Yourlawyer.com (Medical Malpractice News)

The Devastating Consequences of Botched LASIK Surgery

Tue, 13 May 2008 00:00:00 -0700

Although the US Food and Drug Administration (FDA) is finally reviewing complaints from LASIK patients who have suffered from a variety of issues, including blurred vision and dry eyes, its actions come too late for many who suffer from irreversible eye damage. The FDA has received 140 reports of LASIK-related problems between 1998 and 2006, representing just a sampling of what has gone wrong with LASIK.

LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye's cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism. LASIK was approved a decade ago and an estimated six million Americans have undergone LASIK surgery with hundreds of thousands of Americans undergoing LASIK yearly. The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of LASIK remains unknown.

Take the case of Patrick Sheahan who underwent LASIK at the age of 23 at LASIKPlus. When Patrick—a street police officer—went in for a consultation at LASIKPlus they said he was a perfect candidate; his vision problems were so mild that he could almost see without his glasses. Following LASIK surgery at LASIKPlus, Patrick’s left eye began to deteriorate until all he could see out of it was light; he experienced daily dizzy spells and migraine headaches. Patrick began taking painkillers and consulted with his optometrist who told him his left cornea was severely damaged and misshapen.

Patrick made an appointment with Dr. Gerald Horn of LASIKPlus, the man who performed the botched LASIK surgery. Horn kept Patrick and his grandfather waiting an unbelievable five hours before finally examining Patrick and admitting to a major complication. Horn blamed the laser, saying there may have been a malfunction and there was nothing further he could do. In addition to shoddy surgical work, Horn was extremely rude to Patrick and his grandfather, rushing the two men out before answering their questions, saying he had a meeting to attend and if they had more questions, they would have to make another appointment to see him. Horn offered no options for vision correction and no sympathy toward his now-blind patient.

After consulting with many corneal experts, the conclusion was that Patrick—now blind in one eye—needed a corneal transplant. Corneal transplants involve cutting the cornea out of the eye and replacing it with a donor cornea. The surgery involves dozens of stitches—30 for Patrick who received his transplant in July 2003. Also, optical stitch removal is tedious; can take many visits; and can only be done a few at a time, when the stitch loosens, and with a needle-like instrument while the patient is conscious.

Patrick paid $18,000 dollars for the transplant and additional $4,000 for a follow-up lens implant in 2005. Patrick’s doctors expect that Patrick will have to undergo many other future procedures and warn that his cornea can reject at any time. Patrick has lost nearly two years of income, his entire savings, and his position as a street officer; he will never be able to work in the same capacity due to his vision problems.

Dix Hills Doctor Settles First Hepatitis C Medical Malpractice Case

Mon, 12 May 2008 00:00:00 -0700

Dr. Harvey Finkelstein, the Dix Hills doctor who the state Department of Health says exposed thousands of patients to blood-borne pathogen infections such as hepatitis B and C and HIV/AIDS by reusing syringes, has settled a medical malpractice lawsuit with a Syosset man who claimed he contracted hepatitis C in Finkelstein’s office.  Finkelstein continues to practice and has now settled an unprecedented 11 malpractice lawsuits in eight years. Less than 200 of the state's 80,000 doctors have settled that many cases, according to Washington-based consumer group Public Citizen.

The financial settlement marks the first resolution of several lawsuits filed after the Department of Health investigation found that Peter Mattmuller, 66, was infected in Finkelstein's office. According to the lawsuit, infection occurred because Finkelstein used a syringe multiple times on the patient seen before Mattmuller—Steve Corrado, 53—contaminating multidose vials that were then the source of Mattmuller’s injections. Corrado, now on disability, said he began receiving injections from Finkelstein in the mid-1990s after a work injury left him with debilitating back pain. In 1999, Corrado said he became ill, was diagnosed with hepatitis C—a blood-borne disease that can cause severe liver damage—and immediately called Finkelstein, with whom he had become close. In a July 20, 1999, medical document, Finkelstein notes Corrado's diagnosis: "Hep C x 20 years.” Raymond Bookstaver, 49, of Hicksville was being treated by Finkelstein for a degenerative disc disease in his back when he was diagnosed in Decemb
er 2004 with hepatitis. Bookstaver received injections of the same medications during the appointment immediately preceding Mattmuller's, according to Health Department and medical records.

  On July 15, 2004, in a procedure that ended at noon, Finkelstein injected Corrado with medications and dyes. About 35 minutes later, Bookstaver was injected with the same four medications: Triamcinolone, a steroid; lidocaine and bupivacaine, both local anesthetics; and ketorolac, an anti-inflammatory drug. Mattmuller was injected with the same combination at 1 p.m. All three men's disease strains are linked and share the same genotype of 1B.

Susan Lewis, of North Massapequa, is suing Finkelstein, claiming he gave her hepatitis C and is also suing the state and county health departments for taking nearly three years to notify her of the doctor's reuse of syringes.

County and state investigators observed Finkelstein in his office in January 2005 and reported that while drawing medicine from multidose vials he reused syringes on three patients. Finkelstein's flawed infection-control techniques prompted authorities to notify over 10,000 patients of their risk for disease last November. In March the Nassau County district attorney's office raided Finkelstein's office and seized medical records and a computer hard drive and are considering whether they can bring felony charges against Finkelstein which could include second-degree assault for causing the infections, falsifying business records, offering a false instrument, and changing or withholding records from the state Department of Health.

Health authorities said they were frustrated by what they believed was Finkelstein's reluctance to turn over records and expanded the investigation to include over 10,000 patients.

77 More Hepatitis C Victims Tied to Endoscopy Center of Southern Nevada

Fri, 09 May 2008 00:00:00 -0700

Seventy seven more former patients of the Endoscopy Center of Southern Nevada have tested positive for hepatitis C, and their illnesses are likely the result of the unsanitary methods employed by the now-closed clinic. The 77 cases of hepatitis C combined with those confirmed earlier bring the number of cases linked to clinics run by the same group of doctors to 85.

In February, the Southern Nevada Health District sent letters to 40,000 people treated at the clinic, advising them to get tested for hepatitis B and C, and HIV. The Endoscopy Center of Southern Nevada has been under investigation since early January, after health officials learned of three people who had been diagnosed with hepatitis C after being treated there. Ultimately, the Southern Nevada Health District said a total of six people were known to have contracted hepatitis C after being treated at the Endoscopy Center of Southern Nevada. Five of them were treated the same day in late September; the sixth is believed to have been infected in July, the district said. The Southern Nevada Health District investigation revealed that “unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients.” In March, a seventh hepatitis C victim, who had been treated at a clinic owned by the same group that owns the Endoscopy Center, was identified.

The hepatitis C virus may have been spread when clinic staff reused syringes and used a single dose of anesthesia medication on multiple patients, the district said. A syringe would become contaminated by the backflow of blood when patients with a blood-borne disease were injected with medication, health officials said. That syringe, in turn, would be reused to withdraw medication from a different vial. That vial could become contaminated and result in infection. The Endoscopy Center of Southern Nevada also regularly performed 2-minute surgeries and reused other disposable devices.

The 77 people are among about 400 former patients of the Endoscopy Center of Southern Nevada who tested positive for the potentially deadly virus since the outbreak was made public Feb. 27, and who provided no other risk factors during follow-up interviews. Authorities can't say for sure how the 77 people were infected, but they know each was treated from March 2004 to Jan. 11 this year at the clinic. None of the 77 had tested positive for hepatitis C prior to their treatment at the clinic.

Officials determined the more than 300 other patients who also tested positive and were interviewed could have contracted the virus through other means, including intravenous drug use, blood transfusions, organ transplants or kidney dialysis, receiving blood clotting agents before 1987, or sexual contact with a person with hepatitis C. Health officials in Nevada still have to conduct interviews with dozens of other hepatitis C victims to determine if their infections could have originated at the Endoscopy Center.

