Risk management is the process by which medical device manufacturers ensure that their devices are used with the minimum of risk. The risk management process involves assessing all theoretical, potential and actual risks for a product (the inputs), assessing the impact of those risks on the user of the device, and putting in place strategies to mitigate those risks (the outputs). Early in the device development process, most of the risks are theoretical. However, as the device moves into clinical use, safety data are generated and real risks are identified or confirmed.
This audio conference presents information about how vigilance (the collection and appraisal of human safety information), supplemented by non-clinical and bench data, feeds into the risk management process, and how the outputs are managed. This sounds like a fairly simple process, but interpreting vigilance data is not always easy. There may be internal corporate resistance to ideal modes of risk mitigation, and it is difficult to deal with risks that arise from misuse of the device. All of these issues are dealt with and illustrated by case studies presented in the audio conference.
Medical Device Vigilance: An Input to Risk Management is being presented by Helen Colquhoun, MD, CEO, with Pleiad Devices and airs on Thursday, July 9, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
