36C26319Q0845-A0002001.pdf

Q&A

Question Answer Question #1: As stated on latest modification in “2. A. Defibrillators (All features below are the minimum required for CLIN 0003 Defibrillator with basic life support features unless stated for CLIN 0006 Defibrillator with advanced life support features)” This implies that all 65 requirements apply to the basic life support defibrillator except xxx and xxxi shown below.

xxx.The defibrillator shall offer different modes for BLS rescuers vs. ACLS rescuers. The default mode at power-on shall be for the BLS rescuer with the capability to manually change to the ACLS rescuer mode.-CLIN 0006 Defibrillator with advanced life support features.

xxxi.Switching between modes shall be easy and the mode that is engaged shall be clearly indicated. The defibrillator shall protect against inadvertent activation of a mode.-CLIN 0006 Defibrillator with advanced life support features.

Since these two requirements are not clinical features, such as EtCO2, what then is the difference between a basic life support and advanced life support defibrillator?

The difference between a BLS and an ALS defibrillator relates to the amount of guidance given based on the end user’s level of training.

For a BLS defibrillator we would expect the guidance provided to be very simple and straightforward with coaching and feedback given throughout the care. The ALS user has significantly more training and experience with codes and therefore, guidance and operation provides for more discretion and flexibility of operation.

Question #2: Do they want internal paddles for every defibrillator as the requirements suggests?

(iii, iv, ix, and x)

We want to ensure that internal paddles are available and meet the criteria of the SOW.

However, we do not need internal paddles at this time. Should these defibs be placed in an open heart OR, we will buy internal paddles at that time. Although this is not a need today, we would hate to have to replace all defibs if the need arises in order to maintain standardization.

Question #3: Current AHA advanced life support protocol is 1 shock then 2 minutes of CPR (See attached CIR.000000000000261.pdf, AHA Guidelines 2015, Part 7, Page S452). Using the AHA protocol would not allow the defibrillator to meet “xix. The defibrillator shall be able to deliver a set of three shocks within 90 seconds.”

Does the VA intend to use AHA guidelines or a local stacked shock protocol of three shocks?

The VA intends to use AHA guidelines

Question #4: Is the VA requesting 3 lead or 12 lead ECG in the requirement below? xxxiii. The defibrillator shall have the capability to monitor ECG, non-invasive blood pressure, pulse oximetry (compatible with Nellcor or Maximo probes), and end tidal CO2”

3 lead