Guidance

DEHP phthalates in medical devices

Updated 1 July 2023

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This publication is available at https://www.gov.uk/government/publications/dehp-phthalates-in-medical-devices/dehp-phthalates-in-medical-devices

The government  has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

Phthalates are chemicals added to polyvinyl chloride (PVC) plastic to make it softer and more flexible. Di (2-ethylhexyl) phthalate (DEHP) is the type used the most in medical devices such as:

  • intravenous (IV) tubing
  • umbilical artery catheters
  • blood bags and infusion tubing
  • enteral nutrition feeding bags
  • nasogastric tubes
  • tubing used in cardiopulmonary bypass (CPB) procedures
  • tubing used in extracorporeal membrane oxygenation (ECMO)
  • tubing used during haemodialysis
  • tubing used during peritoneal dialysis

The flexibility given by DEHP can make medical devices easier to use and less likely to cause damage to tissue. It is also more comfortable for the patient.

Safe use of medical devices with DEHP

MHRA is aware of some issues with plastics that contain DEHP, including:

  • the possibility of the DEHP leaching from the PVC into solutions like blood or nutrition formulas
  • birth defects and infertility in animals with certain doses of the phthalate

Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) conclusion

According to SCENIHR in 2015 there is inconclusive or inconsistent evidence to suggest that medical devices containing DEHP pose an unacceptable health risk to humans, specifically to the reproductive health of men.

The report shows that medical devices containing plasticised PVC with DEHP have an important clinical benefit.

The committee stated that the potential for replacement of DEHP in these products should be considered against their efficiency in the treatment, as well as the toxicological profile and leaching properties of alternative plasticiser materials. The report stated that there is a strong need to develop and collect information about exposure to alternative materials in the conditions of use, to refine the knowledge on their toxicological profile and to develop other alternative materials with a favourable profile for both efficiency and safety.

MHRA’s position is that no additional regulatory measures are necessary when phasing out the use of DEHP in medical devices. The Medical Device Regulations (SI 2002 No 618, as amended) (UK MDR 2002) require any materials presenting a hazard to be replaced as soon as alternatives with a more positive risk-to-benefit balance are available. It seems that DEHP may still be essential in some medical devices in critical circumstances.

In some cases, materials that lead to a significant reduction in DEHP products can improve the risk-to-benefit ratio. A manufacturer’s risk assessment should encourage the move to alternative materials that do not result in exposure to DEHP if it is not essential.

MHRA encourages industry to consider the recommendations of the SCENIHR report and to seek alternatives to DEHP where possible.

Manufacturers of medical devices must follow the UK MDR 2002 or applicable EU regulation for application of a CE mark (MDR / IVDR) before placing their devices on the market. Devices must be CE, UKCA or CE UKNI marked. There are different requirements for the Great Britain and Northern Ireland markets. You can find out more in our guidance on UKCA-marking, which includes information about conformity procedures.

A UKCA mark shows that the medical device complies with the requirements of the UK MDR 2002. We continue to accept CE marked medical devices on the Great Britain market as outlined in this implementation update. The UK MDR 2002 requires device manufacturers to ensure that any risk, such as from exposure to DEHP, is outweighed by the anticipated benefits to the patient. Manufacturers should reduce or eliminate risk as much as possible. The supply of DEHP-plasticised PVC medical devices is in line with the regulations in circumstances where the clinical benefits outweigh the possible risks and cannot be achieved by other means.

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