Regulations Around DEHP in Medical Products: What Healthcare Providers Should Know
Many medical devices and equipment contain a manufactured chemical called DEHP, which refers to the scientific chemical name Di(2-ethylhexyl) phthalate. DEHP is one of the primary ingredients used to make flexible and durable plastics in many medical products.
Unfortunately, medical professionals have found DEHP to be a potential carcinogen to humans exposed to it regularly. In other words, patients have a higher risk of developing cancer if they use medical products that contain DEHP in them. Healthcare providers must be aware of this before treating patients with DEHP-based medical products. Otherwise, they could be risking the lives of the very patients they are trying to treat and save.
It looks like healthcare providers won’t have a choice but to take DEHP seriously. Various government organisations in the United States, Canada, and Europe have enacted several rules and regulations surrounding the distribution of medical products with DEHP in them. The objective is to minimise people’s exposure to DEHP so that they don’t develop cancer, reproductive issues, or other health problems.
Below is an overview of the biggest regulations and guidelines that healthcare providers need to know about DEHP in medical products. Failure to comply with these regulations could result in civil penalties, fines, lawsuits, or the potential loss of their medical or nursing licences.
1) The FDA Sets Labelling Guidelines
The United States Food and Drug Administration protects the health and safety of the public when it comes to health-related products such as medical devices and products. The FDA frequently sets guidelines for companies and professionals to ensure their products remain safe for people to use.
New guidelines usually derive from news about potential hazards associated with certain products or the materials used to make them. The FDA addressed the DEHP situation by requiring healthcare providers to put labels on their medical products that warn people about the DEHP in them. The FDA did not ban healthcare providers from distributing DEHP-based products, just as long as they have labelling that educates users about the potential cancer risks associated with them.
All DEHP warning labels must be clear and easy to find on the product packaging if the chemical is in it. However, the FDA recommends that healthcare providers consider using alternative medical products that do not contain DEHP, especially when treating higher-risk patients like pregnant women and babies.
2) Health Canada Sets Labelling Guidelines
Health Canada is the chief regulator of health products in Canada. It is a Department of the Government of Canada that creates and enforces national health policy for healthcare providers and product manufacturers in the country. Its primary mission is to protect and improve the health and safety of Canadian people by regulating all products that could pose a risk to their health.
The Canadian Environmental Protection Act of 1999 has identified DEHP as a toxic substance to people. Health Canada has not placed an outright ban on DEHP medical devices and products. Still, they have issued a series of recommendations and guidelines to help encourage public safety regarding these products.
The guidelines are more specific about protecting high-risk patients, such as pregnant women, children, and anyone receiving long-term treatment. Health Canada requires healthcare providers and practitioners to minimise the exposure of DEHP-based medical products to these high-risk groups.
Health Canada requires manufacturers to put detailed warning labels on their medical products if they contain DEHP in them. That way, healthcare providers can clearly see the DEHP warnings before using the products to treat patients. If a healthcare provider deems it to be a high risk for their patient, they will know to use a DEHP-free alternative instead.
3) The European Union Sets Deadline to Transition to DEHP-Free Products
The European Union has taken the first bold step toward a DEHP-free society by requiring all medical products to contain no DEHP by July 1st, 2030. This is certainly a much bigger step than the United States and Canada have taken toward ridding their societies of DEHP devices.
The European Union created a series of health and safety regulations in EU countries called the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH). These regulations govern chemical distribution and exposure in the European Union to ensure the public does not get harmed by dangerous chemicals in products.
The REACH regulations have classified and identified DEHP as a “Substance of Very High Concern.” Any chemical with this classification can have serious negative effects on people exposed to it. The European Union has not banned DEHP devices just yet, but it is requiring them to be phased out over the next five years. The European Union wishes for manufacturers to transition toward DEHP-free products by 2030.
In the meantime, medical product manufacturers must label their DEHP-based products if the DEHP concentrations surpass 0.1%. Healthcare providers are encouraged to observe these labels and look for alternative treatment methods to help protect their patients. Why wait until 2030?
4) Japan Requires Review of DEHP-Based Medical Products
The Japanese government is aware of the dangers associated with DEHP. That is why they don’t allow DEHP to be in child toys and food products. However, when it comes to medical devices, manufacturers are permitted to distribute DEHP-based products as long as they follow certain guidelines and restrictions.
Japan requires no more than 1.5 mg/L of DEHP to be in any product distributed in the country. Although DEHP-based medical devices can be marketed and distributed in Japan, the Pharmaceuticals and Medical Devices Agency must review and analyse them to determine their threat level to the public. The agency must approve the medical devices before healthcare providers are allowed to use them.
Conclusion
Do you need harmless medical products to help train your medical students? Pristine Medical is the premier supplier of safe and chemical-free medical products that pose no harm to students or patients. Many of the products are simulations and placebos with no actual harmful ingredients in them. You can feel safe distributing these products to your students and patients without imposing any risk to their health and wellness.