Description
The Department of Veterans Affairs, VA Boston Healthcare System, has awarded a sole source contract to Avery Biomedical Devices, Inc. for a Mark IV Transmitter (Breathing Pacemaker). A fixed price contract was awarded. It is the Governments belief that only Avery Biomedical Devices, Inc. possessed the required FDA approved device to successfully meet the VAs requirement. Please refer to the Sole Source Justification. This is not a solicitation or a request for information; it is notice of a sole source contract award. JUSTIFICATION AND APPROVAL CONTRACT VA241-P-1200 MARK IV TRANSMITTER SOLE SOURCE AWARD JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION PURSUANT TO FAR 6.302-2 1. Identification of the agency and the contracting activity. VA Boston Healthcare System Surgical Service & Spinal Cord Injury Service West Roxbury, MA 2. Nature and/or description of the action being approved. Sole Source award of a firm fixed priced contract to Avery Biomedical Devices, Inc. for an Avery Biomedical Mark IV Breathing Pacemaker 3. Description of the supplies or services required to meet the agency's needs (including the estimated value). Cost: $64,842.00 Avery Biomedical Devices produces a breathing pacemaker which is a phrenic nerve stimulator. It consists of surgically implanted electrodes and receivers and an external transmitter, which sends radio signals to the implants via flexible antennas that are worn over the receivers. It provides a higher quality of life for patients with quadriplegia requiring mechanical ventilation. 4. Identification of the statutory authority permitting other than full and open competition. FAR 6.302-2, 41 USC 253 (c) (2), unusual & compelling urgency. FAR 6.302-1 Only one responsible source *5. Demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited. Breathing pacemakers have been approved by the Food and Drug Administration since 1986 and have been in use by some patients for over thirty years. Avery Biomedical Devices Mark IV Breathing Pacemaker is the only breathing pacemaker with FDA premarket approval for use in persons who require chronic ventilatory support. The transmitter generates a series of impulses which are sent by the antenna through the skin as a radio wave. The receiver converts the radio waves to an electrical impulse which travels down the electrode to the phrenic nerve. The nerve then sends these impulses to the diaphragm causing it to contract, and draw air in. When the impulses stop, the diaphragm relaxes, and exhalation occurs. This series of impulses are repeated cyclically, resulting in a normal breathing pattern. Breathing pacemakers provide a more normal breath since it uses negative pressure to draw air into the lungs rather than forcing air in under positive pressure. This negative pressure ventilation allows for normal speech, and improved ease of eating and drinking. Mobility is also greatly improved. The need for suctioning is reduced dramatically, so pacing patients are less prone to respiratory infections. The reduction of suctioning supplies, ventilator circuits, etc. result in a substantial cost savings as well. 6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a FedBizOps notice was or will be published. The only other like device does not have FDA approval for spinal cord injury (SCI) patients. 7. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable. The pricing offered is catalog list pricing offered to all purchasers of the Mark IV product. 8. Description of the market survey conducted (i.e., names, of firms and the date(s) the firms were contacted) and the results or a statement of the reasons a market survey was not conducted. The intended use of the breathing pacemaker is for spinal cord injured patient care. Due to varying conditions of spinal cord patients, a finite window of opportunity exists to insert the breathing pacemaker. Urgent and compelling conditions exist (defined below) that require that the pacemaker be procured expeditiously. 9. Any other facts supporting the use of other than full and open competition, such as an explanation why technical data packages, specifications, engineering descriptions, Statements of work, or purchase descriptions suitable for full and open competition have not been developed or are not available. Breathing pacemakers require a functioning phrenic nerve and an intact diaphragm to work appropriately. Typical patients have: High spinal cord (C1 - C3) or brainstem injuries There are two surgical approaches which can be used to implant a breathing pacemaker: The first technique involves placing the electrodes on the phrenic nerve in the chest. Refinements in this technique over the years have resulted in the need for only small incision made in between a pair of ribs on each side. Surgeons experienced with minimally invasive surgery have used thoracoscopic techniques and robotically-assisted techniques to make this approach even simpler. The second technique involves placing the electrodes in the neck. This technique has the advantage of avoiding a thoracotomy, but cannot be performed on all patients. For example, the anatomy of the neck is not sufficiently developed in the youngest patients to make this technique appropriate. Although some cases can be performed on an outpatient basis, the average hospital stay is 1-2 days. The decision as to which approach is appropriate for a given patient should be made by the surgeon performing the procedure. Breathing pacemakers require a functioning phrenic nerve and an intact diaphragm to work appropriately. Typical patients have: High spinal cord (C1 - C3) or brainstem injuries Congential or acquired central hypoventilation syndromes Diaphragm paralysis of known or unknown etiology For patients with lower (C3-C4) injuries, there is a chance that the phrenic nerves may have been damaged at the time of the injury. These patients may require some additional preoperative consideration. Common screening procedures include: phrenic nerve conduction studies, diaphragm EMGs, pulmonary function tests, and polysomnography. 10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition. N/A 11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required. The Contracting Activity will continue to promote full and open competition, where possible.