Get the answers to frequently asked questions about PVC in healthcare in our FAQ:
PVC is short for polyvinyl chloride and is made from salt and oil or natural gas. PVC is also known as vinyl and is one of the most widely used plastics in the world with a wide range of applications such as window frames, water pipes, flooring, cables. In healthcare, PVC is used for a wide variety of disposable medical devices and for hygienic ceiling, flooring and wall covering for wet rooms, operation theatres, hospital rooms etc.
For more information about PVC—its history, how it is made, its physical properties and sustainable development of the industry—please visit pvc.org and vinylplus.eu.
PVC is made from 57% chlorine and 43% carbon from oil or gas. The chlorine is derived from common salt, which is an inexhaustible resource. In a chemical process, the salt is split into sodium and chlorine.
The sodium is used for detergents, glass, aluminum, cholesterol-lowering medications and many other applications.
30% of the chlorine produced is used in PVC. The remaining 70% is used in the production, potable water and pool water is disinfected with chlorine. Chlorine is also used to manufacture life-saving medicines – up to 80% of all pharmaceuticals depend on chlorine chemistry – computers, batteries for hybrid and electric cars, firefighter safety gear, and a wide array of other products.
Bio-attributed and circular-attributed certified PVC resins are increasingly available on the market thanks to innovation by the industry.
For more information about PVC—its history, how it is made, its physical properties and sustainable development of the industry—please visit pvc.org and vinylplus.eu.
The plastic material PVC, also known as vinyl, is in itself non-toxic and inert, and recognized as a Polymer of Low Concern by the OECD.
The safe use of PVC in healthcare applications spans more than 70 years. The material has been thoroughly tested by independent bodies, and regulatory agencies in many countries have approved PVC for use in medical devices and other critical areas such as pipes for potable water.
Importantly, disposable products made from medical PVC replaced multiple-use medical equipment made from rubber and other materials. PVC, which is affordable, extremely versatile, easy to sterilise and does not break when used inside the body, resulted in a revolution in healthcare. First, the clean PVC devices eliminated cross-contamination between patients when the material was introduced in the 1950s and 60s. Second, PVC has enabled development and production of an ever-growing range of life-saving medical equipment and made quality, affordable healthcare much more accessible. Read more about how plastics revolutionised healthcare.
Concerns have been raised over the substance DEHP, which is one of the so-called plasticisers that can be used to make medical devices flexible. Due to industry innovation, a range of new plasticisers have been developed. Four of these are now included in the European Pharmacopeia that sets the guidelines for medical devices in Europe and beyond.
PVC combines unique technical properties such as flexibility, versatility, ease of processing, and chemical stability with low cost. This combination means that the polymer has become the material of choice for a wide range of medical applications and for hospital flooring, operation theatre walls and ceilings.
An example of the plastic’s advantages is medical tubing. If a medical tube kinks and stops the flow of medicines, it can mean it can trigger a life threatening situation for the patient. Because of unsurpassed flexibility, PVC-based medical tubing does not kink. See more reasons why PVC is used in medical applications.
Medical devices did exist before the polymer got its breakthrough in the middle of the 20th century. However, these devices were expensive and made from traditional materials such as rubber, glass or metal. The equipment thus had to be reused, causing cross-contamination between patients. The high price restricted access to healthcare, and the limited versatility of these materials meant that medical innovations were slow. A revolution in healthcare happened with the advent of affordable plastics that could be tailored to nearly any piece of medical equipment and mass-produced. Read about how plastics revolutionised healthcare.
There are very specific reasons why some plastics are used for some applications and some for others. See PVC's limitations in the question and answer below.
PVC was first introduced in the 1950s where it replaced fragile glass containers for blood. Since then it’s unique properties has made it the material choice for a wide range of medical devices and other products used in the healthcare sector.
Recently, PVC has shown its value in the fight against COVID-19, both with traditional medical devices and innovative solutions. PVC’s durability, weather resistance, and fire retardancy make it the perfect material for temporary testing and vaccination centers. PVC-based inflatable hoods for ventilators, gowns, gloves, and visors help protect healthcare workers from the virus.
