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Compliance In Focus
Posted by John Lehmann on Tue, May 29, 2012

Do Devices Need More Risk Analysis?

Device RiskRisk analysis is essential in regards to investigational devices. The goal of risk assessment is to remove a hazard or reduce the level of its risk by adding precautions or control measures, as necessary. It’s an important process which can identify problems with investigational products and help eliminate costs, time, and risk associated with recalling the product- but most importantly, protect patients.

A bill titled, “Sentinel Assurance of Effective Devices of 2012,” recently introduced aims to heighten the risk analysis of medical devices. According to the press-release the bill would allow the FDA to more regularly collect, review and trend adverse event data for medical devices. How will this be achieved?

  • Establish an analysis system to identify post market risk and analysis. Currently this system is only applicable to pharmaceuticals under the Federal Food, Drug, and Cosmetic Act (FDC).
  • Establish the Unique Device Identification system that was previously introduced to the FDA. The identification system would allow for easy tracking of adverse events and device recalls.

Overall the bill would greatly increase the amount of information available on the safety and in turn protect patients. However, one aspect of the bill that seems to need clarification is exactly what the FDA plans on doing with this additional information. The FDA Law Blog bluntly states, “Simply gathering data without clear plans for how to use the information may impose resource burdens without commensurate benefits.”

How do you feel about the two main parts of the bill? Do you feel that this is vital for proper risk assessment? Feel free to comment below.

Photo Credit: The Fayj



Topics: Medical Devices, Risk Analysis, Sentinel Assurance of Effective Devices of 2012


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