In the conditions of Australian health care modernization, formation and intensive development of non-state sector, introduction of market mechanisms, etc., health care management bodies should have possibilities for continuous assessment of the level and quality of health care facilities. In the course of daily work, the administration of health care facilities must take into account changes in the external environment of the system, changes in the legal and economic mechanisms of management. In order to coordinate changes and manage effectively, health care management bodies must have a sufficient amount of standardized information, and not consider its collection and analysis an afterthought.
Main research areas
The relationship between medical devices and health systems in Europe and other places has not been studied very extensively, and there is a need for a knowledge of the relationship and influence of health care units on the markets.
The availability of prescription or health care devices in different countries is different, and compliance with drug conditions in health care facilities is not a rule, as well as the compliance of medical devices with FDA regulations in the United States, etc.
More information is required in terms of correlation between health care management and the introduction of health care devices, guidelines regarding medical device access in medical institutions, differences in the clinical practices and compliance requirements between countries, etc.
Looking to implement medical devices
In the United States, health care providers must meet the requirements of the Food and Drug Administration (FDA). In the United States, the Office of the Inspector General of the Department of Health and Human Services, inspects the compliance of medical device manufacturers with the rules and regulations of FDA. Health care professionals should pay special attention to the changes and requirements of health care facilities. Following regulations is a minimum requirement for health care management.
Health care management bodies should pay attention to the compliance of medical devices with health care providers in the United States. According to Health and Human Services’ (HHS) regulations, medical devices, according to the definition of pharmaceutical devices, must be tested and approved by FDA in order to be used in health care facilities. Any resistance to using a device or resistance to its use or compliance with its specifications, according to the FDA definition of a medical device, is considered compliance failure of medical devices with health care providers.
The regulations of FDA also provide ways for patients or health care providers to notify that a health care facility is not complying with the compliance regulation of medical devices, and that those medical devices are not allowed in a health care facility. The notification of compliance failure, according to the definition of medical device, and failure to provide compliance warnings should also be carried out by health care management bodies.
The FDA warns against non-compliance with clinical trials and procedures. The guidelines of FDA provide to health care providers the possibility of monitoring the compliance of medical devices in the case of clinical trials in order to comply with the regulation.
There are times when health care providers cannot provide care to the patients, and in these situations, health care management bodies, according to regulations of FDA, should provide care. In order to meet the requirements of FDA regulations in compliance of medical devices in health care facilities, some health care management bodies have already signed agreements in which they are obliged to carry out the monitoring. Compliance with regulatory regulations is the responsibility of health care management bodies and compliance with FDA regulations is the responsibility of health care providers.
If health care providers do not comply with the regulations and directives, then health care management bodies and health care systems have the right to report them to FDA. According to guidelines of FDA, health care management bodies are responsible for reporting information and data on adverse events, failures to comply with regulations and directives, breaches in compliance of FDA requirements, etc.
The FDA is looking for compliance with compliance warning notices for each and every medical device manufactured by health care providers. According to FDA, there are situations in which health care providers cannot provide care to their patients, and in these situations, health care management bodies should be looking for compliance warning notices in order to comply with the regulations and directives of FDA.