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% 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.
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).
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
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
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
of the study
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.
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.
device suppliers. The adverse discovered through this study will be important
feedback that would be used in further improving the products
government. This research could help the government in monitoring and
evaluating the implementation of the Safe Medical Devices Act of 1990,
including its amendments.
This study will
use a descriptive type of research design, specifically; a comparative
descriptive research design. This
design is appropriate because the hospital will be described in terms of
some basic variables such the number of years it has been in the industry; its
size, categories of services offered, number of medical practitioners, and
medical devices utilized. The hospital will also be described in terms of its
experiences on medical device-related deaths and injuries and how these were
It is also
comparative because the extent of compliance of the hospital will be compared
to the standards of medical device reporting set by the FDA.
and qualitative data will be gathered.
The quantitative part will be on quantifiable variables, such as average
number of patients, hospital size statistics/figures, number of reports
submitted by type of medical device and categories of related adverse
incidents. Qualitative data will be gathered on the experiences of the
hospitals, its medical practitioners, families of patients, and other
stakeholders of the hospital on adverse events.
be different groups of stakeholders: patients, medical practitioners, support
personnel, households of patients, and others who have been directly or indirectly
involved in the medical device- related adverse incidents.
A combination of
purposive and stratified sampling techniques will be utilized. Respondents will
be identified based on the purpose of the study. To ensure that the groups of
stakeholders are represented, a stratified sampling technique will also be
used. This would mean that the population would be divided into groups or
strata and specific number of respondents will come from each.This is to ensure that each group is
that will be utilized are survey questionnaire, interview guide, and
observation checklist. The survey questionnaire will have items on basic
descriptive (basic information about the hospital, its facilities, and
equipment, the patients, and others) whereas the interview guide and
observation checklist will provide qualitative data that will supplement the
data gathered from the questionnaire.
will be tested in terms of validity and reliability. The validity will test the
questionnaire and other instruments to see if they provide answers to the
research questions. The test of reliability is in terms of the instrument can
provide stable results even when conducted twice to the same set of
respondents. It will also be a test of consistency of the scores that will be
derived from the responses.
To analyze the
quantitative data that will be gathered, measures of central tendency (mean,
median, mode), measures of variability (standard deviation, variance), t-test
of difference between means (for two groups), and ANOVA (for three groups) will
Weeks one and two – Determination of the Population for the Study.
This will include knowing the number of target respondents. These include:
medical practitioners, support personnel (laboratory assistants, technicians,
etc), hospital administrators, and direct families of patients who were
affected by the adverse events.
Weeks three and four – Identification of the sample from the
various groups of stakeholders.
Weeks five and six – Preliminary data gathering from secondary
sources. To provide a background of the study, related data from journals,
newspapers, online sources will be obtained.
Weeks seven through ten – Preparation of instruments. This will
include designing the survey questionnaires, interview guide, and observation
checklists. Appropriate items that must be placed in each instrument must have
to be determined.
Week 11 12- Validation of the instruments. Before the questionnaires
are distributed to the respondents, they have to be pre-tested to ensure that
the items are appropriate and adequate.
Week 13 14-Finalization of
the instruments. Results of the validation will be used as basis in finalizing
the instruments. Suggestions provided will be used as inputs in improving the
questionnaires and other instruments.
Week 15 – 20-Data gathering.
This includes distribution and retrieval of the questionnaires, conducting
interviews, and observations.
Week 21 – 22-Preparation of
Coding Sheets. The coding sheet will be where the responses will be posted.
Week 23 25-Tabulation of
Data. After the responses are posted and tallied, the data will be organized in
the form of tables, graphs, or other forms of charts.
Week 26 28 -Organization of Report. At this point the final
research paper will be written where all the research questions are answered.
Week 29 – 31 -Preparation
of Final Report. Checking of the full report and preparing the final form.
32-Presentation of the Study.
Burns, A. C., and Bush,
R. F. (2003).Marketing Research. Pearson Education,
Food and Drug
Administration MedSun Medical Safety Network (2012) Retrieved from
Ghauri, P., and
Gronhaug, K. (2002). Research Methods in Business Studies:
A Practical Guide.
Pearson Education Limited.
Patrick et al.
(2008).”The anatomy and physiology of error in adverse healthcare
events”.Advances in Health Care
Management 7, 3368.
Hospital Virtual Organization (2011) Retrieved from
Robbins, S. P., and
Coulter, M. (2002).Management.Pearson
Revise your needs assessment
and draft, incorporating peer reviews if necessary.
THE PAPER IS ABOVE PLEASE ADD INFORMATION AS PER THE
QUESTIONS IN RED
Format your paper consistent with APA
Create a 10- to 12-slide Microsoft
PowerPoint presentationto generate support from the chief operating officer, chief nursing
officer, clinical engineering director, and nursing unit director.
the proposals background.
speakers notes that provide explanation and references.
Due Thursday 8/2/12
Answers: 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 Answer: The basic medical reporting requirements, policies, and procedures imposed by FDA on hospitals are as following ; Suspected medical device-related deaths; Suppliers may continue producing and gaining profits out of products and services that have been causing death and injuries to innocent people. Basically to gain more profits certain pharmacists sell expired medicines or common drugs with high rates. This will affect to patient and make him suffers a lot. Medical device related serious injuries; 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. That is why more advance and update medical tools must be used in medical fields so that patient may get a better treatment