Do Medical Sterile Drapes count as MOPP?

S

Sclpt

#1
The power for our applied part goes as follows: wall/isolation transformer (60601)/universal power supply (60950)/power supply for applied part (60950)/applied part. The tip of the applied part is then insulated/electrically isolated from the patient via a thick plastic tool and the rest of the applied part is under medical sterile plastic drapes.

Our test engineer claims we fail to comply as 2 MOPPs are not provided across the power supply.

Is this the case?
 
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Peter Selvey

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Super Moderator
#2
Re: Do Medical Sterile Drapes count as MOPP

MOPP does not need to be in the power supply, and can be integral to the applied part.

However, all components forming part of the MOPP should be planned, reliable, and under full control of the manufacturer, and may require production tests. The problem of using sterile drapes is feels more like it is just convenient back-fill, if so likely to be planned, reliable, controlled and production tested. It's possible but you may need to convince the test agency and/or certification body.
 
M

MIREGMGR

#3
Re: Do Medical Sterile Drapes count as MOPP

The company for which I work is a significant maker of sterile disposable drapes, so I think we have some subject matter expertise.

Paper-type and plastic-film-type patient drapes are certainly not appropriate as an electrical insulating element. First, they are not characterized or controlled for electrical insulating characteristics. Second, they have only a very small voltage standoff capability even when dry. Third, paper-type drapes can be wetted by biological fluids, and in this condition can become conductive. Fourth, presence as an insulating layer of an electrical circuit implies at least a theoretical possibility of drape ignition due to resistive heating or arc, and this would constitute a critical patient hazard.

I don't know of any maker of patient drapes that would approve such a functionality for their standard products.

It would be possible to engineer a special drape as an electrical insulating device, but it wouldn't be anything like the normally used products.
 
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