Health Canada Safety Codes

Size: px

Start display at page:

Download "Health Canada Safety Codes"

Katrina Lyons
5 years ago
Views:

1 Health Canada Safety Codes Narine Martel, M. Sc. Consumer and Clinical Radiation Protection Bureau Environmental Radiation Health Sciences Directorate Healthy Environments and Consumer Safety Branch February 5, 2017 Canadian Organization of Medical Physicists Winter Imaging School, Montebello, Quebec

2 Disclosure I have no financial or other conflict of interest to declare.

Health Canada Safety Codes Background: X-ray Safety - Historical developments in Canada Current Federal/Provincial/Territorial Jurisdictions for Radiation Emitting Devices

3 Health Canada Safety Codes Background: X-ray Safety - Historical developments in Canada Current Federal/Provincial/Territorial Jurisdictions for Radiation Emitting Devices What are Safety Codes? Who develops Safety Codes? Who uses Safety Codes? How are Safety Codes Developed/Revised? Which Safety Code is currently under development? Safety Code 35 3

4 Background: X-ray Safety Historical Developments in Canada 1961 Rising concern about hazards to Canadians from the increasing use of x- rays Department of National Health and Welfare convened an X-ray Safety Advisory Committee to investigate and recommend how best to control x-ray hazards. Advisory Committee was comprised of: radiation specialists from Federal/Provincial departments of health medical/scientific/professional associations Industry 4

5 Background: X-ray Safety Historical Developments in Canada The Advisory Committee concluded that regulatory controls were needed and made three basic recommendations: 1. The federal government should pass legislation to control the design, construction and function of all x-ray equipment and steps should be taken to ensure that substandard equipment is not manufactured or imported into Canada. 2. The provincial governments should make regulations regarding the installation of x-ray machines, the safe modes of use and the standards of training of x-ray operators. 3. All x-ray machines should be registered by the appropriate provincial authority. The Committee further proposed that the federal government take the lead role in preparing the codes of practice to be used by the provincial authorities in exercising their responsibilities. The recommendations were endorsed by the federal and provincial ministers of health and became the basis for the Canadian x-ray safety program. 5

6 Current Federal/Provincial/Territorial Jurisdictions for Radiation Emitting Devices Federal Government Health Canada is responsible for the administration of health and safety legislation applicable to the advertising, importation, sale and lease of radiation emitting devices. Radiation Emitting Devices Act and Regulations Food and Drugs Act and Medical Devices Regulations Labour Program of Employment and Social Development Canada is responsible for protecting the well-being of both workers and employers in federally regulated workplaces Canada Labour Code and Canada Occupational Health and Safety Regulations Provinces/Territories have established rules (legislation, policies) governing the installation and use of radiation emitting devices in provincial/territorial facilities. Federal/Provincial/Territorial Radiation Protection Committee mission is to advance the development and harmonization of practices and standards for radiation protection within Federal, Provincial and Territorial jurisdictions. 6

What are Safety Codes? Series of documents to set out requirements for the safe use of radiation-emitting devices. First developed in early 1960 s.

Devices emitting nuclear energy are not addressed in Safety Codes (Canadian Nuclear Safety Commission regulates the use, possession and storage of all nuclear substances in Canada).

7 What are Safety Codes? Series of documents to set out requirements for the safe use of radiation-emitting devices. First developed in early 1960 s. Current Safety Codes cover devices that emit ionizing, non-ionizing and acoustic radiation. Devices emitting nuclear energy are not addressed in Safety Codes (Canadian Nuclear Safety Commission regulates the use, possession and storage of all nuclear substances in Canada). Organization of Safety Codes has changed over time. Current Safety Codes for medical X-ray facilities address: Qualifications/Responsibilities of Personnel Guidance for Minimizing Exposures Facility and Equipment Requirements Quality Assurance Program Quality Control Testing Listing of Safety Codes available here: 7

8 Who Develops Safety Codes? Consumer and Clinical Radiation Protection Bureau (CCRPB), Health Canada Administers the Radiation Emitting Devices Act and Regulations governing the radiation safety of devices imported, sold and leased in Canada. Provides radiation protection guidance/expertise to federally regulated workplaces who install and use radiation emitting devices. Activities: Conduct research Compliance/Enforcement activities Develop guidelines/safety codes Provide information to Canadians about health risks that may be associated with radiation emitting devices Participate in national/international committees on equipment and radiation safety. 8

