Regulation of DEHP

In the last few years, a number of government agencies and expert panels in Europe, the US, Canada, and Japan have reviewed the safety of DEHP, used to soften PVC medical devices.

Each of these agencies and expert panels has found that DEHP exposure from some medical procedures may pose a risk to patients' health.

Europe

In the EU, DEHP is classified as a reproductive toxicant. When stored in pure form it must be labelled with a skull-and-crossbones warning symbol and text reading "TOXIC".

Containers of pure DEHP must be labelled with this symbol. Under incoming EU law, it could become a requirement to label all medical devices containing DEHP with this symbol.

However, products like medical devices are not subject to this rule - even though they can be made up from as much as 20-40% DEHP.

Regulatory contradictions aside, mounting scientific evidence and public concern about the risks of DEHP exposure has led EU authorities to:

  • Begin taking measures to alert users to the presence of DEHP when used in medical devices
  • Set a higher bar for continued use of DEHP, when devices are certified as conforming to EU market requirements

The process has been and will continue to be gradual — and somewhat confused. Three of the most significant steps illustrating the contradictory development of regulation on the use of phthalates in medical devices are as follows:

Revised Medical Devices Directive (2007)

The Directive require all devices containing phthalates to be labelled in some manner — although exactly how has yet to be determined. This measure helps hospitals identify potentially harmful products and choose safer alternatives.

For more information, read our media advisory on the pros and cons of the Medical Devices Directive.

EU Scientific Opinion on DEHP in Medical Devices (2008)

Scientists from the SCENIHR Committee confirmed the growing concern that male babies and offspring of pregnant women are at risk from DEHP exposure during numerous medical procedures.

Read HCWH Europe comments on the SCENIHR opinion, submitted to the European Commission.

Although the European Commission tasked the SCENIHR committee with formulating an opinion in order to inform the Medical Devices Directive, the Directive was passed before the Opinion was complete. The EU essentially disregarded the advisory committee it set up to determine the risks its own legislation should address.

The EU Risk Reduction Strategy for DEHP (2008)

The Strategy, proposed by the Swedish Chemicals Inspectorate (KEMI), initially recommended an immediate ban on DEHP in medical devices used on newborn babies and children's products including toys. The recommendation didn't make it into the final legislation. To add to the confusion, in 2001 the EU Parliament passed Resolution calling for restricting the use of phthalates, including DEHP, in medical devices. The resolution also calls for restrictions on DEHP in domestic products for indoor use.

Regulatory Measures by Non-EU Authorities

 

A number of national authorities are pushing for phase-out initiatives, issuing similar recommendations as to the EU in order to limit DEHP exposure.

  • Germany: The German Federal Institute for Drugs and Medical Devices (BfArM) recommends using alternative products to DEHP-softened PVC medical devices for premature infants and newborns. BfArM also urges medical devices manufacturers to label products containing DEHP and put more effort into developing safer alternatives.
  • USA: Similarly, the US Food and Drug Administration has issued an FDA Safety Assessment and a Public Health Notification urging health care providers to use alternatives to DEHP-containing devices for certain, vulnerable patients. See the FDA Public Health Notification on DEHP.
  • Korea: The South Korean FDA requires manufacturers to label all medical devices containing PVC and DEHP with a warning about the toxicity of DEHP.

BfArM (Germany) Recommendations on the Use of DEHP in Medical Devices

The German Federal Institute For Drugs And Medical Devices (BfArM) has been concerned about the use of DEHP in medical devices for years, visiting the issue twice.

In August 2001, BfArM convened an expert group discussion on the issue of DEHP in medical devices. Participants included health care professional groups, industry groups, and BfArM itself.

On the basis of best-available scientific knowledge about DEHP at the time, the BfArM discussions concluded that:

  • Medical devices manufacturers should accelerate the development of safer, DEHP-free products
  • Manufacturers should provide users with a comprehensive explanation of the risks of DEHP in medical devices, and label their products accordingly
  • In Neonatal Intensive Care Units, DEHP-free products should be used when available and suitable for the relevant procedure, in order to act with precaution and avoid DEHP exposure for premature infants and newborns.

Then in 2004, BfArM initiated a second round of discussions on the issue of DEHP, based on new findings published in a round of new scientific papers.

BfArM again concluded that DEHP exposure should be minimised, with priority given to the highest-risk patient groups: the foetus, premature infants, newborns, and pre-pubescent children.