Stryker T7 Surgical Helmet

Description The VA Boston Healthcare System Surgical Department, Operating Room, is in need of Surgical Helmets, at the West Roxbury Campus. The T7 helmets are used in the OR to prevent infections. All scrubbed OR personnel must wear these along with the disposable sterile covering (Toga or hood). The Department of Veterans Affairs is issuing this Sources Sought Notice in accordance with the FAR 10.002(b)(2) to determine the availability and technical capabilities of qualified sources. The VHA is seeking a qualified source to provide Stryker brand name or equal Surgical Helmet Systems on an agency wide basis. VA intends to award a Firm-Fixed Price (FFP) purchase order IAW FAR 13.302, to a supplier of this equipment. Vendors will be required to deliver Surgical Helmet Systems to the VA Boston Healthcare System Surgical Department. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 Surgical and Medical Instrument Manufacturing and the associated size standard is 1,000 employees. The FAR Provision found at 52.204-7(b)(1) requires that All interested Offerors must be registered in SAM prior to submitting an offer or quotation. You may access the SAM website at https://www.sam.gov/portal/public/SAM/. All quoters must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the Vendor Information Pages (VIP) database at: https://www.vip.vetbiz.va.gov/ at the time of quote submission. This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. Scope Surgical Helmet Systems are used by surgical staff during orthopedic procedures to decrease the patient's risk of deep wound infection (e.g., Staphylococcus aureus) by keeping skin and other particles from falling into the open surgical site. They are also used to protect the surgical staff from potentially infectious aerosols generated by power tools during orthopedic procedures, particularly total knee and hip replacements, and long procedures such as spinal surgery. Aerosols may contaminate mucous membranes (e.g., eyes, nose, mouth) or the respiratory tract. Surgical Helmet Systems can also protect the surgical staff from infectious blood splashes that may carry hepatitis B and C viruses as well as HIV (Human Immunodeficiency Virus). Equipment List: Line-Item Number Part Number Description Quantity 0001 0408-660-000 Power Pack 7 0002 0416-600-000 T7 Surgical Helmet 3 0003 0416-610-000 T7 Surgical Helmet W/LED 8 0004 0408-655-000 Flyte 120v Charger 2 The Department of Veterans Affairs (VA) is seeking vendors who can provide Stryker Surgical Helmet Systems as listed above or equal commodities which meet all of the following salient characteristics: SC # Salient Characteristics Method of Evaluation CLINs SC 1 Shall meet a minimum AAMI Level 4 Testing (Toga) (Association for Advancement of Medical Instrumentation) Literature Review 0004 SC 2 Basic system components must include Helmet w/ light, Hood, Toga, Battery with Charging ability Literature Review 0001 - 0004 SC 3 Helmet must include a variable speed fan for ventilation Literature Review 0002 & 0003 SC 4 Headband in helmet must be adjustable for custom fitting Literature Review 0002 & 0003 SC 5 All areas of the helmet must be accessible for cleaning to prevent cross-contamination Literature Review 0002 & 0003 SC 6 Hood/Toga must be constructed of splash and fluid resistant fabric Literature Review 0004 SC 7 Batteries must have operating life of >= 5 hours Literature Review 0002 & 0003 For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics (SC) specified above. The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the OEM and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number. Instructions to Vendors Responses to this sources sought notice shall include the following: Full name and address of company DUNS number Business Size Manufacturer or Distributor If distributor provide full name, business size and address of manufacturer Country of Origin designation for all products Ability to provide uninterrupted supply of products on a national scale Technical Literature that clearly shows product(s) meet the identified salient characteristics (if submitting an or-equal item) Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified Although not required, vendors responding to this Sources Sought Notice may also submit a Capabilities Statement.