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This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.ElectricalSafetyManual2015A Comprehensive Guide toElectrical Safety StandardsFor Healthcare FacilitiesMatthew F. Baretich, PE, PhD
This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.
This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.ElectricalSafetyManual2015A Comprehensive Guide toElectrical Safety StandardsFor Healthcare FacilitiesMatthew F. Baretich, PE, PhD
This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.This publication is intended to be a helpful information resource,and reflects the expert advice and views of the author.It is not to be construed as legal or regulatory advice.SPECIAL NOTEThis manual contains references to generally accepted, national standards relating to electrical safety. It is importantto note that many state, county, and city codes/standards may be more rigid and enforced by the local authorityhaving jurisdiction (AHJ). The healthcare facility employee designated as responsible for electrical safety policy andprocedures will need to identify the AHJ and determine if additional laws or ordinances apply.Published byAssociation for the Advancement of Medical Instrumentation4301 N. Fairfax Drive, Suite 301Arlington, VA 22203-1633www.aami.org 2015 by the Association for the Advancement of Medical InstrumentationAll Rights ReservedPublication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document withoutthe prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. It is illegalunder federal law (17 U.S.C. § 101, et seq.) to make copies of all or any part of this document (whether internally or externally) withoutthe prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, includingcivil and criminal penalties, and damages of 100,000 per offense. For permission regarding the use of all or any part of this document,complete the reprint request form at www.aami.org or contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633.Phone: 1-703-525-4890; Fax: 1-703-525-1067.Printed in the United States of AmericaISBN 1-57020-582-5
This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.Table of ContentsFOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiINTRODUCTION TO THE 2015 EDITION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ixTarget audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ixResponsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ixManual organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ixChanges from the 2008 edition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xReference sources and citations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xCHAPTER 1: THE ELECTRICAL SAFETY PROGRAM . . . . . . . . . . . . . . . . . . . . . . . . . . 1Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Classification of areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3CHAPTER 2: EQUIPMENT-RELATED SAFETY REQUIREMENTS . . . . . . . . . . . . . . . . . 5Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Portable medical equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Testing—power cord and general condition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Testing—ground resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Testing—touch current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Testing—lead leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Fixed electrical equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Non–patient care equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10CHAPTER 3: FACILITY-RELATED SAFETY REQUIREMENTS . . . . . . . . . . . . . . . . . . . 11Emergency power systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Testing—emergency power systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Isolated power systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Testing—isolated power systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Electrical receptacles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Testing—electrical receptacles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Extension cords and relocatable power taps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 AAMIElectrical Safety Manual, 2015 Editioniii
This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.CHAPTER 4: CODES, STANDARDS, AND REGULATIONS . . . . . . . . . . . . . . . . . . . . 19Association for the Advancement of Medical Instrumentation . . . . . . . . . . . . . . . . . . . . . . . . . . . 19American National Standards Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Facility Guidelines Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20International Electrotechnical Commission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20The Joint Commission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21National Fire Protection Association . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Occupational Safety and Health Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22QUICK VIEW 1: GROUND RESISTANCE AND LEAKAGE CURRENT LIMITS . . . . . . . 23QUICK VIEW 2: POWER LINE COLOR CODES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27QUICK VIEW 3: POWER PLUG WIRING PROCEDURE . . . . . . . . . . . . . . . . . . . . . . . 29QUICK VIEW 4: EQUIPMENT MODIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31QUICK VIEW 5: THE SAFE MEDICAL DEVICES ACT . . . . . . . . . . . . . . . . . . . . . . . . 33Medical device reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Medical device tracking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34QUICK VIEW 6: SPECIAL CASES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Electrical safety testing of plastic-encased devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Electrical safety testing of multiple-device assemblies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Use of equipment with high leakage currents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36Use of unlisted or unlabeled devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36POLICY GUIDE 1: MANAGING MEDICAL DEVICE–RELATED INCIDENTS . . . . . . . . 