PVC in the medical sector
Introduction
There are limited number of domestic players who manufacture and supply medical devices to the healthcare sector. A key mainstay of their activities is the unwavering commitment to actively search for materials and additives which can be used in manufacturing medical devices. These materials must meet stringent standards of health, safety, cost, and environmental compliance to qualify for use in medical devices.
Companies must be able to provide justifications for using specific materials in their medical devices and ensure that all stakeholders have access to accurate information about any associated risks. In recent years, concerns have been raised about the use of PVC in the healthcare sector. Therefore, it is important to address the use of PVC in healthcare based on current knowledge. The purpose of this paper is to explain why PVC is used in the manufacture of medical devices and to assess its impact on the environment and patients.
Facts about PVC
The global annual production of PVC exceeds 25 million tons, with the majority being utilized in the manufacturing of sewage pipes, window frames, gutters, cables, and packaging. Approximately 20% of the total PVC output is purchased by the healthcare industry for the production of various medical products. PVC is a key material in the fabrication of essential medical devices such as suction catheters, urine bags, ostomy bags, blood bags, oxygen tubes, and stomach tubes. The decision to use PVC in these devices is based on its ability to meet stringent safety and performance standards while remaining cost-effective. While it is technically feasible to substitute PVC in some products, the alternatives often result in either exorbitant costs or compromised product quality, rendering them unsuitable for medical use.
PVC in Medical sector
Features
- Non-DEHP and Non-Orthophthalate
- ETO, Gamma & E-Beam Sterilization Capable with Excellent Color Hold
- Ultra-Clear Formula Technology & Color Packages Enhance End Product Look
- Consolidate Global OEM Product Lines
- Fast Approval Cycles: Full Array of Physical Property, Undergoes Biocomp and Regulatory Test.
- The Most Cost Effective
Worldwide Regulatory Performance Standards
- EU REACH SVHC
- EU MDR
- CA Prop 65
- EU ROHS 1, 2 & 3
- Non-DEHP, Non-Orthophthalate
- ADM Compliant
- BPA Free
- Latex Free
- USP Class VI & ISO 10993-5 Compliant
- FDA 21 CFR Ingredients*
*TOTM plasticizer is not listed under FDA 21 CFR for food contact but has a proven history of safe use in medical device applications.
Plasticizers and medical devices
The push to remove DEHP and phthalates from medical devices and other products has gained significant momentum. Many in the medical industry are preparing for a future where manufacturing products containing these substances may no longer have to be a commercial mandate. It is crucial to understand the complexities and trade-offs of the chemistries and compounds in question for effective long-term planning.
1. Have you heard about the movement to remove PVC from healthcare facilities and medical products? Do you fully understand the arguments against PVC and its ingredients? The discussion around PVC may be more nuanced than simply getting rid of it. If you manufacture medical devices, it's important to stay informed about this issue.
2. DEHP is a commonly used plasticizer in PVC, particularly in medical devices. It is essential to understand its role when discussing PVC in medical applications. DEHP, a member of the ortho-phthalate family of plasticizers, has been extensively used in medical -grade PVC for many years without any documented harm to patients. However, there is growing concern and opposition to the use of phthalates, including DEHP, by advocates seeking to restrict their use.
3. Phthalates are a group of oily, colorless, odorless liquids commonly found in everyday products. Not all phthalates are DEHP, so what sets them apart? While all phthalates contain two ester groups, their structures vary, distinguishing them as either ortho-phthalates or terephthalates based on the location of the ester groups. Understanding why one type poses a concern while the other does not can have significant implications for consumers.
4. Studies have demonstrated that certain phthalates can induce cancer in rodents. The question remains: do these findings translate to humans? Ortho-phthalates exhibit biological activity leading to cancer in rodents, whereas terephthalates are mostly metabolized without causing harm. Explore the toxicology data on rodents and learn how to steer clear of phthalates earmarked for regulation.
