SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) is looking to coordinate with its international counterparts in an effort to improve medical device safety.
The Medical Device Single Audit Program (MDSAP) creates a single inspection process that will meet the requirements of all the partner countries involved. In this case, the countries include the U.S., Australia, Brazil, Canada, and Japan. At the start of 2015, major manufacturers of medical devices were invited to participate in the program who are interested in selling devices in the partner countries. MDSAP will be scheduled to begin in 2017.
The process is fairly simple. The investigations of each device, also known as audits, will be conducted by reputable and recognized third-party organizations. Government regulators will then be able to use this information in their inspection reports and safety analyses of a given medical device before offering regulatory approval. The goal of MDSAP is that it streamlines the safety audit process and also allows agencies to share information from other countries. The same devices are marketed across the globe but face different standards in each country. As a result, different information reaches the desks of regulators in other countries than what is presented to the FDA. With MDSAP, ideally everyone will have access to all of the same audit or inspection information. This can help regulators spot trends in device safety. In theory this would alert regulators in the U.S. of increasing failure risks for a specific model or brand of hip replacement parts in the other partner countries.
With the new program, the FDA has agreed to allowed MDSAP audits or inspections substitute for routine FDA inspections that are conducted every two years for all medical devices. The pilot program does not apply to new medical devices or “for cause” compliance inspections.
The hope of such a program is the prevention of the systemic failure by the regulators and the industry with regards to medical products like hip replacement parts, transvaginal mesh, and morcellators. The patterns showing a public health risk would be caught earlier rather than later. By sharing information, agencies will notice dangerous trends more quickly rather than after thousands of patients are hurt and pursuing lawsuits to recover their damages.
This, of course, is all speculation and it is unclear if the MDSAP process will work or if third-party audits will be immune to industry influence. In the meantime, patients must remain vigilant and contact an experienced attorney if they are suffering from injuries potentially caused by a medical device.
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