Healthcare practitioners are the primary users of medical devices for direct patient care. As such, they are in the best position to recognize problems that result from the use of medical devices. The outcome of a device-related adverse event or product problem, as with any other medical product, can be serious and result in illness injury, or even death. The sooner that FDA learns about a problem, the sooner the agency can take action to protect patient and user safety. Healthcare practitioners are major contributors to the knowledge base related to device use and safety through astute monitoring, rapid identification of device-related problems, and reporting these problems. An understanding of the voluntary and mandatory mechanism of reporting will ensure that device problems are reported appropriately and in a timely manner. As the primary users of medical equipment for direct patient care, health care professionals have the training and expertise to improve patient care by reporting actual and suspected problems with medical devices.

Adverse Drug Reaction Reporting Systems↗

PubMed1988

Long-term serial changes in left ventricular function and reversal of ventricular dilatation after valve replacement for chronic aortic regurgitation.

In most patients with aortic regurgitation, valve replacement results in reduction in left ventricular dilatation and an increase in ejection fraction. To determine the relation between serial changes in ventricular dilatation and changes in ejection fraction, we studied 61 patients with chronic severe aortic regurgitation by echocardiography and radionuclide angiography before, 6-8 months after, and 3-7 years after aortic valve replacement. Between preoperative and early postoperative studies, left ventricular end-diastolic dimension decreased (from 75 +/- 6 to 56 +/- 9 mm, p less than 0.001), peak systolic wall stress decreased (from 247 +/- 50 to 163 +/- 42 dynes x 10(3)/cm2), and ejection fraction increased (from 43 +/- 9% to 51 +/- 16%, p less than 0.001). Between early and late postoperative studies, diastolic dimension and peak systolic wall stress did not change, but ejection fraction increased further (to 56 +/- 19%, p less than 0.001). The increase in ejection fraction correlated with magnitude of reduction in diastolic dimension between preoperative and early postoperative studies (r = 0.63), between early and late postoperative studies (r = 0.54), and between preoperative and late postoperative studies (r = 0.69). Late increases in ejection fraction usually represented the continuation of an initial increase occurring early after operation. Thus, short-term and long-term improvement in left ventricular systolic function after operation is related significantly to the early reduction in left ventricular dilatation arising from correction of left ventricular volume overload. Moreover, late improvement in ejection fraction occurs commonly in patients with an early increase in ejection fraction after valve replacement but is unlikely to occur in patients with no change in ejection fraction during the first 6 months after operation.

Adult↗

PubMed1976

Case study. Pseudodivergence paralysis.

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Female↗

PubMedDate not supplied

MedWatch program.

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Adverse Drug Reaction Reporting Systems↗