Medical Devices Alert. No. 113

Date: 2000-09-07

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

---

Contact
MDB Enquiries

---

To: Hospital Administrators

Attention: Respiratory Therapy Departments

Subject: Cleaning of Reusable Resuscitators and PEEP Valves

Resuscitators and Positive End Expiratory Pressure (PEEP) valves are likely to become contaminated during use by microorganism and other foreign material, or by patient fluids. Inadequate cleaning may affect the safe operation of the resuscitator.

The Medical Devices Bureau of the Health Products and Food Branch has recently investigated two similar incidents from different hospitals involving a reusable resuscitator and a reusable PEEP valve. In both incidents, valves in the exhalation pathway were stuck closed, preventing patient exhalation and causing a step-wise increase in lung inflation and the risk of pneumothorax. The resuscitators were assigned to individual patients and were re-used without cleaning. The observation of a dried substance on the valves in the exhalation pathway suggests that patient fluids and condensate from exhalation deposited on them during use and then dried between use, causing them to stick to the valve seat. Similar cases of sticking valves on resuscitators without PEEP attachments have been reported in the past, and may have been caused by inadequate cleaning of the valve components to eliminate surface residue.

The Health Products and Food Branch recommends that Respiratory Therapy Departments review their protocols for cleaning and disinfecting or sterilizing re-usable resuscitators, with or without PEEP valves, to ensure that:

1. Each resuscitator, PEEP valve and its components are cleaned and disinfected or sterilized after every use, in accordance with the manufacturer's instructions; and
   
   
2. The functional operation of the resuscitator and PEEP valve assembly are verified prior to use by carrying out the test recommended by the manufacturer.

Inquiries concerning this Alert and reports of adverse incidents involving the use of resuscitators may be made by calling the toll-free Medical Devices Hotline at 1-800-267-9675, or by contacting:

The Director , Medical Devices Bureau, Therapeutic Products Programme, Room 1605, Main Statistics Canada Building, Tunney's Pasture, Address Locator 0301H1, Ottawa, Ontario, K1A 0L2.

Tel: 613-957-4786, fax: 613-957-7318.

Diane Gorman

Assistant Deputy Minister