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FBO DAILY - FEDBIZOPPS ISSUE OF DECEMBER 26, 2013 FBO #4415
DOCUMENT

65 -- Negative Pressure Wound Therapy Device - Attachment

Notice Date

12/24/2013
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

U.S. Department of Veterans Affairs;Strategic Acquisition Center;10300 Spotsylvania Ave;Fredericksburg VA 22408
 

ZIP Code

22408
 

Solicitation Number

VA11914I0034
 

Response Due

12/16/2013
 

Archive Date

2/14/2014
 

Point of Contact

Berneta Ellis
 

Small Business Set-Aside

N/A
 

Description

The purpose of this Amendment A00001 is to add the below Minimum Technical Requirements (MTRs) for both the Standard and Lightweight devices inadvertently excluded from the original Sources Sought Notice. This amendment also extends the due date for responses from December 31, 2013 to January 6, 2014. MINIMUM TECHNICAL REQUIREMENTS INTENDED USE: NPWT is intended for use to promote wound healing by secondary or tertiary intention by preparing the wound bed for closure through promoting growth of granulation tissue, promoting tissue perfusion, decreasing tissue edema, in the most time efficient healing, while managing exudate and protecting the wound from infection. NPWT is indicated for, but not limited to, chronic, acute, traumatic, surgical, and dehisced wounds, partial-thickness burns, diabetic, pressure, or venous ulcers, flaps and grafts. a. A Lightweight Device MTR1Device Weight : ? 2.5 lbs. MTR2Minimum battery charge ?12 hours. Pneumatic power is acceptable. MTR3*Alarm volume must be sufficiently loud and distinctive to be heard over noise commonly occurring in the areas where the device is used. The alarm volume shall be adjustable, but it should not be possible to turn volume down so low that it is unlikely to be heard 20 feet from the patient's room. [*ECRI Health Devices Volume 31 (pgs. 414 to 415) addressing one of the six JCAHO 2003 National Patient Safety Goals] MTR4Negative pressure range of at least 25-125mmHg MTR5Capable of being disinfected and reprocessed or disposable. MTR6Technical support by telephone available 24 hours per day, 7 days per week MTR7Clinical education; face to face hands on clinical education for clinicians and trainers. Supporting literature available via the company's website. MTR8Education and training for Biomedical Services must be provided upon initial installation and upon request for life of the product. Educational materials must be available by the internet and change notices must be provided. MTR9Education and training for Sterile Processing Services for device cleaning, disinfecting, and reprocessing must be provided upon initial installation and upon request for the life of the product. Educational materials must be available by the internet and change notices must be provided. MTR10Minimum of 1 year manufacturer's warranty MTR11No cost loaner device while warranty repairs are being effected MTR12No cost replacement for items/devices that are not repairable during the warranty period MTR13Equipped for use with an integrated canister MTR 14Human Factors: We will require evidence of human factors engineering analysis of the device design and usability. (A copy of the original 510 (k) document will suffice to meet this requirement. If unavailable, must be addressed as separate submission on internal documentation). b. Standard Device MTR1 Minimum battery charge: 4 hours MTR2Must be equipped to include an integrated canister that secures to main device. MTR3*Alarm volume must be sufficiently loud and distinctive to be heard over noise commonly occurring in the areas where the device is used. The alarm volume shall be adjustable, but it should not be possible to turn volume down so low that it is unlikely to be heard 20 feet from the patient's room. [*ECRI Health Devices Volume 31 (pgs. 414 to 415) addressing one of the six JCAHO 2003 National Patient Safety Goals] MTR4Capable of being disinfected and reprocessed or disposable. MTR5Technical support by telephone available 24 hours per day, 7 days per week MTR6Clinical education and training must be provided at initial installation of product and upon request for the life of the product. MTR7Education and training for Biomedical Services must be provided at initial installation of product and upon request for the life of the product. Educational materials must be available by the internet and change notices must be provided. MTR8Education and training for Sterile Processing Services for device cleaning, disinfecting, and reprocessing must be provided at initial installation of product and upon request for the life of the product. Educational materials must be available by the internet and change notices must be provided. MTR9Negative pressure range of 25mmHg to 200mmHg in both continuous and intermittent modes MTR10Minimum of 1 year manufacturer's warranty MTR11No cost replacement for items/devices that are not repairable during warranty period MTR12No cost loaner device while warranty repairs are being effected MTR13Human Factors: We will require evidence of human factors engineering analysis of the device design and usability. Human Factors: We will require evidence of human factors engineering analysis of the device design and usability. (A copy of the original 510 (k) document will suffice to meet this requirement. If unavailable, must be addressed as separate submission on internal documentation).
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/b7fd6c8e61452c9124b397940c0ea9b9)
 

Document(s)

Attachment
 

File Name: VA119-14-I-0034 A00001 VA119-14-I-0034 A00001.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1140552&FileName=VA119-14-I-0034-A00001003.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1140552&FileName=VA119-14-I-0034-A00001003.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03257952-W 20131226/131224233823-b7fd6c8e61452c9124b397940c0ea9b9 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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