Disposing of a Medical Device

RCW

Quite Involved in Discussions
#1
My customer has returned a medical device that was in use. It was determined that it cannot be repaired and my customer has asked me to dispose of it. It is not contaminated with any body fluids or such. It contains a lithium battery so I will be removing that and processing that through our recycling program. The circuit boards inside are RoHS compliant and lead free so I'm assuming I can just throw those and the rest of the unit in the dumpster??

Is anybody aware of any regulations or guidelines on the disposal of medical devices?
 
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joylc

#2
My previous medical device employer required that the device be rendered unusable but I'm pretty sure that was for liability, not regulatory, reasons. Usually this was achieved via incineration at contract facility. However, there were instances where we just bent/cut/defaced items and put them in the garbage.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
My customer has returned a medical device that was in use. It was determined that it cannot be repaired and my customer has asked me to dispose of it. It is not contaminated with any body fluids or such. It contains a lithium battery so I will be removing that and processing that through our recycling program. The circuit boards inside are RoHS compliant and lead free so I'm assuming I can just throw those and the rest of the unit in the dumpster??

Is anybody aware of any regulations or guidelines on the disposal of medical devices?
Hi,

Medical devices disposal regulations usually cover design and labelling (as far as the manufacturer is concerned) and apply to the device population as a whole, not to a single unit. I think that in your case you should just treat it as you would have any other electronic appliance that you wanted disposed (with the added bonus that you actually know this one inside out). In short, I don't think there are "medical devices regulations" that apply to this disposal act, however there may be some general local regulations, depending on where you're located.

I recommend that if you have a local facility for disposal/recycling of electric equipment you drop it over there after rendering it unusable. Another aspect to consider is the (slim?) chance that that specimen might end up in the wrong hands in terms of competitive intelligence.

Cheers,
Ronen.
 

rob73

looking for answers
#4
So long as the device is rendered inoperable (to stop unintended re-use) and the device is disposed of according to your local requirements (recycling, hazardous waste, batteries etc) you should have no problems.
We had a comment from our CB auditor about how our process waste was dealt with i.e as long as it was inoperable when disposed, he was happy. I have heard of instance where reject medical device have been resold as new by some enterprising goons.
 
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