According to the latest news from medical and pharmaceutical arena, The United States Food and Drug Administration (USFDA) has decided to revamp and update the procedure of Post Marketing Medical Device Surveillance. The move is being viewed as a precautionary measure put-up by the FDA to tackle and avoid growing number of Defective Products and lawsuits associated with various medical devices. The agency is of the view that growing number of personal injuries and accidents due to medical devices and equipments ought to be checked.

According to various reports there was an acute need of such a surveillance system that could put a tab on the quality and worthiness of a medical device marketed in the region of the United States. With this move, FDA is all set to adopt a new plan for post marketing medical device surveillance that could ensure a higher quality to various medical device or equipments that are being sold by companies and brands.

The news surfaced after the FDA published a report detailing the roadmap of their plan. The report was released with the title ā€œStrengthening our National System for Medical Device Postmarket Surveillanceā€.

The report states clearly that despite having an efficient and robust surveillance system in place there is a scope for improvement as the number of lawsuits is growing. Four major changes that are being proposed with this release are:

  • Incorporating and establishing a unique device identification system that could help us as well as the consumer gathering adequate information about a particular device
  • Incorporating and promoting UDI system into electronic health information.
  • To revise and modernize adverse event reporting system in theUnited States
  • Promoting development of national and international device registries for selected product
  • Formulate, plan and execute new methods for evidence generation and other post marketing surveillance related works like synthesis and appraisal.

Moving onto the same line FDA has started working on its first suggestion that entails incorporating and establishing unique device identification (UDI) system. The idea started translating into practice in July after FDA mandated the need of carrying a unique numeric or alphanumeric code to identify and locate a particular device, its model and manufacturer. However the FDA has made it clear that no UDI should furnish any information pertaining to the consumer and/or person associated with the consumption of the device.

Asides, the FDA recommends that the system be phased in starting with the highest-risk devices and that low-risk while over-the-counter (OTC) devices would be exempted.

According to various experts in the pertaining arena it took almost five years for the FDA to land into this point. The FDA started testing and experimenting UDI in 2009 however due to some reasons it remained stonewalled until now

The main goal of FDA with this move is to channelize and streamline the drug adverse effects reporting system. The agency believes that UDI will help them get exact information about the adverse effects associated with these medical devices once they are marketed. With this, FDA will be launching a searchable database on all medical devices that will be made available to the public. The move will also enable patients gather adequate information about medical devices like hip implant, knee implant or trans-vaginal mesh.