1、Designation: F2401 04 (Reapproved 2010)Standard 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 the case o
2、f 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 needsand concerns of persons with implanted,
3、 active, medicaldevices 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.
4、Although these 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 powere
5、d products, including 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 pa
6、rentheses are for 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 limita
7、tions prior to 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 impl
8、anted, patient 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 d
9、etector.2.1.4 electromagnetic 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 secur
10、ityscreening applications 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
11、. These types ofmedical 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 c
12、ontraband material, 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 throug
13、hthe detector.3. 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 train
14、ing, and informa-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.1This practice is under the jurisdiction of ASTM C
15、ommittee F12 on SecuritySystems and Equipment and is the direct responsibility of Subcommittee F12.60 onControlled Access Security, Search, and Screening Equipment.Current edition approved May 1, 2010. Published May 2010. Originallyapproved in 2004. Last previous edition approved in 2004 as F2401 04
16、. DOI:10.1520/F2401-04R10.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4. Significance and Use4.1 This practice is intended to be used as a guide for thedesign, configuration, and operation of security checkpoints tominimize expos
17、ure of ambulatory medical devices to theelectromagnetic fields emitted by metal detector security sys-tems. Guidance is 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
18、in the training ofcheckpoint screeners to address the concerns of persons withambulatory medical devices and to respond 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
19、 concernsmay be addressed.4.4 This practice is intended to aid medical device manu-facturers to provide consistent information for medical deviceusers, patients, and checkpoint screeners.5. Procedure5.1 Checkpoint LayoutThe security checkpoint shall bearranged and configured to minimize medical devi
20、ce exposureto the metal detector emissions. This shall be facilitated by freetraffic flow through the checkpoint, which 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 d
21、ivestiture of metallic objectsbefore screening.5.1.2 Provide identifiable queuing area for the human trafficflow through 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 obstructi
22、ons prevent a person from freely passingthrough the archway unhindered. A distance of at least 1 mbeyond the archway exit 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 th
23、ewalk-through metal detector archway for security personnel.5.1.5 Provide a secondary screening area for manual scan-ning 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 secondar
24、y screening area, if allowed bysecurity policy.5.2 SignageTypically security checkpoint metal detectorsare visible and identifiable. Signage is suggested to alertpersons with concerns about their medical devices and directthem to security staff for assistance. An example is “Metaldetector in use. Pe
25、rsons with medical devices needing assis-tance should notify security personnel.”5.3 ReportingIncidents of medical device 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
26、checkpoint supervisor.Information about the incident should be recorded with asmuch of the following information as appropriate 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 Equip
27、ment and Personnel InvolvedType ofequipment (for example, handheld metal detector or walk-through metal detector), manufacturer, 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,patie
28、nts physician name and contact information.5.3.4 Medical Device InformationAs much detail aboutthe active medical device 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
29、 photocopy of the patientsmedical device implant identification card (if available) mayprovide some portion of this information.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
30、,how long the patient was in the archway, and for handheldmetal detectors, how long the detector was held over or nearthe 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 de
31、scription of what thepatient experienced and when, and what the consequences ofthe incident were for the patient and medical 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 re
32、ported to the FDAsvoluntary reporting program, MedWatch (4).5.4 Screening Procedures:5.4.1 IdentifyThe use of signage and trained operatorsallows the identification of persons with medical devices whomare concerned about potential medical device disruption andthose who are concerned that their devic
33、es may cause the metaldetectors to alarm. Identification by the medical device user ornotification to the checkpoint screener 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 whe
34、n privacy is a concern.5.4.2 AssessMethods to assess concerns of persons withmedical devices may include a brief interview 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 in
35、formation may be ob-tained from medical device information cards often supplied bymedical device manufacturers. The checkpoint operator shouldcheck this card to verify patients name, type and location ofmedical device, and any recommended restrictions to metaldetector exposure. Checkpoint operators
36、should respect therequests of the patient while following security screeningprocedures.F2401 04 (2010)25.4.3 Address ConcernsMethods of addressing patientconcerns may vary depending on the type of security require-ment and the availability of alternate screening methods.Proper training of security p
37、ersonnel will allow appropriateassessment and implementation of a prescribed security screen-ing method. The patient may have concerns that include themedical device may cause the security equipment to alarm orthe patient has been advised to minimize or avoid exposure tohandheld or walk-through meta
38、l detectors.5.5 Alternative Screening ProceduresAlternative proce-dures are often useful in addressing the needs and concerns ofpatients. The following alternative procedures should be con-sidered when establishing security policy.5.5.1 Limited searches with handheld metal detectors thatminimize med
39、ical device exposure by using hand searches inthe area of the medical implant.5.5.2 Hand search for a patient who has been advised 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
40、 denial of access to certain areas.5.6 Minimize ExposureThe most basic method of address-ing concerns is to minimize exposure. Examples 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 st
41、op within the archway.5.6.2 Checkpoint supervision that encourages persons towalk through the center of the archway of a walk-throughmetal detector at a reasonable pace without pausing.5.6.3 Checkpoint prescreening procedures that encouragethe divesting of metallic objects as a means to minimize the
42、need for multiple security checkpoint screening operations.5.6.4 Allowing the patient to describe the location of amedical device 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 ahandhel
43、d metal detector. Knowledge of the location of themedical device can allow a checkpoint screener to expedite asearch in that body 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 th
44、e area of the medical deviceif allowed by the policy.5.6.7 Maintaining a “No Standing Zone” in and around awalk-through metal detector. 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
45、 Fig. 1). The electromagnetic field emissionfrom walk-through metal detectors decrease rapidly withdistance. Beyond these zones, concern for medical devices isminimal.6. Keywords6.1 active medical devices; electromagnetic fields; hand-held metal detector; medical devices; security checkpoint;securit
46、y screener; walk-through metal detectorFIG. 1 Walk-Through Metal Detector Traffic Flow and Exclusion Zone for Medical Active Device PatientsF2401 04 (2010)3APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 This practice addresses the environment in the vicin-ity of security checkpoints that use me
47、tal detectors. Thesemetal detectors have the potential of disrupting the function ofactive, ambulatory medical devices. Although instances thatrequire additional precautions are rare, awareness to thesepossibilities is important. A procedure for addressing medicaldevices benefits the safety and well
48、-being of the patients andthe effectiveness of the security checkpoint. A uniform estab-lished procedure also assists physicians and medical devicemanufacturers in providing advice to their patients and allowscheckpoint operators to establish procedures consistent withthis advice. By following these
49、 procedures, the patient isaccorded a minimal amount of intrusion while maintaining theintegrity of the security checkpoint.X1.2 The use 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-w
