What Do You Think?

[jonnyb25]

This is truly scary. Of all the hospitals that use these things and probably had the same illness and deaths apparently only one set of doctors bothered to seriously look for what was causing the problem and report it publicly enough to get the company and the government to pay attention.

FDA apparently knew about the problem and did nothing to stop it.

And the nightmare is we are soon going to be forced to go to a system of medicine where we have even less say about what is done to us or what doctor we can go to. The hospitals and doctors will care even less than they do now, with the new system they get paid the same regardless of if they do a good job or not. And we still have to pay the government for the ones that are incompetent or just don’t care if the person they treat lives or dies.

At least now if the treatments we get seem wrong or ineffective we can change doctors or hospitals. I suspect that will not be the case under the new medical extortion system.


copied from:
http://www.msnbc.msn.com/id/41914778/ns/health-infectious_diseases/


Colo. hospital blew whistle on contaminated wipes

By JoNel Aleccia
Health writer
msnbc.com
3/7/2011

It took fast-acting doctors at a Colorado hospital to flag problems with tainted alcohol wipes now tied to a massive recall and growing reports of potentially deadly infections, including the case of a 10-year-old boy already battling leukemia.

Medical experts at The Children’s Hospital in Aurora said they became alarmed last fall when a few youngsters developed bloodstream infections caused by the rare bacteria Bacillus cereus.

“It just didn’t make sense,” said Dr. Christine Nyquist, the hospital’s medical director of infection prevention. “Based on the kind of patients they were, the organism, the bacteria, didn’t make sense.”

They included Peyton Armstrong, 10, of Glenwood Springs, Colo., who developed a high fever and intense pain last October within 12 hours of placement of an IV line and a medical port to start chemotherapy treatment for leukemia.

“He was on the brink of death,” said Jessica Armstrong, 40, Peyton’s mother. “The cancer didn’t even matter at that point.”

Within weeks, hospital officials were stunned to confirm that Peyton’s infection — along with what Nyquist would describe only as "a couple"of others — was caused by contaminated alcohol wipes produced by the hospital’s sole supplier: the Triad Group of Hartland, Wis.

Hospital used 2,500 wipes a day
“This is something really common in use in hospitals,” said Nyquist, noting that the hospital uses about 2,500 wipes each day. “When that is identified as the common source, everyone kind of goes, ‘Wow.’”

Federal Food and Drug Administration officials credit the hospital with sparking an investigation that led to Triad’s voluntary recall of hundreds of millions of alcohol swabs, wipes and pads widely used in hospitals, clinics and homes. Michael Rogers, the FDA’s acting director of the Office of Regional Operations, said inspectors were sent to the plant on Nov. 29, 2010, immediately after receiving The Children’s Hospital report.

However, the FDA’s own internal inspection documents showed that the agency knew of problems with contamination and sterilization at Triad as early as 2009. Rogers has said the FDA was working with Triad to correct conditions voluntarily and that, at the time, officials didn't believe the plant's practices posed an "imminent health hazard."

In an e-mail to msnbc.com, Eric Haertle, Triad's chief operating officer, said he couldn't respond to questions about sterilization and contamination at the plant because of pending litigation.

Already worried about battling leukemia, Armstrong said she and her husband, Noel, 42, a podiatrist, were shocked beyond words that their son was sickened by a tainted cleansing product.

“The thing they used to clean his skin instead put a deadly infection in his body,” she said.

Peyton's infection delayed the start of vital treatment for chemotherapy and intensifed the boy's anxiety about future care, says his mother.

"He worries that when he gets infected, he will die," said Armstrong, who helped her son through a grueling phase of chemotherapy last week. "And all pain is associated with being infected."

Peyton's infection is only one of a growing number of horror stories blamed on the Triad wipes. Msnbc.com previously reported that infections with Bacillus cereus tied to the wipes led to open-heart surgery for Joe Postich, 55, of Madisonville, Tenn., and to the death of Harrison Kothari, 2, of Houston. In addition, more than 100 people have now reported other potential infections related to the wipes, according to Houston lawyer Jim Perdue Jr., who represents the Kotharis and expects to file a lawsuit soon on behalf of the Armstrongs.

Nearly a million cases recalled
On Jan. 3, the Triad Group recalled all lots of alcohol prep pads and wipes, including many sold under the private labels of grocery stores such as Safeway and Kroger and drugstores such as Walgreens and CVS.

The recall covered 975,922 cases of product containing hundreds of millions of individual items, according to FDA documents. The alcohol products are sold in Canada and Europe as well as the United States.

The products were suspected of being contaminated with Bacillus cereus, bacteria that are common in the environment and sometimes associated with foodborne illness, but not usually with hospital-acquired infections. It's a spore-forming bacterium that can survive the 70 percent isopropyl alcohol solution used in the wipes, microbiologists say.

In addition, Triad Group also recalled lots of sterile lubricating jelly in December after the same inspection confirmed problems with contamination and sterility.