9 CCRPB within the Organizational Structure of Health Canada Health Canada Audit and Accountabilty Bureau Chief Financial Officer Branch Communications and Public Affairs Branch First Nations and Inuit Health Branch Health Products and Food Branch Healthy Environments and Consumer Safety Branch Strategic Policy Branch Regulatroy Operations and Regions Branch Therapeutic Products Directorate Consumer Product Safety Directorate Environmental and Radiation Health Sciences Directorate Medical Devices Bureau Consumer and Clinical Radiation Protection Bureau Radiation Protection Bureau 9

10 Who uses Safety Codes? They are primarily for the instruction/guidance of persons employed in Federal Public Service departments and agencies and those under the jurisdiction of the Canada Labour Code. Safety Codes are incorporated by reference (as amended from time to time) in the Canada Occupational Health and Safety Regulations, Part X, Section They serve as guidance to provincial and territorial governments Ex. Alberta Radiation Protection Regulation Ex. Ministère de santé et services sociaux (2009 Plan d action sur la réduction de l exposition aux rayonnement) Referenced by professional colleges and organizations: Ex. Canadian Organization of Medical Physicists Ex. Diagnostic Accreditation Program, College of Physicians and Surgeons of BC Used by teaching institutions Ex. Radiation Safety Institute of Canada 10

11 How are Safety Codes Developed/Revised? 1. Identifying need for new/revised Safety Codes and prioritization Factors considered by CCRPB, including: availability of new technologies in Canada and how widely they are used changes in international/national standards and/or Canadian regulations ex. standards by the International Electrotechnical Commission ex. amendments to the Radiation Emitting Devices Regulations Changes in international radiation safety recommendations ex. publications of the International Commission on Radiological Protection New scientific evidence pertaining to radiation safety/risk Concerns/gaps identified by others, such as: Federal departments/agencies Provincial/territorial governments (ex. Ministries of Health and/or Labour, typically through the FPT Radiation Protection Committee) Professional organizations (ex. COMP, CAR, CAMRT) Other interested parties contacting CCRPB 11

12 How are Safety Codes Developed/Revised? 2. Process for Developing/Revising Safety Codes CCRPB staff initiate and lead work on Safety Codes Working group may be established (ex. as done for development of Safety Code 36 - Mammography) During development, CCRPB collaborates and consults extensively with key stakeholders including: Federal/Provincial/Territorial Radiation Protection Committee Other relevant Federal/Provincial/Territorial government departments Professional colleges/associations/organizations (ex. COMP, CAR, CAMRT) Industry groups (ex. MEDEC, DIAC, ElectroFed) National experts Draft Safety Codes undergo national consultation to give opportunity to all interested parties/public to provide comments and input. (ex. typically through posting on Gov. of Canada website) Review and consideration of comments and development of final draft. Translation of final documents (English and French versions) Publication - Posting on Government of Canada s website 12

13 Which Safety Code is currently under development? Safety Code 30 Radiation Protection in Dentistry has been identified for revision. Published in 1994, revised in 2000 New international standards for dental x-ray equipment published 2012 (IEC and IEC ) New dental x-ray technologies available in Canada (ex. Digital Imaging Systems, Conebeam Computed Tomography) Amendments to RED Regulations, Schedule II, Part II, Dental X-ray Equipment, anticipated this year (spring/summer). Current Status: CCRPB conducting analysis of gaps in current version of Safety Code 30 Collection and analysis of reference documents Next Steps: Working Group to be established April 2017 Drafting of new Safety Code Consultation anticipated March

provincial/territorial adoption of SC 35 Recommended development of analogous guidelines for NM, MRI, US A review

14 Safety Code 35 Published in 2008 Adopted/adapted by some provinces/territories Applied/reviewed by many Canadian medical physicists Identified strengths/areas for improvement COMP Position Statement 2013 Endorsed provincial/territorial adoption of SC 35 Recommended development of analogous guidelines for NM, MRI, US A review and prioritization of existing/new Safety Codes planning for FY 2017/18. CCRPB welcomes input and collaboration from COMP, CAR, CAMRT. 14

15 Consumer and Clinical Research Bureau: 775 Brookfield Rd. Ottawa, ON K1A 1C Thank you. 15

First Nations and Inuit Health Services Accreditation Community. Information. September 2014

First Nations and Inuit Health Services Accreditation Community Information September 2014 Health Canada is the federal department responsible for helping the people of Canada maintain and improve their