A medical device is just one component of a minisystem that delivers a clinical benefit to the patient. As device-related minisystems increase in number, the hazards associated with their use become more varied, and the clinical environment, more complex. Devices can become nonfunctional because of electromagnetic interference (EMI), or they can become fire-ignition sources for patients who are undergoing treatment in oxygenenriched environments. Such medical device-related events require a clinical engineering investigation of the event and recommendations to prevent similar, future events. Because corrective recommendations frequently involve hospital professional staff and processes, they must be integrated into the total hospital safety program. The authors of the chapters in this section on safety address many of these issues and make recommendations for assuring a safe clinical environment. Methodologies for making the clinical environment safer are described in the first four chapters. Patail (Patient Safety and the Clinical Engineer) gives the perspective of an experienced clinical engineer working within the National Center for Patient Safety (NCPS), showing that the clinical engineer is ideally suited a leadership role in promoting patient safety. Such systematic techniques as root cause analysis and failure mode and effects analysis, and tools such as process-flow diagrams, hazard-scoring matrices, and decision trees have enabled the NCPS to make measurable positive strides in a short time. Epstein and Harding (Risk Management), with their extensive experience in advising health care organizations on risk-management issues, present a comprehensive overview of this subject and present guidelines for adoption of effective techniques and programs. Vegoda and Abramson (Patient Safety Best Practices Model) bring their formidable expertise in information technology (IT) to bear on the patient safety issue as they outline a model system for patient safety best practices. Baretich (Hospital Safety Programs) provides an expanded view of hospital safety going beyond safety as applied only to medical devices. He describes the safety structure and requirements of a complete hospital safety program as required by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The program encompasses the safety of staff, patients, and visitors from the various hazards in a health care environment. He emphasizes that, in order to be most effective, the safety-related aspects of clinical engineering practice must be integrated into this hospital-wide safety program. Shepherd (Systems Approach to Medical Device Safety) identifies the five fundamental components of a medical device-related minisystem, a system that delivers at least one clinical benefit. In addition, he discusses the way these components can fail in such a manner as to prevent the clinical benefit from being delivered and may result, instead, in an injury or death. By means of this generic model, one can understand ways in which a patient might experience a particular hazard as well, and one can employ methodology to trace the fundamental causes of an injury back to the latent causes that were present in the minisystem. As the number and complexity of medical devices have increased, so have reports of interactions between various minisystems. Miodownik (Interactions between Medical Devices) explores some of the interactions among device-related minisystems when they are connected and operating simultaneously on or around a patient. Through case studies, he shows that the patient-selection criteria might not always identify those within a population who might be harmed by a diag
nostic or therapeutic intervention. Device–device and device–patient interactions might directly result in an injury or a malperforming minisystem. His engineering analysis gives warning that clinical engineers must remain vigilant in order to detect unexpected minisystems interactions.