September 18, 2010 (Original publish date) • By Dennis Beaver
Last week we told you about a fraternity at the University of Wisconsin at Madison that wanted to be sure anyone who planned to drive home after a party was below the legal limit for a DUI arrest, so they had them blow into a breathalyser. Only those who “blew” numbers well below .08 were permitted to drive.
Their breathalyser was “cleared” by the FDA, “approved” by Department of Transportation and advertised as giving “professional accuracy.” They had suspicions about accuracy issues with the device that night which were confirmed the next day. Several students were stopped by the police, and blew much higher numbers – the kind that can lead to a DUI arrest.
In fact, their device could not show an accurate blood alcohol level because, like most consumer breathalysers sold today, it uses semiconductor technology, valid only for screening – to verify if a person has consumed alcohol, but not the specific percentage blood alcohol content.
“But it was sold as being able to accurately measure and display blood alcohol levels,” a disappointed fraternity “bro” told me.
The Feds are allowing false claims to be made
Breathalysers sold in the United States must be “cleared” by the Food and Drug Administration and shown “safe and effective as “screening devices” but this does not men they can measure breath alcohol content accurately. The Department of Transportation, U.S. Coast Guard, and other federal agencies issue “clearance” and “approval” certifications at several different levels of accuracy. The highest is “evidentiary,” meaning the results can be used in court.
But semiconductor breathalysers have never been approved for use in court. If the justice system does not trust them, that fact should be taken into consideration as part of a buying decision.
There is widespread, misleading use of the FDA approval for screening devices. A recent breathalyzer accuracy and reliability study conducted by a major Texas university strongly criticized the FDA and sellers, describing many of them as “exploiting consumer interest by marketing these devices in a way that is misleading to the general public.”
You and the Law asked the FDA what, if anything, they are doing to protect the public from these false claims:
“Once we become aware of untrue or misleading claims [concerning the use of our approvals] we address them. If there was a compliance action taken involving these devices, that information would be available on the FDA website.”
We could find no evidence that the FDA has taken action against any of the hundreds of untrue and misleading advertising claims which use their breathalyzer approvals.
Credible manufacturers are concerned
“While a few sellers do make it clear their devices are only designed for alcohol screening, others use descriptions which aren’t just misleading, but encourage reliance on the numbers given. This is scary stuff we’re talking about, because when used as directed, these types of breathalysers can lead to precisely the opposite of what you’re trying to prevent,” warns Barry Knott, president and CEO of Denver-based Lifeloc Corp., which sells accurate – fuel cell – breathalysers to law enforcement, the medical profession, as well as consumer versions of those devices.
“Buyers must read everything closely and look for the word “screening” in advertising statements, on the box, or package insert. If it’s there, then you know that the only thing this device is good for is to see if the person using it has consumed alcohol; that’s all it can reliably do.”
“If you find the words fuel cell, then you’re getting the same technology that law enforcement uses. Anything else – regardless of how it is described – simply cannot be trusted to give you an accurate measure of blood-alcohol concentrations,” he cautions.
His comments were echoed by Jenny Yoder, Spokesperson for Q-3 Innovations based in Independence, Iowa. Their company sells both semiconductor and fuel cell breathalysers.
“We have always had very clear statements that semiconductor devices are intended for screening purposes. When other companies just say that their device is FDA approved, this is inherently misleading. It creates the feeling their product is going to be more accurate than a screening device can be. The FDA and other U.S. governmental agencies need to address these issues,” she maintains.
You and the Law has had the opportunity to test fuel-cell breathalysers sold by Lifeloc, BacTrack and Q-3 Innovations. They were tested against breathalysers used by law enforcement, and all were extremely close in readings. Prices range from approximately $150 to $250, and each company has highly informative websites.
Unless only a screening device is needed, it is this writer’s opinion that a fuel-cell type is the only breathalyzer to ever consider buying. It can prevent a DUI and save lives.
Dennis Beaver practices law in Bakersfield and enjoys hearing from his readers. Contact Dennis Beaver.