Managing Medical Device Incident Investigations.

When medical device-related incidents occur in the clinical environment, it’s important for the healthcare organization to respond quickly and effectively. This paper outlines seven steps that will help the organization conduct an investigation that will protect its interests, comply with federal regulations and accreditation standards, and improve patient safety by avoiding recurrences. The paper emphasizes the role of engineering design in reducing the likelihood and impact of medical device-related incidents.

HEALTHCARE FACILITY MANAGEMENT IN THE UNITED STATES

In the United States there is a close association between medical technology management (clinical engineering) and healthcare facility management (facility engineering). It is useful for clinical engineers to understand the work of facility engineers because both professions represent the application of engineering expertise to support safe and effective patient care. This article provides an overview of healthcare facility management practice in the United States.

Clinical engineering workshops in latin america.

For more than fifteen years the Pan American Health Organization and the American College of Clinical Engineering have conducted workshops in Latin America and the Caribbean. The workshops have focused on clinical engineering and healthcare technology management. The author has participated in workshops in Costa Rica, Nicaragua, and Colombia. Descriptions of these workshops will be presented.

Medical device incident investigation.

FDA Medical Device Reporting regulations require investigation and reporting of certain device-related incidents. Medical device incident investigation is also a key component of risk management for healthcare delivery organizations. However, the fundamental objective of incident investigation is to identify the root cause of an incident and mitigate the risk (probability x severity) of recurrence.

The square peg and the round hole: Murphy's Law and medical device connections.

Engineers have long been aware of Murphy's Law: If anything can go wrong, it will. When applied to medical device design, Murphy's Law indicates that if there is a way that a medical device can be set up incorrectly then someday, somewhere it will be set up incorrectly. In the clinical environment the result may be patient injury or death. Despite this received wisdom, clinical engineers continue to encounter examples of medical device design that invite users to do the wrong thing, with potentially harmful results. This paper focuses on electrical and other connectors incorporated into medical device designs. Examples of potential and actual misconnections, from the earliest days of clinical engineering to the present, are presented and discussed.

Advanced clinical engineering workshops in Central America.

Over the past ten years the American College of Clinical Engineering has conducted numerous Advanced Clinical Engineering Workshops in developing countries around the world. Most of the recent workshops have been conducted in Latin America and the Caribbean in cooperation with the Pan American Health Organization, an affiliate of the World Health Organization. This presentation describes workshop objectives and topics. It also describes the author's participation in workshops conducted in Costa Rica (2002) and El Salvador (2003).

Medical technology management in U.S. hospitals.

Medical technologies move from research and development through manufacturing and marketing into the healthcare delivery system. Within the healthcare delivery system, hospitals rely heavily on medical technologies (and the medical devices they enable) to provide diagnosis, treatment, and monitoring in patient care. Managing these devices from acquisition through application in patient care is a formidable task. Hospitals must act to maximize the benefits of medical devices while minimizing adverse side effects. They must do so within a highly regulated and cost-constrained environment. This paper describes the challenges hospitals face and the strategies they employ in their efforts to achieve cost-effective medical technology management. The role of clinical engineering is discussed.