1、Designation: F2401 04 (Reapproved 2010)F2401 16Standard Practice forSecurity Checkpoint Metal Detector Screening of Personswith Medical Devices1This standard is issued under the fixed designation F2401; the number immediately following the designation indicates the year oforiginal adoption or, in th
2、e case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 The following practice is intended to address the needs and concerns of persons with i
3、mplanted, active, medical devices oractive ambulatory medical devices, as well as passive implanted medical devices, while maintaining the integrity of the securitycheckpoint.1.2 Active and passive implanted medical devices are being used at an increasing rate as a means to prolong and improve quali
4、tyof life. Although these medical devices are typically designed to operate in the electromagnetic environment experienced in dailylife, there is a potential for the disruption of active medical device function when exposed to certain electromagnetic fields emittedby commonly encountered electricall
5、y powered products, including handheld and walk-through metal detectors used in securitycheckpoint screening. In addition, some active or passive implanted devices may trigger the unintended alarm of the metal detector.1.3 The values stated in SI units are to be regarded as the standard. The values
6、shown in parentheses are for information only.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regula
7、torylimitations prior to use.2. Referenced Documents2.1 ISO Standards:2ISO 14117 Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiacpacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devicesISO 14708-1 Implants f
8、or surgery Active implantable medical devices Part 1: General requirements for safety, marking andfor information to be provided by the manufacturerISO 14708-2 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakersISO 14708-3 Implants for surgery Active implantable medica
9、l devices Part 3: Implantable neurostimulatorsISO 14708-4 Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumpsISO 14708-5 Implants for surgery Active implantable medical devices Part 5: Circulatory support devicesISO 14708-6 Implants for surgery Active implantab
10、le medical devices Part 6: Particular requirements for active implantablemedical devices intended to treat tachyarrhythmia (including implantable defibrillators)ISO 14708-7 Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implantsystems3. Terminolo
11、gy3.1 Definitions:3.1.1 active medical devices, nelectrically powered medical devices, usually employing electronic circuitry, for humanphysiological monitoring or to deliver medical treatment or therapy such as drugs or electrical stimulation. These devices can beimplanted, patient worn, or both.3.
12、1.2 ambulatory medical devices, nany medical device (active or nonactive) that can be body mounted, worn, implanted, orotherwise mobile with the patient and thus subject to screening at the security checkpoint.1 This practice is under the jurisdiction of ASTM Committee F12 on Security Systems and Eq
13、uipment and is the direct responsibility of Subcommittee F12.60 onControlled Access Security, Search, and Screening Equipment.Current edition approved May 1, 2010Oct. 1, 2016. Published May 2010October 2016. Originally approved in 2004. Last previous edition approved in 20042010 asF2401F2401 04. 04
14、(2010). DOI: 10.1520/F2401-04R10.10.1520/F2401-16.2 Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,Switzerland, http:/www.iso.org.This document is not an ASTM standard and is intended only to
15、 provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof
16、 the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.3 archway, nphysical structure of a walk-through metal detector.3.1.4 electromagnetic field, nwhen refere
17、nced in this practice, it describes the energy field created by the metal detector asa means to produce a response to materials with electrical conductivity or magnetic susceptibility, or both. The electromagneticfields used in metal detectors for security screening applications are typically low fr
18、equency and vary with time and locations.3.1.5 handheld metal detector, nportable metal detector product used by a security screener to provide localized searches ofa person.3.1.6 passive (nonactive) medical devices, nnonelectrically powered medical devices. These types of medical devices mayhave su
19、fficient metallic content to cause a response from a metal detector. These devices can be implanted, patient worn, or both.3.1.7 security checkpoint, naccess point equipped with personnel and screening devices used as a means to control the flowof weapons or contraband material, or both.3.1.8 securi
20、ty screener, ntrained person performing the necessary functions at a security checkpoint.3.1.9 walk-through metal detector, npermanently placeda stationary metal detector product typically in an archway form thatis typically permanently fixed in a particular location but may be temporarily fixed, is
21、 typically constructed in an archway form,and that provides a search of the entire body as a person passes through the portal of the detector.4. Summary of Practice4.1 This practice provides the means to identify, evaluate, and screen persons with ambulatory medical devices and reportincidences invo
22、lving medical device users.4.2 These means shall include security checkpoint layout, signage, screening procedures, screener training, and information forthe medical community (physicians, nurses, device manufacturers, patients, and so forth) about checkpoint security procedures toencourage the stan
23、dardization of information and media provided to persons with medical devices.5. Significance and Use5.1 This practice is intended to be used as a guide for the design, configuration, and operation of security checkpoints tominimize exposure of ambulatory medical devices to the electromagnetic field
24、s emitted by metal detector security systems.Guidance is presented for signage and information to help identify persons with ambulatory medical devices and process themthrough the security checkpoint.5.2 This practice is intended to help in the training of checkpoint screeners to address the concern
25、s of persons with ambulatorymedical devices and to respond to their needs.5.3 This practice is intended to aid the medical community in advising medical device users who may be affected to identifythemselves at security checkpoints so their concerns may be addressed.5.4 This practice is intended to
26、aid medical device manufacturers to provide consistent information for medical device users,patients, and checkpoint screeners.6. Procedure6.1 Checkpoint LayoutThe security checkpoint shall be arranged and configured to minimize medical device exposure to themetal detector emissions. This shall be f
