Medical Devices and Medication

Medical Devices and Medication

"Reliability and Safety of Medical Devices: Introduction"
Triodyne Safety Brief v. 5 #3 (October 1989)

James R. Wingfield

Medical devices are regulated by the Food and Drug Administration. Companies involved in this specialized area must conduct their business in an atmosphere of formality not present in other areas of commercial product development. Past FDA emphasis has been on manufacturing compliance. However, recent indications are that the design phase of product development will receive greater attention.

"Status of Standards of Practice in Pharmacy"
Triodyne Safety Brief v. 5 #4 (January 1990)

James T. O'Donnell

Forces affecting standards, including laws and regulations, accrediting agencies, legal opinions, and professional organizations are discussed, and compliance is evaluated. Promulgation of standards is examined from positive and negative viewpoints.

"Electromagnetic Interference and Electrostatic Discharge Testing on Medical Products: An Introduction"
Triodyne Safety Brief v. 8 #2 (February 1993)

Richard M. Bilof

Electromagnetic Interference (EMI) and Electrostatic Discharge (ESD) testing are essential elements to the design of almost any new electronic or electromagnetic product. The effects of EMI and ESD are described. Several examples are presented of hospital equipment subject to EMI and ESD, and of mechanisms developed to eliminate them.

"Reliability and Safety of Medical Devices, Part 2"
Triodyne Safety Brief v. 8 #2 (February 1993)

James R. Wingfield

The development of safe, reliable medical devices requires the implementation of a rigorous and disciplined approach throughout the design phase. The monetary pay-back of program planning and design assurance activities is expected to exceed the incremental cost to development. A rigorous design approach also fulfills the responsibility of manufacturers to exercise diligence in the design of critical medical devices.

"Understanding Adverse Drug Reactions"
Triodyne Safety Brief v. 8 #2 (February 1993)

James T. O'Donnell

As many as 1.5 million persons are hospitalized annually because of adverse drug reactions. This paper outlines the types of reactions, the importance of recognizing them, the elements involved in such reactions, and caregivers' countermeasures.