Tag Archives: traceability

Not actually tested – The 510(k) Ancestry of a Metal-on-Metal Hip Implant

In recent years, metal on metal hip replacements have been causing problems, depositing worn-off metal around the body and having to be taken out. A NEJM paper shows the ancestral tree of hip replacements. The authors describe how new devices’ safety … Continue reading

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Radical traceability problem

Could the SI system be breaking down?  The kilogram (yes, THE kilogram) is no longer that. The International Prototype Kilogram (IPK) has been surreptitiously changing its weight. Is it insured?  Is it accredited?  How do they accredit the traceability of the standard … Continue reading

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