Important Information on Anti‑Theft and Metal Detector Systems and
Pacemakers, ICDs, and Spinal Cord Stimulators

(You are encouraged to copy and distribute this information)

September 28, 1998

To:

Cardiologists Cardiovascular Surgeons

Emergency Physicians

Neurologists

Neuro Surgeons

I am writing to let you know that the operation of certain medical
devices, including pacemakers, implantable cardioverter/defibrillators
and spinal cord stimulators, may be affected by the electromagnetic
fields produced by anti‑theft systems and metal detectors. The number of
reported significant patient injuries is very low, and we are working
with both the manufacturers of medical devices and the manufacturers of
anti‑theft systems and metal detectors to resolve this issue. In the
meantime, you may use the following information and recommendations to
help your patients prevent or minimize any adverse effects.

Sources of interference

Anti‑theft systems:

Anti‑theft systems, also called electronic article surveillance (EAS)
systems, are used in a wide variety of settings, including supermarkets,
shopping malls and libraries. They typically consist of one or two
columns placed opposite each other near entrances and exits. Several
technologies are currently on the market, but generally an
electromagnetic detection field is produced between the two columns and
an alarm sounds if an article with a special tag is carried between the
columns.

Metal detectors:

Metal detectors for airport and facility security applications can be
either portals that a person walks through, or can be hand‑held
\"wands\" that are passed over a person's body. Metal detectors use
various technologies involving magnetic fields to detect the presence of
metal.

Reported interactions

In the past 10 years, FDA has received 44 adverse event reports where
EAS systems and metal detectors appeared to interfere with the routine
function of implantable pacemakers, implantable
cardioverter/defibrillators and spinal cord stimulators. Similar events
have also been reported in the literature. We believe that EAS systems
or metal detectors can potentially interact with other electronic
medical devices as well.

Pacemaker interactions

We have received 18 reports of interference of pacemakers from both EAS
systems and metal detectors. The types of responses to the interference
reported were: shifts in pacing rate; alteration to programmed pacing
therapy; presyncope and syncope; and chest pain.

Effects reported in the literature from clinical laboratory
investigations include: reversion to noise mode (asynchronous pacing at
a predetermined rate); oversensing resulting in inhibition of pacing
output in either chamber; and atrial sensing of the EAS field resulting
in \"tracked\" ventricular pacing at pre‑set limits. These reactions
were typically transient.

Implantable cardioverter/defibrillator (ICD) interactions

We have received 2 reports of ICDs inappropriately shocking patients;
one patient was leaning against an EAS system, and the other was being
scanned with a hand‑held metal detector. In 7 other reports, ICDs
reverted to \"monitor only\" mode after being exposed to metal
detectors.

Spinal‑cord stimulator interactions

We have received 17 reports of overstimulation from implanted
spinal‑cord stimulators when persons with these devices passed through
security systems. (It was not reported whether the security systems were
EAS systems or metal detectors.) Patients reported pain, jolts and
shocks; in one case, a patient fell and was injured.

Recommendations for patients

Interactions with EAS systems and metal detectors are unlikely to cause
clinically significant symptoms in most patients. However, to be on the
safe side, you may wish to advise patients with electronic medical
devices, particularly those who are dependent on the device (e.g.,
pacemaker dependent), to take some simple precautions:

· Be aware that EAS systems may be hidden/camouflaged in entrances and
exits where they are not readily visible in many commercial
establishments.

· Do not stay near the EAS system or metal detector longer than is
necessary and do not lean against the system.

· If scanning with a hand held metal detector is necessary, warn the
security personnel that you have an electronic medical device and ask
them not to hold the metal detector near the device any longer than is
absolutely necessary; or you may wish to ask for an alternate form of
personal search.

Reporting adverse events

FDA solicits your help in collecting data on adverse events related to
electromagnetic interference from EAS and metal detector systems as well
as any other source. Practitioners who are employed by health care
facilities that are subject to FDA's user facility reporting
requirements should follow the reporting procedures established by their
facility. Practitioners can also report the incident directly to
MedWatch, the FDA's voluntary reporting program. The reports can be
submitted by phone at 800‑FDA‑1088, by fax at 800‑FDA‑0178, or by mail
to: MedWatch, Food and Drug Administration, HF‑2, 5600 Fishers Lane,
Rockville, MD 20857.

Getting more information

If you have any questions regarding this letter, please contact Nancy
Pressly, CDRH, Office of Surveillance and Biometrics, HFZ‑510, 1350
Piccard Drive, Rockville, MD 20850, FAX 301‑594‑2968, or e‑mail
nap@cdrh.fda.gov. Additional copies of this notification can be found on
the FDA webpage at http://www.fda.gov/cdrh/safety.html. Postmarket
safety notifications

can also be obtained through e‑mail on the day they are released by
subscribing to our list server. To subscribe, visit
http://list.nih.gov/cgi‑bin/wa?SUBED1=dev‑alert&A=1 Additional
information on medical devices and electromagnetic compatibility can be
found on the FDA webpage at http://www.fda.gov/cdrh/emc/index.html.

