This op-ed was published in Plastics Today, 11 October 2019.
By Ole Grøndahl Hansen, Project Manager, PVCMed Alliance.
Maybe the use of PVC in the medical sector has been under the radar in the media for some time, as Norbert Sparrow indicates in PlasticsToday in an article on alternatives to PVC. Yet, so much has happened in the world of PVC and plasticizers in recent years that a black-and-white approach to the use of PVC in healthcare does not do the topic justice.
Both in terms of the health issues related to phthalate exposure and the recycling of medical devices, groundbreaking developments are ongoing. Indeed, these developments call into question if it makes any sense to develop and market “PVC-free” alternatives. According to a recent report on PVC by the Danish EPA, the alternatives often are more expensive than PVC and, maybe more importantly, their environmental advantages lack documentation.
First of all, the most critical concerns related to the use of PVC in the healthcare sector are risks associated with patients’ exposure to phthalates (i.e., DEHP). After many years of regulatory work, the EU has adopted a new Medical Device Regulation, which means that the presence of DEHP in medical devices very soon will be something of the past.
In 2017 the EU adopted the new Medical Device Regulation, which will come into force in 2020. It strictly restricts the use of DEHP and other substances of very high concern and encourages the use of alternatives. Continued use of DEHP above 0.1% will now require robust justification by medical device manufacturers. This justification will include an analysis of user exposure to DEHP from the device. And it shall also contain an explanation as to why possible alternatives are inappropriate to use. The EU Commission has just published comprehensive guidelines on how companies must justify the continued use of DEHP. And this guideline is mandatory!
It will be very hard for medical device manufacturers to assert that alternative plasticizers are inappropriate to use, as four new plasticizers were added to the European Pharmacopoeia in 2017. This is the fruit of the labor of companies within the medical PVC value chain, which have worked hard to develop alternatives to DEHP plasticizers for medical applications, and it can be considered a real breakthrough that four of them now are approved by the European Pharmacopeia. The new plasticizers are Hexamoll DINCH, BTHC, TOTM and DEHT.
When it comes to sustainable development, PVC offers some unique potential that is difficult to match by alternative materials. Besides being safe and affordable, PVC is actually the polymer that is best suited for recycling, keeping its technical properties through numerous recycling cycles. Also, many of the devices are used on patients for a few seconds and then thrown away. These advantages have led to the setup of medical device recycling systems in the healthcare sector in several countries.
In Australia and New Zealand, around 170 hospitals collect IV bags, face masks and oxygen tubing for recycling. The scheme is run by the Vinyl Council of Australia with support from medical device manufacturer Baxter, which also supports a recycling scheme in Guatemala. In the UK, collection and recycling is done through the RecoMed pilot scheme, which is supported by VinylPlus. In South Africa, PVC IV bags are turned into school shoes. Also in Denmark and Norway hospitals are working with the PVC medical industry to develop recycling schemes for PVC-based medical devices. In all instances, the collection and recycling is done without risk to hospital staff, patients or recyclers, as the PVC medical devices have only been used on pre-screened patients and have not been in contact with bodily fluids or medicines. This practice can be likened to collection schemes for deposit bottles. As high-grade PVC is used for medical devices, the recyclate can be turned into a variety of useful products.
The potential for medical device recycling is huge. It has been estimated that a hospital with 300 beds could easily recycle 2.5 tonnes of medical devices each year. By recycling medical devices, hospitals can contribute to substantial carbon and energy savings: Every kilo of recycled PVC replaces the same amount on the market. For each kilo of recycled PVC, 2 kilos of CO2 are saved. Recycled PVC’s primary energy demand is up to 90% lower than virgin PVC production. At the same time, hospitals can save money on waste management by sorting out devices for collection and recycling rather than sending them to costly incineration.
Coming back to alternatives to PVC, I believe that recycling often is ignored in the innovation process. Many alternatives to PVC are manufactured using several polymers in multilayer constructions. When different polymers are used, recycling is made impossible due to different melting points.
Also within the healthcare sector we have to take sustainable development into account when it comes to innovation. In the future it will not be regarded as sufficient only to design for performance and patient safety. Design for recycling has to be added in the innovation process of medical devices. This includes that only non-hazardous substances are used in the product and that the device only consist of one polymer.