PVC owes its success to a number of factors. If transparency and anti-kinking properties are needed, PVC is the only choice.
Its versatility and ease of processing allow for the manufacturing of mono-material devices that consist of both soft and rigid parts. This property is essential to recycling, which is in place in many hospitals around the world.
PVC can be used in a range of temperatures and it retains flexibility, strength, and durability at low temperatures.
PVC formulations exhibit excellent strength and toughness. For example, vinyl gloves possess very good resistance to tearing to protect both doctors and patients and help prevent the spread of infection, germs, and disease. They offer a viable alternative solution to latex allergies.
PVC is characterized by high biocompatibility and hemocompatibility, and this can be increased further by appropriate surface modification.
Materials used in medical applications must be capable of accepting or conveying a variety of liquids without themselves undergoing any significant changes in composition or properties. PVC has excellent chemical stability and thereby meets these demands.
PVC is compatible with virtually all pharmaceutical products in healthcare facilities today. It also has excellent water and chemical resistance, helping to keep solutions sterile.
Plasticized, flexible PVC medical devices can be easily sterilized via steam, autoclave, radiation (electron beam or gamma rays) or ethylene oxide methods, while maintaining key properties such as flexibility and resistance to tears, scratches, and kinks. Rigid unplasticized PVC medical devices can be sterilized using low-temperature steam (60 to 80°C), radiation, or ethylene oxide.
PVC can be easily welded to itself or with other plastics by heated tool welding and vibration welding. The strong bond strengths obtained enable the fabrication of collection bags or oxygen tents without the need for adhesives.
PVC is thermally responsive. This means tubes can be designed to be stiff enough for insertion, but will then quickly soften in the body, thereby reducing trauma during use and removal.
Last but not least, PVC is very cost effective.
Like all materials, PVC has its limitations.
PVC is made of macromolecules that are highly flexible due to the internal rotation of the main chain carbon-carbon bonds. Consequently, PVC has a low softening temperature compared with other plastics of a similar molecular structure.
PVC will degrade by chain scission when exposed to the high-energy radiation needed in some sterilization processes. Chain scission will lead to the formation of radicals that can react with oxygen to form oxidized products, leading to discoloration. Tinting agents that correct the color of the product after exposure to radiation help offset the color change, but the transparency of the device is lost. For some PVC formulations, the color can revert close to the original color after a few weeks of storage.
Ortho and terephthalate plasticizers are widely used in flexible PVC devices because of their compatibility with PVC. Some alternative plasticizers may be less compatible and will tend to migrate to the surface. One may have decreasing content of plasticizer near the surface and an accumulation on the exterior of the surface. Surfaces will feel greasy and look dirty. The PVC below the surface will become brittle in time and may be destroyed by movements.
Flexible formulations are susceptible to staining by substances based on oleophilic solvents, which may result in a loss of clarity, transparency, and gloss if the medical device is not stored in a clean environment.
Flexible PVC may stiffen at low temperature, which may be a limitation for some liquids needing to be stored at very low temperatures.
Further, PVC is not suitable for some sensitive drug-delivery systems because of adsorption issues and loss of active ingredients.
PVC cannot be used for implants because of tissue interactions over prolonged periods of contact.
Chlorine is one of the most widely produced chemicals in the world and a building block for a wide range of chemical processes. It is manufactured from common salt, NaCl. About 30% of all chlorine is used for the production of PVC.
The remaining 70% is used to disinfect drinking water and treat wastewater, in manufacturing of pharmaceuticals – up to 80% of all medicines depend on chlorine chemistry – batteries for hybrid cars, solar panels, wind turbine blades, polyurethane insulation, polycarbonate protective face shields for firefighters, and many other products.
It is important to note that many chemicals, plastics and medicines use chlorine, although the end product is chlorine free.
