and the CANADIAN MEDICAL
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
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
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
Fact sheet on bisphenol-A
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
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-
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
with the food and packaging industry to find
alternate solutions for canned goods where
the inner lining contains BPA.
405 The West Mall, Suite 900, Toronto, Ontario M9C 5J1
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