FDA > CDRH > Medical Device Safety > Talk About Metal Allergies!

Talk About Metal Allergies!

By Deborah Yoder, Nurse Consultant and Terrie Reed, MedSun Project Coordinator

Problem Description

Many implanted devices are made of, or contain, stainless steel and other metals that can trigger sensitivity or allergic reactions. Stainless-steel medical devices that release nickel and other metal ions can trigger metal contact allergies and result in adverse patient outcomes. The incidence of nickel contact allergies in the overall adult population is estimated at 10% with a higher prevalence in women than men.⁽¹⁾ Metal surgical clamps and coronary stents are examples of implanted devices associated with local or systemic allergic reactions.^(2,3,4)

Reported Incident:

FDA received a voluntary MedWatch medical device adverse event report describing a potential metal allergy in a patient that recently received an implanted stainless-steel stent to treat a serious heart condition. The surgical team asked if the patient had any allergies during the pre-surgical preparation. The patient did not report her metal allergy. After a successful procedure, the patient reported symptoms consistent with a systemic allergic reaction for which she was successfully treated. The patient did not realize the stent contained metal until she read the product brochure after discharge from the hospital.

Even if patients know they have a metal allergy, they may need to be prompted to communicate this information. Pre-procedure questions to identify potential allergic reactions are often directed toward issues such as drug reactions or sensitivities to latex products. Metal allergies or sensitivities may not be emphasized or discussed during a pre-procedural patient assessment.

Recommended Actions:

• Specifically discuss metal allergies as part of your pre-surgical patient assessment.
• Document metal allergies and sensitivities on the patient's surgical check list, on the cover of the patient's medical record, and on the appropriate page within the patient's medical record.
• Encourage patients to document and carry an allergy/sensitivity card in their wallets/purses.

References

1. Schafer T, Behler E, et al. Epidemiology of contact allergy in adults. Allergy 2001;56:1192-6.
2. Ross IB, Warrington RJ, Halliday WC. Cell-mediated allergy to a cerebral aneurysm clip:Case report. Neurosurgery 1998;43:1209-11
3. Koster R, Vieluf D, et al. Nickel and molybdenum contact allergies in patients with coronary in-stent restenosis. Lancet 2000;356:1895-7.
4. Gimenez-Amau, Riambau V, et al. Metal-induced generalized pruriginous dermatitis and endovascular surgery. Contact Dermatitis 2000;43:35-40

Updated February 6, 2004