Please see the two Shared Health memos regarding a new online provincial product complaint form that has been specifically created to capture issues with large volume pumps and supplies:

1. For All Clinical Staff and Anesthesiologists: Important Reminder to Document all Patient Safety Incidents and Product Complaints – Large Volume Pumps
2. For Program Directors and Managers of Health Services only: Documentation of Patient Safety Incidents and Product Complaints – Large Volume Pumps. Contains key points for staff huddles, product complaint tags for printing and a poster with a QR code to access the provincial product complaint form.

SH-SS Staff are requested to use the QR code in poster to pin or bookmark the product complaint form web page on work computers and tablets to allow quick access and to begin using this form effective immediately for all issues with large volume pumps and supplies. When electronic data entry is completed, staff are able to click a link and see the number of product complaints and can be reassured that their work to enter data is visible and being noticed.

This new form has information that Health Canada requires to review the product so it is imperative that we report all issues. A reminder to also document issues on Safety Event Reports and Medical Device reporting to Health Canada. Minimal or no documentation indicates that there is no issue.

A Patient Safety Incidents and Product Complaints – Frequently Asked Questions (FAQ) is available with additional information.

If paper versions of new product complaint form are completed by staff, it is requested that a facility Administrative Assistant or designate enter data into electronic form.

The current SH-SS Product Vendor Complaint Form and process will continue to be used for all other product complaints for the time being.

Submitted by: Lorraine Cassan, Regional Lead – Acute Care & Chief Nursing Officer