some shipped product, has been contaminated via some accidental indirect contact with something that came in from a user site?

At my company, our procedure assumes incoming product from user sites is contaminated. We assume that that product has not already been sanitized irrespective of what we've been told, and sanitize it before any further actions are taken. Until sanitization, we control contact with that product so as to avoid secondary contamination.
In most of the companies I worked we took the safest approach and handled the returned product as contaminated until the company sanitizes it. Too many variables to risk contamination and infection.
 
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