In light of impending regulatory measures and considering patient safety and peace of mind, key medical industry players, such as OEMs, are exploring alternative, non-phthalate plasticisers for medical devices.
From catheters to feeding tubes to IVs, medical tubing made with flexible PVC plays an important role in medicine because it is used so often and in virtually all hospital departments and health care clinics. Seeking a plasticiser option that performs similarly to di-ethylhexyl phthalate (DEHP) that many OEMs are currently using for in their tubing products, manufacturers of tubing products are turning to alternate non-phthalate plasticisers to satisfy customer preferences and regulatory requirements.
Alternative to DEHP and TOTM
To help meet the long-term needs of medical OEMs and compounders as well as provide a solution to changing regulations related to plasticisers in medical products, Eastman Chemical Company has a new plasticiser that offers an alternative to DEHP and tris (2-ethylhexyl) trimellitate (TOTM). Eastman 168 SG non-phthalate plasticiser — an enhanced grade of the Eastman 168 non-phthalate plasticiser designed specifically for use in sensitive applications — is one of the newest offerings on the market for use in medical tubing and bags.
OEMs that are considering switching plasticisers want a non-phthalate option for their products that offers technical performance that is consistent with competitive products currently on the market, has the highest value in use and comes with extensive test data.
In some cases, it can be a drop-in replacement for general-purpose plasticisers which offers similar performance properties. It provides low-temperature flexibility and has an extensive toxicological profile and good non-migration properties.
When developing sensitive applications such as enteral feeding devices, OEMs need easy access to reliable data and test results about the plasticiser options that could be used in the materials they are considering. This data offers peace of mind when changing the plasticiser or the material of an existing device or selecting something new for a device in development.
Although OEMs still must conduct their own testing per regulatory bodies, they can be assured that the devices will be approved when plasticiser data and toxicological profiles are readily available. Because Eastman 168 SG has undergone comprehensive testing, it offers the promise of supply continuity and the most stringent quality assurance protocols. This non-phthalate plasticiser is held to high purity standards and is certified by REACH, the European Community Regulation on chemicals and their safe use. By using 168 SG, customers also gain access to proprietary ISO 10993 and USP Class VI test data. Given the lengthy process for medical product development and regulatory approval, having this comprehensive testing profile available means OEMs can move forward with product development with confidence.
Shift to non-phthalate plasticisers
As healthcare professionals and consumers become more knowledgeable about the materials and plasticisers used in medical devices, their preferences are driving a technology shift to non-phthalate plasticisers. In turn, OEMs are likely to find that switching to a non-phthalate plasticiser is easier than they may have imagined. In addition to serving as an alternative to DEHP and TOTM, Eastman 168 SG also can be an alternative to acetyl tributyl citrate (ATBC) and 1, 2-cyclohexane dicarboxylic acid diisononyl ester (DINCH).
Staying ahead of regulatory changes
Those OEMs that proactively switch to a non-phthalate plasticiser for medical tubing will no longer have to worry about quickly adapting if regulatory requirements mandate use of non-phthalate plasticisers in the medical products. Denmark and France already are working toward a ban on plasticisers that contain phthalates, including those used in medical applications.
With research being done on ortho-phthalate plasticisers, the European Union has issued a sunset date on the use of DEHP by 2015 under REACH.
Author: Dr Martin Stimpson, Global Market Development and Key Account Manager, Adhesives and Plasticizers Business Unit, Eastman Chemical Company
Pictures: Many manufacturers of tubing products are turning to alternate non-phthalate plasticisers to satisfy customer preferences and regulatory requirements. Eastman Chemical Company has a new plasticiser available to the medical market: Eastman 168 SG non-phthalate plasticiser. (photos: Eastman)