This year’s theme is Risk Management and Post-Market Surveillance. Risk is part of the entire product life-cycle that includes post-market. Post-market surveillance is a collection of processes and activities so safety and effectiveness of medical devices can easily be monitored. These activities are designed to generate information to quickly identify potentially harmful effects of poorly performing devices and other safety problems, accurately characterize real-world device performance and clinical outcomes, and facilitate the development of new devices, or new uses for existing devices. This is an important area in medical device safety, and the statistics clearly support why – the number of product safety related recalls has increased by over 160% between 2007 and 2011. The amount of penalties levied has been astronomical including a single $286M agreed fine and incarceration for a few executives for gross negligence. With the changes in FDA regulations aimed at streamlining the warning letter issuance process, medical device companies of all sizes are being written up for multiple quality system infractions.
Risk management is a critical component of product safety and quality. How? What is the true cost of a 483? Do you have the quality system to manage various aspects of product safety?
Increasingly, companies are implementing risk models that are designed to address divisional or geographical requirements and harmonized globally across the enterprise. It is no longer acceptable to simply have a risk assessment model for each product line or market served without the coordination or visibility that a centralized risk management process provides. Risk models should address all parameters and have controls in place to address issues as they occur in the marketplace – linking back to FMEAs developed during the design process. The risk model plays a part in the management of all events and incidents, investigations, CAPA and even customer complaints and field service reports. The risk model ought to be standardized to ensure that each division or business unit uses the same relative terminology and methodology to perform the appropriate risk assessment at each step in the process: from pre-market to post market.
Another major initiative for the FDA and for MD&D companies is the soon-to-be-mandated Unique Device Identifier (UDI) regulation that is part of the entire stream of quality processes to help improve the quality of information in medical device adverse event reports. Much like the electronic Medical Device Reporting (eMDR) requirements that were instituted several years ago, the UDI database will enable consumers, health agencies and regulators to review and analyze adverse event reports, correct use of the device, and help provide a safer, more secure distribution chain (in case of counterfeit products). The UDI database will enhance information sharing on a global basis and make device safety and recall information more widely available at the unit level.
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