Reusing single use medical devices
Due to a WSJ article based on a GAO report, reusing single use medical devices, is a somewhat hot topic lately. Key phrase from the article is right here:
AMDR, the reprocessing group, is fighting efforts to require that patients go through formal informed-consent processes. Mr. Vukelich says informed consent is meant for experimental treatments and clinical trials, and not for devices that are legally marketed and approved by the FDA.
The sterilization of reprocessed is probably validated, but it doesn't sound like the performance of reprocessed devices is, I wonder what kind of traceability is required for these devices. I don't see how you can hold the device manufacturer responsible for any problems that come from a reprocessed device since it is basically an off label use. I'm not sure that is a good deal for about 50% off the cost of the devices listed, a saw blade or tourniquet is one thing, but an ultrasound catheter?
It should also be kept in mind that some of the high cost of these devices comes from the regulatory burden placed by the FDA on these products. Some of the cost savings of reprocessing come from letting the reprocesser skip some of these. Why not ease the regulatory burden on the original manufacturer if it is safe to do so? Maybe someone should make a saw blade labeled for zero-use, then reprocess it and see how the costs work out.
Update: A good article on the subject from Halifax Personal Injury Lawyer Blog.
3 comments:
Hello
My name is Selina. I am an industrial/product design student currently studying at UTS in Sydney, Australia. I am current researching the medical device design field as part of the industry we wanted to look further into.
Your blog is very interesting and insightful. I was wondering if I could ask you a couple of questions regarding the medical device design field in the United States. Your time and help would be a great help.
You could contact me at selina@miyni.com
Thank you and I hope to hear from you soon.
Kind regards
It’s a bit choppy, simply because I didn’t focus much time on laying down the camera path - I just wanted a quick turn around. But, aesthetically I think the result is kind of neat… resembling a hand held camera with the shaky
A single use device is a tested and validated for single use only. A reprocessed device may go through a stringent sterilization process but the performace of the device is still in question.
I completely agree that the original device manufacturer should not be responsible for any problems that come from a reprocessed device since it is basically an off label use. I feel that like HIPAA law there should be a disclosure for use of reprocessed device.
I am sure you would like to know if you are going to be operated with a reprocessed device or a original device.
Raj Nihalani, MD, RAC
www.trialmed.com
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