Safety Engineered Devices (SED)

With increasing concerns of occupational exposure to blood-borne viruses in healthcare settings, AHS is committed to using safer sharps devices that are designed to protect workers from injuries. However, with an increasing range of sharp safety devices on the market, deciding what to purchase is not a simple task.

Contracting, Procurement and Supply Management and Workplace Health and Safety (WHS) are working with AHS vendors to keep current with new developments in SED technology.

The Occupational Health and Safety legislation states that SEDs must be supplied and used with only two exceptions:

  • The use of the SED is not clinically appropriate, and
  • The SED is not commercially available.

The Safety Engineered Devices Waiver Process is in place to accommodate the rare occasion where a SED cannot be used in the workplace. The waiver applications are reviewed by WHS and only applies to physicians and staff working in AHS operated facilities.

Definitions

Conventional Device – A sharps device that does not offer sharps injury protection.

Medical Device – Health or medical instruments used in the mitigation, treatment, diagnosis, prevention of a disease or abnormal physical condition.

Safety Engineered Device (SED) – A device that has a built in sharps injury protection mechanism such as an attached sheath covering the needle or scalpel after use or needles that retract after use. Other types of safety devices include blunt needles or needle-less systems. SEDs protect the user from exposure to blood borne pathogens or chemical hazards (i.e., cytotoxic medications).


Waiver Process

In order to address legislative documentation requirements, the following procedure must be completed.

  • Complete the Use of Conventional Devices Waiver Request form. The form should be completed electronically and returned to Workplace Health and Safety (WHS) at the email address provided below.
  • A completed Safety Engineered Device Hazard Assessment must accompany the waiver request form. If the applicant requires support in completing the hazard assessment, they may contact their WHS office for information. Each complete submission will be logged and tracked for quality assurance. A decision will be communicated to the originator. The originator is accountable for communicating the results of the decision to the affected departments/areas.
  • Incomplete submissions (i.e., missing or incomplete waiver or hazard assessment forms) will be returned to the originator and further consideration will be suspended pending resubmission of a completed package.
  • Waivers will be approved for a maximum of one year from review and waiver renewals must be submitted within 30 days of the waiver expiration. The originator will be responsible for ensuring the timeline is met.
  • The originator must keep a copy of the waiver in an accessible location in the event an Occupational Health and Safety Inspector requests the documentation.
  • Waivers may be suspended or revoked by WHS if it is discovered that the conventional device is being used for a non-approved application.