The impacts on patient safety of changes in the design of medical products and devices used in patient care settings

Abstract

Changes in medical product or device design can have important implications in patient safety. An altered device interface may change the ability of a clinician to use the device properly, even if the underlying functionality of the device is the same. When a new device is brought into a health care setting, issues may occur at various stages, including acquisition, deployment, and continuing education. This paper examines reported patient safety events related to the introduction of new or changed devices into the health care environment. Communication was found to be a root cause of some events. In particular, lack of communication to the end user of product differences can result in misuse in the patient care setting. Recommendations include increased clinician input at the product selection and deployment stage and documentation of changes in product interface or use instructions to improve end user training and point-of-use aids.