Is Competency with our Equipment a Safety Problem?

Joachim S. Gravenstein, M.D.

An FDA study which used modem anesthesia machines especially modified to produce different dangers and faults was recently reported in the ASA Newsletter (Lees DE: Pre-operative check-list revisited. August, 1991, 55(8):9-11). The results of the study were disappointing; many anesthesiologists clearly did not have a thorough understanding of their anesthesia machine.

These observations do not come as a surprise to experienced clinicians. The relentless progress of technology in anesthesia has confronted us with an ever-growing number of machines and devices, and with it have grown the difficulties of thoroughly understanding the underlying technology and mastering the operation of the devices. As clinicians, we like to remind our friends from industry that our primary interest is the patient and that we do not Re to divert our attention from the patient to equipment which, after all, is there to help us rather than to challenge us.

The problem we encounter may be described with this imaginary but not unlikely scenario:

The anesthesia staff of Hospital X decides to buy a device from Company Y. The device is a sophisticated intravenous drug delivery system that also monitors a number of parameters. The device promises to offer distinct advantages in the care of a category of patients requiring anesthesia. When the device is delivered to the department, an ‘in-service’ is arranged. This takes place from 2 to 4 P.M. on a workday. Only about half of the anesthesiologists in the department can attend; the others are busy in the operating room. Of those who attend the in–service, the majority will use the equipment right away, but one or two have assignments elsewhere, and thus will not be able to become thoroughly acquainted with the new apparatus. Half a year later, during an emergency at midnight, one of the anesthesiologists who went through an in–service but subsequently did not use the equipment has a patient in great need of the equipment but he cannot recall some of the details of its operation.

Instructions

Of course, the equipment came with a 3-inch thick manual that describes in great detail how the unit works. This book, however, was written by engineers who were proud of the great flexibility and sophistication of the unit they had designed. The unit, therefore, had multiple knobs triggering cascades of programs suitable to make the unit perform in any one of many different modes. However, before the manual describing the sophistication of the apparatus was sent out, the corporate attorneys of the company went over the manual and added disclaimers and cautionary statements, all couched in a language not designed to make for easy reading. The anesthesiologist did not need to worry about the shortcoming of this printed material because it had long since been lost. Thus the clinician had to decide whether to deny the patient the benefit of a potentially useful device or to attempt to operate it as fully and correctly as he possibly could figure out.

The Committee on Education and Training of the APSF has met repeatedly during the last two years to discuss this difficult issue with representatives from a number of companies. All participants in these discussions agree that we do have a problem and that the problem has many facets, prominent among them:

1. Clinicians tend to be very busy, working long and often unpredictable hours. This makes it difficult for them to be available when educational in-service exercises are planned, particularly if these are extensive. A single in–service may well be inadequate because a lesson learned will soon be forgotten unless the clinician uses the equipment regularly after a successful session.

2. The designers of equipment used by anesthesiologists do not always take clinical realities sufficiently into account. The manufacturers’ pride in providing elegant operational features is understandable; but some sophisticated features may add only marginally to the utility of the equipment while contributing significantly to the requirement for extensive educational sessions before the equipment can be used properly. Standardization of equipment has been achieved in many areas, for example, the arrangement of gas pedal, brake, and clutch in automobiles. In anesthesia the manufacturers of equipment have many opportunities to standardize features of their equipment and thus make life easier for the clinician. Organizations of users of the equipment have been slow to formulate guidelines which might be helpful to industry. Beyond voluntary standardization, many improvements relating to the man-machine interface of equipment are conceivable.

3. The instructional material that comes with equipment is frequently woefully inadequate. The descriptions do not cater to the requirements of the clinician and ease of understanding. Furthermore, even though the equipment will be used by many different clinicians, most units come with only one set of instructions which have a tendency to get lost in busy hospitals.

What can be done about these problems?

The question has been raised whether anesthesia personnel should demonstrate mastery of operation of the equipment before they can actually use it in the clinical setting. The analogy has been made that this would be no less than is required of pilots who must demonstrate their competence in the operation of specific aircraft before being permitted to operate the aircraft. Anesthesia practice does not lend itself to such an approach. Yet, we must recognize that we do have problems and we must begin to work toward their solutions.

We believe that these problems need to be addressed by clinicians and by industry. We recommend for discussion the following three steps suggested to minimize the existing problems:

1. We recommend that representatives from anesthesia and industry put their heads together to identify problems and to work toward a solution, perhaps with help from experts in human factors. For example, to assess the magnitude of the problem, the manufacturers of anesthesia machines and ventilators or of certain monitors might prepare a simple questionnaire covering basic features of the equipment. Anesthesia providers might then test themselves (anonymously) to see whether or not they have an adequate grasp of key features of the equipment. If not, their shortcomings should offer the manufacturers excellent information on how to improve the design of the equipment, the operation manual, and the in–service approach.

2. We recommend that practitioners and departments determine if members have an adequate understanding of the equipment in use in the given department. If the result of such a determination shows that deficits exist, the practitioners or the department should develop locally appropriate solutions to improve the situation.

3. We recommend that industry make more use than heretofore of clinical input in the design of their equipment and in the description of their equipment and its operation. We also recommend that the equipment be accompanied by Operator Manuals for every individual user.

The work required to improve what we believe to be a problem will not be completed overnight, but a joint effort of clinicians and industry should greatly benefit our patients.

Dr. Gravenstein, University of Florida, Gainesville, is chairman of the Anesthesia Patient Safety Foundation Committee on Education and Training.