Caustic soda, which is the other product that is obtained when salt is split into sodium and chlorine, is also crucial for our society. It is for example essential for the production of alumina, pulp and paper, and plays a critical role in water treatment, drinking water purification, cleaning agents, pharmaceuticals, and food processes. Modern society would simply not function without chlorine chemistry.
Learn more about chlorine’s role in society.
In Europe, the chlor-alkali industry today uses membrane technology, which avoids using mercury and contributes to significant energy savings compared to other technologies.
During the last decades, the chlor-alkali industry has made a targeted effort to phase out mercury cell technology for chlorine production. In the EU chlorine production is now mercury-free as all plants have shifted to membrane technology. This technology is safe and contributes to significant energy savings. The same shift to mercury-free chlorine production is happening in the rest of the world through the Minamata Convention.
Dioxins emissions from industrial production in general have been nearly eradicated during the last decades. European PVC resin manufacturers committed already in 1995 to a charter to tightly limit dioxin emissions. Manufacturing is also tightly controlled by Best Available Techniques and EU regulations.
PVC is mainly a building and construction material for durable applications that are recycled after many years of service. However, the majority of PVC medical devices are short term, disposable products. For safety reasons, non-recyclable medical PVC waste and other hospital waste streams are generally managed through incineration with energy recovery. This is a highly effective waste management method. When incinerated, the waste is combusted at high temperatures that destroys contaminants and reduces the waste volume dramatically. Typically, the thermal energy can be used to generate electricity and in some instances district heating.
Hospital waste management processes have been improved over the last decades to make energy recovery sustainable and efficient. In addition, recent experiences show that recycling of medical waste has the potential to be successfully implemented in healthcare settings like hospitals.
Concerns have been raised about the potential emission of waste substances from PVC energy recovery. The production of waste substances depends on incineration conditions. In modern, well-run incinerators, these substances – acid gases in form of HCl and dioxins and furans – are appropriately managed on the basis of the strict procedures and standards set up under the EU legislation. This means acid gases
Most PVC-based medical devices, such as tubing and flexible containers, are made from soft PVC. To make the product soft, a so-called plasticiser is added to the PVC compound. Because of technical properties and low cost, the phthalate DEHP was in the past the main plasticiser for PVC medical applications. Yet DEHP has come under scrutiny by regulatory and medical authorities. Today, several alternative plasticisers are available for medical applications. These include TOTM, DEHT, DINCH and BTHC which are all approved by the European Pharmacopeia for medical applications. These new plasticisers allow healthcare professionals and patients to benefit from PVC’s unique properties such as softness without using phthalates of concern.
For blood bags more R&D is needed to replace DEHP. In Europe, some uncertainties remain on how the blood bags will be classified in the Medical Device Regulation, which raises some doubts on how the DEHP-free blood bags will have to be certified by the notified bodies. In the meantime, it is crucial for patient safety that blood bags plasticized with DEHP continue to be available.
Replacing DEHP is a top priority for both blood bag manufacturers and blood banks. That is why the Blood Transfusion Association, which organizes leading blood bag manufacturers, and the European Blood Alliance, which represents European blood banks, are collaborating to replace DEHP.
DEHP continues to be used in blood bags for several reasons, which are closely tied to recent regulatory developments, patient safety considerations, and the challenges faced by the industry in transitioning to alternatives:
- Regulatory Extension for DEHP Use: The European Commission's amendment (EU 2023/2482) to the REACH regulation (EC No 1907/2006) extends the sunset date for the use of DEHP in medical devices to July 1, 2030. This aligns with the transitional periods specified in the Medical Device Regulation (MDR), providing additional time for the industry to adapt to DEHP-free alternatives. The original sunset date for DEHP under REACH was set for May 2025.
- Patient Safety and Validation: Ensuring patient safety is paramount. The transition to DEHP-free blood bags requires comprehensive evaluations and validation processes. The alignment of the DEHP sunset date with the MDR transitional period allows for thorough testing and validation of approximately 18 million blood bag sets annually. This is crucial to ensure patient safety during the transition to non-DEHP materials.
