Brussels, 1 July 2014 – On Friday 27th June the European Commission released Green Public Procurement (GPP) Criteria for Electrical and Electronic Medical Devices (Healthcare EEE).
These are the first European GPP criteria being published specifically for the healthcare sector. The criteria are voluntary and focus on energy performance requirements for electrical and electronic medical equipment. These energy saving criteria, in addition to contributing to reducing the carbon footprint of the healthcare sector, if implemented in the purchase of electrical and electronic medical equipment, will allow hospitals in developing countries to carry on their operations in case of frequent power cuts.
However, regrettably, criteria on chemicals, which were initially agreed and foreseen to be included in the GPP criteria by the majority of stakeholders to the decision making process, have been left out by the Commission and do not appear in the final published version. Notably, an award criterion on Bisphenol A (BPA), a classified reprotoxic, requiring that specific parts, particularly coming into contact with the body of patients, of certain medical devises (such as incubators, ventilators, dialysis equipment, infusion pumps) used for the treatment of neonates and chronic disease patients should not contain BPA, has not been approved by the European Commission in inter-service consultation and has been excluded from the final published text of the GPP criteria.
“This is very unfortunate”, comments Grazia Cioci, Deputy Director of Health Care Without Harm (HCWH) Europe, “as the inclusion of the award criterion on BPA represented an opportunity to set a voluntary criterion to limit the use of BPA in certain medical devices coming into contact with vulnerable patients. In addition, this specific award criterion has been agreed by NGOS and industry representatives during the advisory meetings and it is disappointing to note that the European Commission is the least ambitious of all stakeholders involved in this process”.
Apparently the European Commission decided against the phase out of Bisphenol A (BPA), even in the case of a voluntary measure, because studies on substitutes for BPA, such as other Bisphenols, do not guarantee that these alternative chemical substances are safer than BPA. However, it is not clear whether the European Commission has looked into the feasibility and viability of substituting polycarbonates that contain Bisphenols with non- polycarbonate materials.
HCWH Europe has published a factsheet highlighting the hazard of BPA and the need to limit the exposure of vulnerable patients, in particular neonates and infants, to this hazardous chemical. BPA has been shown to leach from medical devices containing PVC (similarly to phthalates), from polymerized plastics in devices by diffusion of residual BPA left behind after the manufacturing process and from dental sealants in normal conditions of use.
The scientific community has considered leaching from medical devices as an important source of exposure to BPA in humans. BPA has been found in a variety of human tissues and fluids such as placental tissue, breast milk, urine, blood, and saliva. Healthcare professionals are concerned about patients potentially experiencing increased exposure to BPA as a result of the use of this chemical in medical devices and with the possible adverse health effects for vulnerable and chronically ill patient groups. Read the joint declaration on hazardous chemicals in medical devices for more on the demands of European healthcare professionals on this issue.
To find out more about the EC GPP Criteria for electrical and electronic medical equipment, visit http://ec.europa.eu/environment/gpp/eu_gpp_criteria_en.htm
To learn more about the use and exposure to BPA in the healthcare sector, read Hazardous Chemicals in Medical Devices Bisphenol A (BPA).
PRESS: Rosalind Simpson - Communication & Press Officer (HCWH Europe)
E: firstname.lastname@example.org T: +32 2503 4911 / +32 483 71 67 86
POLICY: Grazia Cioci – Deputy Director (HCWH Europe)
E: email@example.com T: +32 2503 0481