With increasing pressure on device manufacturers to move away from DEHP in PVC, OEMs are seeking a plasticizer option that performs similarly without the related, potential health concerns.
Medical device manufacturers face pressures from regulatory, non-governmental organizations, and consumer forces regarding the medical tubing materials currently in use. Ortho-phthalates in general — and di-ethylhexyl phthalate (DEHP) specifically — are under increased pressure. These regulatory measures are compelling key medical industry players, including medical device designers and original equipment manufacturers (OEMs), to look for alternative, non-phthalate plasticizers for devices such as tubing.
Medical tubing made with flexible polyvinyl chloride (PVC), which can be found in devices such as respiratory circuits, catheters, feeding tubes, and IV bags, plays a key role in medicine. To find a plasticizer option that performs similarly to DEHP, the material many device designers and OEMs currently use for tubing, device designers are turning to alternate non-phthalate plasticizers to satisfy regulatory requirements and customer preferences.
There are several non-ortho-phthalate alternatives on the market, and no shortage of assessments reviewing the alternatives for safety and suitability.
Looming Regulatory Measures
Regulations regarding the materials used for medical tubing are looming in the United States, and some are already being implemented in Europe.
In the United States, the Environmental Protection Agency (EPA) Endocrine Disruptor Screening Program includes reviewing DEHP. The EPA also has a Design for the Environment (DfE) program to look at the alternatives to eight phthalates in every application in which they are currently used. In addition, the Food and Drug Administration (FDA) has said it has no cause for concern for the continued use of PVC medical devices containing DEHP as the plasticizer for most medical procedures
and patients. Additionally, the FDA has stated that alternatives to DEHP or PVC, however, should be considered for “at-risk” patients, such as neonates and long-term intravenous patients.
In Europe, changes already are taking place. This year, the Danish Environmental Protection Agency and Ministry of Health published their review of DEHP alternatives in medical devices. Beginning in July 2015, France will have legislation that bans DEHP from neonatal and nursing-mother applications, with a proposal to extend the ban to all medical devices after an alternatives assessment is complete. With research being done on ortho-phthalate plasticizers, the European Union (EU) has issued a sunset date for most applications on the use of DEHP and three other ortho-phthalates in February 2015 under the European Commission’s Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation. Medical devices fall under different rules in the EU Medical Devices Directive.
At an August 2013 plenary meeting, several proposed amendments to this directive were introduced. Some of these amendments called for the substitution of all identified carcinogens, mutagens, reprotoxins (CMRs), endocrine disrupting substances, and ortho-phthalates in medical devices. The proposed timelines are long enough to allow OEMs and device designers to consider thoughtful substitutions. For example, the amendments call for the substitution of CMRs and endocrine disruptors from all medical devices by 2026 and ortho-phthalates from invasive medical devices for children and nursing women by 2020 and for all populations by 2026.
Staying Ahead of Regulatory Changes
Device designers who proactively switch to a non-phthalate plasticizer for medical tubing applications will no longer have to worry about quickly adapting if (more likely, when) regulatory requirements mandate use of non-phthalate plasticizers in medical products. There are several non-ortho-phthalate alternatives currently available, and regulatory and governmental bodies are actively reviewing and recommending materials for medical device use.
Some device designers have already made the switch to alternative plasticizers in some product lines in the United States, but for those considering alternative materials for the development of new devices or the redevelopment of current devices, it is important to realize early in the process that replacing DEHP with an acceptable alternative will require a reformulation of the PVC compound being used to manufacture the device. This will ensure that the performance and appearance will be similar to the current devices. In addition, requalifications or recertifications will be necessary in most instances.
The preferences of healthcare professionals and device designers who are becoming more knowledgeable about the materials used in medical devices, along with looming regulatory changes, are driving a technology shift to non-phthalate plasticizers. In turn, the device designers and OEMs will likely find that switching to a non-phthalate plasticizer can be easy.
Filed Under: Materials • advanced