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?

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 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.

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