36C24426Q0405_1.docx

SUBJECT*

Aspen Total Joint Program (Brand Name or Equal to)

GENERAL INFORMATION

SET-ASIDE

135 East 38th Street

Erie PA

COUNTRY

CONTACT INFORMATION

Network Contracting Office 4

1010 Delafield Road Pittsburgh PA 15240

POINT OF CONTACT*

Contracting Officer Andrew Taylor andrew.taylor3@va.gov 724-679-2327

ADDITIONAL INFORMATION

Presolicitation Notice Presolicitation Notice

DESCRIPTION

Presolicitation Notice

Aspen Surgical “Symmetry” Orthopedic Instruments Brand Name or Equal

Background: The Department of Veterans Affairs, Erie, PA VA Medical Center, Surgical department is implementing a Total Joint Initiative to expand and sustain its ability to perform shoulder, knee, and hip surgeries in house. This initiative supports the delivery of comprehensive orthopedic care, improves access for Veterans, and reduces reliance on community care. As part of this initiative, the Erie, PA VA Medical Center has already invested in standardized surgical platforms and equipment, including powered surgical instruments, to ensure consistency, interoperability, and operational readiness within the Surgery department. These investments were made to establish a reliable, system-based approach to Total Joint replacement procedures.

To fully support the Total Joint Initiative, our Surgery department requires the acquisition of reusable orthopedic surgical instruments necessary to assemble standardized instrument trays for use during shoulder, knee, and hip total joint procedures. These instruments must be suitable for repeated use in a high-volume surgical environment and compatible with existing VA sterilization and operating room procedures.

Scope of Work: The Erie, PA VA Medical Center requires the procurement of brand name or equal to Aspen Surgical “Symmetry” orthopedic instruments to support our newly established Total Joint Initiative. The instruments shall be suitable for inclusion in standardized orthopedic instrument trays and must be compatible with existing operating room workflows, sterilization methods, and clinical practices at the Erie, PA VA Medical Center.

Brand name requirement (Brand Name or Equal): Aspen Surgical “Symmetry” Orthopedic Instruments

Salient Characteristics:

The following salient characteristics for the orthopedic surgical instruments must meet all of the following to be considered technically acceptable. These characteristics represent the minimum needs of the Erie, PA VA Medical Center’s Total Joint Program and are required to support shoulder, knee, and hip joint replacement procedures.

Functional Equivalence – Instruments must be functionally equivalent to the reference brand name items and capable of performing the same surgical tasks in shoulder, knee, and hip total joint procedures. The instruments must be appropriate for:

· bone cutting and resection

· bone manipulation and exposure

· retraction and tissue handling

· malleating and impaction Dimensional and Design Equivalence – Instruments must be dimensionally comparable to the referenced items including:

· Comparable blade widths, lengths, and curvatures

· Comparable working end geometry Minor dimensional variations are acceptable provided they do not affect surgical function or tray compatibility.

Materials and Construction – Instruments must be constructed of surgical grade materials, such as stainless steel, suitable for orthopedic surgical use. Construction must support repeated use in a high-volume surgical environment. Instruments must be free of manufacturing defects and finished to standards appropriate for surgical instrumentation. These instruments must be intended for reusable surgical use and comply with all applicable FDA, AAMI, and VA standards.

· AAMI ST79

· AAMI ST81

Sterile Processing and Reprocessing Compatibility – Instruments must be compatible with existing Erie, PA VAMC, Sterile Processing Services (SPS) workflows. Instruments must be compatible with moist heat (steam) sterilization, which is the standard sterilization method used by the Erie, PA VAMC. Instruments must be capable of being:

· Manually cleaned

· Ultrasonically cleaned

· Processed in automated washer and disinfectors

· Suitable for use in wrapped trays or rigid containers Instrument design must allow effective cleaning of hinges, joints, crevices, and working surfaces.

Security & Privacy:

The vendor will not be on station therefore the Certification & Accreditation (C&A) requirements of VHA Handbook 6500.6 do not apply to this requirement; therefore, a Security Accreditation package is not required. No C&A or MOU/ISA is required. Sensitive information exposure as part of this contract involves applicable security controls within the facility as part of the VA Information Security Program. If there are any questions related to privacy, please have a member of your staff contact the VA Privacy Service at 202-461-6309. If there are any questions related to information security, please have a member of your staff contact the Office of Cyber Security at 304-262-7733.

Delivery:

All items must be FOB Destination, 30 Days ARO, to the following location:

Erie VA Medical Center Attn: Distribution Center 135 E. 38th Street Erie, PA 16504

Monday – Friday from 8:00am – 4:00pm End of Document Page 1 of