37Take care of the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Report to risk management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Sequester the device and associated materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Preserve patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Investigate the incident . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Report to the FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Avoid recurrences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38POLICY GUIDE 2: MANAGING MEDICAL DEVICE ALERTS AND RECALLS . . . . . . . 39Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Responsibilities of the safety officer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Responsibilities of the HTM department . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39POLICY GUIDE 3: MANAGING RENTED AND LEASED MEDICAL EQUIPMENT . . . . 41Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Responsibilities of the clinical department . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Responsibilities of the purchasing department . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Preferred vendors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Alternate vendors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Responsibilities of the HTM department . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41ivElectrical Safety Manual, 2015 Edition AAMI
This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.POLICY GUIDE 4: MANAGING PERSONALLY-OWNED ELECTRICAL DEVICES . . . . . 43Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Patient notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Handling exceptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44POLICY GUIDE 5: ISOLATED POWER SYSTEM RISK ASSESSMENT . . . . . . . . . . . . 45Risk assessment process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Risk assessment factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Preparing for the risk assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46POLICY GUIDE 6: LOCKOUT/TAGOUT REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . 47General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Sequence of lockout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Restoring equipment to service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49FURTHER READING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 AAMITable of Contentsv
This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.viElectrical Safety Manual, 2015 Edition AAMI
This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.ForewordMost of the general populace know the basic rulesof electrical safety, such as don’t stand in water whilehandling live electrical equipment or exposed wires aredangerous. Most of them also take for granted thatelectricity is safe when these basic rules are followed.They have little appreciation for all the engineeringyears of experience and safety standards that havehelped to make it so safe for the general population.As this Electrical Safety Manual so ably illustrates,there are many aspects of electrical safety beyondthese few basic principles.In spite of the best efforts of those who writestandards on electrical safety—myself included—those in the healthcare field charged withimplementing and interpreting the various standardsneed some help. The different standards sometimesoverlap, and may even conflict. Even definitions maydiffer.Matt Baretich has done an excellent job of pullingtogether this Electrical Safety Manual and making itaccessible to readers. As Matt has shown with thislatest edition, there is definitely a need to refresh.With the aid of this manual, I hope that you will beable to help your organization comply with relevantsections of the various standards on electrical safety.Keep in mind that this manual is not intended to bethe final authority, rather a guide to the pertinentstandards. When compliance with a pertinentstandard is essential, go back to the source standard.Alan Lipschultz, PE, CCE, CSPPresident, HealthCare Technology Consulting LLCNorth Bethesda, MDIn addition, electrical safety thinking has changedover the years. The 2012 version of NFPA 99, forexample, removed many of the “nice to have”aspects of the earlier editions as the document wastransformed from a voluntary standard into a “code”on an equal footing with the National Electrical Codeand the Life Safety Code. AAMIElectrical Safety Manual, 2015 Editionvii
This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.viiiElectrical Safety Manual, 2015 Edition AAMI
This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.Introduction to the 2015 EditionTARGET AUDIENCEThis document is directed toward those whoare responsible for electrical safety in healthcarefacilities. A healthcare facility may be a clinic, anoutpatient surgery center, a nursing home, a hospital,or a complex healthcare system incorporating anycombination of facilities that provide patient care. Tosimplify the presentation, the Electrical Safety Manual(ESM) uses the term “healthcare facility” to representany of these units.RESPONSIBILITYpersonnel. It should be noted that electrical safetyprocedures for medical devices and healthcareenvironments are not intended to be separate fromother equipment maintenance activities. They shouldbe integrated into a comprehensive equipmentinspection and maintenance program for the facility.In addition, accreditation and regulatory agenciesexpect clinical unit managers and equipmentoperators to be aware of their roles in ensuringcompliance with appropriate codes and standards,and to have access to documents that demonstratecompliance.Departments within