1. Dr.-Ing. M.S.TULEIMAT Dr.-Ing. M.S.TULEIMAT (PhD, Med. Equipment Safety, (W) Germany) The Patient, The Safety, The Medical Equipment & The Medical / Clinical Engineer

2. THE CHALLENGE The challenge in medical care services lies in: Effective planning and implementation Efficient utilization of limited resources BUT SIMULTANUOUSLY - providing effective medical care - ensuring highest patient safety

3. PATIENT SAFETY Patient safety in hospital includes: - The “plant” hospital related safety (building, mechanical, electrical, infection control, ….. etc.). - Diagnosis related safety. - Medication related safety. - Safety of medical equipment.

4. MEDICAL EQUIPMENT DEFINITION & APPLICATION Medical equipment are equipment used / applied in / on the body of the patient for the purpose of diagnosis and / or monitoring and / or treatment.

5. SAFETY AS A SYSTEM Any safety system consists of the following factors and their inter-relation / correlation: - The technical / technological factor. - The human factor. - The environmental factor.

6. THE FACTORS OF A SAFETY SYSTEM Technical/ technological Environ- mental Human Note: It is not only the factors which determine the system, it is equally, if not more, their interaction / correlation.

7. DEFINITION OF SAFETY Safety is not an absolute value. It is a statistical value. It can be defined as an “accepted risk”, which is to minimize, whereby a “rest risk” remains, influenced by many factors such as : - Technical & technological development. - Economical possibilities & limitations. - Sociological & cultural conditions. - Acceptance of risks (readiness to take risk).

8. GOAL & MEANS OF SAFETY ENGINEERING The goal of safety engineering is to minimize the “rest risk” with all means available / possible / most effective: - Technical / technological - Personal / educational - Environmental / informational / organizational

9. PATIENT SAFETY AND MEDICAL EQUIPMENT The Patient is in the center of care in hospital, but he is also helpless in the center of what in the industry, long time ago, identified as “latent endangering potentials” (i.e. drugs, electricity, radiation) Therefore, safety of medical equipment in hospital means consequently safety of the patient first, but also of user and any other.

10. SAFETY-CATEGORIZATION OF MEDICAL EQUIPMENT Medical Equipment Special Techniques General Medical Equipment

11. SAFETY-CATEGORIZATION OF MEDICAL EQUIPMENT Special Techniques (w/ special safety precautions & regulations) X-Ray & CT (Computed Tomography) Magnetic Resonance (M R I) Nuclear Medicine & Radiation Therapy

12. SAFETY-CATEGORIZATION OF MEDICAL EQUIPMENT General Medical Equipment Category I Life supporting or by failure / error patient endangering w/ lethal outcome possible Category II By failure / error patient endangering possible but w/o lethal outcome Category III By Failure / error no patient endangering possible Notice: From safety point of view, categories I & II shall not be allowed. All medical equipment must be of category III per se or via constructional / conceptional measures on / in the equipment or their operation ( safety circuits, redundancy, stand-by,.. etc).

13. FAILURE / ERROR CLSSIFICATION Medical Equipment Failure / Error TechnicalEnvironmentalHuman

14. FAILURE / ERROR CLSSIFICATION Technical Error / Failure Component / Fabrication Failure / Error Concept Failure /Error (Equipment / Service) Interference Failure /Error

15. FAILURE / ERROR CLSSIFICATION Environmental Failure / Error Information / Communication Failure / Error Energy Failure Foreign Fields, Transportation / Storage Failure /Error

16. FAILURE / ERROR CLSSIFICATION Human / User Failure / Error Individual Conditional (knowledge, training, etc) Situation Conditional (stress, ergonomic, etc)

17. ERROR RATE CLASSIFICATION Rate Probability (per equipment & hour) 10 -7 and less very improbable 10 -7 – 10 -5 improbable 10 -5 – 10 -4 rather probable 10 -4 and more probable Notice: 10 -4 per equipment & hour = 0.876 per equipment & year

18. OSTRANDER REPORT ( USA ) In an ICU: 43/145 failures was user error. By monitoring systems: 58% of reported failures were due to not enough training of the user. In a questionnaire by hospital engineers: 50% of the equipment failures are due to user error. The reported accidents / failures are the top of an ice berg (worst case situation).

19. OSTRANDER REPORT Ostrander gives the following reasons for user / human errors: Lack of knowledge / training. Unjustified expectation. Stress (most of serious incidents happen in ER). Changes in equipment (sometimes as consequence of bad design).

20. STRESS AS A MAJOR REASON FOR HUMAN ERROR Physical stress: temperature, time, expectation, etc. Physiological stress: sleep irregularities, illness, etc. Psychological stress: fear, frustration, social/economical pressure, etc.

21. FIELD STUDY, Germany (HOSPITAL DATA) Total number of the medical equipment: 610 equipment. Average failure/error rate : 2.8 x 10 -5 per equipment and hour. 74% of the failures/errors was classified as technical/equipment failure/error. 18.3% of the failures/errors was classified as human/user failure/error.

22. FIELD STUDY, Germany (HOSPITAL DATA) EQUIPMENT GROUP FAILURE/ERROR RATE (per hour & equipment) x 10 4 1. ICU (vital functions) 0.65 2. Dialysis / Infusion 2.9 3. Diagnostic/Electromedical 0.52 4. Medical Imaging 2.25 5. Therapeutical Equipment 0.74 6. Laboratory Equipment 0.184 10 -4 per equipment & hour = 0.876 per equipment & year

23. CRITICAL EVALUATION Do not depend on the failure classification in repair reports. If mentioned in repair reports, following are most likely indicators of human error, even if they are not classified as such in repair reports : - parametric re-adjustments. - equipment OK. - damages (hoses, cables, indicators). - user explained. - soil / pollution. (user error : hospital data reports 18.3%, critical evaluation 55%) +) Do not depend only on reports! Make interviews! ( user error: in reports 17.3%, in interviews 49.3%) ++) +) M.S.Tuleimat: Developing an integrated concept for the safety of medical equipment in hospital, Reihe 17: Biotechnik, NR.36, VDI Verlag, 1987. ++) J. Hennig u.a.: Human factors in nuclear power plants, Band I & II, TUV-Verlag, 1977

24. 2005-AHRQ Critical Care Safety Study (USA) +) AHRQ : Agency for Healthcare Research & Quality In ICU: - Adverse events occur at a daily rate of: 0.81 per 10 patient / bed - Serious errors occur at a daily rate of: 1.5 per 10 patient / bed - 45% of the adverse events were deemed preventable - Safe use of medical devices in ICU depends on many factors (education, training, proper selection …etc) +) results mentioned in ECRI – book: Critical care safety

25. WHAT TO DO To make the safety of the medical equipment higher, data/information/ following up/equipment “CV” is needed to point out weak points and suggest the appropriate safety concept. Following up is costly and efforts and time consuming ( will not be done volunteerly ). → No following up without “ pressure “ → Pressure means regulation. Education and training again and again.

26. REMEMBER The best surgery is not always the newest one, it is that one, which the surgeon can properly control and manage.