Ensuring safe, effective healthcare technology

Adverse events involving medical devices continue to occur. Understanding and learning from these events is crucial to protecting patients from harm. John Amoore describes how the safe and effective application of medical devices can be enhanced by analysis of care processes using holistic models. 

Safe and effective is the core requirement for medical devices application in healthcare. Safe, because it should do no harm; effective, because it should add value to the care. Most applications are safe and effective, but failures do occasionally occur. The importance of using failures to learn how to prevent repetitions demands an open-minded analysis of the causes that recognises the nature of the care environment and inter-relationships between its elements, rather than assuming device malfunction or misuse.

The patient, care team, medical device, care plans and operating procedures and the clinical environment and its infrastructure constitute a care system. Each element interacts to support care. Reason¹ shows, using the Swiss Cheese model, how weaknesses in the elements and their interactions combine to cause accidents. His model shows how protections and barriers prevent failures causing adverse events.