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Information update

Archived – Reminder to use lancing devices for blood sampling as directed

Starting date:: August 1, 2007
Posting date:: August 1, 2012
Type of communication:: Information Update
Subcategory:: Medical Device
Source of recall:: Health Canada
Issue:: Usage
Audience:: General Public, Healthcare Professionals
Identification number:: RA-110002169

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Health Canada is reminding Canadians and health care professionals that lancing devices must be used as directed in order to minimize the risk of transmitting blood-borne pathogens, including hepatitis B, hepatitis C. and HIV.

Lancing devices are used by individuals and health care professionals to take blood samples, often for blood glucose monitoring in patients with diabetes. They consist of a hand-held tube into which a small surgical knife known as a lancet is loaded. The device is held against the skin and a button is pressed to release the lancet. An end cap controls the penetration depth of the lancet. It is important for users to carefully read the manufacturer's instructions and labelling to ensure that the device is used appropriately.

There are three types of lancing devices: disposable, reusable for individual use only, and reusable for multiple patients. Disposable lancing devices are intended to be used once and then the entire unit must be disposed in an appropriate safety container. Reusable lancing devices for individual use only are intended for multiple use by one patient and should not be shared. Finally, some lancing devices are intended for use on multiple patients and in these cases careful attention must be paid to the manufacturer's cleaning and disinfecting directions, including which components of the device must be replaced and properly disposed of between uses.

In January 2006, Health Canada issued a public advisory and a Notice to Hospitals recommending that safety precautions should be followed when using blood lancing devices. This reminder is being issued following the reports of additional incidents received by the Department since January 2006, indicating improper use of lancing devices.

Individual users of lancing devices who have questions about the safe and proper use and handling of these products are urged to communicate with the manufacturer of their device or with a health care professional.

Any cases of serious or unexpected adverse incidents should be reported to manufacturer or 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