27、acilitated by free traffic flow through the checkpoint, which in turn minimizes the durationof time a person remains inside the archway. To accomplish this checkpoint layout, the following points should be considered.6.1.1 Provide an area for divestiture of metallic objects before screening.6.1.2 Pr
28、ovide identifiable queuing area for the human traffic flow through the security checkpoint. The traffic start point shouldbe at least 30 cm before the archway entrance.6.1.3 Provide a path of free flow to ensure that no distractions or obstructions prevent a person from freely passing through thearc
29、hway unhindered.Adistance of at least 1 m beyond the archway exit where stopping for hand inspection of parcels or retrievingitems from the baggage screening X-ray system is recommended.6.1.4 Provide no standing no-standing zones of 40 cm on each side of the walk-through metal detector archway for s
30、ecuritypersonnel.6.1.5 Provide a secondary screening area for manual scanning with a handheld metal detector or hand searching, or both, asprovided by the security policy.6.1.6 Provide a means for bypass of the walk-through detector directly to the secondary screening area, if allowed by securitypol
31、icy.6.2 SignageTypically security checkpoint metal detectors are visible and identifiable. Signage is suggested to alert personswith concerns about their medical devices and direct them to security staff for assistance. An example is “Metal detector in use.Persons with medical devices needing assist
32、ance should notify security personnel.”F2401 1626.3 ReportingIncidents of medical device disruption from exposure to the security equipment that result in injury to the deviceuser or complaint should immediately be reported to the security personnel, preferably to the checkpoint supervisor. Informat
33、ionabout the incident should be recorded with as much of the following information as appropriate and available under thecircumstances.6.3.1 Date, time, and location of incident (for example, facility name or address and security checkpoint location).6.3.2 Security Equipment and Personnel InvolvedTy
34、pe of equipment (for example, handheld metal detector or walk-throughmetal detector), manufacturer, model, model number, serial number, and settings.6.3.3 Patient InformationName, address, telephone number, e-mail, patient age, sex, height, weight, and if available, patientsphysician name and contac
35、t information.6.3.4 Medical Device InformationAs much detail about the active medical device as possible, including the medical devicetype (for example, type, make, model, and serial number), device location on or implanted in body, and medical device settings(if known).Aphotocopy of the patients me
36、dical device implant identification card (if available) may provide some portion of thisinformation.6.3.5 Summary of IncidentAdescription of what happened, including communication with the patient before, during, and afterthe incident. For walk-through metal detectors, how long the patient was in th
37、e archway, and for handheld metal detectors, howlong the detector was held over or near the medical device location and at what distance. A figure of the patient and screeningequipment showing the patient location and direction is useful.6.3.6 Patient ComplaintSummary description of what the patient
38、 experienced and when, and what the consequences of theincident were for the patient and medical device.6.3.7 Any communications with the patients physician after the event.6.3.8 All incidents involving medical devices that result in patient injury or complaint should be reported to the FDAs volunta
39、ryreporting program, MedWatch MedWatch.(31).6.4 Screening Procedures:6.4.1 IdentifyThe use of signage and trained operators allows the identification of helps to identify persons with medicaldevices whomwho are concerned about potential medical device disruption and those who are concerned that thei
40、r devices maycause the metal detectors to alarm. IdentificationNotification by the medical device user or notification to the checkpoint screenershould be done before the medical device user enters the archway or is scanned by a handheld metal detector. The screener shouldbe prepared to handle infor
41、mation discreetly when privacy is a concern.6.4.2 AssessMethods to assess concerns of persons with medical devices may include a brief interview with the person toidentify the type of medical device, any medical device user safety concerns, or advice received by the device user from theirhealthcare
42、provider. Additional information may be obtained from medical device information cards often supplied by medicaldevice manufacturers.The checkpoint operator should check this card to verify patients name, type and location of medical device,and any recommended restrictions to metal detector exposure
43、. Checkpoint operators should respect the requests of the patient whilefollowing security screening procedures.3 Burlington, D.,“Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators,” Food and Drug AdministrationNotification and Reference L
44、ist, Available: http:/www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062288.htm. http:/www.fda.gov/cdrh/safety/easnote.html, Sept. 1998.FIG. 1 Walk-Through Metal Detector Traffic Flow and Exclusion Zone for Medical Active Device PatientsF2401 1636.4.3 Address Concern
45、sMethods of addressing patient concerns may vary depending on the type of security requirement andthe availability of alternate screening methods. Proper training of security personnel will allow appropriate assessment andimplementation of a prescribed security screening method. The patient may have
46、 concerns that include the medical device maycause the security equipment to alarm or the patient has been advised to minimize or avoid exposure to handheld or walk-throughmetal detectors.6.5 Alternative Screening ProceduresAlternative procedures are often useful in addressing the needs and concerns
47、 of patients.The following alternative procedures should be considered when establishing security policy.6.5.1 Limited searches with handheld metal detectors that minimize medical device exposure by using hand searches in the areaof the medical implant.6.5.2 Hand search for a patient who has been ad
48、vised to avoid metal detector searches entirely.6.5.3 It must be recognized that for some security applications hand searches may not be considered adequate and may resultin a denial of access to certain areas.6.6 Minimize ExposureThe most basic method of addressing concerns is to minimize exposure.
49、 Examples of methods tominimize exposure are:6.6.1 Checkpoint layout designed for free flow through a walk-through detector without obstructions that would cause a personto stop within the archway.6.6.2 Checkpoint supervision that encourages persons to walk through the center of the archway of a walk-through metaldetector at a reasonable pace without pausing.6.6.3 Checkpoint prescreening procedures that encourage the divesting of metallic objects as a means to minimize the need formultiple security checkpoint screening op
