May 12, 2011

Design for Cleaning

The FDA has issued a mandate to manufacturers of re-usable medical devices to design with re-cleaning of the these devices in mind. This mandate is in response to an on-going effort to reduce the risk of infection, contamination, or disease transmission due to improperly cleaned devices. Device design should include smooth interior surface, avoidance of sharp corners and blind spots, as well as easy disassembly for cleaning. Material choice should be selected with reprocessing in mind.

More information can be found on the FDA's web site.

Posted by admin
May 11, 2011

Metal-on-Metal Hip Implants

Hip implant.jpg

The on-going discussion of patient response to metal-on-metal hip implants has recently increased. For the past few years, papers presented at ORS and AAOS have discussed concerns about tissue response to metal ions and debris liberated from wear in metal-on-metal hip implants. These articles allege that the metal ions can result in pseudo-tumors in some patients. The FDA has recently requested that all orthopedic manufacturers who produce a metal-on-metal (MOM) implant conduct clinical studies on patients who have received a MOM implant. A NY Times article discusses the nature of this request. A recent NPR story also talks about issues with MOM, and Depuy's recent recall of their ASR system.

Posted by CatherineCerasuolo
May 5, 2011

The FDA Will Be Hosting A Public Workshop on The Reprocessing of Reusable Medical Devices


The FDA will be hosting a public workshop on the Reprocessing of Reusable Medical Devices on June 8th and 9th, 2011 in Silver Springs, MD. The purpose of the workshop is to discuss factors affecting reprocessing quality, device design as it relates to reprocessing reusable medical devices, reprocessing methodologies, validation methodologies, healthcare facility best practices, and FDA’s plans to address the identified issues. CPG researcher Stephen Spiegelberg is an invited speaker at the workshop. Further information and registration details can be found here.

Posted by admin
April 29, 2011

The Next ASTM Meeting for Medical Device Development (Committee F04)

The next ASTM meeting for medical device development (Committee F04) will be meeting from May 15-17th, 2011, in Anaheim, California. This meeting will focus on ASTM standards development for the characterization of UHMWPE, PEEK, and other biomedical plastics, as well as testing protocols for medical devices and cleanliness of medical devices. Contact Cambridge Polymer Group for more details, or visit the ASTM web site.

Posted by admin
April 25, 2011

Medical Grade Polymers 2011

The  Medical Grade Polymers 2011 conference will take place September 13 - 14, 2011 at the Hilton City Avenue in Philadelphia, Pennsylvania, United States. The program will have papers from top medical device manufacturers and polymer suppliers, including details of high performance implantable materials, coatings, cardiovascular devices, antimicrobials and hygiene, and many other topics.

Cambridge Polymer Group researcher Stephen Spiegelberg will be presenting a paper on the use of antioxidants in medical grade thermoplastics.

More information on the conference call be found at the Medical Plastics Website.

Posted by admin
April 25, 2011

Cement Extrusion Tester

Measurement of cement curing kinetics is critical for both R&D and quality control, but has traditionally required use of either complex and costly rheometers or highly variable qualitative tests for handling characteristics. The new Cement Extrusion Tester (CET), designed by engineers at Cambridge Polymer Group, provides accurate curing kinetics data and quantitative determination of handling characteristics from a single, rapid test.
Designed for analysis of PMMA bone cement, the CET can provide accurate viscosity data for any reacting system with viscosity in the range of 50-5000 Pa*s, including:

    • Quality control
    • Validation
    • Rapid R&D screening
    • Biomedical materials testing
    • General cement cure times
cement thing.jpg

Go to our web site at for more information.

Posted by admin