Hypothesis

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How may the
findings be used by FDA in further reviewing its Safe Medical Devices Act and
in further improving the effectiveness of the implementation of the
corresponding policies, procedures, and processes?

Hypothesis

1.There is a
significant difference between the degree of compliance to Medical Device
Reporting imposed by FDA and the extent of compliance of hospitals,
particularly, Patton – Fuller
Community Hospital.

Significance
of the study

1.Protect Patients
and families. The results of the study may help the hospital to improve its
services and be careful in the use of its medical devices.

2.Benefit hospital
management and administration. This study would reveal some loopholes in their
operations, particularly in the implementation of policies and procedures in
relation to the use of their medical devices.

3.Benefit medical
device suppliers. The adverse discovered through this study will be important
feedback that would be used in further improving the products

4.Benefit the
government. This research could help the government in monitoring and
evaluating the implementation of the Safe Medical Devices Act of 1990,
including its amendments.

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