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The Office of Sterile Processing (OSP)

OSP VHA DIRECTIVE 1116  /Office_Sterile_Processing/images/Directive1116.png

VHA Directive 1116(2) Management of Critical and Semi-Critical Reusable Medical Devices that governs sterile processing has undergone a significant update. The directive was amended on June 13, 2024 and September 9, 2024.

Major changes were made to the directive. Click below for access to the full directive and references for the changes:

VHA Directive 1116(2) Management of Critical and Semi-Critical Reusable Medical Devices

Major Changes:

1.  Adds the Department of Veterans Affairs (VA) medical facility Patient Safety representative to the VA medical facility Reusable Medical Devices (RMD) Management Board membership.

2.  Adds a VA medical facility Infection Prevention or Infectious Disease representative to the Veterans Integrated Services Network (VISN) RMD Management Board membership.

3. Updates the link to the Office of Sterile Processing Staffing Tool.

4.  Assigns oversight responsibility to the VA medical facility Associate Director of Patient Care Services to ensure the VA medical facility Sterile Processing Services (SPS) Chief obtains a VA recognized sterile processing certification no later than 1 year after appointment.

5.  Assigns oversight responsibility to the VA medical facility SPS Chief to ensure the VA medical facility SPS Assistant Chief and SPS supervisory positions obtain a   VA recognized sterile processing certification no later than 1 year after appointment.

6.  Removes requirement that RMD stored on crash carts must not be stored in a monitored environment.

7.  Removes requirement that non-high risk RMD must have competency validation completed prior to assigned task performance and clarifies that competency renewal must follow VA accrediting agency guidance.

8.  Clarifies that RMD used in human research must follow VHA Directive 1761, Supply Chain Management Operations, dated December 30, 2020.

9.  Updates paragraph 7.f. to state that VHA must not knowingly use critical or semi-critical reprocessed single-use devices from third party vendors.

10. Adds clarification that critical and semi critical single use devices can be recycled only for the purpose of collecting raw materials but not for reuse. See paragraph 7.f. 

VHA Directive 1116(2) Management of Critical and Semi-Critical Reusable Medical Devices describes the requirements for VHA SPS Certification. This process, previously referred to as “Level 2” certification, has undergone significant revision.To maintain consistency with the national directive, the Office of Sterile Processing (OSP) has updated the procedures for requesting assignment of the VHA SPS Certification exam once all prerequisites and eligibility have been met. Prerequisites include 400 hours of hands-on reprocessing and attestation by the SPS Chief or Associate Director of Patient Care Services (ADPCS) if the person taking the exam is the SPS Chief.