The Use Of Systematic Training To Minimize Risk In Operating Medical Devices

Abstract

This paper describes four requirerents for training that can minimize legal and medical risk in the operation of medical devices. developing effective training is also described. Introduction A systematic process for Effective, safe operation of most medical devices requires that both sides of the human-machine interface function properly. The majority of speakers at this symposium have focused on the machine side of that interface. This paper concentrates on the design of the human coqponent. In the preparation of medical device operators, at least three factors appear necessary to minimize legal and medical risk: training that produces reliably competent Performance, tests and documentation to certify that a ccmpetent level of performance has been achieved, and an organization that will maintain post-training performance at a canpetent level over time. to reliably competent performance. and maintenance of performance will be cited briefly. The assunption is that the audience for this volume has little familiarity with instructional design. Requirements of Training This paper will focus on the design of training that leads Issues related to the testing Training t o minimize risk has at least four requirements: it leads to highly reliable performance, it is accessible to all target audience members who need it, and the content and expected levels of student proficiency are consistent over time and across instructors. These requirements will be elaborated. Reliability. Given the high medical and legal risk associated with the operation of many medical devices, training must result in consistently good performance. Reliability, to borrow from a software description, has been defined as "the probability of error-free operation of a ccmputer program for a specified time in a specified environment" 16, w . 151. This appears applicable to human performance. is tested during developent, a high probability of competent performance can be obtained. members of the population that will operate a medical device presents a challenge. devices at many hospitals are multilingual and widely varying in educational preparation. After hospital discharge many patients require home nursing care provided by dispersed, multilingual individuals who vary in educational preparation and receiye little supervision. entire range of this variegated audience; for example, the reading level of training materials must be simple for trainees with relatively little education, yet adult in tone. teachers of a course to emphasize different parts of the content or skim sections they individually consider less important. For example, in training for a new imaging device, one instructor may go into detail on patient positioning under the device, while another instructor may skim that information and stress the operation of the device. Once the optimal content is determined, it should be held uniform across students. instructors are more denanding than others or have more stringent expectations for some parts of the course than others. A good training program for device operation brings a high percentage of its students to a uniformly high mastery level. Effective training will meet all four requirements. For instance, when the training is pilot tested (see below), With good training that Accessibility. Making effective training available to a l l Individuals who operate the various Device instruction must be accessible to the Content Uniformity. It is not uncomon for different Standards Uniformity. As we all found in college, s o w --