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Misuse of blood lancing devices - Notice to Hospitals
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(PDF Version - 53 KB)Contact: Marketed Health Products Directorate (MHPD)
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
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 1, 2, 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 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
References:
1. Douvin C, Simon D, Zinelabidine H, et al. An outbreak of hepatitis B in an endocrinology unit traced to a capillary-blood-sampling device. N Engl J Med 1990;322:57-8.
2. Desenclos JC, Bourdiol-Razes M, Rolin B, et al. Hepatitis C in a ward for cystic fibrosis and diabetic patients: possible transmission by spring-loaded finger-stick devices for self-monitoring of capillary blood glucose. Infect Control Hosp Epidemiol 2001;22:701-7.
3. CDC. Transmission of Hepatitis B Virus among Persons Undergoing Blood Glucose Monitoring in Long-Term Care Facilities - Mississippi, North Carolina, and Los Angeles County, California, 2003-2004. MMWR. 2005; 54: 220-223.
