65--Neuro Spine Instrument CO 589-A83030

?.## STATEMENT OF REQUIREMENTS Surgical Instrumentation Neuro Surgery Harry S. Truman Memorial Veterans Hospital Columbia, MO seeks procurement of various surgical instrumentation to perform various Lumbar Spine procedures. An example of the procedures to be performed include but are not limited to the following: 1. - Lumbar spine laminectomies and discectomies - - 2. Posterior lumbar decompression and fusions - 3. Anterior and posterior Cervical decompression and fusions. - 4. - Minimally invasive stabilization of cervical, thoracic, and lumbar spines in trauma patients. The surgical instruments Shall be constructed of solid 300 or 400 series German stainless steel, to ensure that the instruments maintain performance. The instruments must also be assembled within the manufactured country or show significant proof of an internationally recognized quality assurance program. Certificate of authenticity will need to be provided. All instrument surfaces must be visibly smooth and must not contain casting marks, ruff box locks or grind marks. All instruments must be new and reusable. Laparoscopic like or MIS (Minimally Invasive Surgery) type instruments must be able to be taken apart for cleaning or specific IFU s (Instructions for Use) and cleaning instructions provided. Instruments with lumens or cannulas will need to constructed in a manner that they can be manually cleaned with a brush (or similar cleaning device) where the cleaning instrument is exits the instrument channel completely in order to ensure proper cleaning. Any exceptions must be completely documented in quotation. Instruments that utilize flush ports must contain device specific IFU s and cleaning instructions and will be allowed after the documents and instruments are evaluated by the receiving facilities SME (Subject Matter Expert). IFU s that indicate cleaning and disinfection needs to be performed within one hour will not be accepted (excluding pre-cleaning at point of use). Instruments with identifying numbers (model part numbers) on the instruments must be the same as those listed on the purchase order or quotation. Third party etching or engraving will not be acceptable. Each instrument past present and future containing unique identification number must be exactly the same as the original. Replacements provided under warranty/replacements must be exactly the same as the original. No matter the amount of instrumentation requested, delivery capabilities need to be within a forty-eight hour period excluding rare instruments. Vendor must have a warranty/repair/replacement service that has one (1) week typical turnaround time. Atypical or specialized instrumentation must be made available within three (3) weeks. Vendor must have the ability of repairing the full spectrum of surgical instruments. All manufacture defects and repairs (not including abuse and misuse) will be replaced at no cost to the vendor as long as the instruments are in use at the receiving facility (Limited Lifetime). Complete warranty information must be included in submission. Any warranty periods under 1 year will not be considered regardless of submission. Comprehensive repair costs and transportation process must be listed clearly using the requesting facilities location/information. All repaired instruments must bring the instrument back within the original manufacture specifications. A sample of each instrument under bid will be provided to the requesting facility at no cost to the government. Instruments will undergo compete reprocessing cycle using ANSI/AAMI guidelines and RE (Reprocessing Equipment) manufactures recommendations. Instruments will be subject to pre-vacuum steam sterilization not exceeding 275°F, neutral PH enzymatic detergents and ultrasonic cleaning methods. Evaluation of quality and performance will be competed and used as the primary deciding factor for award. Vendor will provide a no cost return authorization for samples once the review is finished. IFU s, cleaning and maintenance instructions will be provided with quotation. Instrumentation must be compatible with Pre-vacuum steam sterilization cycle, 270°F temperatures with a 4-minute exposure as reflected in the instructions. Complex instruments requiring specialized cleaning will have device specific instructions provided. Only the original manufacture documents will be accepted which excludes all emails, individually typed word documents and faxed of photographed copies. Documents will only be accepted in an electronic format. Vendor will be required to provide in services at the receiving station on all complex/new instruments as determined by the SPS Chief. This information can be provided in advance of quotation. Instruments must be compatible with the Instacount Plus Instrument tracking software program. Every part of the Statement of Requirements SOR must be addressed or the offer will not be considered. Vendor can submit a bid even if they cannot meet all specification within the SOR however, clarification on how quoted item(s) provided is equal or exceeds the standing requirements of the SOR.