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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 17, 2018 FBO #6111
DOCUMENT

65 -- ACL Instrument Tray Intent to Orally Solicit - Set-aside for SDVOSBs - Attachment

Notice Date

8/15/2018
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 20;5115 NE 82nd Ave;Vancouver, WA 98662
 

ZIP Code

98662
 

Solicitation Number

36C26018Q9703
 

Archive Date

8/25/2018
 

Point of Contact

Luke.Nesse@va.gov
 

E-Mail Address

Luke.Nesse@va.gov
(Luke.Nesse@va.gov)
 

Small Business Set-Aside

N/A
 

Description

STATEMENT OF WORK (SOW) 1. Contract Title. We are purchasing instrumentation to perform ACL reconstruction. Once we have the instrumentation our goal would be to provide our surgeons with instrumentation that would allow them the options necessary to perform an ACL however they deem an individual patient requires. 2. Background. The VA hospital is in need of the instrumentation. There are too many potential problems we can encounter when trying to get our vendors to provide us with instrumentation for each and every case we perform. 3. Scope. This is a surgical set. All of the use of this instrument will be in the Operating Room. The instruments will need to go through our Central Processing before they can be used in the hospital and then again after each use to ensure sterility between cases. 4. Specific Tasks. As the instruments are secondarily important to the implants they allow us to implant most of the information in this section will be directing your attention to our specific needs in the implants we use for ACL reconstruction. We have broken the information up into sections that help clarify what our needs are for different parts of an ACL reconstruction. Femoral Fixation We need a soft tissue adjustable suspension button between 4.3mm and 5.0mm in diameter. This button must have a single pull suture to tension and cannot require two handed tensioning that requires alternating tension on every other suture. It also cannot have anything that prevents the sutures from being infinitely tightened. Also, we need the button to be tensioned by pulling on the proximately, not by being pulled down distally into and through the joint space. We need a lateral fixation cross pin fixation option. The pins need to be made out of a bio-composite material that has been researched and tested in actual humans not just animals. Research must be supported by CT scans and MRI s showing what the product s material does between 18 and 36 months. We need the material to be absorbed by the body and replaced to bone by 36 months. We need interference screws that can be used with soft tissue and/or bone tendon bone ACL reconstruction. The screws must have a wide thread pitch allowing for insertion with much less torque for insertion. Also, their construction material must meet the same standard as #2 in femoral fixation. It must be a material that has been researched and tested in actual humans not just animals. We need the material to be absorbed by the body and replaced to bone by 36 months. Tibial Fixation We need a sheath and screw fixation system for tibial fixation. The system must be cannulated and come with options of 23mm and 30mm implants. The sheath must separate the tendon bundles into 4 quadrants allowing for ultimate fixation strength and tendon to bone healing. Also, both the sheath and screw must be made of bio-composite material. The material must meet the same standard as #2 in femoral fixation. It must be a material that has been researched and tested in actual humans not just animals. We need the material to be absorbed by the body and replaced to bone by 36 months. We need interference screws that can be used with soft tissue and/or bone tendon bone ACL reconstruction. The screws must have a wide thread pitch allowing for insertion with much less torque for insertion. Also, their construction material must meet the same standard as #2 in femoral fixation. It must be a material that has been researched and tested in actual humans not just animals. We need the material to be absorbed by the body and replaced to bone by 36 months. Reamers We need fully fluted reamers, acorn reamers, and low profile reamers. All reamers must be reprocessable and come in whole and half sizes from 6mm 12mm in diameter. We need a retro reaming system. We need guides that will allow us to ream both femoral and tibial tunnels. The actual disposable retro cutting system needs to be adjustable to different diameters, so that one device may be used to drill multiple different diameters of tunnels in one patient. Also, a single device must be used to drill all sizes and half sizes from 6mm 12mm. We cannot stock multiple different sizes of the same device so a single size adjustable device is imperative. We also need femoral tunnel guides, both transtibial and anteriormedial approach options. We also need a tibial tunnel guide. Our specific needs require a guide that has hard stops at our preferred 45, 50, and 55 degree options. We cannot have a free moving guide that s only control is a hand tensioning system, that would allow for too much error and variation. 5. Performance Monitoring (if applicable). Performance Monitoring can be done in several ways. Our Central Processing team can help us make sure that our instruments are properly maintained. Our Nursing staff can help by monitor performance by making sure all implants are properly recorded for billing purposes. And finally our surgeons may be asked their opinions at any time to ensure their needs are being met. 6. Security Requirements. The contractor employees shall not have access to VA sensitive or computer information and will not require routine access to VA Facilities. The contractor employees shall require intermittent access only and will be escorted by VA employees while at VA Facilities. No background investigation is required 7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). This section does not apply to this purchase. 8. Other Pertinent Information or Special Considerations. This section does not apply to this purchase; a. Identification of Possible Follow-on Work. N/A b. Identification of Potential Conflicts of Interest (COI). There are no conflicts potentials in this purchase. c. Inspection and Acceptance Criteria. COTR will have full availability to any instruments purchased. 9. Risk Control This section does not apply to this purchase, as there is no risk associated to the purchase of surgical instruments. 10. Place of Performance. All of the use of this product will be inside the operating room inside the VA hospital. 11. Period of Performance. The expectation of the VA is that upon procurement of a PO number that the company supplying our instruments will do so in a timely manner. 12. Delivery Schedule. This section is not applicable to this purchase.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PoVAMC/VAMCCO80220/36C26018Q9703/listing.html)
 

Document(s)

Attachment
 

File Name: 36C26018Q9703 36C26018Q9703.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4543966&FileName=36C26018Q9703-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4543966&FileName=36C26018Q9703-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN05038606-W 20180817/180815231303-0babf7069f91747967da2aeea7b3562a (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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