1、Designation: F 2401 04Standard Practice forSecurity Checkpoint Metal Detector Screening of Personswith Medical Devices1This standard is issued under the fixed designation F 2401; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the
2、year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 The following practice is intended to address the needsand concerns of persons with implanted, active, medica
3、ldevices or active ambulatory medical devices, as well aspassive implanted medical devices, while maintaining theintegrity of the security checkpoint.1.2 Active and passive implanted medical devices are beingused at an increasing rate as a means to prolong and improvequality of life. Although these
4、medical devices are typicallydesigned to operate in the electromagnetic environment expe-rienced in daily life, there is a potential for the disruption ofactive medical device function when exposed to certain elec-tromagnetic fields emitted by commonly encountered electri-cally powered products, inc
5、luding handheld and walk-throughmetal detectors used in security checkpoint screening. Inaddition, some active or passive implanted devices may triggerthe unintended alarm of the metal detector.1.3 The values stated in SI units are to be regarded as thestandard. The values shown in parentheses are f
6、or informationonly.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to
7、use.2. Terminology2.1 Definitions:2.1.1 active medical devices, nelectrically powered medi-cal devices, usually employing electronic circuitry, for humanphysiological monitoring or to deliver medical treatment ortherapy such as drugs or electrical stimulation. These devicescan be implanted, patient
8、worn, or both.2.1.2 ambulatory medical devices, nany medical device(active or nonactive) that can be body mounted, worn, im-planted, or otherwise mobile with the patient and thus subjectto screening at the security checkpoint.2.1.3 archway, nphysical structure of a walk-throughmetal detector.2.1.4 e
9、lectromagnetic field, nwhen referenced in thispractice, it describes the energy field created by the metaldetector as a means to produce a response to materials withelectrical conductivity or magnetic susceptibility, or both. Theelectromagnetic fields used in metal detectors for securityscreening ap
10、plications are typically low frequency and varywith time and locations.2.1.5 handheld metal detector, nportable metal detectorproduct used by a security screener to provide localizedsearches of a person.2.1.6 passive (nonactive) medical devices,nnonelectrically powered medical devices. These types o
11、fmedical devices may have sufficient metallic content to causea response from a metal detector. These devices can beimplanted, patient worn, or both.2.1.7 security checkpoint, naccess point equipped withpersonnel and screening devices used as a means to control theflow of weapons or contraband mater
12、ial, or both.2.1.8 security screener, ntrained person performing thenecessary functions at a security checkpoint.2.1.9 walk-through metal detector, npermanently placedmetal detector product typically in an archway form thatprovides a search of the entire body as a person passes throughthe detector.3
13、. Summary of Practice3.1 This practice provides the means to identify, evaluate,and screen persons with ambulatory medical devices and reportincidences involving medical device users.3.2 These means shall include security checkpoint layout,signage, screening procedures, screener training, and inform
14、a-tion for the medical community (physicians, nurses, devicemanufacturers, patients, and so forth) about checkpoint secu-rity procedures to encourage the standardization of informationand media provided to persons with medical devices.4. Significance and Use4.1 This practice is intended to be used a
15、s a guide for thedesign, configuration, and operation of security checkpoints tominimize exposure of ambulatory medical devices to the1This practice is under the jurisdiction of ASTM Committee F12 on SecuritySystems and Equipment and is the direct responsibility of Subcommittee F12.60 onControlled A
16、ccess Security, Search, and Screening Equipment.Current edition approved May 1, 2004. Published May 2004.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.electromagnetic fields emitted by metal detector security sys-tems. Guidance is
17、presented for signage and information tohelp identify persons with ambulatory medical devices andprocess them through the security checkpoint.4.2 This practice is intended to help in the training ofcheckpoint screeners to address the concerns of persons withambulatory medical devices and to respond
18、to their needs.4.3 This practice is intended to aid the medical communityin advising medical device users who may be affected toidentify themselves at security checkpoints so their concernsmay be addressed.4.4 This practice is intended to aid medical device manu-facturers to provide consistent infor
