Misuse of blood lancing devices - Notice to Hospitals

Starting date:

March 24, 2009

Posting date:

March 24, 2009

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001950

• Related AWRs

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Issued Important Safety Information on the Association of Blood Lancing Devices and Transmission of Blood-Borne Diseases

March 24, 2009

To: Hospital Chief of Medical Staff, Manager of Nursing Home, Long Term Care Facility and Community Pharmacy Setting.

Please distribute to the relevant Departments, Emergency Medicine, Internal Medicine, Surgery, Geriatrics, Nursing, Pharmacy, Diabetic Education Units and/or other involved Departments as required and other involved professional staff and post this NOTICE in your institution.

Subject: Misuse of blood lancing devices

Health Canada is aware of incidents where lancing devices designed for use in single patients were inappropriately used to obtain blood samples from multiple patients by health care professionals. This misuse may pose a risk of transmission of blood-borne pathogens.

Lancing devices are used by individuals and health care professionals to take blood samples for glucose monitoring. There are three categories of lancing devices: disposable, reusable for single patient and reusable for multiple patients. The endcap of the lancing device is the cover protecting the needle and governing its depth of penetration into the skin. While the endcap of multiple-patient lancing devices are designed to be changed or sterilized, the endcap of single-patient lancing devices is not. Therefore the endcap of a single patient lancing device may come in contact with blood during sampling resulting in transmission of blood-borne pathogens including hepatitis B, hepatitis C and HIV if inappropriately used on multiple patients ^{Footnote 1 Footnote 2 Footnote 3}

In order to minimize the risk of cross-contamination of blood-borne diseases associated with the use of blood lancing devices, Health Canada recommends the following:

• Do not use single-patient lancing device on more than one patient. Health care facilities should ensure the lancing devices they use are designed for sampling multiple patients.
• Clean or change the end-cap of multiple-patient lancing devices according to manufacturer's instruction.
• Lancet must be changed each time blood is being sampled. Users should keep in mind that changing the lancet doesn't eliminate all risk of cross-contamination and that the proper lancing device should be used according to directions and clean appropriately to minimize the risk of contamination.

Health Canada previously issued a Public Advisory (2006), a Notice to Hospitals (2006) and an Information Update (2007) to warn healthcare providers and patients about this safety issue. Since the last notice, Health Canada received additional incidents reports of lancing device misuse by healthcare professionals and patients indicating that healthcare professionals are still inadequately informed about this risk.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. 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 incidents related to medical devices should be reported to the marketing authorization holder 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

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The 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)
E-mail: MHPD_DSPC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Related AWRs

Blood lancing devices and Transmission of Blood-Borne Diseases - Advisories, Warnings and Recalls for Hospitals

2006-01-12 | Health products

Advisory

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

2007-08-01 | Health products

Advisory

Archive – Sharing Blood-Lancing Devices Could Result in Transmission of Blood-Borne Diseases

2006-01-31 | Health products

Advisory