Archived - Notice to Hospitals - Important Safety Information on Reprocessing of Mercury-Filled Esophageal Dilators

Starting date:

February 22, 2006

Posting date:

February 22, 2006

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001345

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Issued Important Safety Information on Reprocessing of Mercury-Filled Esophageal Dilators

February 22, 2006

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Surgery, Gastroenterology, Nursing, Central Processing, and other involved professional staff and post this NOTICE in your institution.

Subject: Reprocessing of Mercury-Filled Esophageal Dilators

Health Canada recently received a report from a Canadian hospital describing how the flexible outer shell of a mercury-filled esophageal dilator ruptured during inadvertent autoclave reprocessing of the device. As a result of this rupture, mercury spilled and contaminated the autoclave as well as other devices being sterilized concomitantly. Due to the environmental and health considerations associated with mercury spills, all contaminated materials had to be recycled or disposed of as hazardous waste.

Esophageal dilators (or bougies) are used as a series of elongate tubes of increasing thickness passed in succession to dilate esophageal strictures of various etiologies. These devices consist of a flexible outer shell and are weighted by a central chamber filled with either liquid mercury or tungsten gel. Due to the potential for age-related degradation of the outer shell, these devices have a finite serviceable lifetime and may come with an expiry date. Autoclaving of these devices further stresses the outer shell, accelerating the aging process and predisposing the device to rupture.

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

1. Discuss this notice with involved staff at your institution to increase awareness.
2. Review the labelling of these devices with particular attention paid to the storage, cleaning and reprocessing instructions. If in doubt about the proper care of these devices, contact the manufacturer.
3. Do not use these devices beyond the recommended expiry date. Regularly inspect the devices for visual signs of wear such as splits or cracks in the outer capsule. Be aware that certain conditions (heat, direct sunlight, frequency of use, other) may accelerate the device's aging process and predispose the device to early failure.
4. If your institution currently uses mercury-filled esophageal dilators, maintain appropriate health and safety procedures to address potential mercury spills and the eventual need for proper disposal of the devices. Mercury-free alternatives, such as tungsten-filled esophageal dilators, are available.

Health Canada depends on health care professionals to report adverse incidents related to medical devices. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any serious 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: 2003D

Ottawa, Ontario K1A 0K9

Tel: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Reporting Form and Guidelines can be obtained from the Health Canada web site.

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

Email: MHPD_DPSC@hc-sc.gc.ca

Tel: (613) 954-6522

Fax: (613) 952-7738