PVCMed Opens Debate on Plasticisers and Waste Management Challenges

In an exclusive report for Medical Plastics News, newly formed PVCMed, a Europe-based allied group of manufacturers with an interest in medical PVC, have said that they want to open the debate on plasticisers and PVC waste management in the healthcare industry. The report follows up issues previously reported about DEHP, waste single use PVC device management—including recycling—and a response to claims about PVC by the PVCFreeBloodBag project.

The report is as folllows.

Introduction

PVC has made it possible for patients and healthcare professionals to access a wide range of medical applications with optimal technical performance, safety and comfort in use. However, concerns regarding PVC healthcare applications have been raised regarding DEHP (a plasticiser now increasingly being replaced) and PVC waste management. The PVC industry, through the PVCMed Alliance, is willing to address these issues and to open the debate on plasticisers and waste management.

1. PVC and plasticisers

As with all medical devices, flexible PVC medical equipment containing plasticiser is subject to stringent pre- and post-market control and evaluation procedures to ensure safety and performance. Therefore, PVC medical applications have been largely tried and tested; and proved to provide safe and high-quality healthcare applications.

DEHP: In order to make the PVC material soft and flexible, plasticisers are added. The assessment of potential risks related to phthalates and in particular the use of the plasticiser DEHP (di(2-ethylhexyl) phthalate) in PVC medical devices has been subject to scientific and policy review by the European Union (EU) authorities¹. As of March 21, 2010, a specific labelling requirement has subsequently been introduced across the EU^{2 3} for all devices containing phthalates that are classified as carcinogenic, mutagenic or reprotoxic (CMR)⁴.

The PVCMed Alliance believes that the EU labelling requirements will probably result in a substitution of DEHP in all medical applications where alternative plasticisers are validated or in the process of validation. Moreover, the decision by the French Government to ban the use of DEHP in specific healthcare applications for vulnerable patient groups, which will come into force in July 2015, will of course also speed up the substitution process.

It is however very difficult to determine how fast this substitution will take place. The medical device industry is justifiably a conservative business sector where a substance which has been used with apparent safety for over 50 years is not easily substituted.

The PVCMed Alliance and its members actively support the EDQM (European Directorate for the Qualtiy of Medicine) in the update of the European Pharmacopoeia⁵. The EDQM recently published a request for information on medical devices based on alternatives to DEHP in Pharmeuropa 25.1⁶.

“With a view to replacing di(2-ethylhexyl)phthalate (plastic additive 01) or providing alternatives,other plasticisers are being considered in the revision of this chapter; to this end, authorities and manufacturers are requested to submit information on any ‘non-DEHP’ plasticisers, typical amounts used, suitable specifications and analytical procedures for additive testing as well as complete information on relevant authorised medicinal products or certified medical devices”.

The PVC industry welcomes the fact that the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is currently reviewing the latest scientific evidence on the use of DEHP and other plasticisers in PVC medical devices, with a report expected by March 2013.

New plasticisers: It is extremely encouraging to see that thanks to its commitment to innovation, continuous improvement of safety, performance and cost efficiency, the value chain has made alternative plasticisers available for almost all healthcare applications. Indeed, other plasticisers besides DEHP, such as adipate plasticisers, Butyryltrihexylcitrate (BTHC), Cyclohexane-1,2-dicarboxylic acid, diisononylester (Hexamoll DINCH), Di(2-ethylhexyl)terephthalate (Eastman 168), polymerics and trimellitic acid, 2-ethylhexylester (TOTM), have been used for years for the large majority of healthcare applications. These other plasticisers perform their technological function with PVC just as well as DEHP did.

Some of them (for example BTHC, Hexamoll DINCH and TOTM) have been shown to be suitable substitutes for DEHP in blood bags as they are capable of stabilising red blood cells and have no effect on the other essential blood properties.

Hexamoll DINCH is used in enteral nutrition, for medical tubing systems and in pediatric applications, especially in platelet bags. Migration of Hexamoll DINCH has been shown to be about 10-fold lower when compared to DEHP.

Also, TOTM (tri-2ethylhexyl trimellitate) has being used in medical tubing for enteral nutrition products for a few years. TOTM has an excellent migration profile outperforming DEHP with regards to the permanence of the plasticiser.

In December 2012, France adopted a ban on DEHP in medical tubes. Alternatives such as Hexamoll DINCH and TOTM are available and make the phase out of DEHP in these applications possible in a safe and responsible way.

PVC medical equipments plasticised with these innovative products keep the key properties of PVC. These include kink resistance, bonding to rigid components without the need for adhesives, ease of sterilization using various processes, high clarity, flexible and resistant, hermetic sealing properties and ease of processing.

2. PVC and waste management

Unlike most PVC applications, the majority of PVC medical devices are short term, “single-use” products.

Incineration: Traditionally, the only waste management solution for medical plastic waste has been incineration. Concerns have been raised about the potential emission of waste substances from PVC incineration. It is important to point out that the production of waste substances depends on incineration conditions. In modern, well-run incinerators, these substances are appropriately managed on the basis of the strict procedures and standards set up under the European legislation (EU Directive 2000/76/EC).