5. DEHP and other ortho-phthalates are still commonly used, but there is a growing trend towards regulations limiting their use. The positive news is that there are currently commercially viable and cost-effective alternatives available. Some options to consider include: - Terephthalates such as DOTP - Non-phthalates like DINCH and TOTM.
Disposable PVC – a hygienic revolution
In the late 1950s, PVC gained prominence in healthcare products, allowing manufacturers to create higher-quality items at a lower cost. This led to the development of disposable medical devices, significantly improving hygiene standards in healthcare. PVC is commonly used in these devices due to its ability to meet strict safety and performance requirements while remaining cost-effective. While it may be technically feasible to replace PVC in some products, doing so would either be too expensive or result in inferior product quality. The transition to disposable products helped prevent potential infections that could arise from reusing glass, metal, or rubber items, making healthcare facilities more efficient and cost-effective. The choice of material is crucial for ensuring patient safety and quality of life.
Flexible tubes
If a catheter tube needs to navigate through all the bends of the human body, it must be soft and flexible. For instance, a tube used for draining the stomach should not kink when bent to ensure proper passage. Inadequate passage during the emptying process could lead to serious harm to the patient, such as vomiting or, in extreme cases, suffocation.
Smooth surface
The catheter tube's surface must be smooth to facilitate easy and gentle insertion and removal. A rough surface can damage the mucous membrane and significantly raise the risk of infection.
Bags should be odor-proof and noiseless
Ostomists have undergone a procedure in which their intestines have been redirected to an opening on the stomach. Waste is collected in a bag that is connected to this opening. It is crucial that these bags do not create any noise or odor issues. Since the bags are in constant contact with the skin, they must also be gentle and comfortable to wear around the clock.
The only material meeting all these requirements – PVC
It is crucial for medical disposables to be hypoallergenic and non-toxic to patients. They should also be durable enough to withstand sterilization without compromising their properties. Additionally, the material used should be weldable or adhesive-friendly for secure connections, and the manufacturing costs should be kept low. Currently, PVC is the only material on the market that meets all these criteria for specific medical disposables.
Inserting a tube can be very uncomfortable for a child as it is inserted through the nose into the stomach and passes through the throat. To minimize the need for repeated insertions, the tube is left in place for as long as possible. For long-term use, the tube must be able to withstand the stomach's acidic environment without deteriorating. Additionally, it should have a smooth surface, be soft, comfortable, and resistant to kinking. These qualities are important to minimize discomfort during tube insertion and reduce the risk of tissue damage. Using PVC is essential to ensure that the tubes are cost-effective while maintaining these properties.
Environment of medical devices made from PVC
What is PVC?
PVC, or polyvinyl chloride, is a material derived from rock salt and crude oil. Salt accounts for over half of the raw materials used in PVC production, making it a sustainable resource.
Environmental Effects of PVC
In recent years, there has been a notable increase in efforts by both industry and regulatory authorities to assess the environmental impact of PVC and its additives. The environmental effects of PVC are well-documented, unlike many alternative materials. According to environmental authorities, the primary focus of the environmental impact of PVC in medical devices is on two key areas:
1. Waste incineration
2. Phthalate plasticizers
Waste Incineration
During the incineration process, chlorine is released from PVC waste and any chlorine residues from salt in waste such as food and used diapers. This chlorine forms hydrochloric acid in the stack gases. All incineration plants must be equipped with emission filters to neutralize the hydrochloric acid, preventing pollution of the atmosphere. However, in approximately half of the incineration plants, a residue from the purification process must be deposited as solid waste in specialized landfill sites. Efforts are currently underway to find solutions to this issue.
Dioxins are often associated with the incineration of PVC. Environmental authorities need to ensure that reducing the amount of PVC in waste will not impact the release of dioxins from incinerators or the dioxin content in the neutralization residuals. The formation of dioxins is also linked to the production of PVC raw material. Authorities estimate that the production of PVC raw material contributes to about one percent of total dioxin formation.
