What are the basic medical reporting requirements, policies, and procedures imposed by FDA on hospitals along the following?

Integrating theory and research needs assessment

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{0e601fc7fe3603dc36f9ca2f49ef4cd268b5950ef1bbcf1f795cc00e94cdd119} 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 public.

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The effects of
withholding critical information will have adverse effects in the short and
long terms. Suppliers may continue producing and gaining profits out of
products and services that have been causing death and injuries to innocent
people.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.

Medical errors,
also called “adverse events,” include missed and delayed diagnoses, mistakes
during treatment, medication mistakes, delayed reporting of results,
miscommunications during transfers and transitions in care, inadequate
postoperative care, and mistaken identity. Patient safety also encompasses the
concept of “reliability.” Reliability in health care is defined as patients
getting the intended tests, medications, information, and procedures at the
appropriate time and in accordance with their values and preferences.
System-derived errors can occur when clinicians are tired after working long
hours, stressed or cutting corners because they are in a hurry. Environmental
factors like noise and lighting can distract clinicians. Mistakes also can be
made because of a lack of standardized equipment and practices. For example, it
is easy to understand how a patient can be administered the wrong medication if
two different medicine vials look the same and the doctor is in a hurry when
grabbing a medication. Providing clearly labeled, color-coded bottles or
storing similar-looking vials in separate locations can help prevent mistakes
like these from recurring (Patrick et al, 2008).

Research problem

This research
project intends to determine the degree of compliance of the Patton – Fuller Community
Hospital with the Safe
Medical Devices and policies and procedures in ensuring the safety of medical
devices used.

research questions are

1.What are the basic
medical reporting requirements, policies, and procedures imposed by FDA on
hospitals along the following?

Suspected medical device –related deaths

Medical device – related serious injuries

Other medical device-related adverse events

2.What have been the
experiences of the hospital/s in relation to: suspected medical device-related
deaths, medical device –related injuries, and other medical device-related
adverse events, and how were these addressed?

3.How may the
existing adverse – event reporting system of Patton – Fuller Community
Hospital be described
along the aforementioned variables (Robbins & Coulter, 2002).

4.To what extent has
the hospital been complying to the policies and procedures imposed by the FDA
in accordance with:

1Medical Device Act
of 1990,

2Medical devices
amendments of 1992, and


5.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?


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.

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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