Human Error And Quality Control In Medical Devices
BoardJoin the board Staff Submit Content Contact Us Archives ResourcesWebcasts White Papers Salary Survey News Home - > News - > Designing Medical Devices to Minimize Human Error Designing Medical Devices to Minimize Human Error Posted by mddiadmin on May 1, 1997 Share Medical Device & Diagnostic Industry Magazine HREF="/mddi/by_issue.html">MDDI Article Index An MD&DI May 1997 Column HUMAN FACTORS Medical device designers should be familiar with the causes of end-user error and use safety analysis techniques to reduce its likelihood. Error is universal: everyone commits errors every day. Most are trivial, but some can combine with other events to cause an accident. In the medical domain, errors can lead to serious injuries and even death.1 Research and common experience both demonstrate that human error can be blamed for most accidents. In his book, Set Phasers on Stun, Steve Casey recounts the prominent role of human error in many well-known accidents, including the fatal radiation-overdose accident involving the Therac radiation therapy device.2 Human error is estimated to cause or contribute to up to 90% of accidents both generally and in medical devices.3,4 Even though there are unique products and usage circumstances in the medical industry, the types of errors that lead to accidents are the same as those that occur in other industries.5 One human error expert summed it up by saying, "There are few or no medical errors; there are many errors that occur in medical settings."6 Medical device manufacturers, therefore, should study what is known about human error and use such information to reduce its occurrence in the use of medical devices. DEFINING HUMAN ERROR One of the simplest definitions of human error is that it is any action or omission that causes results that users neither foresee nor intend. Most errors have benign consequences, but they sometimes spread through a system or combine with other circumstances to cause accidents. Both errors and accidents are unintended. Some human error is random, occurring be
Find Out How Quality Management System Solutions All Solutions Audit Management Batch Records Bill of Materials (BOM) Change Control Corrective Action (CAPA) Customer Complaints Deviations Management Document Control Food Safety Nonconformance Out of Specification Quality & Compliance Consulting Quality Management Risk Management Supplier Management Training Management Pricing Pricing Options QMS for Every Business Size Calculating ROI IT Resource Considerations Medical Device Solutions Design Control Device History Records Medical Device Reporting (eMDR) Pharmaceutical Solutions Clinical Management Trial Master File (eTMF) Regulatory Management Submissions Management COMPLIANCE Stay On Top of Ever-Changing Regulations and Quality http://www.mddionline.com/article/designing-medical-devices-minimize-human-error Standards Find Out How FDA 21 CFR 21 CFR Part 11 21 CFR Part 111 21 CFR Part 1270-1271 21 CFR Part 210-211 21 CFR Part 606 21 CFR Part 820 ISO ISO 9000 ISO 9001 ISO 13485 ISO 14000 ISO 14971 ISO 15189 ISO 17025 Other Regulations & Standards TS 16949 CLIA Canadian Standards EU Annex 11 Need Help With Compliance Quality http://www.mastercontrol.com/newsletter/pharmaceutical/reducing_human_error_manufacturing_floor_0310.html & Compliance Consulting RESOURCES Get Best Practices, Industry Insights, Solution Demos and More Find Out How Resource Center White Papers Case Studies Testimonials Blog - GxP Lifeline ABOUT US The #1 Enterprise Quality Management Software (EQMS) since 1993 See What We Do Company Info Who are we? Contact Us Careers News & Events Our Team Executive Team Partners For Pharmaceuticals and Biotechnology Reducing Human Error on the Manufacturing FloorBy Ginette M. Collazo, PhD. Jun 15, 2010 | Free Downloads | | As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in the pharmaceutical and related manufacturing environments. Sadly, little is known about the nature of these events mainly because quality event investigations end where human error investigations should begin. Human error is about explaining human behavior. Chemical engineers explain product behavior, mechanical engineers explain equipment behavior, industrial engineers explain process behavior, but who explains human behavior? When we investigate quality events, the focus of those investigations rely on explaining what happened in the process and how the product was
from GoogleSign inHidden fieldsBooksbooks.google.comhttps://books.google.com/books/about/43rd_European_Quality_Congress.html?id=WxfzjgWG6yYC&utm_source=gb-gplus-share43rd European Quality CongressMy libraryHelpAdvanced Book SearchGet print bookNo eBook availableEdiciones Díaz de SantosAmazon.comBarnes&Noble.comBooks-A-MillionIndieBoundFind in a libraryAll sellers»Get Textbooks on Google https://books.google.com/books?id=WxfzjgWG6yYC&pg=PA416&lpg=PA416&dq=human+error+and+quality+control+in+medical+devices&source=bl&ots=1EisHsFb8g&sig=0bGdCqJ5PbuGLb7MPG3HHFcS--w&hl=en&sa=X&ved=0ahUKEwjXv8GQz93PAhWCLB4KHY PlayRent and save from the world's largest eBookstore. Read, highlight, and take notes, across web, tablet, and phone.Go to Google Play Now »43rd European Quality Congress: proceedings book : Madrid, 9-11 June, 1999Ediciones Díaz de Santos, 1999 - Business & Economics - 382 human error pages 0 Reviewshttps://books.google.com/books/about/43rd_European_Quality_Congress.html?id=WxfzjgWG6yYC Preview this book » What people are saying-Write a reviewWe haven't found any reviews in the usual places.Selected pagesTitle PageTable of ContentsIndexCommon terms and phrases43rdE uropean achieve actions activities AIRTEL ALSTOM analysis application approach areas assessment audit benchmarking Business Excellence Business human error and Unit certification client communication company’s competences competitive concept continuous improvement culture customer satisfaction defined documentation EFQM Model employees ensure environment environmental established European European Quality Award evaluation external factors Figure function global Human Resources identify implementation important indicators industry innovation integrated internal involved ITESM Jaume I University knowledge management management systems manufacturing measures medical devices needs objectives operation organisation organization participation performance personnel phase present procedures programme quality assurance Quality Congress quality cost quality improvement Quality Management quality management system quality system requirements responsibility SANICAL sector Spain specific staff standards strategies structure sub process suppliers target Total Quality Total Quality Management Unión Fenosa University usersBibliographic informationTitle43rd European Quality Congress: proceedings book : Madrid, 9-11 June, 1999PublisherEdiciones Díaz de Santos, 1999ISBN849308820X, 9788493088200Length382 pagesSubjectsBusiness & Economics›Industries›GeneralBusiness & Economics / Industries /
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