Do IV and blood bags and tubing pose harm to patients?
Some healthcare professionals express concern and caution that the IV bags and tubing, which are used in many critical and sensitive applications, may be actually be harmful to the health of specific patients. In France, the Senate passed a law in 2012 that unilaterally bans the use of tubing containing DEHP (di (2-ethylhexyl) phthalate) from maternity, neonatal and pediatric wards. Said law is to be implemented in July 2015 pending a possible action from the European Commission on scientific justification of such findings
DEHP Content Of PVC
Medical devices such as blood bags, IV bags and tubing are made of PVC (polyvinyl chloride) which contains a chemical agent called DEHP. This agent softens the rigid PVC material and reports from medical journals suggested that phthalates in general, including DEHP, might be chemicals that mimic human hormones which can cause damage to the male reproductive tract leading to decreased fertility.
DEHP: Approved Phthalate Softening Additive For PVC Medical Devices
According to Health Care Without Harm – an organization promoting environmentally responsible health care, DEHP is the only and currently approved phthalate softening additive to be used to soften the PVC medical devices. However, a 2001 FDA study cited the resolution drafted by the House of Delegates of the American Medical Association (AMA) which mentioned that some of the adverse effects of DEHP to male infants which have been documented included:
- Respiratory distress
- Pathological changes to lung tissue that resembles hyaline membrane disease
- Historical damage to the testes
- Testicular and epididymal atrophy and agenesis
Additional studies on the potential risks of PVC devices were decided upon by the American Medical Association and urged the US FDA to invest more efforts in examining such risks and identifying alternative devices.
PVC Bags Pose Harm
In 2012, the European Council of Vinyl Manufacturers (ECVM) criticized and contested the life-cycle assessment (LCA) carried out by the PVCfreebloodBag project which essentially concluded that the PVC blood bags pose a significant risk to human health and should be phased out and replaced with PVC-free alternatives. However, according to ECVM, this conclusion contradicted the findings made by the Scientific Committee on the Emerging and Newly Identified Health Risks of the European Commission that says there is no conclusive scientific evidence that DEHP exposure via medical treatments has adverse or harmful effects in humans.
Fact: PVC Satisfies Strict Criteria In Performance
The fact is, PVC is the best material that satisfies the strict criteria in terms of performance, safety and cost for medical applications, specifically for devices intended for single use. More than 25% of all plastic-based disposable medical devices used in hospitals are made from PVC and this is attributed to the numerous advantages of PVC over other materials, including:
- Easy sterilization
- Transparent
- Cost effective
- Chemically stable
- Easy to process by varied technologies
- Long shelf-life
- Convenient to use
- Soft and flexible
Blood Bags And Other Flexible Containers
These lightweight and non-breakable containers are crucial and important to modern healthcare. Emergency treatment of accident victims rely a lot on PVC blood bags. Aside from being light, they are also almost tear-proof (without using scissors or cutters), space saving, and more convenient than glass. In addition, the PVC medical devices are easier to handle and safe as they cannot break and cause injuries.
Still The Best Option For The Job
PVC medical devices which are designed to be worn on the body such as colostomy and urine bags provide comfort to patients and healthcare providers as they are noiseless and odor-proof. The advantages provided by PVC material remains unmatched by other thermoplastic polymers used to replace flexible PVC in medical tubing, especially when considering the mandatory factors needed for modern medical use. Tubing used in medical devices are required to possess the following properties:
- Flexibility
- Clarity
- Kink resistance
- Scratch resistance
- Toughness
- Suitability for sterilization
- Ease of bonding with common adhesives or solvents
Delivering Safety And High StandardsÂ
With ECVM claiming that there is at present no viable plastic material that could pass scientific justifications, ECVM likewise urges caution when disseminating alarming information about safety of PVC in blood bags. Without scientific validation on the harm caused by DEPH contained in PVC materials, PVC blood bags and tubing have been proven to be instrumental in delivering high standards of quality healthcare to patients.
Reasons To Develop Alternatives
All this information considered, that doesn’t mean manufacturers should stop pursing the development of alternatives to PVC and other potentially harmful plastics. As more consumers are questioning the use of plastics once though totally safe–even BPA-free plastic have lead to a major shift in material safety debates–those manufactures and material developers that can create products that perform as well as the standards and quell safety fears will see significant success and demand.
What are your thoughts on safety issues in products that are still the best possible option for where and why they are used?
Article Sources:
http://www.npr.org
http://www.nursezone.com
http://www.bbraunusa.com
