departments 169 220 setting standards on guard: the ... · index medicus, pubmed/medline,...

1
www.aami.org/bit May/June 2020 IN THIS ISSUE FEATURES 178 ANALYSIS Using the FDA MAUDE and Medical Device Recall Databases to Design Better Devices Teresita C. Liebel Tara Daughert Alexandra Kirsch Sharifah A. Omar Tara Feuerstein 189 ANALYSIS Using Data to Decrease Corrective Maintenance Turnaround Times Kevin Hatcher David Miller Devang J. Patel Nicole Patterson 196 FEATURE Five Ways to Encourage Stakeholder Voice in the Healthcare Industry Meena Andiappan DEPARTMENTS 162 FRONTLINES 163 THE ROUNDUP 166 TEN QUESTIONS WITH... 167 ASK THE JOINT COMMISSION 202 ROUNDTABLE DISCUSSION Supporting Medical Devices during Unprecedented Challenges 209 VIEW FROM THE TOP Finding the Strong Leader within Ourselves to Do the Good Work of Healthcare, Health Technology 212 BRIGHT IDEAS Hoag HTM Takes the Lead on Managing Equipment Life Cycles 216 CYBERINSIGHTS COVID-19 and What It Means for Cybersecurity Axel Wirth 220 SETTING STANDARDS The IEC 60601 Series: Quick-Use Guide Alex Grob 223 STERILIZATION CENTRAL Drying and Storage of Flexible Endoscopes: An Area of Growing Concern Tamara Behm Nancy Robinson 228 TROUBLESHOOT IT Accuracy of Various Thermometer Types Is Important to Consider during the COVID-19 Pandemic Becky Crossley 230 READING ROOM Clinical Engineering Handbook, 2 nd edition Reviewed by James Eric Myers 232 FINAL WORD Business Interests and Public Health: Are They Mutually Exclusive? Eric Rosow 169 COVER STORY 161 Biomedical Instrumentation & Technology (ISSN 0899-8205) is published bimonthly by the Association for the Advancement of Medical Instrumentation, 901 N. Glebe Rd., Suite 300, Arlington, VA 22203. © 2020, Association for the Advancement of Medical Instrumentation. Publishing services provided by Allen Press, Inc. Membership: AAMI members receive a complimentary subscription. Contact membership at AAMI: (800) 332-2264 ext. 1214. Subscription rates (yearly): Individuals: online only, $195; U.S. print & online, $225; non-U.S. print & online, $280. Institutional: online only, $250; U.S. print and online, $280; non-U.S. print & online, $325. Single back issues (when available): $35 (US) and $40 (International). Subscriptions are available on a calendar-year basis only. Send orders and remittances to Biomedical Instrumentation & Technology, 810 E. 10th Street, P.O. Box 1897, Lawrence, KS 66044, (800) 627-0326 ext. 404. Editorial: Visit www.aami.org/ publications/BIT/guidelines.html to view the complete author guidelines. Send general correspondence to the Publications Department, AAMI, 901 N. Glebe Rd., Suite 300, Arlington, VA 22203; (703) 525-4890, ext. 1225. Advertising: Send correspondence to Tom Lasch (email: [email protected]; phone: 440-247-1060). General AAMI advertising information available at www.aami.org/advertising. Index, Archive: Biomedical Instrumentation & Technology is indexed, archived, or listed by the following: CINAHL Info Systems, Crossref, DeepDyve, Ebsco, Embase, Index Medicus, PubMed/Medline, Referativnyi Zhurnal, and Thomson Reuters. Photocopies: Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by Allen Press, Inc. for libraries and other users registered with the Copyright Clearance Center (CCC) Transaction Reporting Service, 222 Rosewood Drive, Danvers, MA 01923. Periodical postage is paid at Arlington, VA, and additional mailing offices. Visit AAMI on the web at aami.org Staying Vigilant Against Medical Device Vulnerabilities ON GUARD: Chris Hayhurst © Copyright AAMI 2020. Single user license only. Copying, networking, and distribution prohibited.

