Extract
Recent advances in orthopaedic implant development have increased the
expected in vivo longevity of such devices and are the result of extensive
research and development activities, including the evaluation of orthopaedic
implants retrieved at the time of revision
surgery1. Therefore,
to help to ensure continued innovation, it is important for the hospital to
appropriately notify the device manufacturer of adverse events such as implant
revisions. In fact, the United States Food and Drug Administration's (FDA)
Safe Medical Device Act
(SMDA)2 requires the
hospital to notify the device manufacturer of adverse events, and an implant
revision meets the definition of an adverse event. There is generally
perceived to be a low level of provider compliance with adverse event
reporting
requirements3, which
may negatively impact patient safety. For example, higher reporting rates
could lead to implant recalls being issued earlier, saving patients from an
unnecessary procedure. While physicians generally agree with the importance of
adverse event reporting
activities4, many
are unaware of the reporting tools available to them. This paper will
demonstrate how adverse event reporting can affect patient safety and will
identify reporting tools that are readily available to members of the
health-care industry.