19、mation for medical deviceusers, patients, and checkpoint screeners.5. Procedure5.1 Checkpoint LayoutThe security checkpoint shall bearranged and configured to minimize medical device exposureto the metal detector emissions. This shall be facilitated by freetraffic flow through the checkpoint, which
20、in turn minimizesthe duration of time a person remains inside the archway. Toaccomplish this checkpoint layout, the following points shouldbe considered.5.1.1 Provide an area for divestiture of metallic objectsbefore screening.5.1.2 Provide identifiable queuing area for the human trafficflow through
21、 the security checkpoint. The traffic start pointshould be at least 30 cm before the archway entrance.5.1.3 Provide a path of free flow to ensure that no distrac-tions or obstructions prevent a person from freely passingthrough the archway unhindered. A distance of at least 1 mbeyond the archway exi
22、t where stopping for hand inspection ofparcels or retrieving items from the baggage screening X-raysystem is recommended.5.1.4 Provide no standing zones of 40 cm on each side of thewalk-through metal detector archway for security personnel.5.1.5 Provide a secondary screening area for manual scan-nin
23、g with a handheld metal detector or hand searching, or both,as provided by the security policy.5.1.6 Provide a means for bypass of the walk-throughdetector directly to the secondary screening area, if allowed bysecurity policy.5.2 SignageTypically security checkpoint metal detectorsare visible and i
24、dentifiable. Signage is suggested to alertpersons with concerns about their medical devices and directthem to security staff for assistance. An example is “Metaldetector in use. Persons with medical devices needing assis-tance should notify security personnel.”5.3 ReportingIncidents of medical devic
25、e disruption fromexposure to the security equipment that result in injury to thedevice user or complaint should immediately be reported to thesecurity personnel, preferably to the checkpoint supervisor.Information about the incident should be recorded with asmuch of the following information as appr
26、opriate and availableunder the circumstances.5.3.1 Date, time, and location of incident (for example,facility name or address and security checkpoint location).5.3.2 Security Equipment and Personnel InvolvedType ofequipment (for example, handheld metal detector or walk-through metal detector), manuf
27、acturer, model, model number,serial number, and settings.5.3.3 Patient InformationName, address, telephone num-ber, e-mail, patient age, sex, height, weight, and if available,patients physician name and contact information.5.3.4 Medical Device InformationAs much detail aboutthe active medical device
28、 as possible, including the medicaldevice type (for example, type, make, model, and serialnumber), device location on or implanted in body, and medicaldevice settings (if known). A photocopy of the patientsmedical device implant identification card (if available) mayprovide some portion of this info
29、rmation.5.3.5 Summary of IncidentA description of what hap-pened, including communication with the patient before, dur-ing, and after the incident. For walk-through metal detectors,how long the patient was in the archway, and for handheldmetal detectors, how long the detector was held over or nearth
30、e medical device location and at what distance. A figure ofthe patient and screening equipment showing the patientlocation and direction is useful.5.3.6 Patient ComplaintSummary description of what thepatient experienced and when, and what the consequences ofthe incident were for the patient and med
31、ical device.5.3.7 Any communications with the patients physician afterthe event.5.3.8 All incidents involving medical devices that result inpatient injury or complaint should be reported to the FDAsvoluntary reporting program, MedWatch (4).5.4 Screening Procedures:5.4.1 IdentifyThe use of signage an
32、d trained operatorsallows the identification of persons with medical devices whomare concerned about potential medical device disruption andthose who are concerned that their devices may cause the metaldetectors to alarm. Identification by the medical device user ornotification to the checkpoint scr
33、eener should be done beforethe medical device user enters the archway or is scanned by ahandheld metal detector. The screener should be prepared tohandle information discreetly when privacy is a concern.5.4.2 AssessMethods to assess concerns of persons withmedical devices may include a brief intervi
34、ew with the personto identify the type of medical device, any medical device usersafety concerns, or advice received by the device user fromtheir healthcare provider. Additional information may be ob-tained from medical device information cards often supplied bymedical device manufacturers. The chec
