ASTM E3173-2018 Standard Guide for Decommissioning and Disposal of Medical Equipment.pdf

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1、Designation: E3173 18Standard Guide forDecommissioning and Disposal of Medical Equipment1This standard is issued under the fixed designation E3173; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number

2、 in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This standard guide addresses decommissioning anddisposal of medical equipment.1.2 Decommissioning and disposal of medical equipment isdone w

3、hen equipment is no longer needed due to obsolescence,is inoperable, or has met a scheduled replacement milestone.Decommissioning is the first physical process in the dispositionprocess and includes proper identification, authorization fordisposition, and sanitization of the equipment, as well asrem

4、oval of Patient Health Information (PHI) or software, orboth. Disposal method is dependent upon many factors thatwill be described in this standard guide.1.3 This guide does not include detailed disposal methodprocedures or sales requirements or restrictions specific to anyregulatory body or the var

5、ious levels of government in whichan entity may operate. This guide also provides practices thatare common to many operations and provides flexibility to bestintegrate external requirements.1.4 While this standard describes common safety and envi-ronmental considerations associated with the decommis

6、sioningand disposal of medical equipment, it does not purport toaddress all of the safety concerns, if any, associated with itsuse. It is the responsibility of the entity using this standard toestablish and apply appropriate safety, health, and environ-mental practices and determine the applicabilit

7、y of regulatorylimitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World

8、 Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E2135 Terminology for Property and Asset ManagementE2306 Practice for Disposal of Personal PropertyE2858 Practice for Sales of Personal Property3. Terminology3.1 DefinitionsFor additional defini

9、tions for property andasset management, see Terminology E2135.3.2 Definitions of Terms Specific to This Standard:3.2.1 decommission, vto remove from active service.3.2.2 medical equipment, nnon-expendable, tangible,moveable property needed for the performance of, primarily oruniquely, a medical task

10、.3.2.3 sanitization, nthe process of removing undesiredfeatures such as chemical, biological contaminants from allsurfaces, and personal or sensitive data from data storagedevices.4. Summary of Guide4.1 Hospitals and medical organizations decommission anddispose of many types of highly complex medic

11、al devices andequipment.4.2 Entities must understand what equipment is to bedisposed, ownership and use agreements, and restrictions ondisposal as part of the decommissioning process.4.3 An appraisal by an accredited member of the AmericanSociety of Appraisers (ASA)3or the Association of Machineryan

12、d Equipment Appraisers (AMEA)4should be performedprior to decommissioning expensive and complex medical orscientific equipment to better understand the potential value of1This guide is under the jurisdiction of ASTM Committee E53 on AssetManagement and is the direct responsibility of Subcommittee E5

13、3.30 on Decom-missioning and Disposal of Medical Supplies, Medical Equipment, and Hospitals.Current edition approved July 1, 2018. Published July 2018. DOI: 10.1520/E3173-18.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For

14、Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3American Society of Appraisers (ASA),11107 Sunset Hills Rd, Suite 310,Reston, VA 20190, http:/www.appraisers.org.4Association of Machinery and Equipment Appraisers (AMEA), 315 SouthPatri

15、ck Street Alexandria, Virginia 22314, http:/www.amea.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established

16、in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1the equipment. In some cases, extensive decommissioning ofmedical equipment prior to sale or transfer can reduce

17、 the valueof the equipment. When a certified appraisal is not available, anabbreviated or “desktop” appraisal can be performed.4.4 Decommissioning should be conducted by authorized/trained personnel to ensure the safety of everyone concernedwith the disposal process.4.5 Disposal methods considered s

18、hould maximize the ben-efit to the entity, minimize the risk subsequent to the disposal,and ensure compliance with regulations and restrictions ondisposal method.5. Significance and Use5.1 This guide identifies common processes to safely de-commission and dispose of medical equipment. The objectivei

19、s to identify common challenges unique to medical equipmentto help ensure that the identification, authorization fordisposition, and proper sanitization of the equipment is com-pleted prior to disposal teams getting involved in the process.5.2 This guide provides information to consider whenchoosing

