Medical equipment manufacturers, distributors of devices and healthcare facilities are required to submit annual reports to the Food and Drug Administration (FDA) regarding the safety of medical devices or other products. Although this process takes time and requires a lot of data-gathering, have a great influence on the overall well-being of the u.s. health care system.Read below to find out why the FDA reports to more secure than these products is important.
1. Although the FDA put medicines and medical devices through a safety tests before approving their release on the market, only a small batch of each product is tested. Some problems may remain to be discovered during the testing period and appear only when the product is used on a large scale. Reports submitted by manufacturers or health care facilities may help the Administration to intervene early, before too much damage.
2. Personally evaluate every single medical product is an almost impossible task, even for a large organization like the FDA. Labour and the amount of money that the Administration would have to invest to do this are unimaginable. The annual reports submitted by the manufacturers and users of devices will help the Administration to focus only on situations that have been shown to be dangerous and do not waste time or money on evaluation of medical equipment perfectly safe.
3. reports submitted by the producers and distributors of medical devices FDA halt the release of certain, potentially hazardous, pieces of equipment to the public. This can prevent people from getting hurt or even lose their lives. Even if the device or medication has already been used on patients, the FDA still has the ability to restrict its use so no further damage can be caused.
4. reports submitted on hazardous products help FDA weeding out defective medical products or correct the malfunction if possible. In this way, the Administration is committed to improving the overall safety of the products used in the United States and to increase the public’s faith in the FDA approved products.
5. reports from various sources, such as health professionals, producers, distributors and patients, accepting the FDA can easily store and analyze data about a wide variety of these products. The database that created the Administration on the basis of the reports received to any interested party seeking the safety of a particular medical device or drug. The fact that reports are made public data helps to promote a health care system safer and more transparent, you can trust both medical professionals and patients.
The FDA warning for safer products, was created as a means to make the health care system of the United States a safer environment and to protect the well-being of patients. Considering all the reasons listed above, the importance of the presentation of the report to the Administration regarding side effects of medicines in undeniable: cuts costs, saves time and guarantees the safety of these products available in the market.