Health Product InfoWatch - May 2017 - Page 2

New health product safety information

The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.

Safety brief

Disposable plastic syringes - clarification of intended use

Safety reminder

All disposable plastic syringes in Canada regardless of manufacturer are licensed for immediate drug administration and fluid aspiration only. There is a potential risk of decreased medication potency if these syringes are used for storage of medication.

Action taken by Health Canada

Health Canada has previously communicated on this issue with regard to specific disposable syringes. Since then, Health Canada has been working with all manufacturers of disposable plastic syringes marketed in Canada to update their labelling to align with the intended use of these devices. Device labelling now contains directions such as: “for immediate use” or similar wording (e.g., “not for drug storage”). The updated wording may appear in the following locations:

  • Syringe peel-away / pouch labels
  • Syringe box labels
  • Package insert

Syringes that are sold pre-filled with heparin, saline or any other drug product were not subject to this labelling update.

For more information

More information can be found on the Institute for Safe Medication Practices (ISMP) Web site. In addition, some individual manufacturers have also communicated directly to clients on this label update.

Report health or safety concerns

Health Canada encourages the reporting of reduced medication potency with the use of disposable plastic syringes to the Regulatory Operations and Regions Branch through the toll free hotline (1-800-267-9675). The adverse incident reporting form and guidelines can be found on the Health Canada Web site.

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