Sincerely yours,

D. Bruce Burlington, M.D.

Director, Center for Devices and Radiological Health

Additional Literature (alphabetical order):

1.Beaugeard, D., Kacet, S., Bricout, M., and Camblin, J. Interference
between cardiac pacemakers and electromagnetic antitheft devices
(translated from French). Arch Mal Coeur, vol. 85, 1992, pp.457‑1461.

2.Coperman, Y., Zarfati, D., Laniado, S. The effect of metal detector
gates on implanted permanent pacemakers. PACE, vol. 11, 1988,
pp.1386‑1387.

3.Dodinot, B., Godenir, J., and Costa, A. Electronic article
surveillance: a possible danger for pacemaker patients. PACE, vol.16,
part 1, 1993, pp.46‑53.

4.Eisenberg, E., Waisbrod, H. Spinal Cord Stimulator Activation by an
Anti‑Theft Device. J. Neurosurg., vol. 87, 1997, pp. 961‑962.

5.Lucas, E., Johnson, D., and McElroy, B. The effects of electronic
article surveillance systems on permanent cardiac pacemakers: an in
vitro study. PACE, vol.17, part 2, 1994, pp. 2021‑2026.

6.Mathew, P., Lewis, C., Neglia, J., Krol, R., Saksena, S. Interactions
between electronic article surveillance systems and implantable
defibrillators. PACE, vol.20, 1997, 2857‑2859.

7.McIvor, M., Environmental Electromagnetic Interference from Electronic
Article Surveillance Devices: Interactions with an ICD. PACE, vol. 18,
part 1, 1995, pp. 2229‑2230.

8.McIvor, M., Johnson, D., Reddinger, J., Floden, E., Becker, G.,
Sheppard, R., Mayotte, M. Study of pacemaker and implantable
cardioverter defibrillator triggering by electronic article surveillance
devices (SPICED TEAS). PACE, (in press).

9.Moss, C.E., Case studies: exposure to electromagnetic fields while
operating walk‑through and hand‑held metal detectors, Appl. Occup.
Environ. Hyg., 13(7), 1998, pp. 501‑504.

10.Mugica, J., Henry, L., Podeur, H. Study of interaction between
pacemaker users and EAS systems. PACE, vol.21, 1998 (NASPE Abstracts
Part II), p.895.

11.Mugica,J., Henry, L. Interferences entre les stimulateurs cardiaques
et les systems de detection antival. Stimucoeur, Tome 25, No. 4, 1997,
pp. 287‑288.

12.Tan, K., Hinberg, I. Can Electronic Article Surveillance systems
affect implantable cardiac pacemakers and defibrillators. PACE, vol.21,
1998 (NASPE Abstracts Part II), p.960.

13.Wilke, A, Kruse, T., Hesse, H., Funck, R, Maisch, B. Interactions
between pacemakers and security systems. PACE, vol. 21, 1998,
pp.1784‑1788.

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Additional Background Info from Richard Denny and Julius Jimeno, EPA

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    Questions have been raised about potential harm that could be created when

    pregnant women walk through metal detectors or are exposed to hand-held

    metal detectors.  We find no evidence to suggest that there is a potential

    for harm.

    HELP:  How do you handle those pregnant women that think there is a

    potential for harm and are not willing to be exposed to walk-through metal

    detectors?

    Here's the facts that we have uncovered:

    The current standards regulating the design and manufacture of Walk-through

    Metal Detectors, Hand-held Metal Detectors devices are the following:

    1. National Institute of Law Enforcement and Criminal Justice (NILECJ)

    NILECJ-STD-0601.00, June 1974. Walk-through metal detectors for use in

    weapons detection.

    2. NILECJ-STD-0602.00, October 1974. Hand-held metal detectors for use in

    weapons detection. (NTIS: PB-242 015; PC A02, MF A01)

         Note: the NILECJ standards set maximum field strength.

    4. Practice F1468-95 Standard Practice for Evaluation of Metallic Weapons

    Detectors for Controlled Access Search and Screening - American Society for

    Testing and Materials (ASTM) - Committee F12 on Security Systems and

    Equipment, Subcommittee F12.60 Controlled Access Security, Search, and

    Screening Equipment

    	Note: the F1468-95 specifies certain health, safety, and human factors

    criteria pertaining to the usage of this detection equipment, the standard

    does not purport to address all of the safety concerns, if any, associated

    with its use.

    Currently there are safety and health issue associated with certain medical

    devices, including pacemakers, implantable cardioverter/defibrillators and

    spinal cord stimulators, which may be affected by the electromagnetic

    fields produced by anti-theft systems and metal detectors (Article

    enclosed).

    The devices are considered generally safe for public use, according to the

    manufacturers, although, research on EMF is still being conducted on the

    long term effects.

    RICHARD  L.  DENNY,  CSP

    Safety  &  Occupational  Health  Manager

    USEPA