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Blood lancing devices and Transmission of Blood-Borne Diseases - Advisories, Warnings and Recalls for Hospitals
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NOTICE TO HOSPITALS - Health Canada Issued Important Safety Information on the Association of Blood Lancing Devices and Transmission of Blood-Borne Diseases
January 12, 2006
To: Hospital Chief of Medical Staff, Nursing Homes, Long Term Care Centres and Health Clinics
Please distribute to the relevant Departments of Surgery; Emergency Medicine, Pharmacy, Pediatrics, Anesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required and other involved professional staff and post this NOTICE in your institution.
Subject: Misuse of blood lancing devices
Lancing devices used to obtain capillary blood samples for glucose monitoring consist of a hand-held tube into which a lancet is loaded. The device also has an endcap which may or may not be removable. The device is held against the skin and a button is pressed to activate a spring-loaded mechanism that releases the lancet which pierces the skin and automatically retracts. Depending on the labelling claims, some lancing devices are for single use, or for multiple uses on the same patient, or, if the endcap can be changed or sterilized, for use on multiple patients.
There have been several cases in Canada and abroad1 where the devices were inappropriately used by healthcare workers to obtain blood samples from multiple patients. This misuse may result in transmission of blood-borne viruses, including Hepatitis B Virus2, 3, 4, 5, and Hepatitis C Virus6. Accordingly, Health Canada reminds health care workers that these devices must be used with care to minimize the risk of transmission of blood-borne diseases.
HEALTH CANADA RECOMMENDATIONS:
Follow carefully the instructions in the device labeling and pay special attention to the following:
- If a lancing device is labeled for single patient home use, do not use it on multiple patients.
- Do not reuse lancets for blood sampling. Dispose of them in an appropriate sharps container after a single use.
- If the non-removable endcap is indicated for use by more than one patient, ensure it is properly disinfected between patients according to instructions in the labelling. If the labelling contains no instructions for disinfection, do not use the device on multiple patients.
- If a lancing device has a removable endcap, ensure it is changed every time a new patient is tested. Do not use the same endcap on different patients.
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
References:
- UK Medicines and Healthcare products Regulatory Agency. Lancing devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices. Medical Device Alert 2005/063. 2005 Nov. 28.
- Polish L.B., Shapiro C.N., Bauer F., Klotz P., Ginier P., Roberto R.R., Margolis H.S., Alter M.J. Nosocomial transmission of Hepatitis B virus associated with the use of a spring-loaded fingerstick device. New England Journal of Medicine 1992;326:721-725.
- Centers for Disease Control and Prevention. Nosocomial transmission of Hepatitis B Virus infection with reusable fingerstick blood sampling device: Ohio and New York 1996. MMWR Morb Mortal Wkly Rep 1997; 46(10):217-21.
- Schrijver, K. De and the Eurosurveillance editorial team. Hepatitis B transmission in care homes linked to blood glucose monitoring, Belgium and the United States. Eurosurveillance 2005;10(1-3): 55.
- Centers for Disease Control and Prevention. 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, 03/11/2005; 54(09): 220-223.
- Desenclos JC, Bourdiol-Razes M, Rolin B, Garandeau P, Ducos J, Brechot C, Thiers V. 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 Nov;22(11):701-7.