The Endoscopy Center was owned by doctors Dipak Desai and Eladio Carrera, whose Nevada medical licenses have been suspended pending state Board of Medical Examiners hearings. The Endoscopy Center of Southern Nevada is the subject of a criminal probe being conducted by the Las Vegas Metropolitan Police Department, the FBI, the Nevada Attorney General's office and the Clark County district attorney.

Reused Insulin Pens Probed at Nassau University Medical Center

Fri, 09 May 2008 00:00:00 -0700

Nassau University Medical Center (NUMC) has expressed concern over possible reuse of insulin pens in more than one patient and said yesterday it will be sending letters to as many as 185 diabetes patients who might be victims of such medical malpractice. The letters will urge patients to be tested for hepatitis C, hepatitis B, and HIV. The hospital said it was still not clear whether an insulin pen—a pre-filled syringe meant to be used in a single patient to dispense insulin—was used in more than one patient and Dr. Steven Walerstein, the hospital's medical director, said there were no reports of any resulting infection.

Arthur Gianelli, NUMC's chief executive, said nurses reported hearing about a possible syringe reuse and NUMC opted to err on the side of caution. "We don't know if it actually happened, but there was enough hearsay to conclude it might have happened," Gianelli said. "We decided we have to do the best we can to protect people's health." NUMC said it removed all insulin pens and notified the state Department of Health, which was on-site yesterday investigating the potential problem.

Because the single use insulin pens are designed for use by one patient, they are widely considered safer than using syringes with multidose vials. The devices were introduced at NUMC on November 26 following intensive staff education on the pens’ use.  

The hospital said only those patients known to have ever used the Lantus SoloSTAR and NovoLog FlexPen from November 26 to May 5 would be notified to come to the NUMC for a free blood test and follow-up. Patients call 516-296-4333 for screening and counseling. Diabetic patients who have not used the pens are not considered at risk, the hospital said. In the meantime, Walerstein said the hospital has reverted to multidose vials for delivering insulin.

According to Walerstein and other hospital officials, a nurse on the medical intensive care unit reported a suspicion—about a month ago—that insulin from one patient's insulin pen was withdrawn into another patient's syringe. When interviewed, all the nurses said they knew of no such practice. The hospital's quality control team interviewed nurses on other floors and some admitted to having heard of the practice; however, none had direct knowledge of pens reused in multiple patients.

When syringe pens are reused, it is possible for drops of blood containing viruses to be transmitted from one patient to another via the insulin pen's syringe. Walerstein said there were no reports that had occurred. After attaching a needle, the user adjusts the proper dose on a dial and then pushes the plunger to inject the medicine. Each cartridge typically holds a 28-day supply of insulin before it is discarded; needles are disposed following each use.

In November, the state health department announced Dix Hills Doctor, Dr. Harvey Finkelstein, infected at least one patient three years earlier when he delivered medication using shoddy techniques and a multidose vials. Earlier this year, Dr. E. Jacob Simhaee, a Manhasset-based obstetrician-gynecologist admitted to reusing syringes when administering flu shots to at least 36 patients last fall. The state initiated its investigation of Simhaee’s practice in December following a complaint filed with the Nassau County Department of Health.

LASIK Dangers Require Caution

Mon, 05 May 2008 00:00:00 -0700

LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye's cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism. LASIK was approved a decade ago and an estimated six million Americans have undergone LASIK surgery with hundreds of thousands of Americans undergoing LASIK yearly. The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of LASIK remains unknown.

Recent testimony before an advisory panel to the US Food and Drug Administration (FDA) is revealing that in as many as five percent of all cases, LASIK can be not only be ineffective, LASIK can lead to side effects that include severe dry eye, eye pain, blurred vision, and an inability to drive at night. To date, the FDA has received 140 letters of complaints and "The FDA has called this a quality-of-life issue, because patients are complaining that their vision isn't sharp, they have poor night vision, some have glare or halos, some complain that their eyes are dry," said Dr. Robert Cykiert, associate professor of ophthalmology at New York University Langone Medical Center. FDA advisers recommended the agency clarify warnings regarding LASIK, including: Photographs to clearly show what people with side effects see, such as glares and light bursts; information indicating how often patients suffer side effects, such as dry eye; and clear information outlining the conditions under which someone should be dis
qualified from LASIK, such as large pupils or severe nearsightedness.

Those considering LASIK should be fully evaluated in advance for conditions such as dry eye, which affects an estimated 10 million Americans and is a painful condition in which there is a reduction in either the quality or quantity of tears, necessary to maintain ocular lubrication. Contact lens, birth control pills, antihypertensive medications, and antihistamine use can lead to dry eye. Those with moderate-to-severe dry eye should be advised prior to LASIK surgery since the eye will certainly be drier afterward, said Dr. Ernest Kornmehl, a LASIK surgeon in Wellesley and a spokesman for the American Academy of Ophthalmology. Kornmehl warns that some surgeons don't see their patients until the day of surgery, which means that initial exams and conversations were left to someone else increasing the likelihood that pre-existing conditions—such as dry eye—are missed.

Patients should speak to their surgeons directly and ask how many LASIK procedures the surgeon has conducted and when. Look for a physician who is fellowship-trained in corneal diseases and, "You have to choose your physician carefully," said Darlene Dartt, director of scientific affairs at Schepens Eye Research Institute. "And go to a reputable place where you are carefully screened, to make sure your eye is properly evaluated."

Dr. Norman Saffra, director of ophthalmology at Maimonides Medical Center in New York City, says that LASIK is not for everyone, especially those with a misshapen or excessively thin cornea, early cataract formation or big pupils, dry eyes, or underlying conditions such as lupus or rheumatoid arthritis. In addition to glare and halos side effects, some patients have had corneal transplants, Starr said.

Doc at Center of Nevada Hepatitis C Outbreak Barred from Practicing Medicine

Wed, 30 Apr 2008 00:00:00 -0700

The doctor implicated in the Endoscopy Center of Southern Nevada hepatitis C outbreak won't be able to practice medicine again - at least until a10-count state Board of Medical Examiners complaint against him is resolved. Dr. Dipak Desai is the owner of the Endoscopy Center, where unsanitary practices exposed thousands of patients to blood born disease. Desai also runs several other Nevada clinics. Yesterday, Clark County District Judge David Wall issued a temporary restraining order against Desai, forbidding him from practicing medicine for the time being.

In February, the Southern Nevada Health District sent letters to 40,000 people treated at the clinic, advising them to get tested for hepatitis B and C, and HIV. The Endoscopy Center of Southern Nevada has been under investigation since early January, after health officials learned of three people who had been diagnosed with hepatitis C after being treated there.

Ultimately, the Southern Nevada Health District said a total of six people were known to have contracted hepatitis C after being treated at the Endoscopy Center of Southern Nevada. Five of them were treated the same day in late September; the sixth is believed to have been infected in July, the district said. The Southern Nevada Health District investigation revealed that “unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients.” In February, the Southern Nevada Health District sent letters to 40,000 people treated at the clinic, advising them to get tested for hepatitis B and C, and HIV.

The hepatitis C virus may have been spread when clinic staff reused syringes and used a single dose of anesthesia medication on multiple patients, the district said. A syringe would become contaminated by the backflow of blood when patients with a blood-borne disease were injected with medication, health officials said. That syringe, in turn, would be reused to withdraw medication from a different vial. That vial could become contaminated and result in infection.

The subsequent investigation of the clinic revealed even more substandard practices. Several staff members told investigators that biopsy equipment labeled for single use was reused for multiple patients after disinfection. Others reported that they were directed to reuse bite blocks - devices put in patients’ mouths for some procedures - on multiple patients.

Desai now faces a 10-count complaint against him, and on Monday, state Attorney General Catherine Cortez-Masto asked for the restraining order. Cortez- Masto also requested a restraining order against Dr. Eladio Carrera, who worked at and is a co-owner of the center. That request was still pending.

Judge Wall said that the temporary order against Desai was warranted because the Board of Medical Examiners "has demonstrated a likelihood of success on the merits" of its complaint against the doctor. He also said "imminent and irreparable harm will result" if the order isn't issued.

