Medical Device Link.

April 1999 MD&DI
Selected Contents

COVER STORY:
Next-Generation Diagnostics: Big, Small, and Fast
by Steve Halasey

From total laboratory automation to personal healthcare monitors, the application of advanced technologies is rapidly creating a new generation of IVDs.

MEDICAL PLASTICS:
Opportunities for PVC Replacement in Medical Solution Containers
by Len Czuba

New materials developed for use in flexible bags can offer significant advantages.

ETO STERILIZATION:
EtO Sterilization: Microbiological Aspects of Process Validation
by Susan Edel Satter and Paul J. Sordellini

Deliberate decision making during the structuring of microbial challenges, product loads, and biological indicators can provide a validation process for EtO sterilization that ensures accuracy, the absence of microbes, and a smooth testing procedure.

SPECIAL SECTION:
Using Thin-Wall Heat-Shrink Tubing in Medical Device Manufacturing
by Mark Saab

A reduction in device size is among the advantages of shrink tubing, which has a wide range of applications.

FIRST PERSON:
Global Harmonization and Mutual Recognition Efforts: Keeping Up The Pace
by Fred S. Halverson

An executive specializing in international regulatory affairs assesses the current movement toward globalization and identifies key areas requiring the most urgent action.

WASHINGTON WRAP-UP:
Careful Study Marks Henney's First Months
by James G. Dickinson

The new FDA commissioner plays it close to the vest while expressing a willingness to work with the industry.

R&D HORIZONS:
Injecting New Life into Plastics Processing Equipment
by Jennifer M. Sakurai

Although room-sized systems still exist, equipment is becoming smaller, transportable, and capable of handling jobs of various demands.

HELP DESK:
Pyrogenicity Testing; EtO Sterilization

Richard F. Wallin, DVM, PhD, is president of NAMSA (Northwood, OH) and lead author of a series on ISO 10993 that was published in MD&DI throughout 1998.

Paul J. Sordellini of Quality Solutions Inc. (Annandale, NJ) is a consultant serving the medical device industry.

SNAPSHOT:
A Winning Team: PDP process helps VP gain knowledge of FDA issues
by Kassandra S. Kania

EDITOR'S PAGE:
Changing the Menu, A New Source for Business Information
by John Katz

To succeed in today's ultracompetitive device market, executives need access to specialized business information that can be hard to find. an upcoming publication is designed to meet this need.