What’s In That Device?

by Julie Kirst 11/22/2011 2:55:00 PM

At a trade show about a year ago, a vendor told me that with so much work shipped overseas these days, it is hard to vouch for the quality of all the components in a medical device. Along these lines, I received a release from UL Environment Inc, a business unit of Underwriters Laboratories. The company released a white paper about environmental product declarations (EPDs). According to the release, environmental product transparency has become important for manufacturers and building operators. It defined an EPD as, “an internationally accepted, third-party reviewed report detailing a product’s environmental impacts throughout its life cycle, and often includes additional performance, health, and company information.” It suggested that an EPD could be considered an environmental “nutrition label.”

Would this make sense for medical devices, to know the content of components and how they affect health and the environment? Does the makeup of devices and test equipment concern you? The release said EPDs promote transparency and facilitate a comparison of impacts among products in the same category. Would knowing the impact of a component sway a purchasing decision?

How would this benefit the profession—or not?

 

Comments

Posted by Medical insurance companies, 11/29/2011 3:17:01 AM

Good blog ! Thanks for this informative post

Posted by vsarmiento, 12/4/2011 4:12:55 PM

In general, it is the FDA that has the responsibilities to scrutinize and assess any component used in every medical devices before they are released and marketed together with an FDA# attesting that the device passed their rigid testing standards.

Except for a few major component(s) that Biomed should do a double due diligence as part of their incoming inspections and for patient safety. This where the actual device performance and operations are simulated. A good example of which is to test and verify if the stated electrical isolations of the device for patient lead wires will hold as per specifications or will be degraded and fail upon being subjected to a series of multiple defibrillator discharges using maximum energy settings.

The same practice standards holds true to every analyzers and test equipment used in the performance of their responsibilities. All of these test equipment must undergo and pass an annual testing and calibrations by an independent entity with calibration certifications that are traceable to NIST.
      

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