Apr 14, 2010

Labeling for Reuse of Single Use Medical Devices

Another relatively new EU requirement effective March 21, 2010 per the revised Medical Device Directive (MDD) (93/42/EEC) M5 is the following:

Where appropriate, the instructions for use must contain the following particulars:
If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;
Now it is not good enough (in the EU anyway) to just put single use device in your instructions for use (IFU), but you also must identify the risks associated with reuse (sepsis/infection is probably common). I'm sure these are already documented in your risk analysis already, just cut and paste them into your IFU. Apparently anyone already using the device off label by reusing it will be deterred by the listing of potential risks, a new mitigation is born.

This seems like a potentially slippery slope to me, why not have every warning list potential risks if not followed? Is it okay to exceed the shelf life? After all, there are no risks listed- how bad could it be? If it was really bad wouldn't they list more than just a rule like they do with reuse?

Anyway, it is not hard to comply with this requirement and we like to sell stuff in Europe, so we're in.

See my previous post on the new MDD phthalates labeling requirement.


Dr. Ulman said...

I just discovered your blog. I would like to follow it regularly.

Rizwan ali said...

good info on the labeling of the resources of a single-use medical devices thanks for sharing
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