Besides the medical board's activity, the Endoscopy Center of Southern Nevada health crises is the subject of a criminal probe being conducted by the Las Vegas Metropolitan Police Department, the FBI, Cortez Masto's office and the Clark County district attorney.

LASIK Worries Prompt Discussion of Alternatives

Tue, 29 Apr 2008 00:00:00 -0700

Federal regulators have received 140 complaint letters about LASIK and Food & Drug Administration (FDA) advisers are recommending the FDA clarify LASIK warnings. LASIK—laser-assisted in situ keratomileusis—involves cut a flap in the cornea, via laser, for corneal reshaping with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism. There are no guarantees of 20/20 vision and long-term safety remains unknown.

LASIK is not for everyone, especially those with misshapen or excessively thin cornea, early cataract formation, big pupils, dry eyes, or underlying conditions such as lupus or rheumatoid arthritis. LASIK risks include lost vision, painful dry eye, glare, and night-vision problems. Serious complications affect about one percent of the cases and FDA estimates place customer dissatisfaction at five percent. Aggressive marketing makes patients falsely believe clear sight is guaranteed, complained Dr. Jayne Weiss of Detroit's Kresge Eye Institute, who chaired the FDA advisory panel.

One in four patients seeking LASIK is deemed a poor candidate. It’s unclear how many patients are appropriately screened; some forge ahead anyway. "Some patients are just not a cornea laser eye surgery patient," stresses Dr. Kerry Solomon of the Medical University of South Carolina, a spokesman for the American Society for Cataract and Refractive Surgery. "There are still other options for them.... And some are, quite frankly, better suited to staying with their glasses and contacts."

Pre-LASIK laser called Surface Ablation or Wavefront-Guided PRK (photorefractive keratectomy) does not require cutting a flap into the cornea—the flap cuts nerve receptors that critics say never fully return to normal, thus increasing the risk of painful dry eye—a laser reshapes the cornea's surface. Patients occasionally suffer haze as corneas heal, not a LASIK risk. Wavefront-guided PRK uses computer software that provides a three-dimensional map, allowing surgeons to see subtle corneal irregularities, minimizing but not eliminating LASIK and PRK side effects. Those with thin corneas or corneal irregularities can be better PRK candidates and PRK can offer better night vision; however, it takes a few weeks of healing, with eye drops for the discomfort, before sharper vision emerges.

CK, or conductive keratoplasty, corrects farsightedness or astigmatism by beaming radiofrequency waves around the cornea's edge.

Phakic Intraocular Lenses are hard plastic lenses implanted in the eye in front of the natural lens and are for severe nearsightedness, so bad that correction cannot be accomplished with laser. This procedure refocuses light entering the eye for improved distance vision; because the natural lens stays in place, patients can retain close-up vision. Long-term effects are unknown. Warnings of rare problems include retinal detachment, infections, or increased cataract risk.

Refractive Lens Exchange replaces the patient's lens with an artificial lens and is essentially cataract surgery offered to cataract-free people who want LASIK but are bad candidates. Lens options include a multi-focal type that allows for distance and reading vision. Retinal detachment is a risk.

Corneal Rings are transparent crescents the thickness of a contact lens implanted to form a ring around the cornea's edge. Called Intacs, their slight weight flattens the cornea without permanently destroying tissue. While they're only for mild nearsightedness, they can be removed if patients suffer side effects, such as glare.

More Warnings for Lasik Surgery, FDA Panel Says

Mon, 28 Apr 2008 00:00:00 -0700

At a meeting of the U.S. Food and Drug Administration's (FDA) Ophthalmic Devices Panel Friday where post-LASIK quality-of-life issues were discussed, it was recommended the FDA ensure clearer warnings outlining the risks of LASIK, according to the Associated Press. LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye's cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism. Lasik was approved a decade ago and an estimated six million Americans have undergone Lasik surgery. The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of Lasik remains unknown.

The FDA has received 140 letters of complaints. "The FDA has called this a quality-of-life issue, because patients are complaining that their vision isn't sharp, they have poor night vision, some have glare or halos, some complain that their eyes are dry," said Dr. Robert Cykiert, associate professor of ophthalmology at New York University Langone Medical Center. FDA advisers recommended the agency clarify warnings regarding LASIK, including: Photographs to clearly show what people with side effects see, such as glares and light bursts; information indicating how often patients suffer side effects, such as dry eye; and clear information outlining the conditions under which someone should be disqualified from LASIK, such as large pupils or severe nearsightedness.

According to the Associated Press, David Shell of Washington, D.C., had LASIK in 1998 and said he has "not experienced a moment of crisp, good quality vision since. Matt Kotsovolos worked for the Duke Eye Center when he had a more sophisticated LASIK procedure in 2006 and said his doctors classified him as a success because he has 20-20 vision, but Kotsovolos said, "For the last two years, I have suffered debilitating and unremitting eye pain.”

Colin Dorrian, 28, a patent lawyer and aspiring medical student from Philadelphia committed suicide last summer, six years after Lasik surgery left him with visual distortions. Colin was told he wasn't a good candidate for LASIK, but got the surgery at a Lasik center in Canada that has since closed. "If I cannot get my eyes fixed, I'm going to kill myself…. I can't and won't continue facing this horror," he wrote in a his suicide note, adding, "I have other problems like most people do. But this is something else. As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it." On Friday, Colin’s father, Gerald, detailed the six years of eye pain and blurred vision experienced by his son.

Dr. Norman Saffra, director of ophthalmology at Maimonides Medical Center in New York City, says that LASIK is not for everyone, especially those with a misshapen or excessively thin cornea, who have early cataract formation or big pupils, who have dry eyes, or underlying conditions such as lupus or rheumatoid arthritis. Side effects can include glare and halos around lights at night and some patients have had corneal transplants, Starr said.

C-Diff Threatens More Hospital Patients

Thu, 24 Apr 2008 00:00:00 -0700

Cases of potentially deadly diarrhea-related infections—known as CDAD—are on the rise, increasing in U.S. hospitals by over 200 percent between 2000 and 2005. According to a new report by the federal Agency for Healthcare Research and Quality, 300,000 people contracted Clostridium difficile-associated disease (CDAD) and 8,600 died in 2005. Also, there was a 74 percent rise in CDAD cases recorded between 1993 and 2000 and over two million patients contracted CDAD between 1993 and 2005. “It is the next major germ threat,” said Betsy McCaughey, the former lieutenant governor of New York state and current head of the Committee to Reduce Infection Deaths (RID), an agency that focuses on improving infection control in hospitals and health care settings. This incredible spike has experts worried.

C. diff—or clostridium difficile—is a spore-forming, toxin-producing bacterium that infectious disease experts say is growing in speed and virulence similar to methicillin-resistant Staphylococcus aureus—MRSA—and is moving from within hospitals to the community at large. MRSA sickened over 94,000 and caused nearly 19,000 deaths in the U.S. in 2005. Like MRSA, C. diff has become multi-drug-resistant. Only previously affecting the elderly, hospitalized patient, a bolder strain of C. diff is now crippling the healthy.

C. diff is part of the natural flora, or bacteria, in the colon and is an ancient bacterium. Many people can, and do, carry it naturally and it can live in us without causing disease. Carrying C. diff does not mean we have an infection. As a matter-of-fact, it is common in our bodies following birth. The problem arises because what we don't have is the receptor for the toxin—the molecular key that unlocks C. diff's toxin-spewing capacity. Newer, mutant C. diff is fully equipped with the receptor and is capable of boosting toxin amounts, making C. diff lethal. C. diff can cause infections ranging from mild diarrhea to a deadly illness wherein a patient’s entire colon is removed.

C. diff produces hardy spores that can remain on surfaces—bedpans, toilet seats, floors—for weeks. “It’s on every surface,” McCaughey said. “They get the spores on their hands and their food arrives and they ingest the spores with their dinner rolls.” Alcohol does not work; only bleach can kill the spores.

