S03 Brand Name Justification STERIS InnoWave_Redacted.pdf

Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For STERIS Innowave Ultrasonic Cleaners and Accessories

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C244-22-AP-6273

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 4, Commodities 1, 1601 Kirkwood Hwy, Wilmington, DE 19805 PR # 646-22-3-240-0071.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

VA Pittsburgh Healthcare System is requesting brand name Steris Model IWPRO60 Lumens Pro Sonic InnovWave Irrigator & Model IWPCF Sonic Irrigator Thermal Disinfection & Robotic System to ensure our facility has the ability to effectively clean reusable instruments of the DaVinci Surgical Robot. Our facility continues to experience an increase in robotic surgical procedures which requires Sterile Processing Service to be able to provide an immediate solution to thoroughly clean and thermally disinfect the inside of canulated instruments; per AAMI ST79 Standards. The total estimated value of the entire proposed action is $ .

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: This is a Brand Name Only due to the Steris Innowave Ultrasonic Cleaners having the capabilities of not only increasing the reliability of the decontamination process for SPS;

but the new technology will vastly improve cleaning processes and infection prevention for our facility. While the current Ultra Clean System, Inc. ultrasonic cleaner models only provide ultrasonic cleaning for lumened devices, the Steris models also provide thermal disinfection as well soft shot pulses of compressed air through the lumens and spray arms to assist in the drying process. Steris provides the only sonic irrigator on the market that achieves thermal disinfection.

The Steris InnoWave Ultrasonic Cleaners being requested clean many reusable instruments of the DaVinci Surgical Robot. The sonic irrigator uses highly charged fluid jet to remove particles and soils from hard to clean areas on the instruments including inside of channels when connected. This device also has improved ergonomics for staffing removing the trays after cycles are completed by automatically raising and/or lowering the cart depending on the size of the load. This unit/system provides optimal cleaning derived from a recognized, proven, systematic process. It uses sonic activity to target and removes exterior soils from crevices and irregular surfaces; sonic irrigation uses a sonically charged jet of fluid to dislodge and flush soils from intricate channels. The system uses a forceful wash from 6 spray arms to ensure bioburdens are not redeposited on instruments.

The system utilizes compressed air in “power shots” straight through all lumens each cycle, which improves drying results. The system includes a safety feature for a locking lid that ensures it is not operational unless completely closed/secured. Additionally, the tray elevator cannot be raised or lowered whenever something is blocking the path; obstructions are detected and therefore injury/damage is avoided. This system also includes status indicator lights for the user to quickly determine at what point the cycle is in, in progress. Moreover, a foot pedal allows for faster and easier transfers for sterile processing techs who are carrying full trays.