20、 disposal options in order to effectively manage theentitys assets.6. Decision Process6.1 In many hospitals or medical organizations, the medicaldepartment associated with the equipment (that is, SurgeryDepartment, Diagnostic Imaging, etc.) determines that a pieceof medical equipment should be consi

21、dered for replacement.Biomedical Engineering or Healthcare Technology and Man-agement should be included in the decommissioning anddisposal process.6.2 Specific identification of what is to be replaced (anentire integrated piece of medical equipment or a component ofa larger unit) is needed.6.3 Iden

22、tification of ownership of the piece of equipment isrequired as equipment may have been acquired under a grantand the grantor may have placed restrictions on the disposalmethod.6.4 Analysis of disposal options should be considered priorto the decommissioning of the equipment since trade-in orreutili

23、zation within the organization is a beneficial option forreplacements of equipment.6.5 Decommissioning of the equipment must be conductedby trained personnel to ensure safety of everyone involved inthe disposal process.6.6 Disposal method must meet all regulatory requirementsand restrictions for tra

24、nsfers of ownership.7. Procedure for Initial Identification and Analysis ofEquipment to be Disposed7.1 Organizations should follow their official procedures forwho has the authority to identify that a piece of equipment isno longer needed. The request for decommissioning anddisposal should be forwar

25、ded to the property office.7.2 The property office should review every request for thedecommissioning and disposal of a piece of medical equipmentand determine the condition and value of the equipment. Theproperty office must also check the property records andcoordinate with the department that has

26、 the equipment to verifyownership and if there are any restrictions on the disposal ofthe equipment.7.3 Once ownership and disposal authorization has beenverified, then internal transfer may be considered. A review todetermine the best disposal method should be made prior tobeginning the decommissio

27、ning process. Transfers or trade-inof equipment usually require coordination by the gainingdepartment, organization, or vendor and should be done priorto the commencement of decommissioning.8. Decommissioning of Medical Equipment8.1 If transfer or trade-in is determined as the best disposi-tion meth

28、od, then decommissioning takes place through coor-dination with the disposing and receiving department ororganization.8.2 If disposal of the equipment is determined as the bestmethod, then the disposing department should coordinatedecontamination of any chemical hazards and patient healthinformation

29、 removal from the equipment prior to propertydisposal personnel touching the equipment. These processesrequire certification as to how and by whom the decontamina-tion was conducted and that all personal data has been removedfrom the equipment.8.3 Decommissioning of medical equipment includesdeconta

30、mination, sanitization, and in many cases, removal ofnuclear sources, and update of the laser inventory database.8.4 Speed of replacement equipment installation andpreparation, as well as the minimization of medical caredisruptions, must be taken into consideration and planned.8.5 Method of movement

31、 and appropriate training must beincluded if movement of equipment is done with in-houseresources.8.6 If moved to disposal warehouse, equipment should bestored by size/type and intended disposal method. Equipmentshould be labeled to include nomenclature, description, status,and have accompanying cer

32、tificates of sanitization and powersource status attached.9. Disposal of Medical Equipment9.1 Generally the disposal of medical equipment follows theStandard Practice for Sales of Personal Property (ASTME2858) and the Standard Practice for Disposal of PersonalProperty (ASTM E2306).9.2 Particular att

33、ention should be given to ownership, au-thority for disposition, and manufacturer or regulatory restric-tions of medical equipment prior to disposal.9.3 Medical equipment being disposed must be reviewed todetermine if licenses are required by the recipient of theequipment and if any export regulatio

34、ns may apply to theparticular equipment.E3173 1829.4 If nuclear sources are left in the equipment intentionally,transport requirements must be adhered to. In addition, thenational laser database may have to be updated.10. Summary10.1 This guide provides specific guidance for the decom-missioning and

35、 disposal of medical equipment recognizing theunique requirements for safety after use of medical equipment,continued safety of patients and organization personnel in-volved in the decommissioning, and disposal of medicalequipment.11. Keywords11.1 decommission; disposal; sanitizationASTM Internation

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