Medical Device & Diagnostic Industry
May 1998 MD&DI
Selected Contents
COVER STORY:
How to Implement a UPN System
by Karen Longe
Adding universal product numbers to medical devices helps everyone in the supply chain—manufacturers, distributors, and customers—better manage and track products.
FLUID CONTROL:
Shrinking Fluid Control Systems in the Medical Industry
by Jim Klapper
Instruments haven't necessarily changed much in what tasks they accomplish, but market and healthcare influences have altered their size, consolidated their functions, and forced them to do more with less.
ISO 10993-10:
A Practical Guide to ISO 10993-10: Sensitization
by Richard F. Wallin and Paul J. Upman
Testing for sensitivity to chemical extractables from medical devices is a key element of the biocompatibility standards.
YEAR 2000 COMPLIANCE:
Testing Medical Devices for Year 2000 Compliance
by Sunil Kumar Gupta
Manufacturers of devices containing embedded software that stores and processes dates need to ensure that those systems will continue to operate safely in the next millennium.
CLINICAL TRIALS:
Reducing the Duration of Clinical Investigations
by Deborah A. Gorny and Susanne C. Panzera
One company's team shows how to undertake a large-scale effort to reduce clinical investigation time and save money.
ENVIRONMENTAL MANAGEMENT:
ISO 14001: Should Your Company Seek Registration?
by Suzan L. Jackson and Ron Belmont
While ISO 14001 compliance isn't mandatory, it could make medical device companies more competitive and help the environment as well.
ENVIRONMENTAL CONTAMINATION:
Recovering Viable Environmental Particulates
by Robert R. Reich
A case study examining the levels of airborne and surface contaminants through the use of three different incubation processes illustrates the need to ensure the effectiveness of existing systems, especially if the safety of devices could be compromised by increased levels of particulates.
DESIGN CONTROL:
Design Control Measures That Can Boost Return on Investment
by Brian McCay
Carefully implemented design control procedures can improve a company's profitability as well as the quality of its devices.
DEVICE SAFETY STANDARDS:
Harmonizing Postmarket Reporting and Surveillance
by Deborah Blum
FDA is working hand in hand with the Global Harmonization Task Force to develop internationally acceptable device safety standards.
HUMAN FACTORS:
Making Medical Device Interfaces More User-Friendly
by Michael E. Wiklund
Ten design tips for enhancing user interfaces and improving medical device usability.
WASHINGTON WRAP-UP:
A Question of Authority
by James G. Dickinson
CDRH's demand for a PMA instead of a 510(k) for a grandfathered indication raises questions about the center's statutory authority.
R&D HORIZONS:
Artificial Organs Produce Genuine Benefits
by Gary Woo
Current research encompasses almost every conceivable organ system and function.
BOTTOM LINE:
Electronic Commerce: New Technologies Are Transforming Business
by Greg Freiherr
Filled with promise and threat, forms of electronic commerce are growing increasingly prevalent in the device industry.
HELP DESK:
Bioburdens and Validation
John Broad, director of microbiology at NAMSA (Irvine, CA), answers questions about validating the sterilization process. Ed Arscott, manager of microbiology (NAMSA, Northwood, OH); Susanne Anderson, technical specialist in marketing (NAMSA, Irvine, CA); and Dave Parente, manager of operations (NAMSA, Kennesaw, GA), contributed to these replies.
EMI FIELD NOTES:
Blocking ESD at the Enclosure
by William D. Kimmel and Daryl D. Gerke
Electrostatic discharge can be prevented by designing enclosures to withstand necessary voltage and by closing potentially harmful gaps.
FIRST PERSON:
Changing Diagnostic Approaches to Disease: The promise of Genetic Testing
Uwe Bicker
The new president of the European Diagnostic Manufacturers Association discusses the challenges ahead as gene technology advances into the next millennium.
VERBATIM:
Ethics Programs Equal Good Business: The Right Thing To Do
Medtronic's Bruce Johnson talks about how his company created and encourages a legal, moral, and ethical standard of conduct for employees.
SNAPSHOT
A career shift reflects manufacturing expertise: Robert Corson
by Romina Shane
INSIDE MD&M:
The Bug Stops Here: Stricter Environmental Controls Needed
by Jennifer M. Sakurai
EDITOR'S PAGE:
In a World of Faster, Higher Profit Margins, Do Ethics Programs Pay?
by Stacey L. Bell
A mature ethics and compliance program is your insurance in case one of your employees sparks trouble.
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