Charlottesville Personal Injury Lawyer - infection

Studies Show E. coli In Ground Beef Not Ceasing

Greg Webb — Tue, 27 Oct 2009 01:00:00 GMT

Studies show that more than 70,000 Americans become sick each year due to E. coli bacterial infections. Most of these infections come from contaminated beef made into the most “American” of foods, the hamburger. Of the 70,000 infected, about 2,000 are sick enough to be hospitalized and in some extreme cases, victims become paralyzed or die; death happens in about 60 patients annually. Although the government does post regulations in order to keep the contamination at a minimum, many feel this is not enough; even the best precautions can only do so much. In a recent survey conducted by the Centers for Disease Control, for example, the E. coli bacteria contaminated one of every 200 samples of ground beef.

While companies and government inspectors backstop safety procedures by testing sample meat products for E. coli contamination, a procedure that usually takes at least a couple of days to show results, there are still problems. The first is that companies do not want testing conducted unless they do it themselves. According to a recent article published in the New York Times, many meat producers will not sell to processing companies who test the meat upon the delivery’s arrival, before it is mixed with meat from other companies. Producers are worried a positive E. coli test would force them to recall their entire product, including the meat they sold to other processors. Instead, meat companies require the processors only test the finished hamburger so if there is a contamination, it is impossible to trace it back to a single slaughterhouse. The second problem is that it is physically unfeasible and economically unrealistic to test every ounce of meat; it takes only a little E. coli bacteria to make someone sick. Only irradiation, in which meat is treated with a low dose of radiation, kills all of the bacteria. Though this process is deemed safe and effective, public speculation has helped prevent its spread. Many believe the United States Department of Agriculture (USDA) should help to change people’s minds about irradiation in order to ensure the process is more widely used.

Because the producers, processors and government cannot guarantee the safety of meat, they ask consumers to cook it to 160 degrees to kill most of the bacteria.

Originally posted at InjuryBoard by Greg Webb

FDA’s Lax Investigation Leads to Shipment of Contaminated Syringes

Greg Webb — Wed, 01 Jul 2009 08:00:00 GMT

Natalie Fullerton’s parents were thrilled to see their year-old daughter recover from a double-lung transplant. Her father dutifully used fluid-filled syringes to clean a tube that doctors had implanted in her chest to deliver intravenous medication. Despite his fear, bacteria infected the toddler’s blood and she was rushed to the hospital. Four months later, Natalie died in her mother’s arms.

The syringes Mr. Fullerton had been using were part of a contaminated lot made in a factory owned by Lake Zurich businessman Dushyant Patel. That batch and another have since been linked to 4 deaths and 162 illnesses across the country. Inspection reports and other documents show that the U.S. Food and Drug Administration missed several opportunities to prevent the tainted syringes from being used.

Three months before the prefilled syringes were shipped in October 2007, an FDA inspector investigated reports of red, brown, and black particles floating in syringes. She reported that the North Carolina plant managers had a plan to deal with rust, but did not note that the plant had switched to an unreliable sterilization tactic. When the FDA learned a week later that a distributor had recalled 1.3 million syringes, it should have conducted a thorough inspection of the plant, according to its operations manual. An FDA spokeswoman reports that this didn’t happen because the agency is so understaffed that it no longer follows the policy unless the recalled product poses a reasonable probability of serious injuries or death.

Federal prosecutors zeroed in on AM2PAT President Patel. An indictment on fraud, conspiracy, and other charges alleges that his firm produced syringes laced with bacteria and lied about performing sterility tests. Two employees, one a plant manager, were sentenced in February to 4 ½ years in prison for fraud and allowing tainted drugs into the marketplace. Authorities believe that Patel fled to India and are seeking to extradite him.

Patel bought a share of the North Carolina business and took over as president in 2001. Prosecutors allege that the operation was a fraud from the start, and that the firm’s application to make syringes incorporated fake data for a test to establish shelf life of the syringes. Unaware, the FDA gave Patel permission to start production in 2003.