- Challenges in Transitioning to DEHP-Free Alternatives: Despite the existence of promising alternatives like DEHT, BTHC, and DINCH, the industry faces significant challenges in moving away from DEHP:
- Reclassification Under MDR: Blood bag sets containing anticoagulant solutions are being reclassified from class IIb to class III, indicating a stricter regulatory classification.
- Complex Regulatory Environment: Navigating the landscape shaped by various directives, regulations, and the recent amendment adds complexity to the transition.
- National Validation of Non-DEHP Sets: Each non-DEHP blood bag set requires national validation, a process that can be time-consuming and resource-intensive.
- Operational and Manufacturing Challenges: The COVID-19 pandemic has exacerbated operational difficulties, and there are complexities in manufacturing both DEHP and non-DEHP products. Ensuring a stable supply of blood bags during this transition is critical to avoid potential shortages.
- Ensuring Comprehensive Validation: The extended timeline ensures that all non-DEHP blood products undergo the required validations at both national and local levels. This step is essential for maintaining the safety and efficacy of these medical devices.
In summary, the continued use of DEHP in blood bags is influenced by the need to ensure patient safety, comply with regulatory requirements, address the challenges in transitioning to DEHP-free alternatives, and manage operational and manufacturing complexities. The industry, with PVCMed Alliance partner RENOLIT Healthcare in a leading role, is actively working towards adopting safer alternatives, but this transition must be carefully managed to maintain the high standards of safety and efficacy required for medical devices.
Historically, the use of DEHP as a plasticiser in PVC blood collection systems, including bags and tubing, has been integral for maintaining the stability and integrity of red blood cells (RBCs), which is crucial for effective blood transfusions. The updated EU Medical Device Regulation and the REACH regulation now mandate the phase-out of DEHP from blood bags before 1 July 2030.
RENOLIT Healthcare, a PVCMed Alliance partner and leading film producer for blood bags and other medical applications, is at the forefront of this transition. Early test results of blood bags using a prototype non-phthalate PVC film, called RENOLIT Bloodprotect 42Plus, show RBC haemolysis level (0.17 ± 0.1 %) with no significant difference to DEHP (0.16 ± 0.2 %) after 42 days of storage, when using conventional SAG-M storage solution , thereby exceeding the performance of the current DEHP replacements DINCH, DEHT, and BTHC.
By changing to PAGGS-M solution, Dutch national blood organisation Sanquin has found hemolysis rates comparable to DEHP for red blood concentrate (RCC) collected in DINCH plasticised collection bags and stored for 42 days in blood bags plasticised with DINCH, DEHT, or BTHC. The French Blood Establishment (EFS) has found that RCCs stored in a PVC/Citrate/PAGGS-M storage bag for 49 days were compliant with French quality requirements, as were plasma prepared and stored in a DINCH plasticised PVC container.
It will be a long-term endeavour to turn the RENOLIT prototype or other solutions to reality. Nonetheless, a game-changing DEHP-free blood bag is on the horizon.
Concerns regarding the European Pharmacopoeia's decision-making process are understandable, given its significant role in establishing standards for medicines. The European Directorate for the Quality of Medicines & Healthcare (EDQM) oversees the European Pharmacopoeia. The EDQM is a directorate of the Council of Europe, an organization distinct from the European Union, dedicated to upholding human rights, democracy, and the rule of law. Here's how the EDQM ensures impartiality in its decision-making process:
Transparent and Rigorous Process: The procedure for adding substances to the European Pharmacopoeia is designed to be both transparent and based on scientific evidence. Each proposed addition undergoes a thorough review to ensure its safety, quality, and efficacy.
Public Consultation: Before a substance is added, its draft monograph is published in "Pharmeuropa" for public consultation. This allows stakeholders from various sectors, including NGOs, industry representatives, healthcare professionals, and the general public, to provide feedback, ensuring a broad range of perspectives are considered.
