Medical Device Link.

February 2000
MD&DI
Selected Contents

DESIGNER'S NOTEBOOK:
Implementing Design Controls
by Michael A. Kuhn

A step-by-step methodology for analyzing design practices and initiating process improvements creates a stable and supportive design process.

SPECIAL SECTION:
Corona Discharge Treatment for Medical Surface Preparation
by Bruce Stobbe

By increasing a material's surface tension, corona treating makes inks, films, adhesives, and other coatings more adherent.

COVER STORY:
ITE Power Supplies and Medical Equipment
by Frank O'Brien

There are potential pitfalls in using ITE power supplies in medical devices. Knowing applicable standards will help you avoid mistakes.

RADIATION STERILIZATION:
Polymer Materials Selection for Radiation-Sterilized Products
by Karl J. Hemmerich

Choosing the right polymer for a radiation-sterilized device requires an understanding of radiation effects, manufacturing processes, and the product's intended use.

EtO RESIDUALS:
A Guide to ISO 10993-7 and AAMI TIR-19 for EtO-Sterilized Devices
by W. Howard Cyr and Barry F.J. Page

A comparison of ANSI/AAMI/ISO 10993-7:1995 with FDA's 1978 proposed rule for the maximum allowable levels of EtO, ECH, and EG in medical devices.

CLEANROOMS:
Injection Molding under Cleanroom Conditions
by Gernod Dittel and Erwin Bürkle

Product specifications, regulatory guidelines, and ambient conditions all influence the fundamental design considerations for injection molding applications within cleanroom facilities.

WASHINGTON WRAP-UP:
Two recent actions show FDA's readiness to accommodate industry concerns.
by James G. Dickinson

Also:

• Baxter warned on infusion pumps
• Humanitarian use exemption sought
• Don't inspect without cause, HIMA advises FDA
• FDA allows Abbott consent-decree amendment

SNAP SHOT:
An Inside View: CEO Promotes Successful Business Collaborations
by Kassandra Kania

Whether he's negotiating licenses, collaborating with small firms, or overseeing strategic alliances, Donald Hetzel, president and CEO of Instrumentation Metrics Inc. (Tempe, AZ), has a knack for fostering successful relationships between companies.

EDITOR'S PAGE:
Matters of the Heart: A Mixed Bag of Valentine's Day Cardiograms
by John Katz

A sampling of recent heart-care news reveals a mélange of the predictable, the unexpected, and the downright bizarre.