Medical equipment ordinance and lack of personnel: Two contrary factors influencing anesthesia patient safety

Medical Lack of Factors Patient

Equipment Ordinance and Pe&nnel: Two Contrary Influencing Anesthesia Safety

Klaus Peter, MD,* Hans-Jiirgen Dieterich, MD”f Institute of Anesthesiology, Germany.

In January

1984,

ical Equipment

West German legislators enacted the Med-

Ordinance

(MedGV)

ulations ,for both manufacturers

to dffine speczfic reg-

and operators of medical

Ludwig-Maximilians-University

of Munich,

Munich,

Keywords: Anesthesia, human factor, safety, risk; equipment, medical equipment ordinance; quality assurance, staff requirements.

equipment and to offer a measure of safety to patients. We describe the history ?f MedGV,

its regulations, and the mech-

anisms developed to enforce those regulations.

We also eval-

Introduction

uate its impact on clinical practice in light of the current staff shortaRes in anesthesia practice and research in Germany. Finally,

we focus

our discussion on the distinction

between improved equipment

as a minor factor

incidents and the inadequate

manpower

in critical

as a major factor

in anesthesia mishaps. It is unclear what will develop after 1993,

when the national states in Europe form a common

market.

J. Clin. Anesth.

1991;3:259-262

*Professor

and Chairman

tAssistant

Professor

Address reprint requests to Dr. Peter at the Institute of Anesthesiology, Klinikum Grosshadern, University of Munich, Marchioninistrasse 15, 8000 Munich 70, Germany. Received for publication August 3, 1990; cepted for publication January 31, 1991. 0 1991 Butterworth-Heinemann

revised

manuscript

ac-

Progress in medicine is intimately related to technical innovation. Technological advances have led to the development of sophisticated medical equipment that allows us to monitor, control, support, and even emulate vital functions of patients. Unfortunately, this increase in the sophistication of medical equipment is not automatically accompanied by an equivalent increase in the technical and mechanical knowledge of most medical personnel. Consequently, clinicians sometimes use medical instruments without fully understanding how to operate them safely or maintain them properly. Recent studies have shown that incorrect or inappropriate use is to blame for most accidents involving technical medical equipment.’ MedGV was designed to reduce the likelihood of such accidents by defining standards of design, construction, and maintenance of equipment, as well as training of those who operate it.’ But the MedGV covers only a small portion of the field of quality assurance in anesthesia. Quality assurance is of concern because the number of anesthesia staff members required is calculated from guidelines developed in the late 1960s. These guide-

J. Glin. Anesth.,

vol. 3, May/June

1991

259

Special

Adides

lines do not consider the fact that equipment failure is only a minor factor in critical incidents in anesthesia.“,’ Only an increased number of personnel, with an acceptable ratio of anesthesiologists to residents, offers a sufficient chance for supervision and teaching. This will further improve patient safety by influencing the human factor in anesthesia mishaps.

Medical

Equipment

J. Clin. Anesth.,

vol. 3, May/June

C;roup 1 Group Group

2 3

Group

4

of Medical

1991

Equipment

Energy-powered medical devices (see T&e 2) Energy-powered medical implants Energy-powered medical devices not listed in the MedGV appendix (see Table 2) All other medical equipment

Table 2. Group 1 Medical (MedCV Appendix)

Because quality of design and construction of equipment is integral to its safe use, the MedGV includes regulations aimed at ensuring such quality. Manufacturers are obligated to meet the standards of the MedGV, as well as the protective labor legislation and the prevention of accidents ordinance (3.1 MedGV). Certain monitors, such as those of inhalation agents, must be equipped with alarms that warn of overdosage (3.2 MedGV). The control panel and adjusting devices of medical equipment must be labeled with commonly understood inscriptions or standardized pictograms (3.4 MedGV). An operator’s manual, written in German, must be delivered with all equipment (4.1 MedGV). Manufacturers must obtain a license from a designated authority (17 MedGV) before manufacturing certain energy-powered devices, including all energy-powered implants (5 MedGV; see Groups 1 and 2 in Table 1 and the list in Table2). Furthermore, the manufacturer must be able to provide regular service and repair, usually performed semiannually. Credentials of maintenance personnel also must meet published criteria (11.2 MedGV). Before the purchaser is allowed to operate new equipment, the manufacturer or dealer must perform a functional check of the device on-site (9.1 MedGV) and instruct appropriate persons in its proper maintenance and operation, as detailed in the operator’s manual (9.2 MedGV). The construction of all medical equipment in use before the passage of the MedGV must be certified by the proper authorities, or the owner must be able to show continuously documented service and repair records that meet the requirements of the MedGV (22.2 MedGV). The hospital administrator is ultimately accountable for all the equipment used in the hospital, but the development and implementation of safety standards are commonly delegated to the department chairperson because he or she has access to all the department’s equipment and has authority over all its staff. If the chairperson believes that safe medical treatment of patients undergoing certain procedures is not possible because of equipment that falls below a widely accepted technical level, he or she must inform the 260