Expert Groups: The expert groups, which draft and review the monographs, are primarily composed of experts nominated by member states. These experts are selected based on their knowledge and experience, and they operate with a commitment to public health. While they may consult with industry representatives for specific technical insights, the final decision-making power rests with the experts.
Conflict of Interest Policies: All members involved in the decision-making process, including those in expert groups, are required to declare any potential conflicts of interest. This ensures that decisions are made without any undue influence from external parties.
Regular Reviews: Even after a substance is added, its monograph is subject to regular reviews to ensure it remains up-to-date with the latest scientific knowledge. If new evidence emerges about a substance's safety or efficacy, the monograph can be revised or withdrawn.
In summary, the EDQM, under the auspices of the Council of Europe, has robust mechanisms in place to ensure that the addition of substances to the European Pharmacopoeia is impartial and based on sound scientific principles. The primary commitment is always to the safety and well-being of patients. For more information, you can visit the official EDQM website at https://www.edqm.eu/.
The producers have thoroughly tested their new substances. Please note that the development of these alternative plasticisers started years ahead of REACH! Now, under the EU chemicals regulation REACH – which is seen as the strictest in the world – it is up to industry to prove that a substance is safe. REACH requires chemical manufacturers to register substances with the European Chemicals Agency if they are used on the market.
The REACH system ensures that for any plasticiser currently produced safe use can be demonstrated. Regarding medical devices, which are regulated specifically by the Medical Device Regulation, the safe use and benefit-risk analysis in the intended applications need to be provided by the medical device industry.
The data used for these safe use determinations for medical devices comprise acute toxicity, skin and eye irritation, sensitisation, repeat dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and endocrine disruption. As all these chemicals are dual use materials, the whole environmental hazards are covered by the REACH information requirements.
The four plasticisers used in medical devices as listed in the European Pharmacopeia (DINCH, BTHC, TOTM and DEHT) have been used for more than 20 years. No adverse effects have been observed. In addition to the studies undertaken to satisfy the REACH information requirements, DINCH, BTHC and DOTP have been subject to repeat dose toxicity testing on the intravenous route – for a time period that is sufficient to do a safety assessment for medical applications.
Plasticisers are among the world’s most researched substances. Some LMW phthalates have shown to exhibit adverse effects on health and environment, other plasticisers have not. The chemical industry has developed safe alternatives which are based on their comprehensive toxicological profiles safe for all the intended uses. These alternative plasticisers have substituted LMW phthalates nearly to 100% in Europe.
To avoid plasticisers, some are calling to phase out PVC with other materials that do not require plasticisers to be softened. However, just because a plastic material does not need plasticisers, it does not mean it is free from additives that may migrate into the body with possible adverse effects. Today, 10,000 substances are used to provide different properties to different plastics. According to a recent study, nearly 25% of these chemicals have been identified as substances of potential concern because they meet EU’s persistence, bioaccumulation and toxicity criteria. Thus, regretful substitution cannot be excluded if PVC as such is replaced by just other plastics.
- The substitutes are not classified as hazardous according to the CLP Regulation
- DINCH and DEHT were subject to PACT and REACH compliance checks by ECHA. For some other substances minor formal requirements need to be completed to comply with increase production volumes under REACH
- Listed for medical applications by the European Pharmacopoeia
- Meet requirements of the EU Medical Device Regulation
- Evaluated by the European Food Safety Authority (EFSA)
- Evaluated by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES)
- Evaluated by the Danish Environmental Protection Agency
- Evaluated by the Swedish Chemicals Agency
- Evaluated by the European Commission’s Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR)
- Toxicity Reviews by the US Consumer Product Safety Commission
- Assessment by the Australian Inventory of Chemical Substances (AICS)
- Peer-reviewed publications by the US NSF (health advisory board chaired by the US EPA)
PVC is easily recyclable with more than 810.000 tonnes being recycled per year in Europe through the VinylPlus® programme. Depending on the application, PVC can be recycled 8 to 10 times without loss of functional properties.
