VDI 2017 Medical Grade Plastics Guideline

This is the situation: Nothing is more frustrating for processors of plastic products than a versatile material that they have been using for a long time, suddenly being discontinued with very little warning. Or even worse, the material used in an item that is well established in the market, starting to receive user inquiries or complaints. A very annoying situation that most of those who deal with plastics have experienced at one time or another.

Imagine how much more irritating it is then, when a medical device or pharmaceutical packaging has been manufactured from just such a plastic, where, potentially, people's health and well-being depend on its 'functioning'.

In fact, product modifications or withdrawals are just as common in the plastics sector as in other industries. Plastic product manufacturers are subject to the same economic rules as everyone else and also with plastics it can lead to product improvements or adjustments.

Especially when used in medical or pharmaceutical products problems can occur because, due to protracted testing and qualification requirements, it is simply not possible to replace or exchange a raw material in the short-term.

People need to realize that there is no such thing as "medical plastics". In the first instance, plastics in the medical and pharmaceutical sectors are selected for their technical properties. There are some manufacturers that offer "medical types" but the crux of the matter is that this term is not protected or even clearly defined. And as so often in life, there are goodies and baddies. There are polymer producers that are very familiar with the strict requirements of the healthcare industry and that try to address them with the products they offer. But then there are others that see the "medical" label from a marketing perspective and use it as such. In short, for customers, whether processors or OEMs, sourcing plastics for the healthcare sector is like battling through impenetrable undergrowth. Material selection often results in uncertainty and doubt.

Until now!

Well, more precisely, until December 2016. A guidance committee was set up then, under the umbrella of the VDI [Association of German Engineers], to deal with this precise topic, namely the definition of the term "medical grade plastics" and, so, to beat a path through the jungle of the plastics world. Renowned specialists from the medical and pharmaceutical sectors and large, globally active plastics producers, including ALBIS, were involved from the start and over the subsequent 2 years have helped significantly to shape the VDI guideline "2017 Medical Grade Plastics". All the participants had a common objective, namely to provide clarity on what constitutes a true "medical grade plastic" and what service qualities can logically be expected when choosing such materials. This is, in particular, a very high standard of communication and documentation, e.g. change management or extensive support with regulatory issues, not least, compliance with and documentation for the highest quality requirements.

The final draft of the new guideline was published in April of this year in accordance with the corresponding VDI statutes. All interested parties now have the opportunity to register any requests to change the guideline during the consultation and objection period, which lasts until October 2018. The hope is that, when the finalized guideline is published in the fourth quarter of this year, the loophole that has caused so much uncertainty in the market for so long will be closed. ALBIS is very proud to have been part of this initiative and is already working to implement the requirements of the 2017 medical grade plastics guideline for the new ALCOM® MED product line.

Mike Freudenstein

Director Marketing Healthcare