| Consulting
Services for the |
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Medical Device Industry |
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STOP Pathogens, pyrogens, bacteria, fungus, biofilm, microbes, scum, spoilage, filth, glop, slime, slop ..... Before it STOPS YOUR PRODUCT! |
| Welcome: |
| You have entered the NO Pathogen Zone ... You are in NO Pathogen Country ... We play Hardball with Pathogens ... Pathogens are never out of our Crossfire ... OK! You get the point. With over 25 years in antisepsis and septic control / eradication, product design, sterilization there has yet to be a bug problem that has gotten past us. VRE? Hah! Acinetobacter? C'mon! Pseudomonas? Too slow! GRE? GMRSA? Hey, if you can spell it, we can kill it or prevent it. We can not only solve the problems you have, but, best of all, also prevent them from happening in the first place. Sterilization, pyrogens, discoloration, water fouling, whatever. Send your needs our way and the pathogens will take the highway! |
| Our Mission: |
| The medical device industry is fully engaged in reduction, if not elimination, of sepsis. Sepsis - whether caused from a faulty device design or resulting from the use of a device - often leads to serious injury and death. The spread of sepsis results in prolonged hospital visits, repeat procedures, emergency surgeries that shoud not have been needed, staggering costs to patients, hospitals, care centers and manufacturers. Add litigation to the mix and it is crystal clear why device design has become more and more oriented toward preventing infections from occurring and spreading. Infections do not come only from unwashed hands. Poor device design that causes irritations and tissue damage, improperly sterilized products resulting from faulty bioburden analysis or designs with poor sterilant access paths, antiseptic surface treatments that either work against only a few pathogens or cannot consistently perform in the anatomy environment for which it was intended ... these are only a few avenues for the initiation and propagation of infections. It is our goal to troubleshoot your products, improve or redesign them if needed, apply antiseptic materials and treatments to your problems. In short, we intend to help the manufacturer and practitioner in any way we can to reduce nosocomial infections and infections due to home care products to as low as possible. Note: We did not say "as low as practical." As low as possible must be the intention for every failure can potentially lead to a serious injury or a death. The ultimate user is the patient. Our approach has always been and will always be to never allow a device to enter the market that we would not have full confidence in allowing it to be used on ourselves. |
| We will: |
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Engineer
a truly safe and functional medical device design |
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Wade
through FDA approvals and 510(K), PMA, IDE requirements, clinical trials, biocompatibility
protocols |
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Handle
your antimicrobial and antiseptic devices - coatings, materials, treatments -
from design through the FDA |
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Choose
the proper materials for performance, tissue compatibility and resistance to sterilization |
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Choose
the proper device category - Class I, II or III - and the IDE and clinical protocols |
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Interpret,
perform and evaluate the large array of biocompatibility tests required by both
FDA and ISO 10993 |
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Properly
test and evaluate both invasive and non-invasive medical devices |
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Eliminate
sources of bacteria and pyrogens (endotoxins) |
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Determine
high purity water system needs and the FDA requirements |
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Design high performance and cost effective
high purity water systems |
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Apply specialty engineering, such as hydrophilic
and slippery coatings, antibacterial coatings, adhesive systems with sepsis reduction
always the goal |
For specifics see our "Regulatory" and "Engineering" pages. For how we do business see the "Consulting" page.
We got here thanks to 25 years of successful in-depth and in-the-trenches experience.
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Copyright © 2003 Consulting Services for the Medical Device Industry