Phasing out hazardous chemicals from medical devices made easier by new online database
Brussels, 7 July 2014 – Today, Health Care Without Harm (HCWH) Europe launches a new website on safer medical devices (safermedicaldevices.org) to enable healthcare procurers to search for medical devices that do not contain PVC and/or phthalates and are already available on the European market. The products in the database are directly uploaded by medical device manufacturers and checked and approved by HCWH Europe.
"Human health and the environment are threatened by the presence of harmful chemicals in many products, including medical devices that are intended to support the treatment of diseases," says Grazia Cioci, Deputy Director of HCWH Europe. "Many health systems and hospitals throughout Europe have already recognised the need to avoid harmful chemicals and have voluntarily started substituting medical equipment containing phthalates and other hazardous chemicals with safer alternatives," Grazia adds.
Notable examples of phase-out include the Neonatology Unit of the Glanzing Children’s Hospital in Vienna that has implemented a PVC-free policy since 2000 and the Stockholm County Council (SLL) that has been eliminating PVC and phthalates from its hospitals since 1997. Moreover, the phase-out of phthalates in health products is also taking place in an increasing number of hospitals in the Netherlands, Czech Republic, Slovakia, Germany and France.
Both manufacturers and procurers can register free of charge to the database. Upon registration, manufacturers will be able to add a description of their PVC and/or phthalate-free products and procurers will be able to search the database for healthcare products free of hazardous chemicals, find out which alternative materials or plasticisers are used, if any, and leave comments on a product’s quality, should they have specific knowledge of its use. PVC-free and phthalate-free products can be searched by product category, by manufacturer and by country where the product is available, making the search easy for visitors.
In the near future, HCWH Europe is planning to extend the database to include medical devices free of Bisphenol A (BPA), a suspected endocrine disrupting chemical, classified as reprotoxic. The aim of the database is to provide the information that enables procurers to substitute medical devices with safer alternatives.
In addition, HCWH Europe’s new database is supporting, with market-based evidence, an amendment adopted in October 2013 by the European Parliament to Annex I of the EC proposal for a Regulation on Medical Devices (COM2012 542) that foresees the phase out harmful chemicals in medical devices.
HCWH Europe calls once more on European Health Ministers, the European Commission and the newly formed European Parliament to take into consideration the many safer products already available on the market and to show leadership in adopting a new Regulation on medical devices that foresees the substitution of medical devices containing carcinogenic, mutagenic and reprotoxic substances (CMRs) and endocrine disrupting chemicals (EDCs) with safer alternatives, whenever these substances are available, their substitution is technically practicable, and the reliability of the substitute substance is ensured with regard to patients’ health and safety.
1) To learn more about the hazard of CMRs and EDCs please see HCWH Europe’s factsheets on Phthalates and on Bisphenol A (BPA).
2) See the letter sent by HCWH Europe to the 28 EU Health and Environment Ministers for more information on HCWH Europe’s call in support of phasing out hazardous chemicals in medical devices.
PRESS: Rosalind Simpson - Communication & Press Officer (HCWH Europe)
E: Rosalind.firstname.lastname@example.org T: +32 2503 4911 / +32 483 71 67 86
POLICY: Grazia Cioci – Deputy Director (HCWH Europe)
E: Grazia.Cioci@hcwh.org T: +32 495 83 24 41
DATABASE: Cristina Grigore – Research Assistant (HCWH Europe)
E: Cristina.email@example.com T: +32 2503 0481
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 The amendment states that medical devices that are invasive or come into contact with the body of patients or are used to administer, transport or store medicines, body fluids or other substances, including gases in concentrations above 0.1% by weight, shall not contain chemicals that are carcinogenic, mutagenic and reprotoxic (CMRs), such as certain phthalates and metals, or that have endocrine disrupting properties (EDCs), if safer alternatives are available. The amendment still allows the use of CMRs and EDCs in medical devices for a period not exceeding four years through a derogation process. Manufacturers may ask for exemption in the case that the elimination or substitution of these substances is technically impracticable, the reliability of the substitute substance is not ensured or if the negative impact caused by the substitution outweighs the benefits on the patient’s health and safety.