1. An Integrated Risk Management & Safety Program: IRMSP
Baset Khalaf
Tshwane University of Technology

2. Risk Management Insurance policies Claims management
Risk reduction strategies
Incident investigation

3. Process to Managing Risk

4. Understanding Risk Risk is the possibility of suffering harm or loss
Probability of an event
Severity of an event
Risk = Probability x Severity
Risk & Safety are opposite sides of the same coin
Safety means the maximum risk that you can accept

5. Risk Acceptance Probability Acceptable considering the benefit
Generally
unacceptable S e v r i t y
Generally
acceptable
Probability

6. Managing Risks of Technology
Medical equipment planning
Medical equipment maintenance
Managing hazard reports, alerts & recalls
Managing individual adverse events
Proactive: Failure Mode and Effect Analysis (FMEA)
Reactive: Root Cause Analysis (RCA)

7. What is Failure Mode & Effect Analysis
Failure mode Effect and Analysis is a systematic method of identifying and preventing product and process problems before they occur
RCA is a retrospective procedure to determine the cause of a specific event
FMEA is a proactive procedure to look at ALL possible failure modes

8. Safety Management Patient Safety, covered Employee Safety
Environmental Safety

9. Environmental Safety
Safety Officer: receives input, monitor surveillance programs, analyzes safety date
Safety Committee: multidisciplinary, focus of safety activities, reports to highest levels
Departmental safety coordinators: coordinates investigations, introduces safety corrections, coordinates reporting

10. Employee Safety
Occupational Safety and Health Administration (OSHA); acts/regulations
Employee awareness of Safety Issues; infection control, electrical-chemical-radiation-fire-laser safety
Employee training; prior to first encounter & periodically to recognise hazards and protect

11. Integration of Safety & Risk Management
Multidisciplinary committees
Joint safety rounds
Environmental safety
Employee safety
Patient safety
Infection control
Facility, equipment, housekeeping
Break down barriers!

12. Building a Safety & Risk Management Program
Administrative support
Hazard identification
Hazard evaluation
Training
Controls
Record keeping
Program review & improvement
Total involvement

13. Government & Rules Regulate medical device quality
Create systems to share information
Facilitate open communications
Publicize trends
Encourage quality healthcare systems
Acknowledge good performance
LAWS, REGULATIONS, STANDARDS, GUIDELINES

14. CE Department’s Risk Management Program (OSHA Compliance)
Part of the facility-wide safety program
Injury protection fundamentals
Personal protection practices
Special risks
electrical, thermal, chemical, radiation, laser, etc.
Infection control & equipment
Blood Borne Pathogens

15. World Alliance for Patient Safety Medical Devices and Equipment
Strategic Directions
Development of national policy: Regulatory, coordination and management on national level
Quality and safety: standards, performance specifications, tools and risk reduction
Access: quality management systems addressing needs, and acquisition process, donation guidelines and industry collaboration
Appropriate use of equipment in order to reduce risks: education, information and documentation

16. HCT Management and Patient Safety
Responsibility of the following towards patient safety:
Healthcare Provider Organizations – facility & equipment planning & selection
Users – appropriate use
Public & Patients – feedback on equipment problem
Government – standards & regulations
Maintenance Providers – proper maintenance
Constructors/Manufacturers/Vendors - safe design/construction/manufacture & after-sale support

17. IRMSP:Clinical Engineering Activities
Development of medical device safety programs (systems, education, measures, etc)
Risk analysis in planning/replacement
Evaluating risk and safety at time of purchase
PM/inspection with emphasis on safety
Medical device recall and hazard alert management
Medical device adverse incident investigations
Clinical engineering society/foundation activities
Acceptance evaluation of safety
Safety Education
Installation to reduce risk, errors and enhance safety
System Safety Solutions

18. Integrated Risk Management and Safety Program
Questions? Comments?