GrahmA, BransonRD. Approval and surveillance of medical devices. In: BransonRD, HessDR, ChatburnRL, editors. Respiratory care equipment. Philadelphia: JB Lippincott; 1995.
2.
Public Law 101-629. 104STAT.4511. Safe medical devices act of 1990. 28 Nov 1990. H.R. 3095. Health care. 21USC 301 note.
3.
Food and Drug Administration, Department of Health & Human Services. FDA IRB information sheets. 1989;73.
ServantGM, NicksJJ, DonnSM, BrandyKP, LathropC, DeckertRE. Feasibility of applying flow synchronized ventilation to very low birth weight infants. Respir Care1992;37(3):249–253.
6.
BransonRD, CampbellRS, DavisK, JohnsonDJ. Comparison of pressure and flow triggering systems during continuous positive airway pressure. Chest1994;106:540–544.
7.
SassoonCS, del RosairoN, FeiR, RheemanCH, GruerSE, MahutteCK. Influence of pressure- and flow-triggered synchronous intermittent mandatory ventilation on inspiratory muscle work. Crit Care Med1994;22(12):1933–1941.
8.
NishimuraM, HessD, KacmarekRM. The response of flow triggered demand valve systems in infant ventilators. Am J Respir Crit Care Med1995 (in press).
9.
El-KhatibM, ChatburnRL, PottsDL, BlumerJL, SmithPG. Mechanical ventilators optimized for pediatric use decrease work of breathing and oxygen consumption during pressure-support ventilation. Crit Care Med1994;22:1942–1948.
10.
GiulianiR, MasciaL, RecchiaF, CaraccioloA, FioreT, RanieriVM. Patient-ventilator interaction during synchronized intermittent mandatory ventilation. Effects of flow triggering. Am J Respir Crit Care Med1995;151(1):1–9.
VialeJP, AnnatG, BertrandO, GodardJ, MotinJ.Additional inspiratory work in intubated patients breathing with continuous positive airway pressure delivery systems. Anesthesiology1985;63(5):536–539.
13.
KatzJA, KraemerRW, GjerdeGE. Inspiratory work and airway pressure with continuous positive airway pressure delivery systems. Chest1985;88(4):519–526.
14.
SlutskyAS. Mechanical ventilation: American College of Chest Physicians consensus conference. Chest1993;104(6):1833–1859.
15.
LessardMR, GuerotE, LorinoF, LemaireF, BrochardL.Effects of pressure control with different I/E ratios versus volume-controlled ventilation on respiratory mechanics, gas exchange, and hemodynamics in patients with adult respiratory distress. Anesthesiology1994;80(5):983–991.
16.
AbrahamE, YoshiharaG.Cardiorespiratory effects of pressure controlled inverse ratio ventilation in severe respiratory failure. Chest1989;96(6):1356–1359.
17.
MangH, KacmarekRM, RitzR, WilsonRS, KimballWP. Cardiorespiratory effects of volume- and pressure-controlled ventilation at various I/E ratios in an acute lung injury model. Am J Respir Crit Care Med1995;151(3, Part 1):731–736.
18.
KacmarekRM, HessD.Basic principles of ventilator machinery. In: TobinMJ, editor. Principles and practice of mechanical ventilation. New York: Mc-Graw Hill; 1994.
19.
AmatoMBP, BarbasCS, BonassaJ, SaldivaPH, ZinWA, de CarvalhoCR. Volume-assured pressure support (VAPSV): a new approach for reducing muscle workload during acute respiratory failure. Chest1992;102(4):1225–1234.
PfenningerJ, MinderC.Pressure-volume curves, static compliances and gas exchange in hyaline membrane disease during conventional ventilation and high frequency ventilation. Intensive Care Med1988;14(4):364–372.
24.
HIFO Study Group. Randomized study of high-frequency oscillatory ventilation in infants with severe respiratory distress syndrome. J Pediatr1993;122(4):609–619.
25.
GallagherTJ, BoysenPG, DavidsonDD, MillerJR, LevenSB. High frequency percussive ventilation compared with conventional mechanical ventilation (abstract). Crit Care Med1985;13:312.
26.
BarretteRR, HurstJM, BransonRD, DavisK.A comparison of conventional mechanical hyperventilation with two forms of high-frequency ventilation for the control of intracranial pressure in closed head injury. Respir Care1987;32(9):733–740.
27.
HurstJM, BransonRD, DavisKJr. High-frequency percussive ventilation in the management of elevated intracranial pressure. J Trauma1988;28(9):1363–1367.
28.
HurstJM, BransonRD, DavisK, BarretteRR, AdamsKS. Comparison of conventional mechanical ventilation and high frequency ventilation: a prospective, randomized trial in patients with respiratory failure. Ann Surg1990;211(4):486–491.
29.
GluckE, HeardS, PatelC, MohrJ, CalkinsJ, FinkMP, LandowL.Use of ultrahigh frequency ventilation in patients with ARDS. A preliminary report. Chest1993;103(5):1413–1420.
30.
PhelpsJR. Bad-faith reviews: The RS medical case. Medical device & diagnostic industry1994(Sept):30–32.
31.
International Rehabilitative Services Inc, Debra RS Medical v. Kessler (Civil No. SA-93-CA-0242: WED. Tex, March 10, 1994).
32.
U.S. Department of Health and Human Services. Office of device evaluation annual report, 1993.