Worse, there is a new, more virulent strain of C. diff thought to be about 20 times more toxic than previously known strains. The North American Phenotype 1/027 strain has been responsible for deadly outbreaks in Europe, Canada, and the U.S. in recent years and New York is one of 23 states the Centers for Disease Control and Prevention (CDC) has identified as having the highly toxic, mutant strain.

CDAD can be resistant to many traditional antibiotics, forcing use of the stronger vancomycin, but some infections are vancomycin-resistant, making them difficult or impossible to cure. The best treatment is prevention, McCaughey said. Hospitals must improve their hygiene practices and patients must be vigilant about not touching surfaces and keeping their hands out of their mouths. “This is a killer bacterium and we can’t be lazy about it,” she said.

FDA to Hear from Lasik Surgeons, Unhappy Patients

Thu, 24 Apr 2008 00:00:00 -0700

The US Food and Drug Administration (FDA) is finally going to review complaints from patients who underwent Lasik eye-correcting surgery and who have suffered from a variety of issues, including blurred vision and dry eyes. The FDA received 140 reports of Lasik surgery injuries between 1998 and 2006, according to an agency spokeswoman. Lasik was approved a decade ago and an estimated six million Americans have undergone Lasik surgery. The surgery permanently reshapes the cornea; there are no guarantees of 20/20 vision and the long-term safety of Lasik remains unknown.

The FDA will hear from Lasik eye surgeons and dissatisfied patients at a meeting Friday with its outside panel of eye experts and will ask the panel whether educational materials provided to patients considering Lasik require change or update. Regulators agreed to hold the meeting after years of complaints from some patients who say their eyesight has been permanently damaged by Lasik. "My life is a blur," Dean Kantis said. "When I look at a computer screen, I see two pages; when I look up at the moon, I see three of them." Kantis is one of Friday’s scheduled speakers.

Double vision, night-vision disturbances and dry eye are among the side effects listed in literature given to Lasik patients; however, Kantis and others argue that physicians don’t generally focus on these risks. "Just before the procedure, they shove the informed consent form in front of you, but you just sign it and no one reads the fine print," Kantis said.

An FDA spokeswoman said the FDA has no authority over physician handling of patients; however, regulators have agreed to work with the American Society of Cataract and Refractive Surgery on a large-scale study of patients' post-surgical quality of life. As part of the study to examine the relationship between Lasik complications and quality of life issues, are plans to look at psychological problems such as depression. When patients undergo vision-correcting laser eye surgery—such as Lasik—they sign a release form with an extensive list of risks; however, researchers and former patients say a potential complication is not mentioned: Depression leading to suicide. While frustration and sadness can result from any unsuccessful surgery, when left with constant eye pain or permanently impaired vision, the response can be severe. For instance, Colin Dorrian, 28, a patent lawyer and aspiring medical student from Philadelphia committed suicide last summer, six years after Lasik surgery left him with visual distortions. The surgery was conducted at a Lasik center in Canada that has since closed. "If I cannot get my eyes fixed, I'm going to kill myself," he wrote in a note police found, adding, "I have other problems like most people do. But this is something else. As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it."

Lasik laser manufacturers, which include Advanced Medical Optics Inc., Alcon Inc., and Bausch and Lomb are under analyst radar as Lasik procedures are expected to decline five to 15 percent this year because it cost—between $1,500 and $5,000—may not be affordable to many consumers.

More Action Needed on Hospital Infections

Thu, 17 Apr 2008 00:00:00 -0700

A nonpartisan congressional report released this week states that the U.S. government could do more to force hospitals to prevent infections that are killing up to 99,000 people annually. As part of the report’s recommendations, regulators could consider mandating certain core standards, such as hand washing, for which the government could tie reimbursements. It is believed that by setting priorities for those measures which work best, some of the $5 billion in extra costs resulting from hospital infections could be stayed, the Government Accountability Office report said.

The report criticized the U.S. Department of Health and Human Services (HHS) for not coordinating data across agencies and not requiring hospitals to apply recommended practices. "HHS is not exploiting its leverage to reduce or eliminate hospital acquired infections," Cynthia Bascetta, director for health issues at the Government Accountability Office told a U.S. House of Representative committee hearing on Wednesday. "We concluded that leadership from the secretary is required." Experts feel mandating proven practices would be relatively inexpensive; however, health care practitioners would need payment incentives and guidance from regulators and accrediting agencies on the best practices. Meanwhile, Medicare, just expanded the list of hospital-acquired conditions for which it would cut funding. Medicare, the state-federal health insurance plan, spends almost $400 billion on care for about 44 million elderly and disabled people.

Don Wright, a public health official at HHS, acknowledged efforts are needed to improve coordination among agencies saying, "HHS recognizes more work and leadership is necessary to enhance patient safety in this regard.” According to experts, U.S. health care system providers tend to be paid on a fee-for-service basis, which, by its very nature, rewards excess care. "Unfortunately in some ways we get what we pay for," Leah Binder, the chief executive at the Leapfrog Group, a nonprofit that represents employers. "We pay the same even when errors occur that jeopardize a patient's health or life; indeed we pay more for poor performance," said Binder, a former hospital executive.

Peter Pronovost, head of the Quality and Safety Research Group at Johns Hopkins University, told the panel that another problem is the ongoing concern with “trendy” new drugs and technologies and not infection prevention and correct patient care. For instance, last year alone, 94,000 Americans developed MRSA—methicillin-resistant S. aureus; most were infected in healthcare facilities and 19,000 died. The Centers for Disease Control (CDC) says drug-resistant infections in hospitals must be fought with multiple strategies: Better hospital hygiene, enhanced cleaning, and testing. A handful of U.S. hospitals routinely screen and test for MRSA and have found it to be very effective, with one study showing a 50-percent infection reduction. Three states and the Veterans Administration have also ordered MRSA screenings. But the CDC says that testing alone is not sufficient and will not order screenings. The overarching feeling is that the CDC is discounting significant and growing evidence indicating that aggressive hospital testing could significantly cut down the spread of hospital-generated MRSA. Given that the epidemic started with hospital-generated MRSA and with nearly 100,000 MRSA cases last year—20% ending in death—this seems a legitimate course of action.

Petsmart Lawsuit Alleges Transplant Patient's Death Caused by Sick Hamster

Fri, 11 Apr 2008 00:00:00 -0700

Petsmart, Inc.—the nation’s largest specialty pet store—is being sued by Nancy Magee who claims her husband, Thomas, died following a liver transplant wherein the liver was contaminated by a sick hamster sold by Petsmart to the organ donor. The lawsuit was filed in Massachusetts Superior Court this February and was moved to U.S. District Court in Boston this week. The suit seeks unspecified damages.

In court papers, Magee charged that in March 2005, a Warwick, Rhode Island Petsmart sold a hamster infected with lymphocytic choriomeningitis virus, or LCMV, to a woman not named in the suit. The unnamed woman later died of a stroke and her liver was transplanted into Thomas Magee in April 2005. One month following transplantation, Thomas Magee died of LCMV. The suit states two other people who received transplants with organs from the unnamed woman died and a third became seriously ill. The suit also notes that medical authorities confirmed the hamster in question to be infected with LCMV.

LCM, is a rodent-borne viral infectious disease found in the saliva, urine, and feces of infected mice who carry and shed LCMV for the duration of their lives without showing any sign of illness. While hamsters, are not the natural carriers of the disease, they can become infected from wild mice at the breeder, pet store, or home environment. While humans are more likely to contract LCMV from house mice, infections from pet rodents have been reported. Person-to-person transmission is rare outside of transmission from an infected mother to fetus; however, recent investigations confirm organ transplantation as a means of transmission.

