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NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on
Hemodialysis Access Devices |
January 19, 2005
To: Hospital Chief of Medical Staff
Please distribute to the Hemodialysis Units and other involved professional
staff and post this NOTICE in your institution.
| Subject: |
Risk of inadvertent disconnection of hemodialysis vascular
access devices |
Health Canada is concerned about reports of accidental disconnection of
vascular access devices during hemodialysis treatment. This is a rare but
potentially serious problem leading to rapid, significant blood loss and
its sequelae.
Vascular access devices include large bore needles and central venous
catheters as well as any other device used to connect the bloodlines of
the dialysis machine to the patient’s vascular system.
Hemodialysis machines are equipped with venous pressure monitors that
alarm when the value of the pressure in the venous bloodline falls below
the limit set by the user. However, the venous pressure drop resulting
from the inadvertent disconnection of a vascular access device may not
be large enough to trigger an alarm. For example, a disconnection of the
fistula needle may not trigger the alarm because the major source of resistance
in this area of the circuit is the needle itself. Therefore, venous pressure
monitors should be viewed only as one of several safeguards used to detect
accidental disconnection.
Health Canada recommends the following:
- review your centre’s specific policies and procedures
for ensuring the security of the access devices and bloodlines
- verify that the bloodline is firmly attached to the access device
and properly secured
- ascertain that all connections in the blood circuit are properly closed
by staying with the patient during the initial 3-5 minutes of dialysis
treatment
- monitor the patient carefully and regularly
- ensure that the vascular access remains fully visible (not covered
by clothing or other items)
- set a reasonable venous pressure alarm limit and do not disable the
alarm
Health Canada depends on health care professionals to report adverse events
related to medical devices. Problems should be reported to Health Canada
at the following address:
Any suspected adverse incident can be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
For other inquiries: please refer to contact information
Marketed Health Products Directorate
email: MHPD_DPSC@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738
The Medical
Devices Problem Report Form and Guidelines can be found on the Health Canada web site. |
References:
- Baxter Important Clinical Practice Reminder, October 6, 2004.
- Ottawa Hospital- Nephrology Program- Nephrology Practice Alert #36,
September 16, 2004.
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