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.

Update 6/26/2013:  The FDA has issue a draft guidance, see this issue revisited here.

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.

Moved the company

We moved our happy medical device company down the road and I've been spending my time working on projects related to moving. Thrilling stuff, like changing the address on labeling and other documentation, not to mention tracking down various missing items. The cleanroom was moved and the floor done, electricity hooked up, next the whole cleanroom will be scrubbed, the filters turned on and all the furniture will be cleaned and moved in. Then it will be given a few days before its certified and the bioburden checked.

Once that is done we can get started doing installation qualifications (IQ) on the manufacturing equipment. After that we are planning on redoing any validation that involves a manufacturing procedure, but not revalidating things that involve material properties for example. Since the validations require sterile product made at the new facility, away we go. I've written enough validations the past six months I think I could work them up in my sleep. It actually feels like running in place and I think company morale is low due to lack of cash bonuses.

I have a few other projects I work on when I have time, but it is going to take a while to get back to normal after the move. I can only imagine what a nightmare it would be moving a mid-sized or larger company. Although overall it is a good thing as it means the company is doing well enough to expand and grow.

Medical Device IFU and Manual

I mentioned previously that I was working on our Operator's Manual and this post is an extension of that. Our manual and Instructions for Use (IFU) are detailed and thorough and go above and beyond what others in the field have done for a number of reasons.

First off, there is patient safety to think about. A picture or sketch goes much further to describe something than plain text. I'm lobbying to get our software to include videos of various steps. I haven't gotten very far with this yet, sometimes its a struggle to not get everything written in all caps.

Second, we're eventually trying to make sales, why skimp on the manual? Frustrated users cost sales- saving the $5 by printing in black and white and limited documentation is not where you want to cut costs. Established devices can skimp, they've been around for years, everyone already knows how they work. Not us, we need to educate people, mostly everything works the same, but there are some subtle differences. Sure, no one may ever read the manual, but if they do, its only going to make them unhappier if they don't find what they're looking for.

Third, this is 2007, I can snap a picture, edit it, and stick it in the manual in about 3 minutes, likewise with sketches, everything has been drawn in Solidworks, it is not a problem to make a nice little line drawing of anything I could ask for. I can also format things exactly how I imagine them, not to take advantage of these capabilities would be foolish.

Fourth, it is something I enjoy for the most part, which helps.

I say go overboard with this stuff, someone can always remove part later if they find something disagreeable. In the past I was rather amazed at things clinical users did not know, now I am more cynical. We've talked to quite a few people that can't differentiate IV bag sizes. It was a decent struggle to tell a three liter bag from a one liter bag and even after explaining it was still not 100%. We solved this problem by going with one bag size.

The Operator's Manual

I've been working on the dreaded Operator's Manual lately. I have all the important stuff in there, now I'm going to cram it full of useless information until it is twice as thick as it is now. The Operator's Manual is part of labeling and a nearly complete draft is required for FDA 510(k) submittal, some testing labs require one before they do certain testing as well. Writing it has ended up taking a lot more time than I had planned because I know no one will really check it out for quite a while. A couple people will read it of course and have a few comments, but unless I really push hard no one will go through it step by step. Which must be similar to how most other companies do it because I have seen a lot of bad manuals out there.

Things are going pretty well (knock on wood) lately, we even got some critical things done by outside vendors during Thanksgiving weekend. The key seems to be large cash payments. We do have a Dec 31 deadline coming up, I'm not sure who decided that was a good idea. Apparently many MBA programs skip over some basic facts about holidays.