LCMV normally has little effect on healthy people but can be fatal for those whose immune system has been compromised, such as organ transplant recipients. For those, symptoms appear one-to-two weeks following exposure with the first phase lasting a week and consisting of fever, malaise, lack of appetite, muscle aches, headache, nausea, and vomiting. Other symptoms that appear less frequently include sore throat, cough, joint pain, chest pain, testicular pain, and parotid (salivary gland) pain. After a few days of recovery, the second phase occurs which consists of meningitis symptoms—fever, headache, and a stiff neck—or encephalitis symptoms—drowsiness, confusion, sensory disturbances, and/or motor abnormalities, such as paralysis. LCMV can cause acute hydrocephalus, which is increased fluid on the brain and usually requires surgical shunting. In rare instances, infection results in myelitis—spinal cord inflammation—with muscle weakness, paralysis, or changes in body sensation. There has been some link
between the virus and myocarditis—heart muscle inflammation.

Recently, a 15-year-old boy’s parents donated their son’s organs following his death from bacterial meningitis. His organs were deemed healthy for transplantation, but instead of having died from bacterial meningitis, the family learned the boy died of a rare lymphoma, a diagnosis in which his organs would not have been transplanted. Two patients who received the boy’s organs died of the same rare lymphoma and two other’s are undergoing chemotherapy. In those cases when lymphoma-diseased organs have been transmitted, the results have been devastating.

Cost of Medical Errors High, and Not Just in Dollars

Wed, 09 Apr 2008 00:00:00 -0700

Medical errors—or patient safety incidents—are costing the federal Medicare program upwards of $8.8 billion. Worse, in the period from 2004 through 2006, patient safety incidents resulted in 238,337 potentially preventable deaths according to HealthGrades' fifth annual Patient Safety in American Hospitals Study. HealthGrades analyzed 41 million Medicare patient records and discovered that that patients treated at top-performing hospitals had, on average, a 43 percent lower chance of experiencing one or more medical errors compared to the poorest-performing hospitals.

The overall incident rate was approximately three percent of all Medicare admissions evaluated, which accounted for 1.1 million patient safety incidents during the three years studied. Effective October 1, the Centers for Medicare and Medicaid Services are scheduled to stop reimbursing hospitals for the treatment of eight major preventable errors, including objects left in the body following surgery and some post-surgical infections. Given this, the financial implications for hospitals are substantial.

The HealthGrades study also identified hospitals with patient-safety incidence levels in the lowest five percent in the nation and found that Medicare patients who experienced a patient-safety incident during the study time frame, had a one-in-five chance of dying as a result of the incident. Although the overall death rate among Medicare beneficiaries who developed one or more patient safety incidents decreased nearly five percent; however, four indicators—post-operative respiratory failure, pulmonary embolism or deep vein thrombosis, sepsis, and abdominal wound separation/splitting—increased. Medical errors with the highest incidence rates were bedsores, failure to rescue, and post-operative respiratory failure, accounting for over 63 percent of all incidents. Bedsores and post-operative respiratory failure worsened during the study period. Finally, of the 270,491 deaths that occurred among patients who developed one or more patient safety incidents, the vast majority—a staggering 238,337—were preventable.

If all hospitals performed at the level of Distinguished Hospitals for Patient Safety™, approximately 220,106 patient safety incidents and 37,214 Medicare deaths could have been avoided, saving the US about $2.0 billion during 2004 to 2006. "While many U.S. hospitals have taken extensive action to prevent medical errors, the prevalence of likely preventable patient safety incidents is taking a costly toll on our health care systems, in both lives and dollars," said Dr. Samantha Collier, HealthGrades' chief medical officer and the primary author of the study. "HealthGrades has documented, in numerous studies, the significant and largely unchanging gap between top-performing and poor-performing hospitals. It is imperative that hospitals recognize the benchmarks set by the Distinguished Hospitals for Patient Safety are achievable and associated with higher safety and markedly lower cost."

The fifth annual HealthGrades Patient Safety in American Hospitals Study applies methodology developed by the US Department of Health and Human Services' Agency for Healthcare Research and Quality for identification of incident rates of 16 patient safety indicators among Medicare patients at virtually all of the nation's nearly 5,000 nonfederal hospitals. HealthGrades applied this methodology using 13 patient safety indicators to identify the best-performing hospitals, or Distinguished Hospitals for Patient Safety™, representing the top five percent of US hospitals.

Long Island Hospitals Don't Make the Grade with Consumers

Wed, 09 Apr 2008 00:00:00 -0700

According to a recent federal consumer survey, Long Islanders are not satisfied with their hospitals and, on average, Long Island hospitals scored lower in patient satisfaction in eight out of 10 measures as compared with other hospitals statewide or even nationally. "I can't explain it, other than we have a more critical audience on Long Island," said Kevin Dahill, chief executive of the Nassau-Suffolk Hospital Council. "The good news is that so many Long Island hospitals participated and they are going to learn from it.”

For the first time, the Centers for Medicare & Medicaid Services has posted consumer survey information on its Hospital Compare Web site. This year, the survey is voluntary, with the decision to allow the government to release the findings remaining with each hospital. On Long Island, the majority of hospitals—18 out of 23—reported their findings; of 4,486 hospitals nationwide, about half—or 2,521—released patient satisfaction information, according to the Medicare agency. Next year, every hospital will be mandated to publicly report their survey results which currently originated from a random sample of discharged patients from October 2006 through June 2007; hospitals began collecting data in July 2007.

Dahill complained the Web site is difficult to navigate and that "the questions are so subjective." Although he said hospitals must review the data closely, he questioned the survey’s scientific validity. Liz Goldstein, the federal agency's chief of consumer assessments and health care surveys, said the survey was developed in 2002, after "extensive cognitive testing," comments from focus groups, doctors, nurses, and hospital administrators and pilot studies. As of March 29, when the patient-satisfaction data became available, the Hospital Compare site recorded 1.1 million page views; it received 161,000 views the prior week.

Long Island's largest health system—North Shore-Long Island Jewish Health System—did not do well and Long Island Jewish Medical Center in New Hyde Park scored below the state and national average in all 10 areas. North Shore University Hospital in Manhasset scored below the state and national average in eight measures. Mark Solazzo, chief operating officer for North Shore-LIJ, said many changes have been instituted to improve patient satisfaction at its 13 hospitals, including implementing a $1.9 billion capital improvement and ensuring unit manager accountability for patient satisfaction.

Meanwhile, Eastern Long Island Hospital in Greenport scored at or above the state average in all 10 categories and at or above the national average in eight of 10 categories. Paul Connor, chief executive of the 80-bed hospital, said, "This is a small, little hospital that pays a lot of attention to general care."  St. Francis Hospital, the cardiac center, received the highest percentages in seven categories for Long Island and was above the state average in nine. Dr. Akram Boutros, the hospital's chief administrative officer, attributed the high scores to the hospital's maintaining its founding mission: Patient-centered teamwork and a high staff-to-patient ratio.

Five Long Island hospitals did not release results: Brookhaven Memorial Hospital Medical Center in East Patchogue, Long Beach Medical Center, Nassau University Medical Center in East Meadow, Peconic Bay Medical Center in Riverhead, and Winthrop-University Hospital in Mineola.

Medical Mistakes, Drug Reactions Threaten Children

Tue, 08 Apr 2008 00:00:00 -0700

Medical mistakes and adverse reactions to drugs injure 1 in 15 children admitted to the hospital, a new study finds. That study, published in the journal "Pediatrics", found that more than 540,000 kids were subjected to the wrong drugs, accidental overdoses and unfavorable reactions every year while hospitalized - far more than was previously thought.

The study, conducted by researchers at Stanford University's Lucile Packard Children's Hospital, involved a review of the charts of 960 randomly selected children from 12 children's hospitals around the United States. The researchers utilized a list of 15 "triggers" that if found on a patients' chart might indicate possible drug-related problems. The triggers included the use of antidotes for drug overdoses, suspicious side effects and lab tests.

For every 100 children, the researchers found that 11.1 suffered from adverse drug reactions. Of these, 22 percent were preventable, 17.8 percent could have been identified earlier, and 16.8 percent could have been handled more effectively. Fortunately, the majority of adverse drug reactions - 97 percent - caused minor harm, such as nausea and rashes. Unfortunately, only about 3.7 percent of adverse reactions were identified by standard hospital reports. Overall there were far more adverse reactions to drugs among hospitalized children than once thought. Earlier estimates had said that only 2 children per 100 had suffered adverse reactions while in the hospital.

