Dr.-Ing. M.S.TULEIMATDr.-Ing. M.S.TULEIMAT(PhD, Med. Equipment Safety, (W) Germany)

The Patient, The Safety, The Patient, The Safety, The Medical Equipment The Medical Equipment

& & The Medical / Clinical The Medical / Clinical

EngineerEngineer

THE CHALLENGETHE 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

PATIENT SAFETYPATIENT 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.

MEDICAL EQUIPMENT MEDICAL EQUIPMENT DEFINITION & APPLICATIONDEFINITION & APPLICATION

Medical equipment are equipment used / applied in / on the

body of the patient for the purpose of diagnosisand / or monitoring and / or

treatment.

SAFETY AS A SYSTEMSAFETY 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.

THE FACTORS OF A SAFETY SYSTEMTHE 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.

DEFINITION OF SAFETYDEFINITION 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).

GOAL & MEANS OF GOAL & MEANS OF SAFETY ENGINEERINGSAFETY 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

PATIENT SAFETY ANDPATIENT SAFETY ANDMEDICAL EQUIPMENTMEDICAL 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.

SAFETY-CATEGORIZATION OF SAFETY-CATEGORIZATION OF MEDICAL EQUIPMENTMEDICAL EQUIPMENT

Medical

Equipment

Special

Techniques

General

Medical

Equipment

SAFETY-CATEGORIZATION OF SAFETY-CATEGORIZATION OF MEDICAL EQUIPMENTMEDICAL EQUIPMENT

Special

Techniques(w/ special safety

precautions & regulations)

X-Ray & CT

(Computed Tomography)

Magnetic Resonance

(M R I)

Nuclear Medicine &Radiation Therapy

SAFETY-CATEGORIZATION OF SAFETY-CATEGORIZATION OF MEDICAL EQUIPMENTMEDICAL EQUIPMENT

General

Medical

Equipment

Category ILife supporting or by

failure / error patient

endangering w/ lethal

outcome possible

Category IIBy failure / error patient

endangering possible

but w/o lethal

outcome

Category IIIBy 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).

FAILURE / ERROR CLSSIFICATIONFAILURE / ERROR CLSSIFICATION

Medical

Equipment

Failure / Error

Technical Environmental Human

FAILURE / ERROR CLSSIFICATIONFAILURE / ERROR CLSSIFICATION

TechnicalError /

Failure

Component /Fabrication

Failure / Error

Concept Failure /Error

(Equipment /

Service)

InterferenceFailure /Error

FAILURE / ERROR CLSSIFICATIONFAILURE / ERROR CLSSIFICATION

EnvironmentalFailure / Error

Information /Communication

Failure / Error

Energy

Failure

Foreign Fields,

Transportation /

StorageFailure /Error

FAILURE / ERROR CLSSIFICATIONFAILURE / ERROR CLSSIFICATION

Human / User

Failure / Error

Individual

Conditional(knowledge, training, etc)

Situation

Conditional(stress, ergonomic, etc)

ERROR RATE CLASSIFICATIONERROR 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

OSTRANDER REPORT (OSTRANDER REPORT (USAUSA))

• 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).

OSTRANDER REPORTOSTRANDER 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).

STRESS AS A MAJOR REASON STRESS AS A MAJOR REASON FOR HUMAN ERRORFOR HUMAN ERROR

• Physical stress:

temperature, time, expectation, etc.

• Physiological stress:

sleep irregularities, illness, etc.

• Psychological stress:

fear, frustration, social/economical

pressure, etc.

FIELD STUDY, GermanyFIELD STUDY, Germany (HOSPITAL DATA)(HOSPITAL DATA)

• Total number of the medical equipment:

610 equipment .• Average failure/error rate:

2.8x10-5 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 .

FIELD STUDY, GermanyFIELD STUDY, Germany (HOSPITAL DATA)(HOSPITAL DATA)

EQUIPMENT GROUP FAILURE/ERROR RATE

(per hour & equipment) x 104

1. ICU (vital functions) 0.65

2. Dialysis / Infusion 2.93. Diagnostic/Electromedical 0.524. Medical Imaging 2.255. Therapeutical Equipment 0.746. Laboratory Equipment 0.184

10 -4 per equipment & hour = 0.876 per equipment & year

CRITICAL EVALUATIONCRITICAL 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

2005-AHRQ Critical Care Safety Study (USA)2005-AHRQ Critical Care Safety Study (USA)+)+) AHRQAHRQ : Agency for Healthcare Research & Quality: 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

WHAT TO DOWHAT 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.

REMEMBERREMEMBER

The best surgery

is not always the newest one,

it is that one, which the surgeon can properly control and manage.