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  • jjp93 replied to the topic Delay in Recall. in the forum Regulatory Basics for Medical Devices 6 years, 7 months ago

    Many companies follow the steps to make sure that there were precautions taken for a product to be used safely, with many tests done. FDA also would not approve such products if they were not safe for people to use at the time. Many of the issues that occur are packaging issues which are not accounted for until the product is completely finished and ready to send out. These issues can also mean there is a labeling error. Sometimes, however, there are device connection errors and software errors that occur which could be accounted for earlier. I believe that they should take a longer time testing the product and making sure there aren’t any technological and software issues that would cause a lot of the recalls. There was an increase in software issues causing an increase in recalls over the years. If FDA and the company made sure there were no malfunctions for any part of the product, there could be less recalls that come with software issues but this would mean using more time to make sure these issues do not happen. They also should not wait so long once the issue is found in the product. It should be reported and done efficiently where it’s not too late to react. Another reason products would need to be recalled is because of a device component change or problem. There are always better options that arise which could mean that a product can have different components to make it function better. I do not believe recalls can be completely avoided but as long as there are proper documentations and there is traceability, it would mean staying ahead of the recall and fixing it as soon as possible.