According to the researchers, the drugs that were most commonly misused were pain medications and antibiotics. Most common mistakes included not monitoring patients, prescribing the wrong medicine, or wrong doses, the researchers said. The researchers said that the findings show a need for "aggressive, evidence-based prevention strategies to decrease the substantial risk for medication-related harm to our pediatric inpatient population".

Medical mistakes made news late last year when actor Dennis Quaid's newborn twins were given a near-fatal overdose of heparin. Since then Quaid and his wife have been on a crusade to raise awareness of medical mistakes. “These mistakes that happened to us are not unique … they happen in every hospital, in every state in this country,” Quaid said in interview with the TV program "60 Minutes". “It’s bigger than AIDS. It’s bigger than breast cancer. It’s bigger than automobile accidents and, yet, no one seems to really be aware of the problem.”

Quaid himself praised the new study in an interview with the Associated Press, and had this advice for parents with children in the hospital: “Every time a caregiver comes into the room, I would check and ask the nurse what they’re giving them and why.”

Endoscopy Center of Southern Nevada Loses License, Pays Fine

Tue, 08 Apr 2008 00:00:00 -0700

Yesterday the City of Las Vegas handed out a stiff punishment to the owners of the Endoscopy Center of Southern Nevada, the clinic where unsanitary practices many have exposed thousands of people to hepatitis and HIV. Not only has the Endoscopy Center of Southern Nevada lost its business license, but the owners of the practice were hit with a $500,000 fine. But many angry patients who attended a hearing of the city council said they hoped the investigation into the Endoscopy Center's abuses would eventually result in criminal indictments.

In February, the Southern Nevada Health District sent letters to 40,000 people treated at the clinic, advising them to get tested for hepatitis B and C, and HIV. The Endoscopy Center of Southern Nevada has been under investigation since early January, after health officials learned of three people who had been diagnosed with hepatitis C after being treated there. Ultimately, the Southern Nevada Health District said a total of six people were known to have contracted hepatitis C after being treated at the Endoscopy Center of Southern Nevada. Five of them were treated the same day in late September; the sixth is believed to have been infected in July, the district said. The Southern Nevada Health District investigation revealed that “unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients.” Last week, a seventh hepatitis C victim, who had been treated at a clinic owned by the same group that owns the Endoscopy Center, was identified.

The hepatitis C virus may have been spread when clinic staff reused syringes and used a single dose of anesthesia medication on multiple patients, the district said. A syringe would become contaminated by the backflow of blood when patients with a blood-borne disease were injected with medication, health officials said. That syringe, in turn, would be reused to withdraw medication from a different vial. That vial could become contaminated and result in infection.

The subsequent investigation of the clinic revealed even more substandard practices. Several staff members told investigators that biopsy equipment labeled for single use was reused for multiple patients after disinfection. Others reported that they were directed to reuse bite blocks - devices put in patients’ mouths for some procedures - on multiple patients.

Attendees at yesterday's hearing had hoped to hear from Dr. Dipak Desai and others involved in the Endoscopy Center scandal. But there was little legal weight behind the city's request that they testify. Instead, the Endoscopy Center of Southern Nevada and an affiliated clinic lost their business licenses, which the city had already suspended on February 29. According to a report for in the Las Vegas Sun, lawyers for the clinic had contacted the mayors office looking to avoid a full-blown hearing. They agreed to accept the city's decision to rescind the business license, and agreed to pay a $500,000 fine. The fine was paid at yesterday's hearing.

Las Vegas mayor Oscar Goodman said the money could be used to a assist those who were directly affected by the Endoscopy Center debacle. The mayor said it could be spent to offset the cost of blood tests to determine whether the 40,000 people advised to be tested for hepatitis B, hepatitis C and HIV. Goodman also mentioned that it would cost an estimated $500,000 to hire an outside business to organize medical records Metro Police confiscated from the clinic.

Several people attending the meeting - many of them former patients of the Endoscopy Center - told the Las Vegas Sun that they wanted to see more action - preferably in the form of criminal charges - taken against Desai and others. They could have their wish granted soon , as a criminal investigation of the Gastroenterology Center of Nevada's clinics - one of which is the Endoscopy Center - is currently underway.

More Violations Found At Endoscopy Center of Southern Nevada

Fri, 04 Apr 2008 00:00:00 -0700

The unsanitary practices employed by the Endoscopy Center of Southern Nevada have turned out to have been much worse than first reported. In addition to reusing syringes and drawing from single-dose medicine vials for multiple patients, the Endoscopy Center of Southern Nevada regularly performed 2-minute surgeries and reused other disposable devices. These revelations have caused some to speculate that the reused syringes and medicine vials might not be the primary cause of a hepatitis C outbreak linked to the Endoscopy Center of Southern Nevada, but health investigators say that is not likely.

In February, the Southern Nevada Health District sent letters to 40,000 people treated at the clinic, advising them to get tested for hepatitis B and C, and HIV. The Endoscopy Center of Southern Nevada has been under investigation since early January, after health officials learned of three people who had been diagnosed with hepatitis C after being treated there. Ultimately, the Southern Nevada Health District said a total of six people were known to have contracted hepatitis C after being treated at the Endoscopy Center of Southern Nevada. Five of them were treated the same day in late September; the sixth is believed to have been infected in July, the district said. The Southern Nevada Health District investigation revealed that “unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients.” In March, a seventh hepatitis C victim, who had been treated at a clinic owned by the same group that owns the Endoscopy Center, was identified.

The hepatitis C virus may have been spread when clinic staff reused syringes and used a single dose of anesthesia medication on multiple patients, the district said. A syringe would become contaminated by the backflow of blood when patients with a blood-borne disease were injected with medication, health officials said. That syringe, in turn, would be reused to withdraw medication from a different vial. That vial could become contaminated and result in infection.

But now it appears that may have just been the beginning of the dangerous methods employed by the Endoscopy Center. According to a report in the Las Vegas Sun, the clinic regularly engaged in other dangerous practices. Several staff members told investigators that biopsy equipment labeled for single use was reused for multiple patients after disinfection. Records seem to confirm this: 7,800 biopsies or polyp removals were performed in 2007, but only 6,200 biopsy forceps or polyp removal wires were purchased.

The clinic’s staff also told investigators they’d reused bite blocks - devices put in patients’ mouths for some procedures - which cost about $2.25 each. According to the Las Vegas Sun, the clinic’s purchasing records show it bought only about 2,000 bite blocks in 2007, when about 5,800 upper endoscopy procedures, which call for use of the blocks, were performed there. One clinic staffer told investigators that they were permitted to use only four bit blocks each day in each of the Endoscopy Center's procedure rooms.

The Las Vegas Sun also is reporting that on Sept. 21, 2007 — one of the dates on which hepatitis C was passed to patients — one colonoscopy lasted only two minutes and another only three minutes. Several staff members told investigators that anesthesia times had been incorrectly reported to allow for additional billing. This could be insurance fraud and is the subject of an investigation by the Nevada attorney general’s office and the FBI.

Endoscopy Center Doc Has Passport Flagged

Tue, 01 Apr 2008 00:00:00 -0700

A doctor at the center of a Las Vegas hepatitis C outbreak has reportedly had his passport flagged. Should Dr. Dipak Desai, majority owner of the Endoscopy Center of Southern Nevada, try to leave the country, officials in that state would be notified. Unsanitary practices employed at the Endoscopy Center of Southern Nevada have been blamed for several cases of hepatitis C among the clinic's patients.

