Medical Device Link.

August 2000
MD&DI
Selected Contents

EDITOR'S PAGE:
LET THERE BE LIGHT: Illuminating Designs Drive Innovation
by Jon Katz

A recently developed system for detecting incipient cancers exemplifies the ongoing emergence of light-based technologies in device production, diagnostics, and therapeutics.

INSIDE MDDI:
The Science of Particle Counting
by Robert Drummond

MEDICAL PLASTICS AND BIOMATERIALS
Assessing the Performance and Suitability of Parylene Coating
by Lonny Wolgemuth

The material characteristics of parylene make it suitable for demanding medical coating applications that require a combination of biocompatibility, pinhole-free coverage, and high chemical resistance.

WASHINGTON WRAP-UP:
(Washington Wrap-Up) Justify Device Reuse Curbs on Your Labels, FDA Says
by James G. Dickinson

A committee hearing over single-use device reuse establishes new agency priorities but provides little relief for OEMs.

Also:

• FDA Expands List of Class II Devices for Third-Party Review
• Airway Devices Receive Down-Classification
• Cal-Test to Destroy Inventory, Cease Distribution
• CDRH Offers Leveraging Page on Web Site

How Small Is Small? The Effects of Pinholes on Medical Packaging
by Earl T. Hackett, Michael H. Scholla, Stasys Rudys, and John Bletsos

Highly permeable materials can provide effective barrier properties, even when undetectable holes are present.

A Strategy for Quality: Testing in Contract Electronics Manufacturing
by Gregg Nighswonger

The growing complexity of outsourced medical electronics assemblies poses challenges for increasing yields and reducing defects.