Q-Net places emphasis on the free exchange of information and to require of manufacturers the publication of data for the public's review in support of (or at odds with) the safety and efficacy of their medical devices. Marketing claims without published data in their support may be viewed as dubious.
As a patient-advocate site, Q-Net is also committed to the integrity of professional guidelines and, in particular, to the publication of sound and comprehensive professional infection-control and instrument-reprocessing guidelines and recommendations that are evidence-based, committed to patient safety, and independent of undue manufacturer influence.
It is important that medical devices be designed and labeled in conformance with, and consideration of, the recommendations of professional guidelines - not the other way around, which appears to have occurred, with professional guidelines and "recommended practices" being written to conform with the labeling and marketing claims of medical devices.
The integrity of guidelines must be maintained, and professional organizations that author and publish these guidelines must provide recommendations designed to protect the patient without necessarily considering their effect on the labeling of a medical device, which may, at times, be false, misleading, and lacking supporting published data. |