Posted on November 18, 2010 by Albin Paul
Implementation of a computer-automated safety surveillance system of clinical outcomes registries for cardiovascular devices resulted in the identification of a drug-releasing stent that had significantly higher rates of major adverse cardiac events than similar stents
“Monitoring the safety of approved medical products is of vital public health importance, given that in clinical practice such medical products are often used in numbers far greater and in patient populations more diverse than when studied in premarket evaluations and clinical trials,” the authors write. “Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.”
“In conclusion, automated safety surveillance of medical devices is feasible using automated monitoring tools applied to detailed clinical registries and can efficiently help identify emerging potential postmarket safety risks. Automated medical product surveillance can complement existing public health strategies, providing an additional mechanism to assess the comparative safety of approved medical products and improve the quality of health care delivered,” the authors write.
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Filed under: Drug Safety, Patient Safety, pharmacovigilance | Tagged: Drug Safety, medical device safety, patient safety, pharmacovigilance, post market surveillance | Leave a comment »
Posted on September 15, 2010 by Albin Paul
GE Healthcare announced that the Smart Patient Room pilot at Bassett Medical Center has been approved by the site’s Institutional Review Board to begin data collection. The innovative technology solution was installed as part of GE’s healthymagination initiative with the goal of helping healthcare providers to reduce patient safety risks and improve patient outcomes.
“GE is developing a unique solution for the healthcare industry that helps hospitals and staff identify and mitigate patient safety risks while offering meaningful solutions to improve patient outcomes,” said Jan De Witte, President & CEO, GE Healthcare Performance Solutions. “GE’s real-time, adaptable solution will provide actionable data to healthcare providers regarding patient safety and potential medical errors which in turn will affect the necessary behavioral changes to avoid preventable errors.”
The Smart Patient Room can collect real-time information from the system to generate actionable data to manage clinical workflow, and uncover opportunities for influencing process and behavioral changes to create a safer patient environment.
Filed under: pharmacovigilance | Tagged: patient safety, pharmacovigilance | Leave a comment »