Safety and Risk Management

1. Safety and Risk Management

2. Codes and Standards Definitions Standard: A widely recognized and accepted statement of criteria by which an object (product) or action (service) may be measured. Code: A standard which has been made compulsory by an act of legislation.

3. Examples CODE • Canadian Standards Association (CSA) C22.1 • Part 1 of the Canadian Electrical Code (CEC) • Adopted by legislation in Province of Alberta • Enforced by Safety Standards Branch, Alberta Department of Labour

4. Examples STANDARD • Z32.2 - M89 “Electrical Safety in Patient Care Areas” • Z32.4 - M86 “Essential Electrical Systems for Hospitals” • Z32 –04 (Sept. 2004) “Electrical Safety and Essential Electrical Systems in Health Care Facilities” • Voluntary standard • Most hospitals attempt to conform

5. Canadian Standards Association • Non-profit Organization Chartered in 1919 • Accredited by Standards Council of Canada 1973 • Standards Writing • Certification Testing & Inspection • CSA standards reflect national consensus • Producers • Users • Regulatory Authorities • Not Part of Government

6. Canadian Standards Association • Certification indicates that a product, system or service has been evaluated and complies with applicable safety and performance standards. • Only a few production samples are tested by CSA • Incoming safety inspections are still required

7. Alberta Safety Standards Branch • Purpose is to provide safe and uniform electrical environment to citizens of Alberta. • Inspects, tests and certifies electrical equipment not already certified by CSA • Does not certify electromedical equipment (referred to CSA testing facilities)

8. All electrical equipment must be approved before it is used, sold, displayed, advertised, offered for sale, or distributed in Alberta. (Includes devices made in-house or any device which is modified.)

9. Pertinent CSA Standards • Z32-04 “Electrical Safety and Essential Electrical Systems in Health Care Facilities” • C22.2 No. 125 - M84 “Electromedical Equipment” • C22.2 No. 601.1 - M90 “Medical Electrical Equipment, Part 1 General Requirements for Safety” • C22.2 No. 601.2.4 - M90 “Medical Electrical Equipment, Part 2 Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator Monitors • C22.2 No. 151 - M86 “Laboratory Equipment” • C22.2 No. 114 - M90 “Diagnostic Imaging and Radiation Therapy Equipment” • C22.2 No. 204 “Line Isolation Monitors” • Z386 “Laser Safety”

10. Z32-04 “Electrical Safety and Essential Electrical Systems in Health Care Facilities” • Describes elements essential to an electrical safety program in a healthcare facility. • Includes the design, installation, operation, and maintenance of a hospital electrical system.

11. Safety Program Safety • Definition: A state of freedom from injury or damage. • Concept: A combination of the awareness of, and actions taken to prevent injury or damage.

12. Hazards Present in Hospitals • Mechanical • Chemical • Environmental • Biological • Fire • Radiation • Electrical

13. Mechanical Hazards • Injuries • Lacerations, contusions, dislocations, fractures • Failure of mechanical patient support systems • Wheelchairs, ramps, lifts, stretchers, restraints • Absence of general building safety • Loose railings, wet floors, obstructions, improper lifting • Rupture of pressurized cylinders

14. Chemical Hazards • Injuries • Poisoning, burns, eyes, lungs • Toxic compounds • Inhalation • Skin contact • Ingestion • WHMIS (Workplace Hazardous Materials Information System)

15. Environmental Hazards Sources of Pollution • Noise • The threshold of hearing occurs at 0 dB(A) • The threshold of pain occurs at 140 dB(A) • Hospital noise levels typically fall between 50 and 85 dB(A) • Noise levels in infant incubators must be kept to a minimum (less than 60 dB(A)) • The current standard for industrial exposure is 90 dB(A) for an 8 hour workday. • Disposables • The average hospital produces 15 pounds of solid waste per day per bed. • Infectious waste • Incineration is required for all pathological specimens • Radioactive waste

16. Fire • Injuries • Burns, smoke inhalation • Fire requires • Oxygen • Air, O2 and NO2 (Nitrus Oxide) • Flammable substance • Alcohol, solvents, clothing, etc. • Source of ignition • Flame (smoking), sparks (electrical)

17. Radiation Hazards • Injuries • Radiation sickness, cancer, burns, eyes • Non-ionizing Sources • Ultraviolet (sterilization) • Microwave (physiotherapy) • Lasers (surgery) • Ionizing Sources • X-ray (diagnostic imaging) • Cobalt 60 (nuclear medicine) • Radioactive seeds of cesium or radium (nuclear medicine)

18. Biological Hazards • Threat to patients and staff • Disinfection • Reduces number of infectious organisms • Sterilization • Destroys all infectious organisms

19. Electrical Hazards • Explosion and Fire Ignition • Power Interruption • Electric Shock

20. Electrical Shock Hazards • Hospital patients are at higher risk • Use of electrodes and fluid-filled catheters • Weak physical condition • Physiological effects vary with • Path through body • Body resistance • Physical condition of victim • Applied current • Magnitude • Duration • Frequency

21. Electrical Safety Program • Integrates • Environment • Staff • Administration • Patient. • Involves the establishment of • Policies • Standards & regulations • Safety tests and procedures

22. Program Parameters 1. Administrative commitment • Personnel, budgets and authority 2. Electrical Safety Training • Clinical and support staff 3. Safety Committee • Determines hazards • Provides advice • Has authority to initiate change

23. Program Parameters 4. Technical Expertise • External sources (CSA, ECRI, SSB, etc.) • Internal sources (CE) 5. Management and Control Authority to implement: • Controls of personnel and environment • Safety surveys • Equipment inspection • Specification and testing of all new patient instrumentation

24. Priority of Program Implementation 1. Immediate protection of electrically sensitive patients (ICUs). (Safety testing and inspection.)

25. Priority of Program Implementation 2. Investigation of current safety practices • Environment (electrical power distribution system) • Equipment acquisition process • Equipment application • Degree of protection required (risk class) • Degree of reliability (maintenance) • Equipment obsolescence • Degree of immunity from consequences of human failure in operation or maintenance • Consequences of delay • Economic factors

26. Priority of Program Implementation 3. Protection for general patients and personnel in existing facilities as soon as possible 4. Development of formal PM program • Electrical Safety • Performance Assurance

27. Program Implementation • Program specifications must balance • Costs • Benefits • Degree of risk • Involves • Departmental organization and responsibilities • Official policies • Safety and performance testing of equipment and environment • Test schedules

28. Clinical Engineering Services 1. Safety testing • Receptacle wiring, tension, and grounding in patient care areas • Leakage current and grounding of patient-care equipment 2. Performance Testing

29. Clinical Engineering Services 3. Repair • Backup system available • 24 hour service available 5. Incoming safety and performance inspection 6. Education • Lectures and demonstrations on electrical safety, operations and care of equipment are provided to clinical staff 7. Equipment Acquisition