Article Source: msnbc.com
from:msnbc.comPresident of Wisconsin firm accused of tainted products says action is 'first step' to resuming manufacturing
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R.I.P. Harrison. What's the consequence for the FDA officials who admitted, "that they should have taken stronger action sooner." ?
What is the consequence for the Haertles who entered into a business without the proper technical knowledge to make a safe surgical product?
What is the consequence for SEC regulators who neglected Bernie Madoff's operation even after given detailed reports showing that he was ripping people off?
WTF does Madoff have to do with baby wipes? Truly an unexpected deflection.
NYMike: well, Bernie Madoff and the baby wipes are both kind of the same thing.... a$$wipes.
Nothing happens except at the top, where everyone in America gets to receive a message that the FDA is tightening up ship. The real division responsible gets off with a slap, won't get reviews for a quarter or two and then it's back to bureaucracy level oversight again.
Most physicians I have spoken to are actually more outraged at the manufacturer, for it's complete lack of a mandated, internal quality assurance program. That program would have assured that ever quality control procedure would have been in place, followed and corrected, when inconsistencies occurred. This is the main point of having a well run quality assurance program. Anyone in the health care industry that does not take on this challenge, is in the wrong field of endeavor.
Having directed clinical laboratories as a Pathologist (yes, we really are medical doctors to those of you who still think we only do autopsies), I can tell you that when this occurs, laboratories don't even like the phrase 'take a chance', let alone actually take one. They all stopped using not just alcohol wipes, but all products from this company. They are highly unlikely to return, even after and if the company gets a go ahead from the FDA. I have no respect for them, expect likewise thoughts from the great majority of my colleagues and am comforted that there are numerous alternative companies out there, virtually all of them operating in the highest quality standards.
Corporate profits, it's everywhere these days and is what drive our economy.
There was a CEO somewhere getting rich off this to ensure the stockholders where making money in lieu of proper quality assurance, has been happening for awhile now with Chinese manufactured products imported into the US, why would these guys feel any differently.
The fact a company can do this and figures it will just be back and business with little or no repercussion more or less is what has become pathetic these days.
I don't see why people are so upset with the FDA. This is what the USA wants...get rid of regulations and oversight and business will police itself. Right?
That is what we hear over and over...
People of the USA, we have spent the last 30+ years hearing how government is the problem...hearing how government regulation only hurts business and the people of the USA. We have been electing politicians who tell us that government needs to keep out of business affairs.
This is what we voted for, this is what we got. A government too inept, broken and handcuffed to actually oversee the regulations we do have left.
Aren't we all happy?
And the FDA walks free for not doing their job. Gotta love this country!
My question is, what could the FDA have done if the company had not "voluntarily" shut down operation. Does the FDA have the authority to shut the business down ?
This business was forced to shut down afer the FDA discovered it continued to distribute product after it was told not to do so. thus the injunction...preventing it from distribution under any name.
BlueBurner About 4 months after the initial recall something finally happened. I still don't have a grasp on how shut down they really are.
Larry,
First injunction was temporary and accompanied by a the records seizure. Investigation in legal violations is continuing, but the FDA is seeking a PERMANENT injunction (shutdown) unless the company can prove that it can operate in full compliance with the law and FDA regulations.
In other words, the Haertles will have to prove they will do what they should have done in the first place, hire qualified supervisors and Quality Assurance personnel with appropriate medical backgrounds. This also includes providing these people with the necessary tools and authority to insure compliance.
For all the 'market will balance itself' idiots out there, take note.
Companies don't give a damn until the Fed steps in.
That was the point of my earlier post. You just said it more directly than I did...
Yes, let's hear it for all the fans of Paul Ryan and Ron Paul. No FEC, SEC, FDA, EPA, FHA or any other goverrnment regulations. Who needs them. Caveat Emptor should be the rule of the day.
WHAT??? These people are still around and trying to conduct business in the medical field!!!!
The Should be strung up naked at the nearest light pole and hung! They TOTALLY disregaurded the saftey and health of others for big profit. OFF WITH THEIR HEADS IS TOO GOOD A FATE FOR THEM!
Just remember free marketers: Without government regulations, this company would still be killing kids.
Government plays a necessary role in keeping us safe from those who would ignore safety problems in pursuit of profits.
It's not anti-business. It's just sound business.
There's a ton more unreported case relates to Triad products. Some of those cases are unfortunately resting in a grave. The FDA reporting form is 14 pages long. Your not going get a bunch of voluntary reporting of adverse effects until that's fixed.