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Page 1: DEPARTMENTS 169 220 SETTING STANDARDS ON GUARD: THE ... · Index Medicus, PubMed/Medline, Referativnyi Zhurnal, and Thomson Reuters. Photocopies: Authorization to photocopy items

www.aami.org/bit

May/June 2020

IN THIS ISSUE

FEATURES

178 ANALYSIS Using the FDA MAUDE and Medical Device Recall Databases to Design Better Devices

Teresita C. Liebel Tara Daughert Alexandra Kirsch Sharifah A. Omar Tara Feuerstein

189 ANALYSIS Using Data to Decrease Corrective Maintenance Turnaround Times

Kevin Hatcher David Miller Devang J. Patel Nicole Patterson

196 FEATURE Five Ways to Encourage Stakeholder Voice in the Healthcare Industry

Meena Andiappan

DEPARTMENTS

162 FRONTLINES

163 THE ROUNDUP

166 TEN QUESTIONS WITH...

167 ASK THE JOINT COMMISSION

202 ROUNDTABLE DISCUSSION Supporting Medical Devices during Unprecedented Challenges

209 VIEW FROM THE TOP Finding the Strong Leader within Ourselves to Do the Good Work of Healthcare, Health Technology

212 BRIGHT IDEAS Hoag HTM Takes the Lead on Managing Equipment Life Cycles

216 CYBERINSIGHTS COVID-19 and What It Means for Cybersecurity Axel Wirth

220 SETTING STANDARDS The IEC 60601 Series: Quick-Use Guide Alex Grob

223 STERILIZATION CENTRAL Drying and Storage of Flexible Endoscopes: An Area of Growing Concern Tamara Behm Nancy Robinson

228 TROUBLESHOOT IT Accuracy of Various Thermometer Types Is Important to Consider during the COVID-19 Pandemic Becky Crossley

230 READING ROOM Clinical Engineering Handbook, 2nd edition

Reviewed by James Eric Myers

232 FINAL WORD Business Interests and Public Health: Are They Mutually Exclusive? Eric Rosow

169 COVER STORY

161

Biomedical Instrumentation & Technology (ISSN 0899-8205) is published bimonthly by the Association for the Advancement of Medical Instrumentation, 901 N. Glebe Rd., Suite 300, Arlington, VA 22203. © 2020, Association for the Advancement of Medical Instrumentation. Publishing services provided by Allen Press, Inc.

Membership: AAMI members receive a complimentary subscription. Contact membership at AAMI: (800) 332-2264 ext. 1214.

Subscription rates (yearly): Individuals: online only, $195; U.S. print & online, $225; non-U.S. print & online, $280.

Institutional: online only, $250; U.S. print and online, $280; non-U.S. print & online, $325.

Single back issues (when available): $35 (US) and $40 (International). Subscriptions are available on a calendar-year basis only. Send orders and remittances to Biomedical Instrumentation & Technology, 810 E. 10th Street, P.O. Box 1897, Lawrence, KS 66044, (800) 627-0326 ext. 404.

Editorial: Visit www.aami.org/publications/BIT/guidelines.html to view the complete author guidelines. Send general correspondence to the Publications Department, AAMI, 901 N.

Glebe Rd., Suite 300, Arlington, VA 22203; (703) 525-4890, ext. 1225.

Advertising: Send correspondence to Tom Lasch (email: [email protected]; phone: 440-247-1060). General AAMI advertising information available at www.aami.org/advertising.

Index, Archive: Biomedical Instrumentation & Technology is indexed, archived, or listed by the following: CINAHL Info Systems, Crossref, DeepDyve, Ebsco, Embase, Index Medicus, PubMed/Medline, Referativnyi Zhurnal, and Thomson Reuters.

Photocopies: Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by Allen Press, Inc. for libraries and other users registered with the Copyright Clearance Center (CCC) Transaction Reporting Service, 222 Rosewood Drive, Danvers, MA 01923.

Periodical postage is paid at Arlington, VA, and additional mailing offices.

Visit AAMI on the web at aami.org

Staying Vigilant Against Medical Device Vulnerabilities

ON GUARD:

Chris Hayhurst

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© Copyright AAMI 2020. Single user license only. Copying, networking, and distribution prohibited.