1. 1 Risk Management Frank Painter, CE Program Director University of Connecticut 1 June 6, 2015

2. Risk Management “…an organized effort to identify, assess, and reduce where appropriate, risks to patients, visitors, staff, and organizational assets” 2

3. CE Risk Management Issues Device Recalls Device Tracking/Reporting (SMDA) Incident Investigations Medical Technology risks (MRI, laser, anesthesia, radiation, infection control, etc.) Alternate parts EMI interference Disposal of used equipment 3

4. Principles of Risk Absolute safety is generally not achievable Zero risk is generally not achievable What is sought is a balance between safety, utility and resources Optimal safety is not an automatic byproduct of overall good intentions… it requires specific effort! 4

5. Components of risk: Hazards Hazards (to people) – the manner in which a device or system can cause injury Hazards (to things) – the manner in which a device or system can cause damage to equipment, buildings or organization functionality 5

6. Components of risk: Severity All hazards are not equal Different “severities” can be identified Minor Catastrophic 6

7. Components of risk: Probability Hazards are not equally likely to occur, they have a range of probability Highly unlikely Highly likely 7

8. Components of risk: Detectability Hazards are not equally likely to be identified before causing harm, they have a range of probability ObviousUnidentifiable 8

9. 9 TJC Sentinel Events A sentinel event - an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof (Where a recurrence would carry a significant chance of a serious adverse outcome). Organization must conduct a Root Cause Analysis on each Sentinel Event. Organization may voluntarily report Sentinel Events to the TJC Certain types of Sentinel Events are required to be reported (unanticipated death or major loss of function, suicide, Abduction of a patient, Discharge of infant to wrong family, Hemolytic transfusion reaction, wrong site/patient surgery, & a few others) 9

10. 10 FDA Reporting Requirements Safe Medical Devices Act (SMDA) of 1990 Postmarket Surveillance for the monitoring of products after their clearance to market Device Tracking for maintaining traceability of certain devices to the user level. Medical Device Reporting (MDR) regulation of December 1995 (for user facilities and manufacturers) The MDR regulation provides a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices FDA Modernization Act of 1997 10

11. 11 FDA Reporting Requirements Users (healthcare professionals) voluntary adverse event reporting program is called MedWatch used for adverse reactions, product quality problems & product use errors The SMDA requires user facilities to report: device-related deaths to the FDA and the device manufacturer; device-related serious injuries to the manufacturer, or to FDA if the manufacturer is not known; and submit to FDA on an annual basis a summary of all reports submitted during that period. 11

12. 12 FDA Data Manufacturer And User Device Experience (MAUDE) database Medsun – A more carefully managed version An on-line search is available which allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury.on-line search MAUDE is scheduled to be updated quarterly and the search page reflects the date of the most recent update. This data is on ECRI’s HD website too. 12

13. 13 Root Cause Analysis Retrospective probe the reason for problems that occurred get to the root of the problem, not the apparent, surface or proximate cause (special causes) ask - why, why, why To prevent recurrence To create an action plan for improvement 13

14. 14 Root Cause Analysis Process for identifying the basic or causal factors in performance variation Focuses primarily on systems and processes, not individual performance No assignment of blame Find the factors that enabled the event to occur 14

15. 15 Root Cause Analysis Proximate Causes Superficial Obvious Immediate Special causes Root Causes Underlying causes Causes that lead to the proximate cause Common causes 15

16. 16 Proximate Cause Variation Proximate causes Mechanical Malfunction, intoxicated employee, flood, hurricane, earthquake Firing an intoxicated employee who failed to connect the NIBP line correctly will not prevent the same special cause from recurring in the future 16

17. 17 Root Cause Analysis Do not solve problems by eliminating proximate causes Probe, understand and address underlying root causes Proximate causes in one process are usually the result of root causes in a larger system 17

18. 18 Root Cause Analysis Mechanical breakdown of a piece of equipment in surgery –> problem with organization’s PM activities Intoxicated employee -> organization’s screening and hiring practices 18

19. 19 TJC Sentinel Events 19

20. 20 TJC 2014 Patient Safety Goals Goal 1 Improve the accuracy of patient identification.patient identification Minimum of two identifiers Eliminate transfusion errors Goal 2 Improve the effectiveness of communication about test results among caregivers Goal 3 Improve the safety of using medications. Labeling Anti-coagulant therapy issues Goal 6 Clinical alarms management Goal 7 Reduce the risk of health care-associated infections. Follow hand washing guidelines Implement program for MRSA CLABI surgical site infections CAUTI Reduce procedure mistakes Verify the correct procedure and patient Mark the procedure site Call time-out 20

21. 21 Resolved Patient Safety Goals Wrong site-wrong side surgery IV pump free flow MRI safety Surgical fires Ventilator safety Patient falls 21

22. 22 Failure Modes and Effects Analysis Proactive – focuses on the design of the system to prevent future failures Assumes failures will occur Analyzes what could go wrong, the likelihood it will go wrong and the effect if it did Faults or problems are anticipated and designed out Systematic way to examine the design for possible ways failure can occur Minimizes Probability and effect of failure. 22

23. Disaster Planning Managing the risks of potential catastrophic incidents Hazard vulnerability analysis Emergency preparedness plan Planning & Practice = Preparedness 23

24. 24 Incident Investigation Arrive with the right tools (tool box) Document the overall scene – layout Document environmental issues Document the arrangement of the people and their roles Document the settings, connections and nearby but apparently uninvolved equipment 24

25. 25 Incident Investigation 25

26. 26 Incident Investigation Photograph everything – a good camera is important & a microscope Test the equipment – against know standard Do not fix the equipment – spoliation is bad Write the report – nothing but the facts Develop your opinions separately 26

27. 27 Incident Investigation Work with & report to Risk Manager Do things by the book – follow policies and procedures A lawsuit could develop and unproven opinions and conclusions will become facts in the mind of opposing lawyers 27

28. 28 CE Risk Management In Retrospect If you have good well thought out policies and procedures If you inspect and repair equipment, manage recalls and safety issues according to policies and procedures If you work closely with Risk Management during incident investigations Things will go well for CE. 28