Medical Device & Diagnostic Industry
August 1996 MD&DI
Selected Contents
Bar Coding
Industry Embraces UPN
Just a short 18 months ago, the Department of Defense (DOD) announced that by July 1 its suppliers would have to provide universal product numbers (UPNs) on all healthcare products.
Washington Wrap-Up
FDA Expands into Device Marketing
James G. Dickinson
Although the Federal Trade Commission was assigned by Congress to be the lead agency in regulating the marketing of medical devices, FDA's expansion into this area has proceeded swiftly, and without apparent FTC protest, since agency commissioner David A. Kessler came aboard five years ago.
Product Liability
Lohr Ruling Creates Doubt about Future of Preemption
According to device manufacturers, industry innovation may be the primary victim of the Supreme Court's ruling in the Medtronic, Inc. v. Lohr case issued on June 26.
Regulatory Affairs
Leadership and Reform: FDA's Ongoing Duty
Robert L. Sheridan
Virtually everyone, it seems, is in favor of FDA reform. Such sentiments are not new—even within the agency—but the demands being voiced now are qualitatively different from those of the past.
Electronics
The Role of Product Testing in CE Marking
Greg Freiherr
Except for the simplest of medical devices, such as tongue depressors and wheelchairs, there is no direct route to a CE mark—no easy way to win approval to sell that product in the European Union.
Salary Survey
Industry Professionals Gain Ground Against Changing Market
Steven Halasey
Device industry professionals who have been wondering what will be the effects of such industry megatrends as healthcare reform, buyer and supplier consolidation, downsizing, and globalized competition need do so no more. To find the answer, it turns out, they probably do not need to look much farther than their pocketbooks.
Roundtable
Meeting the Challenges of Medical Packaging
For packaging engineers, meeting the demands of an increasingly globalized device industry brings a wide variety of challenges. To examine these and other issues, MD&DI invited a panel of experts in the field of medical packaging to participate in a roundtable discussion.
Clinical Trials
FDA'S Enforcement Options in Clinical Trials
Halyna Breslawec and Nancy Teague
FDA regulates all aspects of clinical trials for medical devices through enforcement of a variety of regulations. The investigational device exemption (IDE) regulation imposes responsibilities on all those involved in clinical investigations, including sponsors, monitors, clinical investigators, and institutional review boards (IRBs).
Electronics
Using Grounding to Control EMI
William D. Kimmel and Daryl D. Gerke
Electromagnetic compatibility is an important consideration in the design and operation of today's sophisticated medical electronic equipment, particularly as portable systems proliferate. Electronic devices can both emit and be damaged by electromagnetic interference (EMI) and must be protected from its harmful effects.
Sterilization
Investigating and Preventing BI Sterility Failures
Paul J. Sordellini and Marjorie Lang
Because microbiological destruction is logarithmic and therefore can only be expressed in terms of the probability of a survivor, the term sterile device does not actually refer to a device that is totally free of viable organisms, but rather to one whose probability of containing a viable organism is so small that it is considered acceptable.
Editor's Page
On Product Liability: Stupidity and Waste Abounding
John Bethune
The sky did not fall on June 26, 1996. As noted on page 12 of this issue, the Supreme Court's ruling on that date in the Medtronic, Inc. v. Lohr case was indeed unfavorable to medical device manufacturers.
