Lecture 5---Apr 27---Taylor

Lecture 5---Apr 27---Taylor - U. S. Department of Health...

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Center for Devices and Radiological Health U. S. Department of Health and Human Services Product Development For Medical Applications (BME 480/680) School of Biomedical Engineering, Science, and Health Systems Drexel University April 27, 2011 Medical Device Risk Management
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2 Center for Devices and Radiological Health Who am I? Alford R. Taylor, Jr. Director, Division of Electrical and Software Engineering Office of Science and Engineering Laboratories WO62-4214 10903 New Hampshire Ave Silver Spring MD 20993-0002 [email protected] (301) 796-2583 Assistance is also available from the Division of Small Manufacturers, International and Consumer Assistance, http://www.fda.gov/cdrh/industry/support. You don’t have to be a small manufacturer to avail yourself of this service!
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3 Center for Devices and Radiological Health Agenda Why is RM important? The RM process in a nutshell Top-down versus bottom-up analysis Popular misconceptions (real-world examples) Techniques for summarizing and presenting RM activities
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4 Center for Devices and Radiological Health Before I forget … While this presentation concentrates on medical device problems, generally, the device industry makes excellent products that contribute positively to public health. We can all do better.
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5 Center for Devices and Radiological Health Top ten problem products by number of recalls 2005-2009 Picture archiving and communications system Radiation therapy system Infusion pump* Automatic external defibrillator* Knee joint prosthesis CAT imaging system Electro-surgical cutting device* Orthpedic manual surgical instrument Continuous ventilator* Fluoroscopic x-ray system
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6 Center for Devices and Radiological Health Risk management in a nutshell
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7 Center for Devices and Radiological Health Steve Kelley, The Times-Picayune, August 25, 2005 Why all the fuss?
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8 Center for Devices and Radiological Health YES . .. TO MEDICAL DEVICE MANUFAC -TURERS. DEVICE RECAL L (with apologies to) Steve Kelley, The Times-Picayune, August 25, 2005 Why all the fuss?
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9 Center for Devices and Radiological Health Risk management’s dirty secret A full appreciation of risk requires 20/20 hindsight. Everything else is just guessing … educated guessing, based on: Prior experience with similar products Experience with the same technologies in other products—possibly from other industry sectors Experience of clinicians, engineers, scientists, lawyers, and other experts and stakeholders. Risk Management Overview
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10 Center for Devices and Radiological Health Risk management in a slightly larger nutshell Identify foreseeable hazards, causes, and contributory factors Assess risk from each hazardous situation Evaluate each risk Apply risk control measures to reduce unacceptable risks to an acceptable level Evaluate overall residual risk Risk Management Overview
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11 Center for Devices and Radiological Health Identify hazards If a device has:
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This note was uploaded on 07/08/2011 for the course BM 501 taught by Professor Kop during the Spring '11 term at Bloomsburg.

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Lecture 5---Apr 27---Taylor - U. S. Department of Health...

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