I can't prove it but had a fine needle biopsy with a site prepped with a Triad death wipe. O guess what? A deep nasty infection. Three trips, 6+ phone calls to the DR. office. Four weeks on antibiotics. The Dr had no clue what was going on. All she could do was treat symptoms. Something she had never seen before. Thousands of dollars out of my pocket.
Hang the bastards!
My grandfather needed a minor surgery a few years ago that developed a major in infection and he was in a coma for weeks he eventually came out of and was never the same after. He passed on a little over a year ago, but still have a gut feeling something like this was involved at the time.
Things like this have always bugged me as the hospital never were too forthcoming in the explaining what happened at the time technically.
Well -- Don -- Welcome to health care in the USA, by far getting to be the worst by leaps and bonds, with being in health care for 20+ years I have seen and heard so many horror stories. Our hospitals are among some of the dirtiest places there are. Your wife's keep the kitchen cleaner than most hospitals and Clinics are. I am not surprised your grandfather got sick, just glad he pulled through...there are so many cases like that ...never get reported.
The USA is at least 15-20 years behind in health care, FDA is one of the problems. If the drug company does not pay them enough under the table money then the drug never makes USA markets. But gets sold overseas and saves lifes and makes a difference in peoples lives in other countries, but you or Family or I, can not buy or have to help Us. There are other factors but, FDA heads the list, along with a few dozen congressmen and women.
I'm waiting for the first comment from a Republican to the effect that this heavy-handed government action will kill jobs in the bacteria-tainted baby wipe industry.
Regulators seem to be doing as good a job as they can in most of these situations given lack of resources and relentless opposition from well-funded opponents. The primary responsibility for safety as always rests with the manufacturer. Unfortunately, it takes a metaphorical kick in the groin to give some corporate executives the message, and in the meantime the innocent suffer.
wipe with your hand's.... save a tree...going green stinks...
Or we could use hemp and never cut another tree down again for paper products.
What are you talking about?
This article isn't about paper or wipes (i.e. toilet paper, baby wipes, hand wipes)... this is about medical prep pads used in hospitals to sterilize the skin, and by people who give themselves injections.
yeah - see we don't need big government, because companies will do the right thing......
yep no need for regulation
Is it too late for us to be told what the brand name(s) were?
Per the FDA recall list of recalled Triad Group alcohol prep pads (wipes), alcohol swabs, and alcohol swabsticks.
Cardinal Health
PSS Select
VersaPro
Boca/ Ultilet
Moore Medical
Walgreens
CVS
Conzellin
Just type Triad recall into google and go to the FDA site.
Target's "Up and Up" brand is also on the list.
Not on the FDA list, but may have been later. Keep in mind these are NOT personal wipes or baby wipes, but surgical prep wipes and swabs for injections and incisions. Think first-aid kits and diabetic supplies for consumer markets.
All of these companies should have similar permanent injunctions...
Yeah, I guess corporations really aren't on our sides after all. Big surprise.
It's all nice and good that the company will work hard to rectify the problems. But, the owners, president, and management of this company knew there were health issues with their products. Yet, they continued to distribute products they knew were contaminated, to a community of compromised patients until the products were seized. Then, they try and put a "positive" spin on the permanent injunction against them. That it's only now, they know what they need to do to correct the problem and hire someone to oversee it. They should have hired this person a long time ago. Companies like this should know that their first responsibility is to the customer; patients, hospitals, medical centers, or doctor's offices. Perhaps if their customers take their business elsewhere, other company's will learn a better civic responsibility or face a major loss of business.
It's BS all of that corporations get away with things of this nature in the first place, it's just more so when it's related to a product that is supposed to be saving lives and they will probably be in the future allowed to continue to profit from producing the same items.
Some things just need to be done right every time. Six Sigma. I wonder if they are a ISO company? Should be.
FDA needs to mind their own business, not sure what that is. But they need to keep their noses out of stuff they have no clue on. FDA has gotten way too much like a Union, One Big Bully.
For years they have been killing our health care system and now the have competition with Obama care, between FDA and Obama be better off in a country that cares for it people
The republicans want to get rid of regulations because its not their business what the manufactures do they don't need regulations for stupid thing like this. The public will quit buying if there is a problem so let the public decide if the company stays in business. Just get the government off their backs, so they kill a few big deal.
Yeah, who works for the FDA anyway. More ex employees from Monsanto???? Our government is messed up and we all need to start demanding more from the people we vote into office. Write you Congressmen and Senators today and tell them you don't like things this way. They may even listen to you!
Presenting something that you know can kill and not caring if it does or not, and then someone dies= murder. Yet these money hungry pieces of thrash won't get more than a slap on the wrist, and the government cleans up after them.