The firm bought empty syringes and filled them with saline or heparin, solutions designed to prevent blood clots from forming in catheters. AM2PAT then sold the syringes to distributors who marketed them to hospitals and pharmacies, earnings nearly $7 million in profits in its last two years. In March 2005, a pharmacist reported finding orange sediment floating in one syringe and spotting an inch-long hair in another. An FDA inspector spent six days in the Raleigh plant three months later, noting nine significant violations, some of which could have an adverse effect on product quality. Shortly after, the FDA sent a warning letter, but it reported in January 2006 that Patel had either fixed or promised to address the major problems. New complaints were lodged in the spring and summer of 2007, including an AM2PAT employee who claimed that management was not adhering to appropriate clean-room temperatures during manufacturing.

The FDA’s Atlanta branch scheduled an inspection for June 26, 2007, but the plant was shuttered when the inspector arrived in Raleigh. By the time an inspector located the new plant, B. Braun Medical had recalled more than 1 million syringes following reports of particles floating in the saline. Six weeks after the inspection, the FDA issued a news release on the B. Braun recall’s finding that the particles were medical-grade silicone, which is capable of causing brain damage or a deadly clot. The FDA now admits that, until reports of injuries mounted, its Philadelphia office did not communicate information about the recall to its Atlanta office.

Toward the end of October 2007, the plant shipped the contaminated heparin-filled syringes. Authorities now link four deaths to the contamination. After the CDC linked the syringes, two investigators and a microbiologist interviewed workers, dug through records, examined equipment, and studied quality control in the factory. Patel had apparently concluded that the white particles that spurred the recall were caused by the failure of a standard sterilization process involving radiation. He adopted “UV light” sterilization, which the FDA says is a non-traditional technique. An employee also told investigators that the company kept two sets of records: one revealing rushed shipments of syringes that hadn’t completed sterilization tests and another fraudulently indicating that the plant was holding syringes on-site for two weeks while chemists conducted sterility tests. Patel responded that someone was sabotaging his records.

Gordon Harnack, a consultant who helps companies prepare for inspections, reviewed more than 120 pages of FDA reports on the AM2PAT plant and concluded that inspectors didn’t look deep enough, even as contamination problems became apparent. Although the syringe case has not received the attention that followed deaths from salmonella-laden peanut paste, consumer advocates say that both breakdowns are the result of a shift from aggressive enforcement to FDA partnership with the industries it is meant to oversee.

In response, FDA Commissioner Margaret Hamburg has pledged to make product safety a top priority. She said that she believes that it is critical for the FDA to take an aggressive approach to inspections and to maintain vigilance in ensuring that manufacturers comply with regulatory, legal, and moral obligation to provide safe products. FDA spokeswoman Siobhan DeLancey had previously defended the agency’s actions, saying that they had inspected the plant multiple times on a relatively low number of complaints and that the agency worked hard to prosecute the plant managers once reports of infections came in. This prosecution came too late for the Fullerton family, however, and many affected individuals have filed lawsuits in Cook County.

Originally posted at InjuryBoard by Greg Webb

Number of Hospital-Acquired Drug-Resistant Bacteria Growing

Greg Webb — Mon, 02 Mar 2009 08:00:00 GMT

More strains of drug-resistant bacteria have been cropping up, rivaling the superbug MRSA that has been making recent headlines. Anicetobacter baumannii, Pseudomonas aeruginosa and Klebsiella pneumoniae belong to category of bacteria called “gram-negative.” These bacteria are difficult to fight because they are wrapped in a double membrane and harbor enzymes that chew up many antibiotics.

While some drugs are still available to treat MRSA, the drugs used to treat gram-negative bacteria are becoming ineffective. Antibiotics known as carbapenems have been the drug of last resort for gram-negatives, but the bugs have developed a way to make an enzyme that dissolves the drugs.

As the best drugs fail, doctors are turning to more dangerous, toxic drugs to treat the infections such as colistin, which side effects include kidney damage and deafness.

