An Integrated Risk Management Safety Program IRMSP Baset

An Integrated Risk Management & Safety Program: IRMSP Baset Khalaf Tshwane University of Technology Advanced Healthcare Technology Management Workshop Mombasa, Kenya — 9 -12 August 2006

Risk Management v Insurance v Claims v Risk policies management reduction strategies v Incident investigation

Process to Managing Risk

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

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

Managing Risks of Technology v Medical equipment planning v Medical equipment maintenance v Managing hazard reports, alerts & recalls individual adverse events v Proactive: Failure Mode and Effect Analysis (FMEA) v 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 v Patient Safety, covered v Employee Safety v Environmental Safety

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

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

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

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

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

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

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

HCT Management and Patient Safety v. Responsibility safety: of the following towards patient 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 •

IRMSP: Clinical Engineering Activities v v v 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? Advanced Healthcare Technology Management Workshop Mombasa, Kenya — 9 -12 August 2006