In several countries the healthcare sector is also partaking in recycling of PVC-based medical devices, which makes good sense: hospitals save money by diverting waste from expensive treatment processes for clinical waste and at the same time contribute to circular economy, reduce carbon emissions and help save energy. The collection and recycling are done without risk to hospital staff, patients or recyclers as the PVC medical devices are collected from non-infectious patients only.
In 2022, VinylPlus launched the collaborative partnership VinylPlus® Med. Aimed at accelerating sustainability in European healthcare through the recycling of discarded single-use PVC medical devices, the project brings together hospitals, waste managers, recyclers and the PVC industry. The scheme collects clean and REACH-compliant PVC waste is recycled into a wide range of value products marketed across Europe, e.g. vinyl wall covering. Belgium is chosen as pilot country. Additional pilot programmes are underway in other European countries.
Recycling schemes for PVC-based medical devices also exist in many other countries. In Australia and New Zealand more than 200 hospitals collect and recycle IV bags, face masks and oxygen tubing. The PVC recyclate is turned into new useful products such as mats, garden hose, and floor coverings.
For documentation on PVC's recyclability check out these studies:
Leadbitter, J. & Bradley, J. Closed Loop Recycling Opportunities for PVC.
PVC, known as polyvinyl chloride, is a popular choice for pharmaceutical packaging due to the following reasons:
- Barrier properties: PVC offers a protective barrier against moisture and contamination. This is essential for preserving the efficacy and shelf life of numerous medications.
- Versatility: Due to its versatility, PVC can be shaped into various configurations, making it suitable for a myriad of pharmaceutical items.
- Transparency: The clear nature of PVC enables both healthcare workers and patients to examine the drug without having to open its packaging. This visual inspection aids in quality assurance and ensures the correct medicine is dispensed.
- Compatibility with other materials: PVC can be combined with other materials like aluminum or PVDC (polyvinylidene chloride) to augment its resistance to moisture and gases, thereby bolstering drug stability.
- Cost-effectiveness: Being economically viable makes PVC a preferred material for pharmaceutical packaging, especially for drugs mass-produced.
- Thermoformability: Heating PVC makes it pliable, facilitating its transformation into blister packs. Post-cooling, it maintains its form, providing a snug fit for the medication.
- Regulatory acceptance: PVC aligns with stringent regulatory and pharmaceutical industry norms regarding safety and compatibility.
- Recyclability: Pharmaceutical packaging made of PVC can be recycled. Initiatives such as VinylPlus® PharmPack advocate for more sustainable solutions in this sector.
Due to unique technical properties, PVC is a chosen material for pharmaceutical packaging for medicines. Recycling technologies exist for PVC-based blister packaging and are used for post-industrial waste. In the recycling process the PVC and aluminum are separated. The PVC is granulated and used for window profiles, pipes, and other construction products, and the aluminum foil is melted and used in new applications.
In response to the growing need for sustainable solutions and recycling practices within the pharmaceutical sector, VinylPlus launched VinylPlus® PharmPack. The joint project with PVC film manufacturers and recyclers aims to further expand the recycling of PVC pharmaceutical blister packaging along the value chain from the production of the pharmaceutical films to the packaging of medicines to the collection and recycling of used packaging.
For safety reasons, blood bags are not recycled. As with other non-recyclable medical PVC waste and other hospital waste streams, blood bags are generally managed through incineration with energy recovery. Learn more about PVC waste management.
In March 2020, a task force made up of leading Belgian virologists and hospital experts studied whether all medical devices and PPE used in connection with patients treated for Covid-19 posed a contamination risk for hospital staff and waste handlers. The task force concluded that by taking appropriate precautions, no quarantine was needed for empty urine bags, packaging, paper and cardboard, disposable curtains, non-stained PPE such as gloves, masks, aprons and other products to qualify as non-hazardous waste. For care materials such as bandages, tissues, pads and disposable linen, a quarantine period of 72 hours was needed before the waste could be collected as non-hazardous waste.
Thus, with appropriate quarantine periods, PPE used for coronavirus treatment can be safely recycled.