Infections from these three bugs are not reportable by law, but voluntary reports in 2002 identified 104,000 gram-negative infections that were resistant to at least some antibiotics. That same year, there were 102,000 MRSA infections reported.

Gram-negative bacteria are harmless to healthy people but infect already-damaged tissue. They enter the body by way of ventilator tubes, catheters, open wounds and burns, causing pneumonia, urinary tract infections, and bone, join and bloodstream infections.

Drug-resistant Pseudomonas caused the death of Brazilian beauty queen Mariana Bridi, who died of sepsis after doctors tried to contain the rampaging infection by amputating her feet and hands and removing her kidneys.

These three gram-negative strains, along with Escherichia coli are among the six leading causes of infections in hospitals, nursing homes and other healthcare settings. Resistant strains are on the rise throughout the United States.

Originally posted at InjuryBoard by Greg Webb

Checklists Lower Hospital ICU Infection Rates

Greg Webb — Mon, 23 Feb 2009 08:00:00 GMT

Hospital-acquired infections originating from tubes and catheters inserted into the body have long been accepted as the norm in intensive care units. These infections include ventilator-associated pneumonia, related to a tube lodged in the windpipe to assist in breathing, urinary tract infections, related to a catheter inserted into the bladder to drain the urine, and bloodstream infection, related to a catheter threaded in the veins reaching the upper chamber of the heart.

For years hospital staff have believed infections were the price patients had to pay for intensive care. At one hospital, for every 1,000 “device days” (for example, 100 ICU patients using a device for 10 days), seven patients would get pneumonia, six would get blood infections and four would get a urine infection. But, staff thought, there were antibiotics to combat the infections, and the insurance company would pay for the nearly $25,000 extra in hospital bills. Moreover, without the devices, many patients would have died.

The Institute for Healthcare Improvement, a nonprofit founded by Harvard pediatrician Donald Berwick, is trying to change those thoughts. The IHI is a nationwide effort to reduce medical errors, standardize treatments, cut waste and bring patient-centered medical care to the bedside. About 4,000 hospitals have participated in the programs.

One major component of the Institute’s plans are checklists for every patient, which have become known as “bundles:” a “ventilator bundle” for patients on a ventilator, “UTI bundle” for patients with urinary catheters, and a “central line bundle” for those with central lines. There is even a bundle for doctors, requiring them to wear a sterile gown, mask and gloves before placing a central line.

While these checklists may include what should be routine behavior from doctors and nurses, routine procedures are typically never followed 100 percent. Without these written guides set by the IHI, checklists are expected to be followed by memory, which is unrealistic.

At the hospital mentioned above, implementing the checklists caused a 50 percent decline in ICU infection rates and a 21 percent reduction in cost per ICU discharge. Where some staff had been skeptical about the initiative to reduce infection rates, simple checklists caused the hospital’s culture of patient safety and quality to change for the better.

Originally posted at InjuryBoard by Greg Webb

Dangerous Drug-Resistant Staph Germ (MRSA) Rising in Children ENT Infections

Greg Webb — Mon, 09 Feb 2009 08:00:00 GMT

Researchers have found an alarming increase in the number of children’s ear, nose and throat infections nationwide, which are caused by dangerous drug-resistant staph germs, nicknamed MRSA. These infections can include ear and sinus infections, and abscesses that can form in the tonsils and throat. Other studies have found the number of skin infections in adults and children has also risen due to MRSA, though the recent study of ear, nose and throat infections is the first to find how common the germ is in deeper tissue infections of the head and neck. MRSA can cause life-threatening invasive infections and because of the germ not responding to penicillin-based antibiotics, doctors are scared it is becoming resistant to other antibiotics as well. Doctors believe the inappropriate use of antibiotics has contributed to the rise.

MRSA head and neck infections most often develop in MRSA carriers, who become susceptible to the germ because of ear, nose or throat infections caused by some other bug. The germ can be picked up in normally healthy people through direct skin-to-skin contact or contact with surfaces contaminated with the germs from cuts or other open wounds. Unlike cold and flu bugs, MRSA germs are not airborne and do not spread through sneezing. Symptoms that it could be MRSA include ear infections that drain pus, or swollen neck lymph nodes caused by pus draining from a throat or nose abscess.

