Medical device manufacturers, device distributors, 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 is time consuming and requires a lot of data gathering, it does have a great influence on the overall wellbeing of the US healthcare below to find out why FDA reporting for safer these products is important.
1. Although the FDA does put drugs and medical devices through a safety test before approving their release on the market, only a small batch out of each product is tested. Some issues may remain undiscovered during the testing period and appear only when the medical product is used at a larger scale. Reports submitted by manufacturers or by healthcare facilities can help the Administration intervene in time, before too much damage has been caused.
2. Personally assessing every single medical product is a virtually impossible task to accomplish, even for a large organization such as the FDA. The manpower and the amount of money the Administration would have to invest in order to do this are unimaginable. The annual reports submitted by manufacturers and device users help the Administration to focus only on situations that have proven to be dangerous and not waste time or money on evaluating perfectly safe medical equipment.
3. Reports submitted by medical device manufacturers and distributors help the FDA stop the release of certain, potentially hazardous, pieces of equipment to the general public. This can prevent people from getting hurt or even lose their life. Even if the device or drug has already been used on patients, the FDA still has the ability to limit its usage so no further harm can be caused.
4. Reports submitted regarding unsafe products help the FDA weed out the faulty medical products or correct their malfunctions if possible. In this way, the Administration strives to improve the overall safety of these products used in the United States and to increase the faith of the general public in FDA approved products.
5. By accepting reports from various sources, such as healthcare providers, manufacturers, distributors, and patients, the FDA can easily store and analyze data regarding a large variety of these products. The database the Administration has created based on the reports it receives allows any interested party to research the safety of a certain medical device or drug. The fact that report data is made public helps promote a safer and more transparent healthcare system, which both medical professionals and patients alike can trust.
The FDA reporting for safer products program was created as a means to make the US healthcare system a more secure environment and to protect the wellbeing of American patients. Taking into consideration all the reasons listed above, the importance of submitting reports to the Administration regarding unwanted effects of medical products in undeniable: it reduces costs, it saves time and most importantly, it guarantees the safety of these products available on the market.