BPA Position Paper v5.qxd

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					www.medec.org/positions_and_issues   bisphenol-A
                                     and the CANADIAN MEDICAL
                                     DEVICES INDUSTRY


                                       MEDEC POSITION                                            ABOUT MEDEC
                                       Medical devices are not currently the focus of Health     MEDEC is the national association
                                       Canada and Environment Canada's concern in regards        representing medical device and
                                       to bisphenol-A (BPA), however, MEDEC is proactively       diagnostic companies. Our members are
                                       monitoring this issue in order to prepare for any         dedicated to serving the healthcare
                                                                                                 community through research and
                                       questions or concerns. The medical device industry is
                                                                                                 development and the provision of high
                                       working with experts to get a comprehensive               quality medical products and services that
                                       understanding of the use, exposure levels and risks of    benefit Canadians - safely and
                                       BPA in medical devices.                                   efficaciously.

                                       With and on behalf of our members, MEDEC will offer       MEDEC members are committed to
                                       advice, support, and recommendations to Health            advancing healthcare in Canada by
                                       Canada and to all stakeholders to ensure a science-       ensuring patients have access to safe
                                       based and patient-safety focused approach to the          medical device technologies.
                                       future use of BPA in medical devices.
                                                                                                 Member companies represent a range of
                                                                                                 medical devices such as operating room
                                       The medical device industry only provides products to     devices and hospital equipment as well as
                                       the Canadian marketplace that meet the safety,            medical specialties such as cardiovascular,
                                       effectiveness and quality requirements of applicable      orthopaedic, ophthalmic, diabetes, and in-
                                       regulations such as the Canadian Medical Devices          vitro diagnostics.
                                       Regulations. If new scientific information and risk
                                       assessment will require the review of current products,   The medical device industry in Canada
                                       MEDEC and its members will address this in the            employs over 35,000 Canadians in close
                                                                                                 to 1,500 corporate facilities, and
                                       appropriate manner in order to ensure that patient
                                                                                                 contributes nearly $6 billion in national
                                       safety is protected.                                      sales per annum.

                                                                                                 MEDEC's mission is to strengthen and
                                       BACKGROUND                                                grow the industry in Canada by working
                                       Bisphenol-A (BPA) is an organic compound used to          closely with governments, medical
                                       make plastic materials such as polycarbonate,             associations and the public to establish an
                                                                                                 environment that supports the adoption of
                                       polyester, polyether ketone, polysulfone, and PVC.
                                                                                                 new technology from both regulatory and
                                       Risks associated with manufactured goods containing       reimbursement perspectives.
                                       BPA are unique to each individual product, as the use
                                       of different products leads to varying levels of          MEDEC members are committed to the
                                       exposure. Health and environmental concerns around        highest standards of professional conduct.
                                       BPA have increased steadily over the past months          MEDEC has designed and adopted a
                                       amongst Canadian government regulators. BPA is one        Code of conduct to promote ethical
                                       of 200 chemicals listed on the Federal Chemical           business practices and socially
                                       Management Plan, which was launched in December           responsible industry conduct to govern
                                                                                                 interactions with healthcare professionals.
                                       2006. As a part of this list, BPA was earmarked as
                                       requiring an update in knowledge and understanding
                                       and subsequently investigated in 2007.
                bisphenol-A BACKGROUND (continued)                                                      THE IMPACT FOR MEDICAL DEVICES
                            A draft risk assessment report published by                                 Medical devices are currently not among the
                            the Minister of Health and the Minister for the                             products of immediate concern to the
                            Environment on April 18, 2008 re-affirmed the                               Ministries of Health and Environment.
                            safety of BPA in the general population, but                                However, once the results of the re-evaluation
                            has taken a precautionary approach with BPA                                 of BPA and the risk assessment of other
                            that is contained in baby bottles and baby food                             products are finalized, action may be taken.
                            containers. Thus these products will be the                                 Given that BPA will likely be designated as
                            first products affected by the changed                                      "toxic" substance under CEPA, the
                            classification of BPA under the Canadian                                    precautionary principle could be invoked
                            Environment Protection Act (CEPA). A tool of                                allowing the Minister greater discretion to
                            the CEPA is the 'precautionary principle' that                              broadly apply restrictions to other products.
                            allows the government to take action prior to
                            the completion of a full scientific inquiry and                             Future action may include:
                            public consultation.                                                        - Setting allowable threshold concentrations
                                                                                                           of BPA
                            The risk assessment finds that infants less                                 - Substitution of a current product by one
                            than 18 months of age are the most                                             made from different materials
                            vulnerable group due to a relatively high                                   - Replacement of the compound BPA by one
                            amount of BPA that leaches into baby formula                                   that is proven safer
                            from feeding bottles. Health Canada contends                                - Restriction of use of a current product for
                            that studies suggest that the migration of BPA                                 certain uses or user groups
                            into the contents of baby bottles is most                                   - Increasing public awareness through
                            elevated when bottles are filled with hot liquids                              changes in labeling to products containing
                            (i.e. boiled water used to prepare baby                                        BPA
                            formula).

                            Health Canada states that both globally and in
                            Canada, the assessment of the general
                            public's exposure to BPA is considered an
                            insignificant risk. On April 14, 2008 the U.S.
                            Center for the Evaluation of Risks to Human                             SOURCES
                            Reproduction concluded that the weight of
                                                                                                    Substance profile of bisphenol-A from the Federal
                            evidence that BPA causes adverse
                                                                                                    Chemicals Management Plan
                            developmental or reproductive effects in                                www.ec.gc.ca/substances/ese/eng/challenge/batch2/batch2_80
                            humans is insufficient to draw any                                      -05-7.cfm
                            conclusions.
                                                                                                    Fact sheet on bisphenol-A
                                                                                                    www.chemicalsubstanceschimiques.gc.ca/challenge-
                            In the case of pregnant women, the Canadian                             defi/bisphenol-a_fs-fr_e.html
                            government is considering additional
                            recommendations regarding exposure to                                   Government of Canada Chemicals Management Plan
                                                                                                    www.chemicalsubstanceschimiques.gc.ca/plan/index_e.html
                            products containing BPA as part of an overall
                            'Healthy Living' program that is targeted                               Information on the Canadian Government's approach to
                            towards the special dietary considerations of                           bisphenol-A
                            this group. It may take up to a year to conduct                         www.chemicalsubstanceschimiques.gc.ca/challenge-
                                                                                                    defi/bisphenol-a_e.html
                            these studies but recommendations may
                            happen within this timeframe.                                           Center for the Evaluation of Risks to Human Reproduction
                                                                                                    (U.S) draft review of bisphenol-A
                            The Canadian government also plans to work                              http://cerhr.niehs.nih.gov/chemicals/bisphenol/BPADraftBriefVF
                                                                                                    _04_14_08.pdf
                            with the food and packaging industry to find
                            alternate solutions for canned goods where
                            the inner lining contains BPA.




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