 October 2006
Medical Device Technology Selected Contents
Materials The Relevance of Haemolysis Testing D.F. Williams
Testing for haemolysis is usually considered an essential part of the strategy for the assessment of biological safety of biomaterials, but the value and relevance of this test is questionable.
Nanotechnology Delivers Microcoatings R.G.J.C. Heijkants
Surface coating techniques are rapidly advancing. Polymer-brush coatings and nanocomposite technology are described and demonstrate the increasing options in material properties that are available to new product developers.
R.R. Mather
The use of biomedical textiles is expanding as a result of innovations in medical procedures and textile technology, and the miniaturisation of electronic devices. Some of their extending capabilities are described here.
Design Adding the Clinician To Medical Device Innovation J. Egan
Statements of Clinical Need is a new mechanism for health-care professionals to communicate clinical needs to potential technology solution providers. The system offers the industry the opportunity of greater market success with the new products it develops.
Manufacturing C. Sparacino
This guide to producing optimum bump tubing reports recent technology developments. Once deemed to be a “black art,” the tube manufacturing process has evolved into being a validatable process.
Plasma Processing and Hydrophobic Surfaces P. Stevenson
A fluorocarbon plasma process is described that can give surfaces enhanced hydrophobicity. It can be used on a range of material surfaces and geometric shapes. The process and the advantages it offers drug delivery and other devices are examined.
New Approaches to Package Integrity Testing R. Hall
An important goal for packagers is the ability to demonstrate the integrity and sterility of each pack and determine its oxygen content with the minimum of wasteful destruction. Two nondestructive inspection systems are described.
Noncontact Form Measurement of Medical Implants C.C. Murphy
Form measurement is an increasingly critical characteristic for medical implants. The techniques available for doing this are outlined together with some of the latest developments in this area, including noncontact form measurement.
T. Kinsella
Surface analysis techniques are important tools to use in the verification of surface cleanliness and medical device functionality. How these techniques can be employed and some example applications are described.
Regulations & Standards Managing Clinical Data For Worldwide Acceptance M.E. Donawa
Manufacturers conducting clinical studies to support medical device safety and performance claims need to ensure that clinical study data are appropriately managed. Not doing so can risk the success of the project related to the clinical study. This article discusses a guideline that can assist in this effort.
P.J. Nolan
Webinars on the revisions to ISO 11607, Packaging for Terminally Sterilised Medical Devices, have prompted many questions from manufacturers and package engineers concerned with validating their packaging under the new requirements. A selection of those questions are reviewed here.
This Month Developments Across the Industry • Chitosan combats biofilm
• Nano research database • Harder demands for auditors • Risk central • RFID and smart packaging • New chair for NHSIL • DIMDI informs • Plunkett award entries • Nonwovens production up
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