In February, the Southern Nevada Health District sent letters to 40,000 people treated at the clinic, advising them to get tested for hepatitis B and C, and HIV. The Endoscopy Center of Southern Nevada has been under investigation since early January, after health officials learned of three people who had been diagnosed with hepatitis C after being treated there. Ultimately, the Southern Nevada Health District said a total of six people were known to have contracted hepatitis C after being treated at the Endoscopy Center of Southern Nevada. Five of them were treated the same day in late September; the sixth is believed to have been infected in July, the district said. The Southern Nevada Health District investigation revealed that “unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients.” In March, a seventh hepatitis C victim, who had been treated at a clinic owned by the same group that owns the Endoscopy Center, was identified.

The hepatitis C virus may have been spread when clinic staff reused syringes and used a single dose of anesthesia medication on multiple patients, the district said. A syringe would become contaminated by the backflow of blood when patients with a blood-borne disease were injected with medication, health officials said. That syringe, in turn, would be reused to withdraw medication from a different vial. That vial could become contaminated and result in infection.

Authorities arranged to have Desai's passport flagged after serving a search warrant at the Endoscopy Center of Southern Nevada last month. While the action would not prevent him from leaving the country, it would allow investigators to attempt to interview Desai before he left the country.

Nurses have told health officials they were directed to reuse syringes and single-dose vials of medicine on multiple patients. It still is unclear who told them to do so and whether that was standard policy at the clinic. According to a report in the Las Vegas Sun, at a public hearing last week attended by 200 people, many expressed outrage that Desai was not under arrest and that he still is allowed to practice medicine, though Desai has voluntarily agreed not to do so for the time being.

Last week, Las Vegas Mayor Oscar Goodman stated his intention to have the city subpoena Desai and other doctors who own the Endoscopy Center of Southern Nevada to testify at a hearing at which the city will consider rescinding the Endoscopy Center’s business license. To keep their city business license, the owners of the Endoscopy Center of Southern Nevada will need to make their case at a public hearing April 7 in the Las Vegas City Council chambers. The city had suspended the clinic’s business license on February 29, as well as that of its related practice, the Gastroenterology Center of Nevada. So far, neither Desai nor any of the other doctors involved with the clinic have made public statements about its practices.

Las Vegas to Subpoena Endoscopy Center of Southern Nevada Doctors

Tue, 25 Mar 2008 00:00:00 -0700

Doctors from the Endoscopy Center of Southern Nevada may finally be forced to break their silence - at least if the Mayor of Las Vegas has his way. The unsanitary practices employed by practitioners at the Endoscopy Center of Southern Nevada are at the center of a hepatitis C scare that could affect thousands of people. Now, Mayor Oscar Goodman says that the doctors who own the clinic will be subpoenaed to testify at a hearing at which the city will consider rescinding the Endoscopy Center's business license.

In February, the Southern Nevada Health District sent letters to 40,000 people treated at the clinic, advising them to get tested for hepatitis B and C, and HIV. The Endoscopy Center of Southern Nevada has been under investigation since early January, after health officials learned of three people who had been diagnosed with hepatitis C after being treated there. Ultimately, the Southern Nevada Health District said a total of six people were known to have contracted hepatitis C after being treated at the Endoscopy Center of Southern Nevada. Five of them were treated the same day in late September; the sixth is believed to have been infected in July, the district said. The Southern Nevada Health District investigation revealed that “unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients.” Last week, a seventh hepatitis C victim, who had been treated at a clinic owned by the same group that owns the Endoscopy Center, was identified.

The hepatitis C virus may have been spread when clinic staff reused syringes and used a single dose of anesthesia medication on multiple patients, the district said. A syringe would become contaminated by the backflow of blood when patients with a blood-borne disease were injected with medication, health officials said. That syringe, in turn, would be reused to withdraw medication from a different vial. That vial could become contaminated and result in infection.

According to the Las Vegas Sun, Mayor Goodman said the city is in the process of subpoenaing the physicians who own the practice — majority owner Dr. Dipak Desai, Dr. Eladio Carrera, Dr. Clifford Carrol and Dr. Vishvinder Sharma. Ten other physicians worked at the clinics. None of the owners of the clinic has made any public statements since the scandal broke. According to the Las Vegas Sun, Desai has voluntarily agreed to stop practicing medicine during the Nevada State Board of Medical Examiners’ investigation of his conduct. The others may still be practicing at other affiliated clinics or in local hospital.

To keep their city business license, the owners of the Endoscopy Center of Southern Nevada will need to make their case at a public hearing April 7 in the Las Vegas City Council chambers. The city had suspended the clinic's business license on February 29, as well as that of its related practice, the Gastroenterology Center of Nevada. The city has alleged that Desai ordered nurses and others at the clinic to reuse syringes in order to save money.

Endoscopy Center of Southern Nevada Results in Shake-Up at State Agencies

Tue, 18 Mar 2008 00:00:00 -0700

The fallout from the Endoscopy Center of Southern Nevada hepatitis outbreak continued yesterday, as the governor of Nevada fired the head of the state's Bureau of Licensure and Certification, and called for the replacement of three other doctors who sit on the Board of State Medical Examiners, as well as the head of that board. However, none of those individuals has resigned, and two charged that the governor is playing politics by asking for their removal.

The Endoscopy Center of Southern Nevada has been under investigation since early January, after health officials learned of three people who had been diagnosed with hepatitis C. Ultimately, the Southern Nevada Health District said a total of six people were known to have contracted hepatitis C after being treated at the Endoscopy Center of Southern Nevada. Five of them were treated the same day in late September; the sixth is believed to have been infected in July, the district said. The Southern Nevada Health District investigation revealed that “unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients.”

The hepatitis C virus may have been spread when clinic staff reused syringes and used a single dose of anesthesia medication on multiple patients, the district said. A syringe would become contaminated by the backflow of blood when patients with a blood-borne disease were injected with medication, health officials said. That syringe, in turn, would be reused to withdraw medication from a different vial. That vial could become contaminated and result in infection.

Earlier this month, the health district sent letters to some 40,000 patients treated at the Endoscopy Center of Southern Nevada, warning them that they should be tested for hepatitis B, C and HIV. Last week, several trial lawyers in the state reported that they were representing nearly 100 former clinic patients who tested positive for blood borne diseases that they suspect originated at the Endoscopy Center. Most of those patients have hepatitis C, but some have HIV, the lawyers said.

Nevada Governor Jim Gibbons yesterday ordered the removal of Lisa Jones as head of the state Bureau of Licensure and Certification. The bureau oversees clinics in the state, including the Endoscopy Center. But three doctors on the state Board of Medical Examiners who Gibbons wants replaced didn't resign immediately. Drs. Javaid Anwar, S. Daniel McBride and Sohail Anjum already had recused themselves from any board meetings dealing with the Endoscopy Center. Gibbons wants the three doctors replaced because of their associations or business dealings with Dr. Dipak Desai, owner of the Endoscopy Center of Southern Nevada. Gibbons also is seeking to replace Tony Clark, the medical board's executive director.

According to the Associated Press, McBride termed the governor's move "outrageous," adding that he won't step down and accusing Gibbons of "trying to inject politics into the board process." He said that if the Board of Medical Examiners seemed to move slowly on the hepatitis issue, it was because Gibbons' Board of Licensure and Certification delayed informing the examiners' panel until after stories of the problem broke.

Clark is also refusing to go quietly, saying he would only resign if asked to by the board. Clark also said he believed the governors call for him to resign was part of political vendetta. Clark, formerly Nevada's adjutant general, ran the state Air and Army National Guard when Gibbons, a decorated military pilot, was ordered to retire as Air Guard vice commander in late 1994. But the governor said that his calls for Clark to be replaced have nothing to do with that incident.

LASIK Surgery to Undergo FDA Review

Tue, 18 Mar 2008 00:00:00 -0700

US health regulators plan to review whether LASIK—laser-assisted in situ keratomileusis— surgery is actually improving patients' lives. Last month, in response to patient complaints, the US Food and Drug Administration (FDA) discussed plans to organize a large, national study to examine the relationship between LASIK complications and quality of life issues, including psychological problems such as depression. According to Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, those discussions have now led to plans for a public meeting to talk about the issue. Schultz said a number of concerns have been raised concerning patient satisfaction with the LASIK vision correction procedure.

