Medical Device & Diagnostic Industry

November 1996 MD&DI
Selected Contents

Interview

Exploring the Long-Term Effects of Implants
Lijian Yu

As part of a five-year $750,000 grant from NIH, LijianYu will investigate what happens to the primary metals—aluminum, titanium, vanadium, cobalt, chromium, and nickel—used in artificial joints following implantation. He and his colleagues will also try to determine how these metals spread to other sites in the body. In this interview with MD&DI, Yu describes the study, the technology behind it, and how its results could affect the development of implants.

Washington Wrap-Up

• FDA Reform Legislation Does a Slow Fade
• Canada, EU Experiment with Harmonization

Communications

Intranets: Using Web Technologies in a Regulated Environment
Morteza Minaee

Managing the documentation necessary to comply with FDA's good manufacturing practices (GMP) regulation and the ISO 9000 series of quality systems standards can place a heavy burden on device manufacturers. It's no wonder that companies are constantly on the lookout for a system that will simplify this task.

Manufacturing

Laser-Manufactured Features in Medical Catheters and Angioplasty Devices
Ronald D. Schaeffer

This article briefly discusses the advantages of using lasers for manufacturing as well as the most common industrial lasers available. Three examples of applying the technology—profiling metal stents, drilling orifices in medical catheters, and drilling orifices in angioplasty balloons—are presented and discussed.

Manufacturing

Computer-Based Systems Streamline Device Manufacturing
Michael J. Major

Increased competition, regulatory and cost pressures, and the ever-increasing speed of innovation are the business drivers for today's device manufacturers, says Phil Couling, product manager for Consilium, Inc. Adding to these global challenges are some of the biggest changes in the healthcare products industry since the beginning of FDA regulation.

Sterilization

Evaluating Sterilizer Performance as Part of Process Equivalency Determination
Paul J. Sordellini

Manufacturers that use EtO to sterilize their products, either in-house or at a contract sterilizer, often validate the cycle in one particular vessel and later find it no longer satisfies their requirements. A validated vessel becomes outgrown when the number of devices manufactured per week exceeds its volumetric sterilization capacity.

Standards

Getting Compliant for the Global Market
Gunter Frey

Although it is still more than a year and a half away, the date of June 15, 1998, is approaching very rapidly for device manufacturers seeking to begin or continue selling in Europe. That's the day the EU's Medical Devices Directive will become fully effective, and when device manufacturers will have to either demonstrate compliance or cease selling in the EU.