Integrating theory and research needs assessment

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% 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.

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.

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