Sarah H. Stec, RAC It depends what you mean by "used" and it depends on the device as well. There are many devices that are reusable that are allowed, like some surgical instruments. Likewise, both the US and EU regulations have provisions for manufacturers as well as refurbishers. So what kinds of devices are you thinking of and what do you mean by "used"?

ZengSha Guo Thank you! I'm trying to find a more recent publication, this one was done back in 2008. If I find it, I'll let you know.

ZengSha Guo Sarah, we are selling factory refurbished equipment that are re-calibrated by the manufacturer and are still FDA approved. Some countries still sees that as a "used" equipment.

Marcus Gould I am assuming from your most recent post that the devices in question have a 510(k) or PMA, but are not CE marked?

ZengSha Guo Correct, however, that is not our target region; we're targeting more developing countries. Ideally, Latin America, India, China, etc.

This is a good question. I must take a look as it interests me.

Rajani Kumar Sindavalam, PMP® Glad that you asked this question. Otherwise I shouldn't have known that used/refurbished devices are allowed. I did my research and I was able to find a very good article.

http://www.ita.doc.gov/td/health/PreOwnedMedEquipment_FINAL_050608.pdf

Hope this helps!!!

Carlos Granada Some countries in Latin America allow this used devices; however, manufacturers must provide an important list of requirements, warranties, service, etc.

CIS countries allow to buy/sell used surgical, CT, angio and X-ray equipment

Edward Romero Is anyone interested in recycling medical devices

Hi there, I am sourcing pre-owned equipment. If you or anyone else has any working equipment that you would like to sell, please connect.

René Becker Carlos pointed to an important point, since Latin American countries have very precise regulations on devices that cannot be considered as "new" devices. The reason is most often historically or health economically based. The definition of what is "not new" is not very easy and needs in most cases a case-to-case analysis.

I sell and service Spacelabs Healthcare monitors here in Minnesota and would like to sell around the world but did not consider this. Thanks

Most countries allow refurbishment of devices. Generally the refurbisher is taking responsibility for the refurbished device and need to demonstrate safety and performance in the same way as the original manufacturer did. Effectively they are making a "new"device using the used device as starting materials/components. There are all kinds of ways to do that ranging from completely retesting on one extreme to formal arrangements between the refurbisher and the original manufacturer for sharing of design and testing information. on the other.

It all becomes a little different if you are talking about single use devices which are "reprocessed". Some countries allow this, others don't. The latest draft European regulations allow limited reprocessing but also allow national override to prohibit the practice. But I don't beliweve that's what you are interested in?

asian countries especially here in the philippines

Yair Penias Based on my current knowledge:
• Forbidden: China, Egypt, Kuwait, Syria, Thailand
• Various restrictions: Argentina, Bangladesh, Brazil, Canada, Columbia, Croatia, Japan, South Korea, Moldova, Pakistan, Peru, South Africa, Turkey, Uruguay, Uzbekistan, Vietnam.

How its possible? I mean how Any one can use " used/ refurbished " implantable devices? Is it safe? On what parameters it can be used?

Carlos Granada Vishesh, I wanted to clarify that are not implantable devices. Based on my experience I have seen guidance, regulations on use/re-use for equipment and some disposables (guide-wires, catheters, guiding catheters, etc). Never I have seen prothesis, stents, pacemakers, ICDs, etc. I would agree with you if that's the case.

Yair Penias Try also this: http://www.ita.doc.gov/td/health/PreOwnedMedEquipment_FINAL_050608.pdf

Edward Romero How big is the medical device recycling market?

Yair Penias Up to $9.37 Billion by 2019;
Refer to: http://www.marketsandmarkets.com/PressReleases/refurbished-medical-devices.asp

René Becker Unfortunately the well known ITA report that Yair is referring to is from 2008 and regulations have changed since then.