The FDA cannot confirm how much of the tainted alcohol product actually has been removed from use, said spokeswoman Shelly Burgess. It's possible that the Triad wipes and pads are still in use by people who already had them in their homes.

The agency is continuing to investigate the Triad situation, Burgess, the FDA spokeswoman, said. According to protocols, the FDA has the ability to seize products or to seek legal action, such as permanent injunction that would bar the firm from making or distributing its medical supplies.

So far, the FDA has issued no warning letters or other consequences to H&P Industries, which does business as the Triad Group.

That’s “unfathomable” to Jessica Armstrong, who has been in contact with Sandra Kothari, mother of the Houston toddler who died after contracting bacterial meningitis caused by a Bacillus cereus infection. His parents blame the tainted wipes.

“We both share a mission that this should never happen to another child,” Armstrong said.

[jonnyb25]

copied from:
http://www.msnbc.msn.com/id/41588330/ns/health-infectious_diseases/?ns=health-infectious_diseases

Parents blame toddler's death on tainted alcohol wipes

By JoNel Aleccia
Health writer

msnbc.com
2/15/2011

The parents of a 2-year-old Houston boy who died from a rare infection are suing makers of recalled alcohol prep products, claiming contaminated wipes and swabs transmitted bacteria that caused his fatal case of meningitis.

Sandra and Shanoop Kothari say their lively, dark-eyed toddler, Harrison, was recovering just fine from surgery to remove a benign cyst from near his brain and spinal cord last fall. But the day before he was set to be discharged after a week's stay, he developed a sudden and severe infection that worsened rapidly, causing multi-organ failure that led to Harrison’s death on Dec. 1, 2010.

Cultures showed he succumbed to acute bacterial meningitis caused by Bacillus cereus, bacteria typically found in rare food poisoning outbreaks, but not in hospital infections.

“They had no explanation as to how he contracted it,” said Sandra Kothari, 37, Harrison’s mother. “They know it’s rare in the hospital.”

Rare bacteria detected
For more than a month, the family grieved without knowing the cause of their loss. Then, on Jan. 5, a relative saw a notice posted online by the U.S. Food and Drug Administration. All lots of alcohol prep wipes, perhaps tens of millions of swabs and pads manufactured by the Triad Group, a Wisconsin medical product supplier, were being recalled.

The reason? Potential contamination with Bacillus cereus.

“These wipes were used in his care every single day, multiple times a day,” said Shanoop Kothari, Harrison’s father.

Officials at Children’s Memorial Hermann Hospital in Houston, where Harrison was treated, confirmed that the alcohol prep products they used were supplied by Triad, said the Kotharis’ lawyer Jim Purdue Jr. Samples of Triad products were taken from the room where Harrison stayed, he added. Shanoop Kothari said the recall offered terrible confirmation.

“We’re confident that that’s the cause,” said Kothari, 38, who works in the banking industry. “There was no other explanation that made any sort of sense. He contracted a very rare bacteria. These swatches were tainted with that bacteria.”

Lawyers filed a complaint Sunday in U.S. District Court in Houston. It charges the Triad Group of Hartland, Wis., with gross negligence and seeks damages for the loss of Harrison’s life.

“Our emotional response over this has been horrible,” said Shanoop Kothari said of his family, which also includes Harrison's 7-year-old sister, Hannah. “We’ve been devastated. We’ve been absolutely crushed.”

Representatives for the Triad Group did not respond to telephone and e-mail requests from msnbc.com to discuss the lawsuit or the recall. FDA spokesman Christopher Kelly said the 35-year-old family firm “did everything correctly” in notifying government authorities about the massive recall. Triad products are sold, often under private labels, in the U.S., Canada and Europe.

Kelly offered no futher details about the recall or whether other injuries have been reported.

Millions of products recalled

The company’s Jan. 5 voluntary notice said they were recalling all lots of pads, wipes, swabs and swabsticks “out of an abundance of caution,” and that they had received one report of a non-life-threatening skin infection linked to Bacillus cereus. However, the notice added that use of contaminated pads “could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients.” There was no indication of how any wipes might have become contaminated.

The bacteria do have potential for devastating infections, according to Dr. Aaron Glatt, spokesman for the Infectious Diseases Society of America.

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.."It can be a pretty bad bug," said Glatt, president of St. Joseph Hospital in Bethpage, N.Y.

Bacillus cereus is a spore-forming bacterium found in soil and occasionally associated with foodborne illness. It can be resistant to heat and to disinfectant and has been known to survive standard sterilization procedures, Glatt said.

Harrison was not quite old enough to be vaccinated against bacterial meningitis when he had his surgery last fall, and even if he were, the recommended vaccine doesn’t protect against that strain of bacteria.

Harrison's mother, Sandra Kothari, said she worries that there may be more people injured or killed by the potentially tainted wipes and swabs, which were widely used in hospitals and sold in stores such as Walgreens and CVS.

“People buy alcohol pads and they last a long time in your bathroom. They’re sitting there now,” she said.

“I wouldn’t want any other mother to go what I’ve gone through.”