Quality System Regulation
This article was originally published in RAJ Devices
Executive Summary
Baxter signs consent decree with US FDA
Baxter signs consent decree with US FDA
Baxter Healthcare and two of its executive officers have signed a consent decree with the US Food and Drug Administration (FDA) regarding two brands of infusion pumps used to control the intravenous delivery of medications, marketed as the Colleague Volumetric Infusion Pump and the Syndeo Patient Controlled Analgesic Syringe Pump. The company will stop manufacturing and distributing the pumps in the United States until it corrects all manufacturing deficiencies, and it complies with current good manufacturing practice and the quality system regulation for medical devices.
The consent decree, which was signed by Robert L Parkinson, Jr, Baxter's chairman and chief executive officer, and Peter J Arduini, the corporate vice president, requires that the company retain an independent consultant to inspect infusion pump facilities and certify that corrections have been made. The FDA will allow the company to provide service maintenance and replace components of pumps purchased before 12 October 20051.
Lincare settles with HHS
Separately, Lincare, a supplier of durable medical equipment accused of paying kickbacks to doctors, has settled with the Health and Human Services' Office of the Inspector General (OIG). The company, one of the US's largest suppliers of durable medical equipment, will pay a total of $10 million dollars, the largest financial settlement ever for the OIG. Lincare has also entered into a five year corporate integrity agreement with the agency, without admitting to any wrongdoing2.
References
1. FDA press release, www.fda.gov/bbs/topics/NEWS/2006/NEW01402.html
2. OIG press release, http://oig.hhs.gov/publications/docs/press/2006/Lincare051506.pdf