News

Health product issues: Protecting and advancing public health

June 5, 2008

How does an agency make decisions when technology, medical practice, companies, and healthcare organizations are continually changing? How can approval decisions be made quickly? We read about recalls for approved products. How safe is safe enough?

Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, will speak to these issues at Regis College on Thursday, Nov. 29, from 6:30 to 8:30 p.m.

The FDA regulates the medical device industry. Implantable pacemakers provide critical life support. Clinical chemistry instruments in hospital laboratories provide information for diagnoses. Home-use tests let us know if we have diseases or are pregnant. Imaging systems help the physician see anatomy and physiologic processes within the body. Robotic systems let surgeons deliver therapy with much less invasive trauma. Information technology allows doctors to examine and treat patients in remote locations.

Health Product Issue Lectures are open to the public and present topics of interest to the general healthcare community. The first lecture in this new series explores medical device issues from the perspective of the U.S. Food and Drug Administration (FDA).

The FDA protects and advances public health by regulating medical products, including devices. Patients and healthcare professionals depend on an array of medical devices: sophisticated implants, therapy devices, clinical chemistry instruments, invasive and non-invasive diagnostic/monitoring equipment, as well as home use equipment.

The FDA makes decisions affecting many technologies, health conditions, and types of users and patients. If decisions are slow or conservative, useful products do not get to patients. If decisions are not careful, patients are injured or their diseases worsened by the products intended to help them.

Schulz directs the FDA Center responsible for medical devices. He will talk about the role of the FDA, the challenges it faces, and initiatives underway to stay abreast of the advances in technology and healthcare. Schultz is a surgeon with many years of experience in the public health service. Schultz came to the FDA in 1994 and has held numerous management positions within the Center for Devices and Radiological Health.

The Health Product Issues Lectures bring healthcare issues to the general public and healthcare community. Continuing education credits are available. The lectures are organized by Regis College’s graduate program in health product regulation. The event is scheduled for Thursday, Nov. 29, from 6:30 to 8:30 p.m., in the College Hall Foyer of Regis College, 235 Wellesley St., Weston.

News