Table 1. Classification (2.1 MedGV)

Equipment

1. Electrocardiographs and phonocardiographs for intracardiac application 2. Blood pressure measurement device for intracardiac application 3. Magnetic blood-flow measurement devices 4. Defibrillators 5. Nerve and muscle stimulators for diagnostic and therapeutic purposes 6. Devices for electroconvulsion therapy 7. High-frequency electrosurgical devices 8. Impulse-generating equipment for lithotrypsy 9. Photocoagulators and laser coagulators 10. High-pressure injection syringes 11. Cryosurgical eqmpment (heating device) 12. Infusion devices (volumetric pumps) 13. Infusion devices (syringe pumps) 14. Perfusion pumps 1.5. Mechanical ventilators 16. Inhalational anesthetic equipment 17. Incubator (stationary and portable) 18. Pressure chambers for hyperbaric oxygen therapy 19. Dialysis 20. Hypothermic equipment (control device) 21. Cardiopulmonary bypass equipment 22. Laser surgery equipment 23. Blood filtration equipment 24. External pacemakers 25. Magnetic resonance imaging equipment

hospital administrator. In this written note, the chairperson must describe the problem and the risks it poses to patients. The responsibility for investigating the situation and ensuring that equipment is properly maintained and operated then reverts back to the administrator.

Training

of Personnel

The use of all medical devices listed in Groups 1, 3, and 4 of the MedGV (Table 1) is restricted to designated personnel. In addition, persons intending to operate Group 1 and 3 devices must attend an orientation presented by the manufacturer or other personnel with commensurate credentials (~.g., skilled staff

Medical equipment ordinance and lack

of the dealing company). Although the MedGV allows manufacturers or dealers to vary the organization and presentation of their orientations to suit the practical needs of different institutions, certain topics must be addressed (10 MedGV) (Table 3).

Inventory The MedGV requires each institution to keep an inventory, which includes the purchase information for all its Group 1 and 3 devices (12 MedGV) (Table 4). In addition, institutions must maintain a service record for each Group 1 device, documenting both routine maintenance and unexpected malfunctions and repairs (13 MedGV) (Table 5). The service records may be kept on paper or in an electronic data base. For practical as well as medicolegal reasons, many institutions have found it helpful to maintain a record for each staff member documenting the instruments he or she has been authorized to operate.

Quality Assurance Before the final parts of the MedGV went into effect in -January 1988, many clinicians were skeptical.” To meet the demands of the ordinance, a variety of administrative and technical duties that were previously unregulated had to be organized, monitored, and documented. Vast inventories of technical medical equipment had to be documented according to strict schema. The two West German societies of anesthesiologies [the Germany Society for Anesthesiology and Intensive Care Medicine (DGAI) and the Professional Association of Anesthetists (BDA)] bolstered the efforts of the MedGV by publicizing its potential for enhancing quality assurance.” In cooperation with representatives of various surgical disciplines, the societies developed and published a set of guidelines for quality assurance in anesthesiology that reflected the stringent regulation of technical equipment required by the MedGV.7 An editorial detailing the new guidelines also was published in a professional journal.8 The guidelines offer recommendations for space and equipment allocation in a variety of departments (e.g., heart surgery and nonoperative theaters such as xray and obstetrics), detail essential equipment for each, and suggest optimal placement of that equipment. The MedGV has quickened the pace of technological advances in anesthesia practice in West Germany. We have practiced anesthesia according to the dictates of the MedGV for nearly 2% years, and we believe that it works. The revised guidelines have made safer

of personnel:

Peter and Dieterich

Table 3. Required Topics of Manufacturer’s Orientation to Technical Equipment in Groups 1 and 3 (4.1 MedGV) Purpose Principles of operation, calibration, Possible uses with other equipment Cleaning Sterilization Assembly Proper application Troubleshooting

Table 4. Equipment

Information in Groups

and testing

Required in Inventory 1 and 3 (12 MedGV)

of

Name of manufacturer Type, serial number, and year of delivery MedGV classification Site of institutional use