The study, which took results from a national electronic database collected from more than 300 hospitals, found 21,009 pediatric head and neck infections caused by staph germs from 2001 to 2006. The percentage that was caused by hard to treat MRSA bacteria more than doubled during that time from twelve percent to twenty-eight percent. While MRSA infection were once limited to mostly hospitals and other health-care settings, almost sixty percent of the MRSA infections are believed to have been contracted outside of a hospital setting.

Originally posted at InjuryBoard by Greg Webb

MRSA Infections Typically Caught In Hospitals, Killing 18,000 People Each Year

Greg Webb — Tue, 09 Dec 2008 08:00:00 GMT

MRSA infections kill more than 18,000 people a year, and six out of seven people infected with the antibiotic-resistant germ contract it at a health care facility. The germ, methicillin-resistant Staphylococcus aureus, spreads by touch or contact, and can enter breaks in the skin as small as a mosquito bite. It can cause painful and treatable skin lesions or slip into the blood; one percent of infections are fatal, and many others result in crippling injuries.

MRSA is typically carried on the skin. Researchers have previously estimated that 1 to 2 percent of the population carries the germ, but Washington hospitals that instituted selective screening found that up to 11 percent of people carried the germ on their skin.

Last fall, the Centers for Disease Control and Prevention announced the astonishing number of deaths caused by MRSA each year. In the past ten years in Washington, hospital patients infected with MRSA jumped from 141 per year to 4,723. However, the hospitals don’t track the germ or infected patients, nor do they have to reveal infection rates. The Seattle Times analyzed documents, including hospital records and death certificates, and found 672 previously unreported deaths caused by MRSA.

Screening for MRSA is quick and painless, only costing about $20, but no community hospital in Washington screens every patient for the germ. Federal veterans’ hospitals screen all patients, and have reduced their cases to almost zero. But the Washington hospitals claim that testing is unnecessary, and that washing hands and wearing protective garments is enough to prevent MRSA from spreading. However, the hospitals claiming these infection control measures are enough are failing to use them, even when state and federal inspectors are around. State records show that seven staff members at one hospital were cited for violating basic infection-control standards during a four-day inspection in 2007, even after advanced notice of the inspection. In fact, most of the state’s 25 largest hospitals have been cited for unsanitary conditions or failure to adhere to fundamental safety standards, according to state and federal regulatory reports dating back to 2005.

In Washington, there are no state or federal mandates for screening patients for MRSA. While cardiac patients, critically ill patients, and patients with weakened immune systems are among the most vulnerable to infections, there is no set screening policy among hospitals. One hospital may test intensive-care unit patients but not those having elective surgery, while another tests patients having elective surgery but not patients in its ICU. The Seattle Times found that in Washington’s 25 largest hospitals, most patients don’t get tested. Those who oppose testing all patients argue that hospitals lack the staff, resources, and space for testing or isolation of patients with MRSA. In addition, they say screening could result in lawsuits where patients picked up MRSA in the hospital after a negative screening upon admission.

The number of deaths caused by MRSA is unknown because of missing information in public health records. When filling out death certificate forms in Washington, physicians are asked to state not only the primary cause of death, but also the chain of events contributing to death. The Seattle Times found multiple instances where an autopsy or medical record showed MRSA, but the death certificate omitted it completely. In addition, an old database of death certificates released by the Washington Department of Health excluded information regarding doctors’ notes, and used an international standardized coding system with more than 13,000 diagnosis codes, none of which are for MRSA. The Seattle Times requested a complete database this year, and found 672 deaths linked to MRSA from 2003 to 2006; the old database did not link any deaths to MRSA.

Nationally, exact numbers of deaths attributed to MRSA are also unavailable, leading to the question Chuck Velte, whose mother died from MRSA, asked: “How many people die of MRSA and nobody ever knows?”

Originally posted at InjuryBoard by Greg Webb