Integrating theory and research needs

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.

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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.

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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).