7 Things to Know About FDA Reporting For Safer Medical Products
The FDA reporting for safer medical products training is a course offered by various healthcare training companies meant to help medical professionals understand more about the new safety standards the Food and Drug Administration has issued. Read on for more information on what you can learn during a FDA reporting for safer medical products training course.
1. The course is part of today’s credentialing training for healthcare professionals and it is usually presented in a text or flash format, with an audio narration, for those who prefer just listening. The training course can be access via laptop, tablets, or smartphones, for the convenience of the users and is available 24/7.
2. The FDA reporting on safer medical products training course usually contains an introduction or background portion where the user can learn more about the FDA and its mission to improve medical products as well as the measures the Administration has taken for this purpose. Some courses will also present some information on the current safety standards the FDA implements for medical devices and human drugs.
3. Next, the course will usually present some insight into the Medical Device Reporting (MDR) course which was created as a means to receive information regarding adverse events on medical devices from manufacturers, importers, or users in order to rapidly recognize and correct the issues.
4. Healthcare professionals will also get the chance to learn about MedSun, the medical product safety network, which was launched by the FDA with the intention to improve collaboration between the FDA and users of medical devices. The goal of the MedSun course is to identify, understand, and solve any issues that arise with the use of various medical devices.
5. The course contains a portion about the Manufacturer and User Facility Device Experience (MAUDE) database which is where reports on adverse events regarding medical devices are recorded. The database can be easily researched by an interested party, by simply introducing a few details, such as product problem, product class, brand name, and manufacturer. The data presented in MAUDE consists of voluntary reports since 1993.
6. Additionally, users will also get the chance to learn about the Adverse Event Reporting System (AERS), which is another database that contains reports submitted to the FDA regarding adverse events of medical devices and medication errors. The data contained in AERS is also a result of voluntary reports, from either healthcare professionals (doctors, nurses, pharmacists or others) or from consumers (patients or families of patients and even lawyers).
7. Following all of the lessons contained within the FDA reporting for safer medical products training course, users will be required to pass a multiple questions test, before they can receive and print their certificate.
These are some of the most important things healthcare professionals should know about the FDA reporting for safer medical products training courses. Some courses may differ a bit, from one training company to another, but the information presented above represents the most basic things contained in such a training course.
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Category: Medicines and Remedies
Keywords: FDA Reporting for Safer Medical Products ,CDRH