ASTM F2401-04(2010)
(Practice)Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
SIGNIFICANCE AND USE
This practice is intended to be used as a guide for the design, configuration, and operation of security checkpoints to minimize exposure of ambulatory medical devices to the electromagnetic fields emitted by metal detector security systems. Guidance is presented for signage and information to help identify persons with ambulatory medical devices and process them through the security checkpoint.
This practice is intended to help in the training of checkpoint screeners to address the concerns of persons with ambulatory medical devices and to respond to their needs.
This practice is intended to aid the medical community in advising medical device users who may be affected to identify themselves at security checkpoints so their concerns may be addressed.
This practice is intended to aid medical device manufacturers to provide consistent information for medical device users, patients, and checkpoint screeners.
SCOPE
1.1 The following practice is intended to address the needs and concerns of persons with implanted, active, medical devices or active ambulatory medical devices, as well as passive implanted medical devices, while maintaining the integrity of the security checkpoint.
1.2 Active and passive implanted medical devices are being used at an increasing rate as a means to prolong and improve quality of life. Although these medical devices are typically designed to operate in the electromagnetic environment experienced in daily life, there is a potential for the disruption of active medical device function when exposed to certain electromagnetic fields emitted by commonly encountered electrically powered products, including handheld and walk-through metal detectors used in security checkpoint 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 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 responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2401 − 04(Reapproved 2010)
Standard Practice for
Security Checkpoint Metal Detector Screening of Persons
with Medical Devices
This standard is issued under the fixed designation F2401; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope implanted, or otherwise mobile with the patient and thus
subject to screening at the security checkpoint.
1.1 The following practice is intended to address the needs
and concerns of persons with implanted, active, medical
2.1.3 archway, n—physical structure of a walk-through
devices or active ambulatory medical devices, as well as
metal detector.
passive implanted medical devices, while maintaining the
2.1.4 electromagnetic field, n—when referenced in this
integrity of the security checkpoint.
practice, it describes the energy field created by the metal
1.2 Active and passive implanted medical devices are being
detector as a means to produce a response to materials with
used at an increasing rate as a means to prolong and improve
electrical conductivity or magnetic susceptibility, or both. The
quality of life. Although these medical devices are typically
electromagnetic fields used in metal detectors for security
designed to operate in the electromagnetic environment expe-
screening applications are typically low frequency and vary
rienced in daily life, there is a potential for the disruption of
with time and locations.
active medical device function when exposed to certain elec-
2.1.5 handheld metal detector, n—portable metal detector
tromagnetic fields emitted by commonly encountered electri-
product used by a security screener to provide localized
cally powered products, including handheld and walk-through
searches of a person.
metal detectors used in security checkpoint screening. In
2.1.6 passive (nonactive) medical devices,
addition, some active or passive implanted devices may trigger
n—nonelectrically powered medical devices. These types of
the unintended alarm of the metal detector.
medical devices may have sufficient metallic content to cause
1.3 The values stated in SI units are to be regarded as the
a response from a metal detector. These devices can be
standard. The values shown in parentheses are for information
implanted, patient worn, or both.
only.
2.1.7 security checkpoint, n—access point equipped with
1.4 This standard does not purport to address all of the
personnel and screening devices used as a means to control the
safety concerns, if any, associated with its use. It is the
flow of weapons or contraband material, or both.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
2.1.8 security screener, n—trained person performing the
bility of regulatory limitations prior to use.
necessary functions at a security checkpoint.
2.1.9 walk-through metal detector, n—permanently placed
2. Terminology
metal detector product typically in an archway form that
2.1 Definitions:
provides a search of the entire body as a person passes through
2.1.1 active medical devices, n—electrically powered medi-
the detector.
cal devices, usually employing electronic circuitry, for human
physiological monitoring or to deliver medical treatment or
3. Summary of Practice
therapy such as drugs or electrical stimulation. These devices
can be implanted, patient worn, or both.
3.1 This practice provides the means to identify, evaluate,
andscreenpersonswithambulatorymedicaldevicesandreport
2.1.2 ambulatory medical devices, n—any medical device
incidences involving medical device users.