Table 5. Equipment

Information Required Only (13 MedGV)

in Inventory

of Group

1

Date of performance check (prior to initial use) Date of manufacturer’s orientation (see Table 3) Names of persons sharing manufacturer’s orientation Dates of service (maintenance and repair) Names of persons servicing or repairing the device Dates, descriptions, and consequences of malfunctions Construction license or equivalent

anesthetic procedures possible by defining the standards for the maintenance and operation of technical equipment. But adequate technical equipment is only of minor importance when focusing on quality assurance in anesthesia practice. The human factor is more influential concerning the rate and severity of critical incidents in anesthesia.“,4 The staff requirements for anesthesia at the beginning of the 1990s were calculated from data provided by the German Hospital Society (DKG) in 1969. These calculations were based on a work-related formula (N = number of anesthesia facilities in use 5 hours per 5 days a week); N + 35% is the number of anesthetists who must be enlisted by the hospital administration.g A few examples show that these calculations do not meet today’s needs. State of the art is “one doctor, one theater.” One anesthesiologist doing two anesthesias simultaneously or anesthesias done by a nurse alone are not acceptable.‘” Legislation today requires adequately trained physicians. Hospitalized patients are older and present a 1. Clin. Anesth.,

vol. 3, May/June

1991

261

S’peciul Articles

higher perioperative risk than they did 20 years agoa result of medical progress by surgeons as well as by anesthetists. But the formula N + 35% does not differentiate between fellows and residents. Consequently, only well-trained, experienced anesthetists can work in the operating room by themselves. This may create a situation in which younger doctors cannot be employed if an institution has no older residents to supervise and teach the young colleagues. Actual practice differs greatly from this strict regulation. There are not enough anesthetists to run all operating rooms with only highly skilled personnel. And the formula N + 35% does not offer an opportunity for adequate supervision. The clinical routine requires young residents to do anesthesia with a minimum of clinical and technical skill. But in case of any complication, the chairperson responsible for these organizational decisions will become liable for committing an “organisatory fault.“” Furthermore, the formula N + 35% does not reflect on work done by the anesthesiologist outside the operating room, such as preoperative visits; patient care in the holding area, the recovery room, or the intensive care unit; postanesthetic visits in the hospital; or running a pain clinic.” A special situation involves the university hospitals throughout Germany. Selected patients, often in poor health, are scheduled at these few centers for extensive operative procedures. Students, as well as colleagues from smaller hospitals, want to learn about subspecialties in anesthesia, such as thoracic or cardiac anesthesia, or intensive care medicine. Only by increasing staff is it possible to improve knowledge and experience for those in training. Investing in training today is necessary to ensure quality patient care and anesthesia delivery in the future.

Conclusion The practice of anesthesia in West Germany was dominated in the past by impressive technical progress caused by legislation introducing the MedGV. This improvement in technical equipment was achieved only because of the efforts of manufacturers, hospital ad-

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ministrators, and operators. These additional tasks unmasked the lack of personnel in anesthesia practice. The efforts of the responsible parties in anesthesia must focus on obtaining the staff needed for patient care as well as clinical and basic research. Additional staff can improve research and anesthesia practice in general, just as the MedGV has improved the technical field.

References 1. Secure

Technique

Medical-Technical

in Mediczne-An Equipment.

Adviser

/Or Sajety

of

Munich: Bavarian Ministry

of Labour and Social Service, 1985. Ordinance (Medizingeriteverord2. Medical Equipment nung, or MedCV), BGBI I, p.93 14.01.1985. 3. Cooper JB, Newbower RS, Long CD, McPeek B: Preventable anesthesia mishaps: a study of human factors. Anesthesiolog?l 1978;49:399-406. 4. CooperJB, Newbower RS, Kitz RJ: An analysis of.m+jor errors and equipment failures in anesthesia management: considerations for prevention and detection. Anesthesiology 1984;60:34-42. 5. Kilian J, Ahnefeld FW, Friesdorf W: The organisation of duties resulting from the medical equipment ordi1987;28:323-26. nance. Aniisth Intensivmed 6. Opderbecke HW: Quality assurance versus determination of personnel requirements. An&h Intemivmed 1988;29: 111. 7. Quality assurance in anesthesiology. Guidelines of the German society for anaesthesiology and intensive care medicine and the professional association of anaesthetists. Antisth Intensivemed 1989;30:307-14. 8. Opderbecke HW: Quality assurance in anaesthesiolog) [Editorial]. An&h Intensivmed 1989;30:285-6. 9. Opderhecke HW: Preliminary determinations of personnel requirements [Editorial]. Aniisth Intensivmed 1989;30: 157. IO. Weissauer W, Opderbecke HW: Admissibility and limits of anaesthesias in parallel. Aniisth Intensiumed 1983;24:214. 11. Weissauer W: Personnel requirements in the field of anesthesiology-medico legal viewpoints. Aniisth Intew tiumed 1989;30: 180-3. U, Eberlein HJ: Patient safety in anaes12. Schulte-Sasse thesia management. An&h Intensivmed 1990;3 1:97- 10 1.