W81XWH-19-R-0036-0001_Attachment-10_Questions-&-Answers.pdf

W81XWH‐19‐R‐0036 Questions Last updated: 6/4/2019

Number Reference Question Answer Resulting Amendments

1 Solicitation

The solicitation describes the ECLS Reduced Dialysate system as a device that provides renal support to critically injured patients. In general, ECLS is administered to support lung and/or heart, but no mention is made to the lung support in [the] solicitation. Thus, a question arises [as to] whether the ECLS Reduced Dialysate merely indicates a CRRT system running with or less than 0.5L of substitution infusion or a system that supports multiple organs including renal and respiratory support.

Please clarify.

Extracorporeal Life Support (ECLS) is defined in this solicitation as any system that pulls blood out of the body and performs an action on the blood replacing the function of a critically injured organ. In this sense, it can be applicable to the lungs, heart, kidneys, or liver. This solicitation is specifically for reducing dialysate required to run continuous renal replacement therapy (CRRT) for kidney support when treating patients with acute kidney injury (AKI). Potential future plans are to incorporate such a technology into a device that provides both kidney and lung support.

SF33, Section C, SOO, Paragraph 1.0 Background and Overview, revised as follows:

"The US Army Medical Materiel Development Activity’s (USAMMDA’s) mission is to develop and deliver quality medical capabilities to protect, treat, and sustain the health of our Service Members and the Joint Program Committee- 6’s (JPC-6’s) mission seeks to drive medical innovation through the development of knowledge and materiel solutions for the acute and early management of combat-related trauma.

Extracorporeal life support (ECLS) is administered to critically ill patients suffering from life-threatening renal injuries. For the purposes of this requirement extracorporeal life support is defined as any system that pulls blood out of the body and performs an action on the blood replacing the function of a critically injured organ. In this sense, it can be applicable to the lungs, heart, kidneys, or liver. This requirement is specifically for reducing dialysate required to run continuous renal replacement therapy (CRRT) for kidney support when treating patients with acute kidney injury (AKI).

Although ECLS is a lifesaving intervention, current technology is limited by the immense logistical footprint required to support these devices. Current standard of care ECLS devices that provide support to the kidneys require ~70L of replacement fluid per patient per day. This is an immense logistical burden in the far forward environment where supply lines are limited or non-existent making the support of these devices infeasible. Therefore, the aim of this effort is to reduce the amount of replacement fluid required to support these patients in a logistically constrained environment."

Solicitation (SF33), Page 8, Section C, Statement of Objectives (SOO), Paragraph 3.0, Table 1.

Product Performance Requirements

According to [the] SOO, the weight threshold is 20lb. It is interpreted that this weight requirement is limited to the device, i.e., not including the weight of any consumables? Please clarify.

The weight requirement includes the device itself and new dialysate reduction technology even if the new technology is a consumable. The weight requirement does not include other standard consumables used for CRRT (e.g. dialysate, dialyzer, tubing, catheters, etc.). In other words, the solution shall not swap out 25lbs. of dialysate for 25lbs. of a different consumable that is meant to reduce the dialysate.

SF33, Section C, SOO, Paragraph 3.0 Product Characteristics, Table 1. Product Performance Requirements, revised to include an asterisk for the "Weight" parameter and the following language:

"*The weight requirement includes the device itself and new dialysate reduction technology even if the new technology is a consumable. The weight requirement does not include other standard consumables used for CRRT (e.g.

dialysate, dialyzer, tubing, catheters, etc.). In other words, the solution shall not swap out 25lbs. of dialysate for 25lbs. of a different consumable that is meant to reduce the dialysate."