(active or nonactive) that can be body mounted, worn,
3.2 These means shall include security checkpoint layout,
signage, screening procedures, screener training, and informa-
This practice is under the jurisdiction of ASTM Committee F12 on Security
Systems and Equipment and is the direct responsibility of Subcommittee F12.60 on
tion for the medical community (physicians, nurses, device
Controlled Access Security, Search, and Screening Equipment.
manufacturers, patients, and so forth) about checkpoint secu-
Current edition approved May 1, 2010. Published May 2010. Originally
rityprocedurestoencouragethestandardizationofinformation
approved in 2004. Last previous edition approved in 2004 as F2401 – 04. DOI:
10.1520/F2401-04R10. and media provided to persons with medical devices.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2401 − 04 (2010)
4. Significance and Use Information about the incident should be recorded with as
muchofthefollowinginformationasappropriateandavailable
4.1 This practice is intended to be used as a guide for the
under the circumstances.
design, configuration, and operation of security checkpoints to
5.3.1 Date, time, and location of incident (for example,
minimize exposure of ambulatory medical devices to the
facility name or address and security checkpoint location).
electromagnetic fields emitted by metal detector security sys-
5.3.2 Security Equipment and Personnel Involved—Type of
tems. Guidance is presented for signage and information to
equipment (for example, handheld metal detector or walk-
help identify persons with ambulatory medical devices and
through metal detector), manufacturer, model, model number,
process them through the security checkpoint.
serial number, and settings.
4.2 This practice is intended to help in the training of
5.3.3 Patient Information—Name, address, telephone
checkpoint screeners to address the concerns of persons with
number, e-mail, patient age, sex, height, weight, and if
ambulatory medical devices and to respond to their needs.
available, patient’s physician name and contact information.
4.3 This practice is intended to aid the medical community
5.3.4 Medical Device Information—As much detail about
in advising medical device users who may be affected to
the active medical device as possible, including the medical
identify themselves at security checkpoints so their concerns
device type (for example, type, make, model, and serial
may be addressed.
number), device location on or implanted in body, and medical
4.4 This practice is intended to aid medical device manu- device settings (if known). A photocopy of the patient’s
facturers to provide consistent information for medical device medical device implant identification card (if available) may
users, patients, and checkpoint screeners. provide some portion of this information.
5.3.5 Summary of Incident—A description of what
5. Procedure
happened, including communication with the patient before,
during, and after the incident. For walk-through metal
5.1 Checkpoint Layout—The security checkpoint shall be
detectors, how long the patient was in the archway, and for
arranged and configured to minimize medical device exposure
handheld metal detectors, how long the detector was held over
to the metal detector emissions.This shall be facilitated by free
or near the medical device location and at what distance. A
traffic flow through the checkpoint, which in turn minimizes
figure of the patient and screening equipment showing the
the duration of time a person remains inside the archway. To
patient location and direction is useful.
accomplish this checkpoint layout, the following points should
5.3.6 Patient Complaint—Summary description of what the
be considered.
patient experienced and when, and what the consequences of
5.1.1 Provide an area for divestiture of metallic objects
the incident were for the patient and medical device.
before screening.
5.3.7 Anycommunicationswiththepatient’sphysicianafter
5.1.2 Provide identifiable queuing area for the human traffic
flow through the security checkpoint. The traffic start point the event.
should be at least 30 cm before the archway entrance.
5.3.8 All incidents involving medical devices that result in
5.1.3 Provide a path of free flow to ensure that no distrac-
patient injury or complaint should be reported to the FDA’s
tions or obstructions prevent a person from freely passing
voluntary reporting program, MedWatch (1).
through the archway unhindered. A distance of at least 1 m
5.4 Screening Procedures:
beyond the archway exit where stopping for hand inspection of
5.4.1 Identify—The use of signage and trained operators
parcels or retrieving items from the baggage screening X-ray
allowstheidentificationofpersonswithmedicaldeviceswhom
system is recommended.
are concerned about potential medical device disruption and
5.1.4 Providenostandingzonesof40cmoneachsideofthe
thosewhoareconcernedthattheirdevicesmaycausethemetal
walk-through metal detector archway for security personnel.
detectors to alarm. Identification by the medical device user or
5.1.5 Provide a secondary screening area for manual scan-
notification to the checkpoint screener should be done before
ningwithahandheldmetaldetectororhandsearching,orboth,
the medical device user enters the archway or is scanned by a
as provided by the security policy.
handheld metal detector. The screener should be prepared to
5.1.6 Provide a means for bypass of the walk-through
handle information discreetly when privacy is a concern.
detector directly to the secondary screening area, if allowed by
5.4.2 Assess—Methods to assess concerns of persons with
security policy.
