Latex Free Labeling

For a new device we spent a bit of time working on "Latex Free" labeling.  From the FDA point of view (801.437), the key point is natural rubber.  The term "natural rubber" includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation.  So while your label coatings may contain latex to give them that glossy look, its most likely synthetic latex (although not always), and you're off the hook.



ASTM D6499 (LEAP assay) can be used to determine if your device tests positive for natural latex and is reasonably cheap insurance that your product is safe.



Recently BS EN980 added a Latex symbol for devices that contain latex.  However, there isn't a corresponding recognized symbol for latex free, so the words Latex Free seem like the way to go.  Many companies, including GE and 3M, use the Latex symbol with an X through it.



While it is easy enough to lay off the latex gloves in your assembly area, what are your suppliers or their suppliers doing?  Although it seems far fetched, a polymer resin handled with someone wearing latex gloves could make its way into your molded part.  I can assure you, tracking down this information is a pleasant way to spend a week.  Updating your Certificate of Conformance requirements from the product development seems like the easiest way to go.

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.

Phthalate labeling in medical devices

Hello my friends, I am a little late, but a relatively new EU requirement per the revised Medical Device Directive (MDD) (93/42/EEC) is the identification of phthalates used in some common medical devices:

If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.

This update was required by March 21, 2010 and your certificate of conformance was probably signed on that date. The main use of a phthalates in medical devices is DEHP in PVC. There are no limitations imposed, but labeling is required (I suggested "Portions of this device contain phthalates").

Since we're involved with tubing and IV bags, we are knee deep in PVC with DEHP. When we started design we had considered trying to go DEHP free, but found the DEHP free PVC alternatives not as robust and as customizable as we wanted. A review of the product risk analysis clearly showed that the risks of a IV bag or tubing leak were many times greater than even long term phthalate exposure (which is now mitigated with labeling...). Maybe the materials will improve in the near future, but right now it doesn't look like it warrants a separate project to go DEHP free, new materials can be worked in as part of other projects as they arise.

I know there was ample warning, but it caught us a bit off guard, luckily we do not have a large inventory to manage or relabel. If there is one lesson I have certainly learned over the past year, it is inventory makes you feel good, but we keep getting burned with costly rework orders due to various changes.