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Health professional risk communication

Association of Transdermal Drug Patches with Thermal Burns During Magnetic Resonance Imaging Procedures – Notice to Hospitals

Starting date:
April 26, 2005
Posting date:
April 26, 2005
Type of communication:
Notice to Hospitals
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Hospitals
Identification number:
RA-170001130

Notice about Health Canada advisories

 
[Text of letter begins]

Health Canada Endorsed Important Safety Information on Magnetic Resonance Imaging Systems

April 26, 2005

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Radiology and Pharmacy and other involved professional staff and post this NOTICE in your institution.

Subject: Association of transdermal drug patches with thermal burns during magnetic resonance imaging procedures

Health Canada is aware of international reports of patient injury associated with the use of transdermal medication patches during magnetic resonance imaging (MRI) procedures. Although no similar incidents have been reported in Canada, this notice is being issued to increase awareness of this problem and provide relevant recommendations.

Transdermal drug patches are adhesive patches used to deliver a dose of drug through the skin at a controlled rate over a period of time. Some transdermal patches contain an aluminum or foil backing in the layer farthest from the skin. This backing helps to contain the drug in the patch's reservoir while it is slowly administered transdermally.Footnote 1

MRI systems produce radio wave pulses of energy. If conductive materials are placed in the MRI field, a concentration of electrical currents sufficient to cause excessive tissue heating could be induced. Though the metallic components found in some transdermal patches are not ferromagnetic, they are conductive and this led to patient burns during MRI procedures in the incidents reported internationally.Footnote 2

In light of this information, Health Canada recommends the following:

  • improve professional awareness of this issue by reviewing this information with appropriate staff members,
  • ensure that pre-MRI patient screening information includes a specific question related to the use of transdermal drug patches,
  • unless it is certain that the patch does not contain conductive material, patients using transdermal patches should be advised to remove their patch prior to the MRI scan; if there are any concerns about the interruption of transdermal drug delivery or the replacement of the patch, the healthcare professional who prescribed the medication should be contacted.

Health Canada depends on health care professionals to report adverse incidents related to medical devices. Any serious and/or unexpected adverse incident related to medical devices should be reported to Health Canada at the following address:

Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675

For other inquiries, please refer to contact information:
Marketed Health Products Directorate (MHPD)
MHPD_DPSC@hc-sc.gc.ca
Tel/Tél: (613) 954-6522
Fax/Télé: (613) 952-7738

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.

[Text of letter ends]
 

References

Footnote 1

Karch AM. Don't Get Burnt by the MRI. Am J Nurs 2004; 104(8): 31.

Return to footnote 1 referrer

Footnote 2

ISMP Medication Safety Alert. April 8, 2004.

Return to footnote 2 referrer