the healthcare facility that maybe responsible for electrical safety include clinicalengineering, biomedical equipment technology,healthcare technology management (HTM),healthcare facilities engineering, or other technicallyqualified components of the organization. In eachhealthcare facility, one or more of these departmentsare responsible for application of this manual inaccordance with facility policies and applicableelectrical safety codes, standards, and regulations.MANUAL ORGANIZATIONHealthcare facilities must have access to appropriatetechnical expertise to effectively apply this manual.When such expertise is not available on staff, thehealthcare facility should work with an externalservice organization or consultant that has appropriatetechnical qualifications.The manual also contains several Quick Views thatsummarize key information for easy reference andPolicy Guides that provide recommendations fordeveloping policies and procedures for use in anelectrical safety program.In most cases, the recommended testing procedurescan be carried out by the healthcare facility’s technical AAMIThe ESM contains four chapters that provide a rangeof information regarding electrical safety, includingdiscussions of codes, standards, regulations, andgeneral concepts upon which the manual is based.The chapters also include recommendationsfor organizing an electrical safety program anddescriptions of electrical safety-related procedures tobe used in the program.For further reference, the manual includes a Glossaryof key terms, a References list of cited material, and aFurther Reading section for additional resources.Electrical Safety Manual, 2015 Editionix
This is a preview of "AAMI ESM4 2015". Click here to purchase the full version from the ANSI store.CHANGES FROM THE 2008 EDITIONThe most fundamental difference between the 2008 and 2015editions is the incorporation of material from the latest codesand standards (listed below). Reference sources used for the2008 edition of the ESM have had significant updates and,in some cases, have been superseded by new documents. Akey objective of the manual is to provide a single publicationthat pulls together critical material from the full range ofapplicable codes and standards.Two major areas of change in the 2015 edition of the ESM arethese: There is additional material regarding facility-relatedelectrical safety. In particular, new material regardingisolated power systems (IPSs) has been added. Materialregarding facility-related safety requirements has beenbrought together in a single chapter (Chapter 3) todistinguish it from material regarding equipment-relatedsafety requirements (Chapter 2). The 2012 edition of NFPA 99: Health Care Facilities Code1represents a fundamental rewriting of the 2005 edition.New and revised material, particularly with regard toIPSs and risk-based building system categories, has beenincorporated into this edition of the ESM.And, as with every edition, efforts have been made to clarifyand expand various topics to enhance the value of the ESMfor its readers. A few topics that, over time, have become oflimited interest have been removed.xREFERENCE SOURCESAND CITATIONSThe ESM is based on material from organizations that havedeveloped codes, standards, and regulations applicable tohealthcare facilities in the United States. Chapter 4 of the ESMdescribes these organizations and their requirements. Thesereference sources are national in scope; however, individualstates or other government jurisdictions may have exceptionsor additions. Moreover, various authorities having jurisdiction(AHJs) may enforce earlier editions of these references.Therefore, readers of the ESM should make themselves awareof local requirements.For simplicity, citations of the reference sources used will beabbreviated as shown in the examples below.The Joint Commission (TJC) document listed belowaddresses accreditation of hospitals. TJC offers severaldistinct accreditation programs; however, the hospitalaccreditation program is the most comprehensive withregard to the topics in the ESM. There are also other hospitalaccreditation organizations, including the Healthcare FacilitiesAccreditation Program (www.hfap.org), DNV GL Healthcare(www.dnvglhealthcare.com), and the Center for Improvementof Healthcare Quality (www.cihq.org), all with very similarrequirements regarding the topics of the ESM.Finally, it should be noted that the 2015 edition of NFPA 99has already been published. However, with regard to the topicsin the ESM, there are only minor differences between the2012 and 2015 editions. The ESM uses the 2012 edition ratherthan the 2015 edition because CMS (Centers for Medicareand Medicaid Services) and TJC have indicated their intent toadopt the 2012 edition of NFPA 99.Full Reference (Example)Abbreviated CitationANSI/AAMI ES60601-1:2005/(R)2012 (IEC 60601-1:2005 MOD) Medical electrical equipment—Part 1:General requirements for basic safety and essential performance, clause 3.2AAMI 60601-1 3.2Guidelines for Design and Construction of Hospitals and Outpatient Facilities, 2014 edition, 2.1-8.3.6FGI Guidelines 2.1-8.3.62015 Comprehensive Accreditation Manual for Hospitals, Standard EC.02.04.03, Element of Performance 1CAMH EC.02.04.03 EP 1NFPA 70: National Electrical Code, 2014 edition, paragraph 517.18NFPA 70 517.18NFPA 70E: Standard for Electrical Safety in the Workplace, 2015 edition, paragraph 120.1NFPA 70E 120.1NFPA 99: Health Care Facilities Code, 2012 edition, paragraph 10.2.2NFPA 99 10.2.2OSHA Electrical Safety Standard, Code of Federal Regulations, paragraph 29 CFR 1910.147OSHA 29 CFR 1910.147Electrical Safety Manual, 2015 Edition AAMI
of information regarding electrical safety, including discussions of codes, standards, regulations, and general concepts upon which the manual is based. The chapters also include recommendations for organizing an electrical safety program and descriptions of electrical safe
