GE donates intensive care monitoring system to college; FDA orders the seizure of unsafe hospital beds; Medrad Inc sales revenues grow; and more.

GE Gives Lift to Biomed Tech Program
GE Healthcare (Waukesha, Wis) has donated a complete intensive care/cardiac care monitoring system to the Biomedical Electronics Technician Program at Milwaukee Area Technical College (MATC). Valued at $350,000, the technology enables students to gain experience servicing and repairing some of the world’s most advanced medical electronics.

“We had pretty good equipment prior to the donation, but this is like going from a Piper Cub to a Stealth Fighter,” says John Stilp, dean of technology and applied sciences, MATC. “MATC has always prided itself on using the same equipment students will encounter in the field. That would not be possible, in many cases, except for the generosity of industry partners such as GE Healthcare. This gift will help us train technicians who will be able to hit the ground running with a thorough knowledge of the latest GE medical technology.”

The gift was facilitated by the Biomedical Association of Southeastern Wisconsin.

“This is a story in which everybody wins: the college, our students, the industry, and, in the end, patients,” says Darnell E. Cole, MATC president. “It’s just one example of how MATC teams with the industry for the betterment of the community.”

Medrad Sales Revenues Grow 17%
In 2004, Medrad Inc (Indianola, Pa) achieved sales revenues of $344 million, an increase of 17% compared to the previous year. This year-end performance exceeds the company’s annual revenue growth goal of 15%, which it has sustained throughout the past 10 years.

Over the course of the year, the company also experienced a corporate reorganization to better serve customers, and its employee base grew almost 10%, with the addition of 121 full-time, permanent employees. The reorganization created three strategic business units within Medrad: computed tomography, cardiovascular, and magnetic resonance.

FDA Orders Seizures of Unsafe Hospital Bed Systems In response to ongoing concerns about manufacturing quality and labeling, the FDA and the Department of Justice have initiated seizures of all finished Vail 500, 1000, and 2000 enclosed bed systems made by Vail Products Inc (Toledo, Ohio). The US Marshal’s office also has seized welded in-process components and all labeling and promotional materials for the Vail 500, 1000, and 2000 products. According to the FDA, use of these systems poses a public health risk because patients can become entrapped and suffocate, resulting in severe neurological damage or death. The FDA is aware of approximately 30 entrapments resulting from use of the Vail enclosed bed systems, of which at least 7 resulted in death. According to the FDA, the enclosed bed systems are misbranded because they are dangerous to health when used in the manner, and frequency, recommended in the unit’s labeling. The beds are further misbranded because they lack adequate directions for use and adequate warnings, thereby placing patients at an increased risk of entrapment and asphyxiation. As of March 22, Vail Products had failed to furnish material or information to the FDA as required by Medical Device Reporting regulations and the Reports of Corrections and Removals regulation. Additionally, FDA inspections of the company revealed that the firm continually failed to follow the requirements of the Quality System regulation when manufacturing enclosed bed systems. Vail Products had previously received two FDA warning letters outlining unacceptable practices. The firm was given an opportunity to correct the violations, but it failed to take appropriate actions.

Dunlee Appoints Northeast Sales Manager
Dunlee (Aurora, Ill), a division of Philips Medical Systems, and a supplier of medical imaging components, has appointed Joseph P. Marzullo to the newly created position of sales manager for the company’s Northeast region. Marzullo has more than 20 years of experience in medical imaging in various sales management roles.

Prior to joining Dunlee, Marzullo was responsible for the CT business in the New England region for Siemens Medical Solutions USA Inc. He also has worked for Philips Medical Systems as East Zone Rad/RF Specialist.

Calibration and Metrology Training Program Available Fluke Corp (Everett, Wash) has released its 2005 calibration and metrology course schedule for North America. The training program offers instructor-led classroom courses, Web-based courses, and self-paced CD-ROM courses. The company also offers temperature calibration classroom seminars through Hart Scientific, a Fluke company. Course topics include Principles of Metrology, Introduction to Measurement and Calibration, Cal Lab Management, Advanced MET/CAL® Procedure Writing, and MET/CAL Procedure Development. Instructor-led classroom courses will be taught in several cities throughout the United States and Canada. Hart Scientific courses will be taught in American Forks, Utah. For course descriptions, schedules, and costs, visit www.fluke.com/2005caltraining  or call (800) 443-5853.