Innovative recycling solutions: Lately a number of hospitals around the globe have been looking for innovative recycling solutions of non-blood contaminated PVC waste. Many sustainable technologies to recycle PVC have been developed (mechanical recycling, feedstock recycling, energy recovery, etc.). In addition, hospital waste management processes have been improved over the past decade to make incineration sustainable and efficient. Indeed recent experiences have shown that recycling of medical waste has the potential to be successfully implemented in healthcare settings therefore contributing to the smart use of resources and improved cost-efficiency.

When used as flooring material, PVC waste management and recycling considerations emerge from the very beginning:

➢ Clean installation waste is collected on the jobsite and returned to the factory where it can re-enter the production process. This avoids construction waste to go to landfill or incineration.

➢ New adhesives (for example spray adhesives) allow to easily remove installed and used flooring material and be recycled easily into a new flooring material.

In order to encourage the development of initiatives in the field of innovative management of non-blood contaminated PVC waste, PVCMed is following several projects in this area. In Australia for example a recycling project that has been running for three years has shown promising results so far. It is estimated that 30% of hospital waste at the Western Hospital in Australia is recyclable plastics of which 30% is made of PVC⁷. Similar initiatives are currently running in Sweden and South Africa.

In the future, PVCMed intends to support and promote recycling initiatives such as those listed above. The fact that PVC is one of the many plastic materials that are particularly well suited for recycling makes these projects even more appealing.⁸

3. Unjustified criticism on PVC healthcare applications

Despite the fact that the use of PVC in healthcare applications has significantly contributed to the high level of patient treatment and safety that benefits everyone, the use of PVC is often criticised in the media by unfounded claims that are lacking scientific justification.

Last year, the industry experienced an astonishing example of misleading communication. An EU funded project called PVCFreeBloodBag published a Life Cycle Analysis (LCA)⁹ on PVC blood bags. A press release based on the analysis stating that “PVC blood bags pose a significant risk to both health and environment” was also issued, spreading out this wrong statement all over the world.

PVCMed called upon a highly recognised LCA-scientist from the Manchester University in the UK to carry out a critical review¹⁰ of the PVCFreeBloodBag LCA. The result of this review is alarming as it clearly appears that the goal of this LCA study is motivated by a desire to phase out PVC blood bags regardless of sound science and the actual LCA results. The authors themselves state that “As quantitative reference to the PVC/DEHP blood bag, a fictional blood bag made from the material high density polyethylene (HDPE) is used.“

However, these fictional blood bags do not exist as they cannot stabilize red blood cells. Since the basic key property cannot be met, this imaginary blood bag is not a suitable alternative and a very questionable point of reference.

Conclusion

PVCMed encourages manufacturing companies and regulatory bodies to continue to collaborate to ensure that innovative developments will further help the PVC medical industry evolve and grow. It is necessary to ensure that PVC-based healthcare technologies continue to benefit patients and meet the needs of healthcare professionals thanks to their key properties, namely optimal technical performance, safety, comfort in use and cost-efficiency.

References

¹ Opinion on the Safety of Medical Devices Containing DEHP-plasticized PVC or other plasticisers on Neonates and Other Groups Possibly at Risk, Scientific Committee on the Emerging and Newly Identified Health Risks (SCENIHR), Health and Consumer Protection Directorate General, European Commission, February 2008 http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_01 4.pdf

²Medical Device Directive 93/42/EEC as amended in 2007 by Directive2007/47/EC. http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:247:0021:0055:EN:PDF

³Since March 2010, a label must be placed on the device itself and/or on the packaging for each unit. The label aims to enable healthcare professionals to use this equipment safely and, where needed, take appropriate precautionary measures for patients at risk of over-exposure.

⁴ CMR: carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Directive 67/548/EEC. http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/l21276_en.htm

⁵ “The texts of the European Pharmacopoeia concern the qualitative and quantitative composition of medicines, the tests to be carried out on medicines, on the raw materials used in the production of medicines and on the intermediates of synthesis.” (a href="http://www.edqm.eu/en/european-pharmacopoeia-publications-1401.html" target="_blank"> http://www.edqm.eu/en/european-pharmacopoeia-publications-1401.html

⁶ href="http://pharmeuropa.edqm.eu/TextsForComment/

⁷ F McGain: Recycling PVC: a new initiative from Western Health. 2010

⁸ The VinylPlus programme has been developed bottom up in industry workshops and with an open process of stakeholder dialogue, including the industry, NGOs, regulators, public representatives and users of PVC. Across Europe, VinylPlus manages, promotes and finances schemes on waste logistics, collection, recycling and new technologies. For more information on PVC waste and recycling, please visit VinylPlus.

⁹ Technique to assess environmental impacts associated with all the life stages of a product

¹⁰ Results of the review: http://www.pvc.org/upload/documents/Critical_review_statement.pdf

Image courtesy of polymer distributor Nexeo, which was named recently as the UK and Ireland distributor for Reslia KemOne's Nakan range of PVC compounds for medical applications.

Hexamol DINCH is a registered trademark of German chemical company BASF. Eastman 168 is a registered trademark of US chemical company Eastman.