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Integrating Theory and Research Needs Assessment

The Patton-Fuller Community Hospital is partnering with the Food and Drug Administration's MedSun Project to improve patient safety by reporting problems with medical devices and ensuring compliance with reporting requirements. MedSun grants of $25,000 are available to fund research designed to improve medical device safety in clinical and operational processes.

Resource: MedSun Project located at:

Discuss your needs assessment and proposal for utilizing MedSun funds to improve medical device policies, procedures, and processes.

Research primary and secondary sources of information related to medical devices and methods to improve adverse event reporting and patient safety.

Confirm the organization has policies and procedures that support the Safe Medical Devices Act of 1990, Medical Devices Amendments of 1992, and state-specific requirements.

Clarify how this project supports short-term goals and sustains long-term objectives.

Develop a timeline for project completion.

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The Safety Medical Devices Act of 1990 was enacted by Congress to increase the amount of information the Federal Drug Administration (FDA) and suppliers receive from users on malfunctions, adverse events, and critical problems with medical devices. Despite the regulation enacted, studies show that there has been widespread underreporting of such events. FDA reports explicitly noted that less than 1% of device problems occurring in hospitals have been brought to their attention.
It was further found that the more serious the problem with the device, the less likely that it is reported. This indicates a large number of hospitals and other medical units have been advertently withholding such very significant information to proper government authorities. This could have been made because of fears that their hospitals may suffer the consequences, but to the detriment of the patients and the general public.
The effects of deliberate withholding of critical information, if not corrected, will have adverse effects both in the short term and in the long run. Suppliers may continue producing and gaining profits out of products and services that have been causing death and injuries to innocent people. On the other hand, hospitals with sub-standard medical devices handled and operated by medical personnel and practitioners with sub-standard knowledge, skills, and competencies, would continue to exist and gain profit, but at the same time continue destroying the lives and quality of family life of many.
It was in this context that this research project, in cooperation with the FDA's MedSun was conceptualized.

This research project intends to determine the degree of compliance of the Patton - Fuller Community Hospital with the Safe Medical Devices Act of 1990, Medical Devices Amendments of 1992, other state - specific requirements as well as the overall policies and procedures in ensuring the safety of medical devices ...

Solution Summary

Integrating theory and research needs assessment is examined.

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