Criterias for June 2011

Transcription

1 Criterias for June 2011 Ecological criteria for the procurement of PVC free medical disposables in neonatology

2 Ecological criteria for the procurement of PVC free medical disposables in neonatology (14001/ ) 1. Introduction Important objectives regarding implementation of environmental protection in the facilities of the Vienna City Administration include reduction of resource consumption (e.g. energy), prevention of substances harmful to the environment, prevention and reduction of waste, the ecologically appropriate treatment of unavoidable waste, as well as reduction of noise and hazardous substances. The aim of this criteria list is specifically to reduc hazardous substances in the procurement of medical disposables for use in the neonatal unit, as well as the avoidance of unnecessary dangers to the health of premature babies. The requirements specified in this criteria list shall mainly apply to the procurement of invasive and insertable medical disposables, as well as products, which come into contact with the skin of premature babies. Information for procurers Avoidance of PVC and plasticisers in medicine Pure Polyvinyl Chloride (PVC) is a brittle, hard synthetic material. In some medical applications, however, some flexibility of the material is necessary, which can only be achieved through adding plasticisers. The most frequently used group of plasticisers is the group of phthalates. Due to the material properties of PVC, the plasticisers are not chemically bound to the PVC matrix and may dissolve away from the synthetic material mainly due to the influence of fatty liquids (e.g. blood, nutrition concentrates). This may lead to a migration of the plasticiser into the human body. In medical products, the plasticiser Diethylhexyl phthalate (DEHP) is used. DEHP belongs to the group of endocrine disruptors. These are chemicals which are suspected to affect the hormone system, to promote the development of specific tumours and to disrupt the development of the human organism or to reduce fertility (Federal Institute for Risk Assessment) [Bundesinstitut für Risikobewertung, 2010]. 2

3 According to the Regulation on classification, labelling and packaging of substances and mixtures, 1272/2008/EC in the applicable version (CLP Regulation), DEHP is classified in category 1B, H360FD (reproductive toxicant, may damage fertility, may damage the unborn child). Since 30 July 2002 DEHP and its chemical preparations containing more than 0.5 % DEHP shall be labelled with the letter T (Toxic) and the hazard symbol (skull) EU-wide due to its reproductive toxicant properties [(BUND, Friends of the Earth Germany) [Bund für Umwelt und Naturschutz Deutschland e.v. (BUND)]. Premature babies are exposed to an increased DEHP intake due to the use of products containing PVC during treatment in neonatal units. Due to their low body weight, they are especially affected by high DEHP doses. Many studies confirm that the developing male reproductive system in particular reacts very sensitively to DEHP. Therefore, boys that have not yet reached sexual maturity are mainly at risk when taking in DEHP (HWH April 2006, Healthcare Without Harm Feb. 2003, [Rossi & Muehlberger, 2000], [Rossi & Schettler, 2000]). Problems for human health and the environment caused by the use of plasticisers and the problems caused by PVC per se are inter alia specified in the study PVC 2008: Facts, Trends, Assessment ( PVC 2008: Fakten, Trends, Bewertung [Belazzi & Leutgeb, 2008], only available in German), which is the basis for the Position paper of the steering committee of the ÖkoKauf Wien - programme on the avoidance of organic chlorine compounds, especially PVC (Positionspapier des Lenkungsausschusses im Programm ÖkoKauf Wien zur Vermeidung von chlororganischen Verbindungen, insbesondere PVC). Labelling of products and packages Since the last change of the Medical Device Directive 93/42 EEC amended by 2007/47/EC labelling of DEHP on medical products is compulsory. The following products shall be labelled if they contain phthalates which are carcinogenic, mutagenic or toxic to reproduction (see list in annex I, Directive 67/548/EEC, e.g. DEHP) [Rinck, 2009] [Eucomed Medical Technology, 2009]: Products for removing or applying medication, body liquids or substances Products for transport or storage of body liquids or substances 3

4 2. Minimum requirements of the provisions in the specification The specification needs to contain at least the following minimum requirements: The following product groups shall be PVC-free for neonatal purposes: Feeding tubes Infusion bags / mixing bags Drug administration sets Infusion lines / filter leads / medication leads 3-way stopcocks Multi-way stopcocks Y connectors Venous catheters Injection syringes Syringe pump lines / infusion pump lines / arterial lines Soothers Feeding bottles Teats for drinking bottles Face masks (no oxygen masks) Prongs/masks (nasal probes) Biliband masks (phototherapy masks) Patient wrist band ECG electrodes Body-worn urine drainage bags Adhesive oximetry sensors Different securing aids and retaining straps 4

5 Data sheets Prevailing data sheets for minimum requirements shall be provided. Minimum requirements not specified in the data sheets are to be produced in the appropriate form upon special request of the ordering party. 3. Packaging Halogenated polymers are in principle undesirable in packaging. Tenderers shall state, whether and in which collection and recycling system according to section 11 of the 1996 Regulation on Packaging, Federal Law Gazette (BGBl.) II No 648/1996 in the applicable version they are participating in. If they are not participating in a collection and recycling system they shall state which measures they take to recollect the packaging put into circulation. 5