Phthalate plasticizers
Phthalate plasticizers are necessary for imparting flexibility and suppleness to PVC, which is vital for manufacturing medical devices. There are different types of chemical substances used as plasticizers, including phthalates, which have sparked concerns. Although regulatory bodies advise manufacturers to discontinue the use of phthalates in softening PVC for medical devices, their goal is to influence standards in this field.
Urine bags are primarily utilized by elderly individuals who have difficulty controlling their bladder muscles and by younger men who have suffered nerve damage, such as from an accident, affecting the communication between the bladder muscles and the brain. They rely on a urisheath or catheter along with a urine bag to collect urine. It is crucial that the bag is secure, odor-resistant, noiseless, and comfortable to wear. The tubing must be flexible enough to withstand bending and twisting without causing blockages in the urine flow. Additionally, the tubing should be gentle on the skin, as it will be in constant contact with the leg. Currently, PVC is the only material that meets all of these criteria and is also a cost-effective option for users.
Health aspects
For forty years, medical disposables have been used without any health issues. Currently, the European Pharmacopoeia recommends using DEHP as the softening agent for medical disposables. However, both authorities and the medical device industry are cautious about the use of phthalates in medical devices due to the potential release of small amounts of phthalates during patient treatment. Some countries list DEHP as a potential carcinogen, but recent research suggests that it is unlikely to have a carcinogenic effect on humans. Despite this, concerns remain about the migration of foreign substances from medical devices to patients, prompting manufacturers to initiate a European research project to explore alternative plasticizers.
It is worth noting that there have been reports of medical disposables softened with phthalates have been used for over forty years without any adverse effects on patients. In the past fifty years, there has been a decline in sperm quality and an increase in testicular cancer cases in men in many Western countries. A report brought out in 1995 suggests that substances with estrogenic effects may be contributing to these issues. While various substances, including some phthalates, are suspected of having estrogenic effects, laboratory tests have not shown any estrogenic effect emanating from DEHP, the most commonly used phthalate for softening medical disposables.
Accumulation of secretions in the airway can have adverse effects. It becomes a serious issue when the patient is unable to cough up the secretions. In such cases, it is essential to remove excess secretions using a suction catheter. This procedure can be very uncomfortable for the patient, often feeling like suffocation. Due to the patient's difficulty in maintaining normal breathing during suction, the procedure should be completed within 20 seconds and not cause any damage to the airway. Therefore, the catheter must have a smooth surface, be soft, comfortable, and kink-free during use. These criteria are best met when using PVC-based medical devices.
Example Applications
- Blood Pressure Tubing
- Blood Transport & Delivery
- Bubble Tubing
- Cable Jacketing
- Catheters
- Dialysis Tubing
- Drainage Tubing
- Endotracheal Airway Tubing
- Enteral Feeding Systems
- Infusion Tubing
- Oxygen Tubing
- Peristaltic Pump Tubing
- Suction Tubing
Reuse
While it may be tempting to reuse medical disposables to reduce waste, it is strongly advised against for several reasons. Firstly, it may not always be possible to thoroughly clean medical devices after use, increasing the risk of disease transmission between patients. Secondly, resterilizing disposables can compromise their quality. Although it is generally recommended to avoid reusing medical disposables, there is ongoing research to find alternative methods for managing these items. Efforts are being made to convert disposables into plastic raw materials that can be used in the manufacturing of other products, potentially reducing the need for incineration in the future.
Summary
The clear consensus is that the benefits of using PVC for manufacturing specific medical disposables far outweigh any potential risks associated with the material. Based on information from various national and international environmental and healthcare authorities, PVC is considered the most suitable material currently available that fulfils all safety and cost requirements.
Author
Dr Muralisrinivasan Natamai Subramanian
Trainer, Polymerupdate Academy
