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.

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 CommunityHospital with the Safe Medical Devices and policies and procedures in ensuring the safety of medical devices used.

The 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 CommunityHospital 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

3State-specific requirements?

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 – FullerCommunity 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.

Research design

This study will use a descriptive type of research design, specifically; a comparative–descriptive research design. Thisdesign 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 addressed.

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.

Both quantitative 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.


Respondents will 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 represented.


The instruments 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.

The instruments 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.

Data analysis

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 be used.

Time schedule

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.

Week 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 http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm

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, 33–68.

Patton-Fuller Community Hospital Virtual Organization (2011) Retrieved from https://ecampus.phoenix.edu/secure/aapd/cist/vop/Healthcare/PFCH/index.aspInc.

Robbins, S. P., and Coulter, M. (2002).Management.Pearson Education

(Asia) Pte.Ltd.

Revise your needs assessment and draft, incorporating peer reviews if necessary.


Format your paper consistent with APA guidelines.

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.

Describe the proposal’s background.

Explainthe benefits.

Include speaker’s notes that provide explanation and references.