Polyvinyl chloride (PVC or vinyl) plays a vital role in healthcare, from medical devices to hospital infrastructure and packaging. Understanding its lifecycle – from production and use to end-of-life management – is essential for assessing its sustainability and addressing concerns about its environmental and health impact.

Production

PVC resin, the basis of vinyl products, is manufactured through a highly controlled process involving chlorine and ethylene, which are combined to create ethylene dichloride (EDC). EDC is then converted into vinyl chloride monomer (VCM), the building block of PVC. The final step involves polymerising VCM at high temperature and pressure to form PVC resin.

Both EDC and VCM are hazardous substances that require strict handling procedures. In Europe, the entire production process takes place in closed systems, ensuring no exposure to workers or the environment.

Strict Safety & Environmental Regulations

European PVC production is governed by some of the most rigorous environmental and occupational safety regulations in the world:

  • Industrial Emissions Directive – Emission limits are set using Best Available Techniques (BAT) to ensure minimal environmental impact.
  • REACH & Occupational Exposure Limits (OELs) – Protect workers by regulating exposure to VCM and other substances.
  • ECVM’s Voluntary Charter – European PVC producers undergo third-party audits to verify compliance beyond legal requirements.

The European Chemicals Agency (ECHA) has confirmed that “the operational conditions and risk management measures implemented in the VCM/PVC industry are adequate and effective to control the risk for workers from EDC and VCM,” and that “the levels of residual ECD/VCM in PVC articles seem to be appropriately controlled in Europe.”

Industry Efforts to Reduce Emissions

The PVC industry has also eliminated or strictly regulated other emissions:

  • No significant emissions of chloroform, hexachlorobutadiene, or PCBs from European VCM plants.
  • No use or emissions of carbon tetrachloride (CCl₄).
  • Dioxins and furans emissions are tightly regulated under the Industrial Emissions Directive, with annual monitoring showing a constant downward trend.

Use

Concerns over vinyl in patient use focus primarily on additives, namely plasticisers in flexible PVC. Historically, DEHP (Di(2-ethylhexyl) phthalate) was the dominant plasticiser in medical devices, but due to health concerns, the industry has transitioned to alternative, medically approved plasticisers.

The following four plasticisers are listed in the European Pharmacopeia as approved for use in medical PVC devices:

  • Di(2-ethylhexyl) terephthalate (DEHT/DOTP)
  • 1,2-Cyclohexane dicarboxylic acid diisononyl ester (DINCH)
  • Butyryl tri-n-hexyl citrate (BTHC)
  • Tris(2-ethylhexyl) trimellitate (TOTM)

These plasticisers comply with strict regulatory standards and have undergone extensive toxicological evaluations under the EU REACH regulation. They also meet the requirements of the EU Medical Device Regulation, ensuring their safety for healthcare applications.

DEHP in Blood Bags: A Unique Challenge

The substitution of DEHP with safer alternatives has been successfully implemented in nearly all medical applications, but blood bags remain an exception. Since the 1950s, PVC plasticised with DEHP has been the only material validated to preserve blood for up to 49 days, ensuring availability for patients, particularly those with rare blood types.

While alternative plasticisers are widely used in other medical devices, the validation of DEHP-free solutions for blood bags remains ongoing. Ensuring that these alternatives maintain blood quality and shelf life comparable to existing PVC-based systems is a key focus for the industry and regulatory bodies.

To address this, the industry is working closely with European blood banks to develop DEHP-free blood bags that ensure patient safety and supply security, ahead of the 2030 sunset date for DEHP in medical devices.

Circularity & End-of-Life

Most vinyl-based medical devices are single-use products designed for hygienic and patient safety reasons. As a result, non-recyclable medical vinyl waste in Europe is primarily disposed of via incineration, often in waste-to-energy plants where permitted. This process ensures the safe destruction of contaminants while significantly reducing waste volume. Additionally, the thermal energy produced from incineration is often recovered for electricity and district heating, contributing to energy efficiency.

Safe Incineration & Emissions Control

Modern waste incineration plants operate under strict EU regulations, ensuring that incineration is safe, efficient, and environmentally controlled.

  • Advanced flue gas cleaning systems neutralise hydrochloric acid (HCl) emissions, keeping them within strict EU environmental limits.
  • Studies confirm that removing vinyl from waste streams does not eliminate dioxin formation, as combustion conditions—not material type—are the primary factor in dioxin emissions.
  • According to the European Chemicals Agency (ECHA), European incinerators can safely process waste containing up to 2% vinyl without issues related to smoke cleaning or corrosion.

Pioneering Healthcare's Circular Plastic Economy

While incineration remains a necessary method for handling non-recyclable medical waste, significant efforts are underway to increase the recycling of vinyl medical devices. VinylPlus® Med and VinylPlus® PharmPack are pioneering initiatives focused on collecting and recycling medical vinyl waste in Europe. These programmes, which are part of global efforts, enhance circularity by transforming used medical devices and pharmaceutical blister packs into new, high-quality products.

Advancing Recycling Through Innovation

New VinylPlus®-driven technologies are reshaping how medical vinyl waste is recovered and repurposed, moving beyond traditional mechanical recycling to unlock new possibilities for handling complex waste streams.

  • Advanced sorting: New scanning technologies can separate PVC from other plastic fractions with high accuracy and detect the presence of DEHP, improving the efficiency of recycling streams.

  • Dissolution technologies: A physical process that selectively dissolves PVC from multi-material waste, extracting legacy additives and recovering high-purity vinyl while removing contaminants.

  • Chemical recycling: Multiple companies are developing processes to integrate PVC into mixed plastic waste streams for pyrolysis, typically containing 3% to 10% PVC.

    • A new VinylPlus-led project successfully demonstrate that a mixed plastic waste stream with 10% can be processed to produce pyrolysis oil for use in a steam cracker, serving as feedstock for new plastics.

As these technologies advance, they enhance the sustainability of vinyl in healthcare by keeping more material in circulation and reducing the environmental impact of disposal.

Challenging Misconceptions About PVC-Free Alternatives

There is a common assumption that so-called PVC-free or halogen-free alternatives are more sustainable, but lifecycle data does not always support this claim. According to the European Chemicals Agency (ECHA), there is a lack of comprehensive life cycle assessment (LCA) data confirming that PVC-free alternatives perform better in terms of environmental impact (ECHA, 2023a; ECHA, 2023b)

Many PVC-free alternatives rely entirely on fossil-based feedstocks, whereas PVC is one of the most resource-efficient materials, composed of 57% salt and 43% ethylene. This lower reliance on fossil resources makes PVC less dependent on virgin petrochemical inputs compared to alternatives that are nearly 100% derived from oil and gas.

In healthcare applications, regrettable substitution is a concern, where banning or replacing one material leads to unintended health or environmental risks. Many alternatives still require various additives or contain other substances, some of which may migrate into the body or lack the same level of toxicological testing and regulatory scrutiny as PVC and its approved additives. This has been highlighted by ECHA, the European Commission, and other parties.

Recycling presents another challenge. PVC is ideal for mono-material products that are easy to recycle mechanically, demonstrated by the VinylPlus Med scheme. In contrast, many PVC-free alternatives are multi-material products that requires more complex and resource-intensive recycling processes.

Without full LCA data on PVC-free alternatives, claims of superior sustainability remain unverified – highlighting the need for a scientific, evidence-based approach to material choices in healthcare.