Integrated data acquisition system for medical device testing and physiology research in compliance with good laboratory practices.
In seeking approval from the US Food and Drug Administration (FDA) for clinical trial evaluation of an experimental medical device, a sponsor is required to submit experimental findings and support documentation to demonstrate device safety and efficacy that are in compliance with Good Laboratory Practices (GLP). The objective of this project was to develop an integrated data acquisition (DAQ) system and documentation strategy for monitoring and recording physiological data when testing medical devices in accordance with GLP guidelines mandated by the FDA. Data aquisition systems were developed as stand-alone instrumentation racks containing transducer amplifiers and signal processors, analog-to-digital converters for data storage, visual display and graphical user-interfaces, power conditioners, and test measurement devices. Engineering standard operating procedures (SOP) were developed to provide a written step-by-step process for calibrating, validating, and certifying each individual instrumentation unit and the integrated DAQ system. Engineering staff received GLP and SOP training and then completed the calibration, validation, and certification process for the individual instrumentation components and integrated DAQ system. Eight integrated DAQ systems have been successfully developed that were inspected by regulatory affairs consultants and determined to meet GLP guidelines. Two of these DAQ systems were used to support 40 of the pre-clinical animal studies evaluating the AbiCor artificial heart (ABIOMED, Danvers, MA). Based in part on these pre-clinical animal data, the AbioCor clinical trials began in July 2001. The process of developing integrated DAQ systems, SOP, and the validation and certification methods used to ensure GLP compliance are presented in this article.
Koenig
Steven C
SC
Jewish Hospital Cardiothoracic Surgical Research Institute, University of Louisville, 500 South Floyd St, Room 118, Department of Surgery, University of Louisville, Louisville, KY 40202, USA. sckoen01@athena.louisville.edu
Woolard
Cary
C
Drew
Guy
G
Unger
Lauren
L
Gillars
Kevin
K
Ewert
Dan
D
Gray
Laman
L
Pantalos
George
G
D004864:Equipment and Supplies; D019983:Guideline Adherence; D007753:Laboratories / Q000592:standards*; D010827:Physiology; D012106:Research; D018511:Systems Integration; D014481:United States; D014486:United States Food and Drug Administration