35、kpoint operator shouldcheck this card to verify patients name, type and location ofmedical device, and any recommended restrictions to metaldetector exposure. Checkpoint operators should respect therequests of the patient while following security screeningprocedures.5.4.3 Address ConcernsMethods of
36、addressing patientconcerns may vary depending on the type of security require-ment and the availability of alternate screening methods.Proper training of security personnel will allow appropriateassessment and implementation of a prescribed security screen-ing method. The patient may have concerns t
37、hat include themedical device may cause the security equipment to alarm orF2401042the patient has been advised to minimize or avoid exposure tohandheld or walk-through metal detectors.5.5 Alternative Screening ProceduresAlternative proce-dures are often useful in addressing the needs and concerns of
38、patients. The following alternative procedures should be con-sidered when establishing security policy.5.5.1 Limited searches with handheld metal detectors thatminimize medical device exposure by using hand searches inthe area of the medical implant.5.5.2 Hand search for a patient who has been advis
39、ed toavoid metal detector searches entirely.5.5.3 It must be recognized that for some security applica-tions hand searches may not be considered adequate and mayresult in a denial of access to certain areas.5.6 Minimize ExposureThe most basic method of address-ing concerns is to minimize exposure. E
40、xamples of methods tominimize exposure are:5.6.1 Checkpoint layout designed for free flow through awalk-through detector without obstructions that would cause aperson to stop within the archway.5.6.2 Checkpoint supervision that encourages persons towalk through the center of the archway of a walk-th
41、roughmetal detector at a reasonable pace without pausing.5.6.3 Checkpoint prescreening procedures that encouragethe divesting of metallic objects as a means to minimize theneed for multiple security checkpoint screening operations.5.6.4 Allowing the patient to describe the location of amedical devic
42、e and to allow the area to be quickly scanned orperhaps avoided during the use of a handheld metal detectordevice. Likely, many medical devices will be detected by ahandheld metal detector. Knowledge of the location of themedical device can allow a checkpoint screener to expedite asearch in that bod
43、y area.5.6.5 Keeping a handheld metal detector at least 2.5 cmfrom a patients body when passing over a known areacontaining a medical device.5.6.6 Using hand searches in the area of the medical deviceif allowed by the policy.5.6.7 Maintaining a “No Standing Zone” in and around awalk-through metal de
44、tector. This includes an area 30 cmbefore the entrance and beyond the exit of a walk-throughmetal detector and 40 cm around the sides of the walk-throughmetal detector (see Fig. 1). The electromagnetic field emissionfrom walk-through metal detectors decrease rapidly withdistance. Beyond these zones,
45、 concern for medical devices isminimal.6. Keywords6.1 active medical devices; electromagnetic fields; hand-held metal detector; medical devices; security checkpoint;security screener; walk-through metal detectorFIG. 1 Walk-Through Metal Detector Traffic Flow and Exclusion Zone for Medical Active Dev
46、ice PatientsF2401043APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 This practice addresses the environment in the vicin-ity of security checkpoints that use metal detectors. Thesemetal detectors have the potential of disrupting the function ofactive, ambulatory medical devices. Although instanc
47、es thatrequire additional precautions are rare, awareness to thesepossibilities is important. A procedure for addressing medicaldevices benefits the safety and well-being of the patients andthe effectiveness of the security checkpoint. A uniform estab-lished procedure also assists physicians and med
48、ical devicemanufacturers in providing advice to their patients and allowscheckpoint operators to establish procedures consistent withthis advice. By following these procedures, the patient isaccorded a minimal amount of intrusion while maintaining theintegrity of the security checkpoint.X1.2 The use
49、 of ambulatory medical devices to care forpatients is increasing. These ambulatory medical devicesgenerally fall into two categories: active devices that areelectrically powered (for example, cardiac pacemakers, im-planted nerve stimulators, and hearing aid devices) and passivedevices (for example, joint replacements such as hip implants,bone screws and plates, and heart valves). There are also activeand passive patient-worn devices (for example, prosthetic armor leg). Some active medical devices may have both animplanted component and removable or wearable co
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