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June 15, 2011

Case Studies

Throughout our history, we have worked on a variety of interesting projects for our clients and our own internal research. Projects have included cleaning systems for ships, hydrogels for biomedical applications, psychorheology of food products, and synthetic tissue models. We have posted case studies on our web site for prospective clients to see the range of projects on which we have worked. Click here to go to our case studies.

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June 10, 2011

Workshop on Reprocessing Re-usable Medical Devices

On June 9-8, 2011, the FDA hosted a workshop to discuss issues involved in the re-processing of re-usable medical devices, such as endoscopes and orthoscopic shavers. The purpose of the workshop was to establish what guidance documents should be established to ensure that reusable devices are being properly cleaned and disinfected/sterilized to ensure patient safety. Representatives from hospitals, regulatory, reprocessors, OEMs, and testing labs discussed the state of instructions for use, cleaning testing and validation, and the risks associated with poor cleaning.

Cambridge Polymer Group presented the most recent work performed at ASTM on standards targeted towards improving medical device cleanliness, and participated in a panel discussion of what future standards will be required.

The archived webcast of the conference can be found on the FDA website. A summary of the discussion can be found here.

CPG presentation on ASTM activities in Medical Device Reprocessing

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May 12, 2011

Potential Detection System for Implant Wear

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Researchers at the University of Nebraska Medical center recently published their results of a study in which they developed an optical imaging agent to detect inflammation due to wear debris generated from implants. In this study, a N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer-based optical imaging contrast agent (P-IRDye) was developed and used for the detection of wear particle-induced inflammation employing a murine calvaria osteolysis model. The particle-induced osteolysis of calvaria was evaluated by H&E, tartrate-resistant acid phosphatase (TRAP) staining and μ-CT after necropsy. One-day post particle implantation, P-IRDye was administrated to the mice via tail vein injection. Live imaging of the animals 6 days after implantation revealed the preferential distribution and sustained retention of the macromolecular contrast agent at the site of particle implantation. Immunohistochemical staining and FACS analyses of the calvaria-associated soft tissue revealed extensive uptake of the HPMA copolymer by F4/80, Ly-6G (Gr1) and CD11c positive cells, which accounts for the retention of the macromolecular probes at the inflammatory sites.

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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.

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May 11, 2011

Metal-on-Metal Hip Implants

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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.

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May 5, 2011

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

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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.

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April 29, 2011

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

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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.

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