September 23rd, 2014
Once, some years ago, your correspondent bought a bag of socks from a well known discount retailer. It seemed a good idea, the socks were awfully cheap. Upon first use however, the socks, all purportedly medium socks, turned out to be a collection of more-or-less randomly sized socks. As your correspondent is not awash in money, the socks were dutifully worn until worn-out.
Socks can be substandard without too much worry, but other products are a lot more critical. If you suffer a heart attack for instance, and you need a defibrillator, its fairly important that this defibrillator perform perfectly. Its the same with almost any medical equipment, from heart monitors and CT scanning equipment to surgical implants, the screws and wires used to bind bits of broken bone together. The uses of all such products are intolerant of error, the standard for performance of medical equipment is very, very high.
Thinking of high standards, it turns out that the medical equipment in Canadian hospitals is tested and certified by the Canadian Standards Association (CSA).
Its true, the CSA is testing medical equipment in Cleveland, Ohio, at the same facility and by the same staff responsible for all of CSA’s famously faked testing and false certifications of consumer products.
They brag: “CSA Group tests and certifies your electro-medical equipment to applicable [standards] to help you obtain the required approvals for your intended markets.” Given what we now know, it would be more accurate to say that CSA “will sell you a certification.” Regardless, the CSA is presently “your expert source” for testing and certification of “a wide variety” of medical equipment, including;
CT scanning equipment
Dental ovens and modelling equipment
In-vitro and robotic sampling and analyzing systems
Mass, photo, x-ray and atomic spectrometers
Microtomes and cell preparation equipment
Mixing and stirring equipment
Refrigerators for storing blood and plasma
Sterilizers and disinfection washing machines
Lets review. In 2010 the CSA was caught running an eight year-long counterfeiting operation in the sales of fake safety certifications of modular buildings. The CSA was caught falsifying test results, skipping entirely whole ranges of safety tests for consumer products, they have been selling blank product certifications to manufacturers, they’ve even had CSA secretarial staff authoring their engineering reports. This is the context in which the CSA is testing and certifying Canada’s operating room equipment. At the same facility. By the same staff.
For the CSA however, “the bottom line is revenue generation.” Under current government regulations, “CSA Group test reports can be used to secure approvals in many international markets.” That’s worrying. Should Canada be infecting the world with substandard certification? “Our extensive experience in electro-medical device [sic] and our experience at bringing projects to fruition gives you the confidence that we are the best partners to work with to bring your product to market.”
Alright, now consider this quote; “Our extensive experience in developing electrical codes and standards gives us valuable technical knowledge [etc.].” But they claimed the opposite in court testimony. Under oath, the CSA said that they only “facilitate” the development of standards and are “not responsible for the technical content.” The CSA’s role in developing standards is “administrative” in nature, not technical in contribution.
So, one story for the court; another story for the doctors.
If CSA’s testing is known to be spotty, and we’re being charitable in that characterization, then what about the medical standards that they develop? Sorry, that they “facilitate”?
Well, as we know, the CSA sells influence on its standards committees, so a medical device manufacturer can purchase the influence necessary “to bring your product to market.” Or, if they’re not keen on buying a few votes on committee, they can purchase the whole process for “$120,000 to $250,000” per piece of desired legislation.
What standards are affected? Oh, quite a few. The regulations for “Cells, Tissues, and Organs for Transplantation and Assisted Reproduction (Z900.1-03 R2008)” is one such standard. How about the standard for “Medical electrical equipment - Part 1: General requirements for safety”? Does that sound important? How about the standard for “Sterilization of Health Care Products - Ethylene Oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices”? Getting these right is fairly important. Indeed, lives are dependent on actual testing, real certification, and objectively developed medical standards.
Your correspondent doesn’t buy socks from the same place anymore, the lesson was learned. If the retailer takes a pass on quality in one area, they’re likely doing it elsewhere too. And since we exposed CSA’s attitude to testing integrity in consumer products and their practice of influence peddling in safety standards, it seems reasonable that the same CSA attitude exists in their other testing and certifications, including medical equipment. And that, my friends, is a lot more worrying than substandard socks.