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Sentec’s Digital Monitoring System Multi-Site Rings and Applicators

Waiver type - Procurement: Nonavailability

Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/16/2023

Procurement Summary

The National Institute of Neurological Disorders and Stroke (NINDS) mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people. In support of its mission, the NINDS Office of the Clinical Director requires Sentec consumables and accessories for its digital monitoring system in support of its MH JR Sleep and Neurodevelopment Service, which currently has six (6) diagnostic sleep systems and four (4) Sentec Digital Monitoring System (SDMS). These additional components needed for the Sentec V-Sign units aid in the monitoring of a patient’s oxygenation and ventilation. It solves NINDS patient noncompliance issue as it is placed on a patient’s skin versus in the airway and can be used concurrently with PAP machines and ventilators. Protocols that NINDS is currently running are sensitive to particular diagnoses and require data that are only reliably available through Sentec V-Sign patented technology, which uses continuous and noninvasive real-time monitoring of transcutaneous CO2 Partial Pressure (PCO2), Functional Oxygen Saturation (SpO2), Pulse Rate (PR), Pulsation Index (PI) and Heating Power (HP) in adult and pediatric patients as well as for PCO2 and HP monitoring in neonatal patients in virtually any clinical setting. This requirement consists of Sentec components that are precisely manufactured for Sentec’s digital monitoring system, which NINDS is using with its ongoing intramural research. These Sentec components required for use of the system on patients include the Multi- Site Attachment ring (mature, intact skin) – single use sensor application ring, recommended for adult, pediatric and neonatal patients with mature/intact skin; Multi-Site Attachment ring (sensitive, fragile skin) – single use sensor application ring, recommended for adult, pediatric and neonatal patients with sensitive and fragile skin; Staysite Adhesive – single use adhesive for multi-site attachment rings (above) to attach to skin with additional adhesive film; Single dose contact gel – contact gel for Sentec system’s transcutaneous sensors; calibration gas for docking station; and Membrane changer – membrane change tool; reloadable. These are Sentec items, which are specifically required for use with Sentec's Digital Monitoring System.

Waiver Rationale Summary

Based on the findings detailed above, Sentec’s Multi-Site attachment rings (mature, intact skin); multi-site attachment rings (sensitive, fragile skin); Staysite adhesive; Single dose contact gel; service gas’ membrane changer are not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Therefore, it is hereby determined, consistent with FAR 25.103(b), that these items are nonavailable.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

Yes

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

423450 - Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers

Date Submitted

08/16/2023

Procurement Instrument Identifier (PIID)

N/A

Solicitation ID

N/A

Procurement Stage

Pre-solicitation

Expected Maximum Duration of the Proposed Waiver

0 - 6 months

Waiver Coverage

Individual Waiver

Funding Agency

NATIONAL INSTITUTES OF HEALTH