Update: Risk of Strangulation of Infants by IV Tubing and Monitor Leads - Notice to Hospitals

Date: 2003-12-29

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The Marketed Health Products Directorate (MHPD) of the Health Products and Food Branch (HPFB) posts on the Health Canada Website safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories are prepared in collaboration with other 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.

December 29, 2003

To: Hospital Chiefs of Medical and Nursing Staff

Please distribute to the relevant Departments of Paediatrics, Anaesthesia, Intensive Care, Emergency, Nursing, Surgery and other involved professional staff and post this NOTICE in your institution.

UPDATE: Risk of Strangulation of Infants by IV Tubing and Monitor Leads

This is an update to the information in the Health Canada Notice to Hospitals dated July 30, 2002. The recommendations in the Notice were discussed by representatives of Health Canada, the Canadian Association of Paediatric Health Centres (CAPHC), and family advocacy groups at a special meeting held June 14, 2003, in Calgary, AB.

The discussion focussed on CAPHC members' concerns that it would not be feasible for healthcare institutions to implement some of the recommendations in the Notice. A paper published shortly before the meeting¹ described two cases in Canada of strangulation involving IV tubing, and proposed preventive measures. Discussions at the meeting, and further consultation between Health Canada and CAPHC have resulted in the following revised recommendations which have been endorsed by both parties.

Health Canada and CAPHC recommend the following:

The hospital environment requires high vigilance by staff in order to avoid adverse incidents that may stem from the use of products and equipment used in diagnosis, prevention, and treatment.

Acute care facilities (tertiary and quaternary), regional and community health care centres, rehabilitation centres, and community and home care organizations should establish policies and procedures that include a risk assessment for each patient, made in consultation with the patient's family. These policies should consider such measures as:

1. Using continuous IV administration only when necessary. For intermittent IV infusion, saline or heparin-locked IV sites should be considered.
   
   
2. Providing an appropriate level of supervision for children who have entangled themselves in tubing, including oxygen tubing, or leads, or are considered to be at an increased risk of doing so. Factors to be considered might include:
   • the child's age and cognitive level
   • the child's mobility and state of agitation
   • the length and number of tubes and leads attached to the patient
     
     
3. Using equipment accessories that restrain or stabilize flexible lines to reduce the potential for them to become wrapped around the child's neck or limbs.

Health Canada evaluates therapeutic products for quality, safety, and efficacy. Their actual use in therapeutic settings is a responsibility of healthcare providers. Health Canada and CAPHC ask that you share these recommendations with your staff or membership and encourage their implementation in the interest of patient safety.

If you have any concerns, problems or complaints pertaining to medical devices, you should report them to Health Canada at the address below, or through a toll-free line at 1-800-267-9675.

Health Products and Food Branch Inspectorate
Health Canada
"A", Holland Cross
11 Holland Ave.
Address Locator: 3002C
Ottawa, Ontario K1A 0K9

References
1. Garros D, King WJ, Brady-Fryer B, Klassen TP. Strangulation With Intravenous Tubing: A Previously Undescribed Adverse Advent in Children, Pediatrics 111:e732-e734, 2003.
 http://pediatrics.aappublications.org/cgi/content/full/111/6/e732