The Use and Misuse Of FMEA In Medical Device Risk Management

Dev Raheja
Dec 14, 2017 - 01:00 PM EST
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Failure Mode and Effect Analysis can be used to assess the efficacy and efficiency of the device in actual use. Failure Mode Effects Analysis (FMEA) can have a number of variations the aim is to thoroughly review what can go wrong in use and what kind of misuses may be made. The device manufacturer must consider how to protect patients in case of misuse of the device such as ventilators and PCA pumps for pain control. Many patients have died from its inadvertent misuse. It is also important to consider processes such as packaging, sterilization, shipping of wrong kits, and labeling. These have many risks associated with them that could adversely affect the performance of the device.

Course Objective

The legal system, the FDA, and the European standards require the device to be safe as long as it is in use. Therefore high reliability is an obvious requirement. Besides, it is a value proposition for the business: zero warranty costs, safe customers, more loyal customers, and more sales. The FDA reviews the results of the risk analysis during pre-market approvals, and FMEA is the most thorough document risk analysis, design control, and device history. Therefore a thorough understanding of FMEA for designing device for reliable and safe performance is a critical marketing strategy.


Course Outline

  • How FMEAs are usually misused in medical devices
  • How to get most value from FMEAs
  • The correct way to conduct FMEA
  • How to get users involved in the FMEA
  • How to integrate FMEA in the risk management process
  • Eliminating design defects to reduce risks of recall
  • Eliminating manufacturing defects to reduce risk of recall
  • Eliminating maintenance mistakes using FMEA
  • New heuristics for getting fast results


Target Audience

  • Senior management
  • Entire engineering staff
  • All technical managers
  • Test engineering staff
  • Regulatory affairs professionals
  • Marketing Managers
  • Service managers
  • Project Managers and engineers
  • Quality Assurance staff
  • IT professionals looking to make the design process efficient

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Dec 14, 2017 - 01:00 PM EST

Duration: 90 Minutes

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Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

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Speaker: Dev Raheja,

Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to come up with elegant solutions using creativity and innovation. Being a true international consultant, he has conducted training in several countries including Sweden, Australia, Japan, Germany, UK, Singapore, Taiwan, South Africa, Finland, and Brazil. He helped a major Midwest company from going out of business to becoming a world leader by eliminating safety mishaps. Prior to be coming a consultant in 1982 he worked at GE healthcare as Supervisor of Quality Assurance and Manager of Manufacturing, and at Booz-Allen &Hamilton as Risk Management consultant for nuclear and mass transportation industry.


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