The RFP Database
New business relationships start here

RFI-Disinfectant_Port_Protectors


Pennsylvania, United States
Government : Military
RFI
Go to the link
This document has expired, therefore the above link may no longer work.

REQUEST FOR INFORMATION (RFI)
Disinfectant Port Protectors


1.0    Introduction
1.1    General. The purpose of this request is to obtain information from industry to support the government's intent to establish a Qualified Supplier List (QSL) for the standardization of Disinfectant Port Protectors. This RFI is an invitation to submit to the Defense Health Agency (DHA) Medical Logistics (MEDLOG) Division Medical Materiel Enterprise Standardization Office (MMESO) the following: technical information and all related supporting documentation for Disinfectant Port Protectors. This request is a market research effort undertaken by the government which will be used for information gathering purposes. The information received may be used for Acquisition Planning purposes and may help define future requirements for the subject item(s). This is not a request for quote or proposal.
1.2    RFI Submission Package. Vendors must provide responses to this RFI via the RFI Vendor Response Worksheet. Complete answers and all supporting documentation must be provided with the vendor's response. Responses for each salient characteristic should be in the form of yes, no, or alternate proposal. Although explanatory comments may be provided for all responses, they are required for "no" responses.

2.0    Scope
Examples of items for this product line could include but are not limited to: Disinfectant Port Protectors designed to be attached to I.V. access points to provide disinfection and protection.

3.0    Characteristics/Specification
Feedback Requested: Respondents are requested to provide information concerning their Disinfectant Port Protectors regarding the following questions:


3.1    Are your Disinfectant Port Protectors manufactured in a TAA compliant country? Please supply the country of origin.
3.2    Are your Disinfectant Port Protectors FDA approved? What type of documentation would you provide to support that?
3.3    Are your Disinfectant Port Protectors designed to attach around the female end of needle-free I.V. connectors? If so, how are they configured to facilitate the attachment (e.g. grooves to improve grip)?
3.4    Are your Disinfectant Port Protectors designed for use on injection ports?
3.5    Do you offer Disinfectant Port Protectors specifically designed to attach to the male end of needle-free IV connectors? If so, please provide part number(s).
3.6    Do your Disinfectant Port Protectors provide a "visual identification" feature (e.g. color coded cap) to support medical facility port protection usage compliance? Please list any other type of "visual identification" feature available on your Disinfectant Port Protectors.
3.7    What disinfecting agent(s) is utilized by your Disinfectant Port Protectors?
3.8    How is the disinfecting agent(s) delivered to the I.V. port (e.g. medical-grade sponge, a non-particulate generating pad, foam disc, or other means of delivery)? Is this method of delivery proprietary?
3.9    List the microbes killed by the disinfecting agent(s) used in your Disinfectant Port Protectors.
3.10    How long does it take for the disinfecting agent to achieve a 99.99% reduction or the minimum 4-log reduction of microbes your product(s) are designed to inactivate? Please provide documentation to support this claim.
3.11    How long do your Disinfectant Port Protectors maintain 99.99% reduction or the minimum 4-log reduction of microbes your product(s) are designed to inactivate?
3.11.1    Is this 99.99% microbe reduction due to the disinfecting agent actively killing microbes during this time? How long does the disinfecting agent remain active?
3.11.2    Is this 99.99% microbe reduction maintained solely due to the port protector cap acting as a physical barrier to any new microbes accessing the I.V. port?
3.11.3    During the time your Disinfectant Port Protector is actively in place, does the disinfecting agent continuously bathe the valve surface?
3.11.4    When used appropriately, is it reasonable to expect some disinfecting agent left at the end of recommended application period? Please explain your answer.
3.12    Do your Disinfectant Port Protectors come sterile or non-sterile, or both?
3.13    What are the Units of Measure/Units of Issue available for procurement?
3.13.1    Do your Disinfectant Port Protectors come in strips? How many Disinfectant Port Protectors per strip?
3.13.2    Please list all forms of packaging available for your Disinfectant Port Protectors.
3.14    What is the shelf life of your Disinfectant Port Protectors?
3.14.1    Where is this information available?
3.15    What product information is described on the product packaging?
3.16    List design feature(s) that differentiate your Disinfectant Port Protector from an IV End Cap.
3.17    List design feature(s) of your Disinfectant Port Protector that assist with its placement on IV port while wearing gloves.
3.18    List design feature(s) that prevent your Disinfectant Port Protector from opening needleless connectors.
3.19    List waste disposal procedure of your Disinfectant Port Protectors.

4.0    Feedback Requested
Please complete the attached RFI Vendor Response Worksheet with indicated information about your Disinfectant Port Protectors.


4.1    Have your Disinfectant Port Protectors been subject to any recall(s)? If so, what corrective actions and/or product modifications have been made in response to the recall(s)?
4.2    Do you have any emerging Disinfectant Port Protectors technology you would like to share?
4.3    Please provide any additional information including relative topics outside of the specific information requested which you consider relevant.
Any information provided in response to this RFI will be considered and treated as unrestricted information which can be used by the Government in any future planning or acquisitions. All information, comments, and suggestions may be incorporated into future acquisition documents, without identifying the source or obtaining prior approval from the source.

5.0    Liability
The Government shall not be responsible or liable for any costs incurred by any party in the preparation and submission of any response to this RFI.

6.0    RFI Responses
6.1    The vendors' responses shall include all detailed information requested in the RFI Vendor Response Worksheet and shall also include: (1) Company name and address; (2) Company POC (Name and Phone Number, Fax Number, and E-mail address); and (3) Commercial and Government Entity (CAGE) Code.
6.2    Supporting documentations are required to be provided by the offeror as attachments to this RFI. The attached spreadsheet must be completely filled out and submitted timely along with all supporting material such as but not limited to Training Literature, FDA approved information, etc.

Points of Contact (POCs):
Mr. Mark Probus, MMESO North Team Leader, mark.c.probus2.ctr@mail.mil, 571-231-5451; and Mr. Gregory Morrison, MMESO North Clinical Analyst, gregory.p.morrison.ctr@mail.mil, 571-231-5905.


Mr. Mark Probus, MMESO North Team Lead, Phone 571-231-5451, Email mark.c.probus2.ctr@mail.mil - Mr. Gregory Morrison, MMESO North Clinical Analyst, Phone 571-231-5905, Email gregory.p.morrison.ctr@mail.mil

    1. Home
    2. Articles
    3. Login or Register

    4. Search

    5. Add/Announce your RFP