Heyo,

I have a friend jus audited and being throw a question by the auditor, " do you have any documented procedure for handling of returned used medical devices from hospital in the case where you need to carry out investigation on this non-conformance used medical device"?

They hav been told that this procedure shall cover the scope on handling of this non-conformance used medical device from returned from end user until the investigation have been conducted.

My friend need the experts here to advise them, is there any requirements stated in ISO 13485 and MDD?

:thanx:

Tiff.....

They hav been told that this procedure shall cover the scope on handling of this non-conformance used medical device from returned from end user until the investigation have been conducted.

My friend need the experts here to advise them, is there any requirements stated in ISO 13485 and MDD?
Hi Tiff,

Are you talking about the disinfection of devices returned as customer complaints? I don't believe that this is covered in 13485, MDD or any other MD standard as it is a health and safety issue.

AAMI ST58: 2005 "Chemical sterilization and high-level disinfection in health care facilities" gives excellent guidance on the use of chemical sterilants to disinfect devices, and ASTM 1518, although intended for the disinfection of endoscopes, offers a clear methodology that is easy to follow.

The key thing to remember is that returned devices must be treated as biohazardous, and although every attempt must be made to clean and sterilize them, the health of the operator must come first, and sometimes that requires that devices are autoclaved before handling, especially if the device is massively contaminated with blood or faecal matter.

I hope I have interpreted your question properly, if not let me know and I will have another go,

Jimmy

" do you have any documented procedure for handling of returned used medical devices from hospital in the case where you need to carry out investigation on this non-conformance used medical device"

Well, it seems to me that, in fact, it would be a "problable non-conformance" in which you have to investigate if it really is or isn´t a NC. This would be the first step. If it´s detected that it is a NC, there should be a investigation (based on the risk management of the device) to detect and correct the NC.

Anyway, this is not strictly required in any regulatory requirement that i know, but i don´t see how it would not be done. For example, in a risk management production and post-production survaillance system (which is a defined requirement from ISO 14971) there must be a procedure of this kind - this is also true in any survaillance system.


This kind of question seems to me as always like the old auditor/auditee debate. Surely there´s no way to handle the situation without a procedure, and in this case, as it´s not something you would always do, in practice i think this would have to be documented for the case it happens. But i think the auditor was, as always, a bit pushy in asking for a documented procedure. A better question would be

"how do you handle returned used medical devices from hospitals in the case where you need to carry out investigation on this possible non-conformance used medical device"

There's many ways to look at this but either way it sounds like the auditor is absolutely right.

Here's two ways to look at it:

If it is a matter of contamination, look at 13485 6.4 d). You want to make sure returned product that has been used doesn't contaminate product you already have.

If its a matter of identification of returned product, look at 13485 7.5.3.1. You need to be able to identify the returned product.

Thanks for the advise and guidance here !

It is true that this a old auditor/ auditee debate!!!

I do agree to prepare this for the case it happen in future time.

They do understand that it shall control and mentioned in the handling of non-conformance product and they do practice the identification of the non-conformance product.

This is a sterilezed disposable medical devices (IV Cathether, Urine bag, and etc.). The auditor is mentioned a scenario that what if the hospital returned this NC - used product to the organization, do you have the procedure to carry out the laboratory investigation and handling of this NC-used product?
Is there any requirements mention in any of the standards?

The auditor insist to have documented procedure to carry out investigation (lab testing) and the handling during the investigation! And what if the organization would not have the facilities to conduct the lab investigation? This will expand the scope of the certification!

:bonk:

Tiff......

Our auditor has brought this up as well for a similar type device.

MD&DI has an article which you could write a procedure from in Sept 1999 issue. I can not link the article, but you should be able to find it.

Our auditor has brought this up as well for a similar type device.

MD&DI has an article which you could write a procedure from in Sept 1999 issue. I can not link the article, but you should be able to find it.

Welcome jckca,

I am sorry that you are unable to post a link. This is an anti-spam feature of the software that had helped us to thwart a lot of spammers.

Instead of an active link, you can post an inactive link - example: abc (dot) com and we well edit it for you. Thank you for your contribution.

…you can also try to check your local (or national) regulatory & statutory requirements for handling & returning contaminated medical devices…

…I believe this is the first thing you should consider (if there are) before going to international standards…

Heyo,

I have a friend jus audited and being throw a question by the auditor, " do you have any documented procedure for handling of returned used medical devices from hospital in the case where you need to carry out investigation on this non-conformance used medical device"?

They hav been told that this procedure shall cover the scope on handling of this non-conformance used medical device from returned from end user until the investigation have been conducted.

My friend need the experts here to advise them, is there any requirements stated in ISO 13485 and MDD?

:thanx:

Tiff.....
Please see ISO 13485:2003 clause 7.5.3.1. Identification
The organization SHALL establish documented procedure to ensure that medical devices returned to the organization are identified and distinguished from conforming products.
Also see 6.4 d) If appropriate, special arrangements SHALL be established and documented for the ....... etc.
You need to have one clear documented procedure how you will handle such a situation. The purpose is to identify, seperate, avoid mix up, prevent contamination of good ongoing products, environment and personnel.
please have a simple and clear procedure documented and implemented (or implementable) as the case is.
Good luck.