6515--Aspen Total Joint Program Brand Name or Equal to

Statement of Need: Aspen Surgical Symmetry Orthopedic Instruments

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

#

Part #

Description

Qty

1

32-3423

Symmetry Hook; Bone; Sharp; Heavy Duty; 19 mm Diameter; 9 in; 228 mm

4

2

28-9406

Symmetry Osteotome; Lambotte; Straight; 1/4 in; 9 in; 228 mm

4

3

28-9420

Symmetry Osteotome; Lambotte; Straight; 3/4 in; 9 in; 228 mm

4

4

28-9425

Symmetry Osteotome; Lambotte; Straight; 1 in; 9 in; 228 mm

4

5

28-9430

Symmetry Osteotome; Lambotte; Straight; 1 1/4 in; 9 in; 228 mm

4

6

28-9440

Symmetry Osteotome; Lambotte; Straight; 1 1/2 in; 9 in; 228 mm

4

7

28-9456

Symmetry Osteotome; Lambotte; Curved; 1/4 in; 9 in; 228 mm

4

8

28-9462

Symmetry Osteotome; Lambotte; Curved; 1/2 in; 9 in; 228 mm

4

9

28-9470

Symmetry Osteotome; Lambotte; Curved; 3/4 in; 9 in; 228 mm

4

10

28-9475

Symmetry Osteotome; Lambotte; Curved; 1 in; 9 in; 228 mm

4

11

28-9480

Symmetry Osteotome; Lambotte; Curved; 1 1/4 in; 9 in; 228 mm

4

12

28-9490

Symmetry Osteotome; Lambotte; Curved; 1 1/2 in; 9 in; 228 mm

4

13

65-2512

Symmetry Elevator; Key; 1/2 in Blade Width; 7 1/2 in; 190 mm

4

14

65-2513

Symmetry Elevator; Key; 3/4 in Blade Width; 7 1/2 in; 190 mm

4

15

55-7025

Symmetry Elevator; Freer; Sharp/Blunt; 4.5 mm Width; Double-Ended; 7 1/2 in; 190 mm

4

16

77-1168

Symmetry Retractor; Hohmann; 22 mm Wide

4

17

77-1118

Symmetry Retractor; Hohmann; 18 mm Wide; w/Finger Ring; 9 1/2 in

4

18

30-4088

Symmetry Forceps; Lahey Goitre Tenaculum; 6 1/4 in

8

19

29-8819A

Symmetry Curette; Cobb; Angled; Size 00; w/Round Handle; 11 in; 279 mm

4

20

29-8820A

Symmetry Curette; Cobb; Angled; Size 0; w/Round Handle; 11 in; 279 mm

4

21

29-8821A

Symmetry Curette; Cobb; Angled; Size 1; w/Round Handle; 11 in; 279 mm

4

22

29-8824A

Symmetry Curette; Cobb; Angled; Round Handle; Size 4; 11 in; 279 mm

4

23

46-3028

Symmetry Driver; Cervical Graft; Unguarded

4

24

31-5105

Symmetry Rongeur; Leksell; 5 mm; Slightly Curved Handle; 9 in; 228 mm

4

25

65-2546

Symmetry Elevator; Cobb Spinal; 1/2 in Blade Width; 11 in; 279 mm

4

26

65-2547

Symmetry Elevator; Cobb Spinal; 3/4 in Blade Width; 11 in; 279 mm

4

27

28-7030

Symmetry Osteotome; Cobb; Curved; 5/8 In Wide; 11 in

4

28

46-2011

Symmetry Osteotome; Curved; 3/8

4

29

46-2506

Symmetry Osteotome; Smith-Peterson; Straight; 1 1/4 in

4

30

27-0401

Symmetry Mallet; 1 1/2 in Head; 2 lbs. Weight; 7 1/2 in; 190 mm

4

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.

Training and Installation:

No installation is required. Formal training is not required.

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

REQUEST FOR INFORMATION INSTRUCTIONS:

It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above.

Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, UEI Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339113 (size standard of 1000 employees). Please answer the following questions:

Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)?

Is your company considered small under the NAICS code identified under this RFI?

Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above?

If not, can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers.

Does your company exceed 500 employees;

Primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied;

Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice;

Obtained an individual or class waiver?

If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available).

If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified?

Must have an authorized distributor letter from the original equipment manufacture.

If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job.

Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number.

If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract?

General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.

Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes?

Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A.

Please provide your UEI number.

This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 12. Telephone responses will not be accepted. Responses must be received via e-mail to andrew.taylor@va.gov no later than, 4:00 PM Eastern Time (ET) on February 17, 2024. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action.

All questions will be addressed by the Contracting Officer, Andrew Taylor. Questions or responses will include the Source Sought number 36C24526Q0286 in the subject line. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award.

Any interested business concern must submit a capability statement addressing its ability to meet the requirements listed above to capability statement shall include a statement regarding how the business concern is engaged in wholesale trade and normally sells the item being supplied and how the business concern will take ownership of the items being delivered. Vendors shall also provide certification, evidence that they are an authorized distributor of the Original Equipment Manufacturer.

If a solicitation is issued, information will be posted on the SAM web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Officer at andrew.taylor3@va.gov include 36C24426Q0286 in the subject line.

DISCLAIMER

This RFI Notice of Intent is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.