medical devices may include a brief interview with the person
5.2 Signage—Typically security checkpoint metal detectors
to identify the type of medical device, any medical device user
are visible and identifiable. Signage is suggested to alert
safety concerns, or advice received by the device user from
persons with concerns about their medical devices and direct
their healthcare provider. Additional information may be ob-
them to security staff for assistance. An example is “Metal
tainedfrommedicaldeviceinformationcardsoftensuppliedby
detector in use. Persons with medical devices needing assis-
medical device manufacturers.The checkpoint operator should
tance should notify security personnel.”
check this card to verify patient’s name, type and location of
5.3 Reporting—Incidents of medical device disruption from medical device, and any recommended restrictions to metal
exposure to the security equipment that result in injury to the detector exposure. Checkpoint operators should respect the
device user or complaint should immediately be reported to the requests of the patient while following security screening
security personnel, preferably to the checkpoint supervisor. procedures.
F2401 − 04 (2010)
FIG. 1 Walk-Through Metal Detector Traffic Flow and Exclusion Zone for Medical Active Device Patients
5.4.3 Address Concerns—Methods of addressing patient 5.6.3 Checkpoint prescreening procedures that encourage
concerns may vary depending on the type of security require-
the divesting of metallic objects as a means to minimize the
ment and the availability of alternate screening methods.
need for multiple security checkpoint screening operations.
Proper training of security personnel will allow appropriate
5.6.4 Allowing the patient to describe the location of a
assessmentandimplementationofaprescribedsecurityscreen-
medical device and to allow the area to be quickly scanned or
ing method. The patient may have concerns that include the
perhaps avoided during the use of a handheld metal detector
medical device may cause the security equipment to alarm or
device. Likely, many medical devices will be detected by a
the patient has been advised to minimize or avoid exposure to
handheld metal detector. Knowledge of the location of the
handheld or walk-through metal detectors.
medical device can allow a checkpoint screener to expedite a
5.5 Alternative Screening Procedures—Alternative proce-
search in that body area.
dures are often useful in addressing the needs and concerns of
5.6.5 Keeping a handheld metal detector at least 2.5 cm
patients. The following alternative procedures should be con-
from a patient’s body when passing over a known area
sidered when establishing security policy.
containing a medical device.
5.5.1 Limited searches with handheld metal detectors that
5.6.6 Using hand searches in the area of the medical device
minimize medical device exposure by using hand searches in
if allowed by the policy.
the area of the medical implant.
5.5.2 Hand search for a patient who has been advised to 5.6.7 Maintaining a “No Standing Zone” in and around a
avoid metal detector searches entirely. walk-through metal detector. This includes an area 30 cm
5.5.3 It must be recognized that for some security applica-
before the entrance and beyond the exit of a walk-through
tions hand searches may not be considered adequate and may
metal detector and 40 cm around the sides of the walk-through
result in a denial of access to certain areas.
metal detector (see Fig. 1). The electromagnetic field emission
from walk-through metal detectors decrease rapidly with
5.6 Minimize Exposure—The most basic method of address-
distance. Beyond these zones, concern for medical devices is
ing concerns is to minimize exposure. Examples of methods to
minimal.
minimize exposure are:
5.6.1 Checkpoint layout designed for free flow through a
walk-through detector without obstructions that would cause a 6. Keywords
person to stop within the archway.
6.1 active medical devices; electromagnetic fields; hand-
5.6.2 Checkpoint supervision that encourages persons to
held metal detector; medical devices; security checkpoint;
walk through the center of the archway of a walk-through
security screener; walk-through metal detector
metal detector at a reasonable pace without pausing.
F2401 − 04 (2010)
APPENDIX
(Nonmandatory Information)
X1. RATIONALE
X1.1 This practice addresses the environment in the vicinity generally do not cause walk-through-type metal detectors to
of security checkpoints that use metal detectors. These metal alarm. However, certain combinations of shape, size, material,
detectorshavethepotentialofdisruptingthefunctionofactive, and settings of the metal detector may result in unwanted
ambulatory medical devices. Although instances that require securitysystemalarms.Mostmedicalimplantsofthistypewill
additional precautions are rare, awareness to these possibilities be detected by a handheld metal detector. Security screening
is important. A procedure for addressing medical devices protocol may require a physical search of the body area to
benefits the safety and well-being of
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.