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

Risk Management Insurance policies Claims management Risk reduction strategies Incident investigation

Process to Managing Risk

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

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

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)

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

Safety Management Patient Safety, covered Employee Safety Environmental Safety

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

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

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

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

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

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

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

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

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

Integrated Risk Management and Safety Program Questions? Comments?