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Steve Bixby
Director, International Sales & Marketing at MorTan, Inc.
February 2016
What are the FDA labeling requirements for disposal of a medical device?
< 1 min reading time

Is anyone aware of the FDA guidance documents to say what medical devices require specialized instructions for disposal? I’m not talking about ones with obvious hazards such as implantables or ones with sharps, but simple Class I single-use devices. A few samples I have around the office don’t mention what to do with the product after use, so when is it necessary to specify?

And if some wording is necessary, what is appropriate? Is a simple “Dispose of properly” sufficient if the product is intended only for use by medical professionals?

source: https://www.linkedin.com/groups/78665/78665-6101170105725575168

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Posted by Steve Bixby
Asked on February 5, 2016 8:00 am
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Private answer
Lisa Roy I would think the material its made of would be a major factor, components within if any, and elements that aren't easily brokendown. curious as to the device....
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Private answer
Steve Bixby Thanks for the input. The products I'm thinking of are non-absorptive plastic, and there would be a considerable amount of sterile irrigating fluids. Logically the possibility of them being hazardous would be pretty low, but do you know if there is a standard or specification?
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Steve Bixby Thanks for the input. The products I'm thinking of are non-absorptive plastic, and there would be a considerable amount of sterile irrigating fluids. Logically the possibility of them being hazardous would be pretty low, but do you know if there is a standard or specification?
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Private answer
Lisa Roy I haven't actually heard of a
"preferred disposal method" for hard plastic, polyethylene/ latex free products. I do know its
"frowned upon"to dispose of in a normal fashion, but not sure of regulations.
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Private answer
Steve Bixby Sorry not to reply sooner--I've been away from my computer (and it's been nice!). That sounds like what I've been finding, that it's sort of an unwritten rule that they shouldn't just be thrown in the trash but I'm not able to find any regulation saying that. Thanks for your help!
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Any medical device that has been in contact with the human body is capable of transferring diseases, and therefore It is a sanitary residue, by that, doesn’t depending of the kind of product. It must be managed with authorized companies. This issue is regulated by management policies related to the environment intead of medical devices regulations.
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