Device evaluation: A Critique

Raake JL , Taeed R , Manning P , Pearl J , Schwartz SM , Nelson DP . Evaluation of a fiberoptic blood gas monitor in neonates with congenital heart disease. Respir Care 2000;45(9):1105–1112.

Chatburn RL . Fundamentals of metrology: evaluation of instrument error and method agreement. Respir Care 1990;35(6):520–545.

Chatburn RL . Evaluation of instrument error and method agreement. AANA J 1996;64(3):261–268. Reprinted in: Respir Care 1996;41(12):1092–1099.

Chatburn RL . Principles of measurement. In: Tobin MJ . Principles and practice of intensive care monitoring. New York: McGraw-Hill; 1998: 45–61.

Chatburn RL , Volsko TA , Brougher P. Evaluating medical devices. In: Branson RL , Hess DR , Chatburn RL , editors. Respiratory care equipment, 2nd ed. Philadelphia: Lippincott Williams & Wilkins; 1999: 709–732.

Bland JM , Altman DG . Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307–310.

Wahr JA , Lau W , Tremper KK , Hallock L , Smith K. Accuracy and precision of a new, portable, handheld blood gas analyzer, the IRMA. J Clin Monit 1996;12(4):317–324.

Federal Register 1992;57(40):7158.