Medical Safety Needles and Syringes

The purpose of this Request for Information (RFI) is to gain knowledge relative to current/future production of Medical Safety Needles and Syringes that meets the below minimum specifications and is manufactured solely in the United States. Responses to this RFI will be used by the Government to make appropriate acquisition decisions. The Government is interested in attaining your current and projected inventory levels over the next 12 months, product specifications and literature as described in the below specification information, and location of manufacturing. The information that you provide will allow the government to assess the current health care industry inventory given the increase in customer demand and the probable effects on the commercial supply chain and distribution network affecting these items. The government is interested in the current and future manufacturing capabilities, location of manufacturing and raw materials, and an outlook on the industry. Please provide any additional information that you feel may be of interest to the Government when reviewing responses to this request. Product Technical Requirements The following are the only acceptable syringes and needles based on their intended use, for this requirement: Dispensing Syringe Dispensing syringes (with Luer lock connection) must be approved by the Food and Drug Administration (FDA) and comply with Occupational Safety and Health Administration (OSHA) Needlestick Safety and Prevention Act requirements as a - safety-engineered product. Syringe Characteristics Low Dead Volume (LDV) Complies with Title 21 Code of Federal Regulations (CFR) and follows International Standards Organization (ISO) 7886-1:2017 Consists of a calibrated hollow barrel and a movable plunger Indicates the capacity of the syringe through a scale on the barrel with .01 demarcation Maintains the fluid in the barrel between the syringe nozzle and the plunger with a stopper Aspirates and injects fluids in and out of the syringe with the plunger Is disposable, single use Uses a Luer lock to accept Luer hub applicator (e.g. needle) Is contained in sterile, individually wrapped packaging Holds 1 milliliter of fluid Syringe Characteristics Non-Low Dead Volume (Non-LDV) Complies with Title 21 Code of Federal Regulations (CFR) and follows International Standards Organization (ISO) 7886-1:2017 Consists of a calibrated hollow barrel and a movable plunger Indicates the capacity of the syringe through a scale on the barrel with .01 demarcation Maintains the fluid in the barrel between the syringe nozzle and the plunger with a stopper Aspirates and injects fluids in and out of the syringe with the plunger Is disposable, single use Uses a Luer lock to accept Luer hub applicator (e.g. needle) Is contained in sterile, individually wrapped packaging Holds 1 milliliter of fluid Hypodermic Needles Hypodermic needles must be approved by the Food and Drug Administration (FDA) and comply with Occupational Safety and Health Administration (OSHA) Needlestick Safety and Prevention Act requirements as a - safety-engineered product. Safety-engineered supplies include needles that prevent sharp injuries with their ability to be either enclosed in an attached shield or fully retracted within the syringe. They must also be sterile and disposable. Needle Characteristics Complies with 21 CFR 880.5570, OSHA Needlestick Safety and Prevention Act and follows International Standards Organization (ISO) Contains a Luer hub that is attached to Luer lock syringe Is contained in sterile, individually wrapped packaging Is safety engineered Needle gauge is 25G Needle length is 1 inch Combination Units for LDV and Non-LDV The Contractor shall provide sterile needle (with Luer hub connection) and syringe (with Luer lock connection) units approved by the Food and Drug Administration (FDA) and comply with Occupational Safety and Health Administration (OSHA) Needlestick Safety and Prevention Act requirements as a - safety-engineered product. Safety-engineered supplies include needles preventing sharp injuries by either; being completely enclosed after use by an attached shield or be fully retracted within the syringe. Sterile needle/syringe combination unit with the specifications listed above for the syringe and needle. Complies with 21 CFR 880.5570, OSHA Needlestick Safety and Prevention Act and follows International Standards Organization (ISO) Is contained in sterile, individually wrapped packaging Is safety engineered Needle gauge is 25G Needle length is 1 inch Is disposable, single use Consists of a calibrated hollow barrel and a movable plunger Indicates the capacity of the syringe through a scale on the barrel with .01 demarcation Maintains the fluid in the barrel between the syringe nozzle and the plunger with a stopper Aspirates and injects fluids in and out of the syringe with the plunger NOTE: The Government is planning solicitation for immediate response needs, as well as making assessments for longer term needs, likely up to five (5) years, for these medical safety needles. The Government is interested in assessing overall availability as well as encouraging domestic production and availability. As stated above, no solicitation(s) is/are yet available.