Schultz did not give a date when the meeting will occur. Companies that could be affected by such a meeting include LASIK device makers such as Advanced Medical Optics Inc. and LASIK providers such as TLC Vision Corp and LCA-Vision Inc. "Obviously, it's a technology that has caught on and is used very, very widely. And there have been questions raised in terms of ... quality of life and what does it actually do for the patient as opposed to the technology itself," Schultz said adding that the meeting will focus on the quality of patients' lives following surgery. Although FDA spokeswoman Karen Riley said the meeting date has not been made public, some analysts have said it could happen as early as next month. Meanwhile, the agency's eye-related panel has tentatively scheduled meetings for April 24-25, May 15-16, September 18-19, and November 20-21.

When patients undergo vision-correcting laser eye surgery, such as LASIK, they sign a release form with an extensive list of risks. Known complications can include dry eyes, glare, double vision, an increased risk of corneal inflammation or infection, and blindness. However, researchers and former patients say a potential complication is not mentioned -- depression leading to suicide.

In July 2007, the FDA responded to petitions from an individual requesting that LASIK procedures be stopped and for a withdrawal of their approval. The agency responded by saying the LASIK devices were safe and effective but advisory panel discussions "could complement" its other safety monitoring. "The post-market information found within our databases, regarding the devices mentioned in your petitions, does not suggest that at this time, there are adverse events that are unanticipated or occurring at an unexpected rate," the FDA said then.

In a research note, analyst Larry Biegelsen—from Wachovia Capital Markets—said the planned FDA meeting could result in a couple of different outcomes. Either doubt could be cast on affected companies because of an uncertain outcome or it "could ultimately be positive for companies" if the panelists decide the surgery does helps patients, especially those which were done with newer technologies, he said.

In 2006, the FDA began to look into LASIK complications and quality-of-life issues and determined more research was needed. A task force including representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study to be conducted by laser eye surgeons across the country.

Dennis Quaid Speaks Out on Heparin Overdose, Medical Mistakes

Mon, 17 Mar 2008 00:00:00 -0700

Accidental Heparin overdoses are a real threat to patients, says actor Dennis Quaid, who nearly lost his children to a medical mistake. Late last year, the newborn twins of Dennis Quaid and Kimberly Buffington were given a massive, accidental overdose of the blood thinner, Heparin, at California’s Cedar-Sinai hospital. The children were given vials of Heparin 1,000 times stronger than what should have been prescribed. Quaid is now speaking out about medical mistakes and is scheduled for an interview on CBS’s “60 Minutes” this Sunday. Quaid and his wife are suing the drug's manufacturer, Baxter International Inc., for negligence in packaging different doses of Heparin in similar vials with blue backgrounds. Baxter has said the product was safe but that a hospital staffer misread the label. According to Quaid, "the nurse didn't bother to look at the dosage on the bottle."

Baxter’s Heparin comes in 10 unit vials for babies and vials up to 10,000 units for adults. The twins were dosed from 10,000 unit vials with two separate over-dosages. The babies began to bleed out just before midnight and were transferred to the neo-natal intensive care. Pharmacy technicians stock Heparin for use in preventing clots and for flushing IVs. Hospital protocol is to keep the different units separated, but a technician accidentally put the 10,000 unit vials in the drawer where the 10 unit vials were stored.

Quaid has said that as many as 100,000 Americans are killed in hospitals by medical mistakes. "These mistakes that happened to us are not unique ... they happen in every hospital, in every state in this country," said Quaid who was speaking in his first TV interview regarding his twins’ overdose. "It's bigger than AIDS. It's bigger than breast cancer. It's bigger than automobile accidents and, yet, no one seems to really be aware of the problem." A 1999 report by the U.S. Institute of Medicine agreed stating, "Good people are working in bad systems that need to be made safer."

In a statement last year, the Quaid’s said, "We were told by upper Cedars-Sinai administration that our children had received only one 10,000 unit dose of Heparin when in fact they had received two 10,000 unit doses over an eight-hour period that we now know of. The hospital's lack of candor has left us with the uneasy feeling that we may never know the whole story,". Hospital staff gave the Quaid’s two-week-old twins—Thomas Boone and Zoe Grace—1,000 times the recommended dose of the blood thinner heparin. "It basically turned their blood to the consistency of water, where it had a complete inability to clot. They were basically bleeding out at that point," Quaid said. Even worse, the hospital did not notify the Quaid’s that anything was wrong until the next day. And, still worse, the Quaids believe someone at the hospital leaked information about the error to the news media.

Baxter International is at the epicenter of another Heparin storm in which 21 deaths and over 700 adverse reactions have been reported in the US. It is suspected that a contaminated ingredient from an uninspected Chinese manufacturer might be responsible for those Baxter Heparin problems.

More Patients Awake During Surgery Than Once Thought

Fri, 14 Mar 2008 00:00:00 -0700

Unintended Awareness - or Anesthesia Awareness - is a terrifying phenomenon affecting one or two of every 1,000 surgical patients. That's about 100 patients daily and 30,000 Americans annually. Unintended Awareness is when a patient wakes during surgery. When this occurs, patients can feel excruciating pain without being able to move or cry out and involves patients having some recollection of surgical events. It is more likely to affect children and occurs in patients whose condition is unstable or in emergency or trauma situations. Patients who experience Anesthesia Awareness may develop acute distress and emotional reactions and later onset of long-term psychological effects.

Most surgical anesthetics consist of a cocktail of drugs: A sleep agent, painkiller, and paralyzing agent. When the paralytic works, the patient is unable to speak or move and advise doctors that the sleep agent has failed.

Experts believed special brain-wave monitors were the best way to prevent Anesthesia Awareness. Now, the first large, independent test of the monitors shows no improvement over older technology. Researchers at Washington University School of Medicine in St. Louis compared two groups of about 1,000 patients each, all deemed at high risk for Anesthesia Awareness. One group was fitted with the leading brain-monitoring system, which uses electrodes on the forehead to measure brain waves and software to calculate likelihood of consciousness. The other used an older device that analyzes exhaled anesthetic gas. Anesthesiologists watched for movement and changes in vital signs and followed protocols to maintain patients’ depth of sleep, adjusting anesthesia levels as needed. Patients were interviewed after their surgeries about what they remembered. Two people in each group experienced awareness; the two with the newer system felt pain as well.

Lead researcher Dr. Michael Avidan said that in two of those cases—one with each system—monitors indicated no problems; in the other two cases, monitors signaled problems. The position of the anesthesiologists group has been that brain wave monitoring should not be done routinely, but may be helpful for certain patients at high risk of awareness. Widespread use would be very costly.

Aspect Medical Systems, a large brain wave monitoring system maker, says its device, the bispectral index or BIS, is used in about 17 percent of the nearly 20 million annual US surgeries in which anesthesia gas is used. The BIS can cost as little as $5,000; however, researchers estimate if it were used on all US patients receiving general anesthesia, the disposable electrodes alone would cost over $360 million yearly. The device, on sale since 1998, “can prevent both too little anesthesia, which could cause awareness, and too much anesthesia, which could cause prolonged recovery and anesthetic side effects” said Aspect’s medical director, Boston anesthesiologist Dr. Scott Kelley.

Avidan’s fellow researcher, anesthesiology professor Dr. Alex Evers, said having doctors closely follow a protocol to maintain patients’ depth of sleep was key to reducing Anesthesia Awareness in both groups. In 2005, guidelines were developed and approved that established protocols to help ensure proper anesthetic dosing and stated doctors should keep watch for Unintended Awareness by checking clinical signs such as movement and using conventional monitoring systems such as electrocardiograms, blood pressure monitors, and heart-rate monitors.

Dix Hills Doctor's Office Raided by Nassau County DA

Thu, 13 Mar 2008 00:00:00 -0700

The Nassau County district attorney's office raided Dr. Harvey Finkelstein's office on Wednesday, a sign that the investigation into the medical malpractice committed by the Long Island doctor is taking on new dimensions. Finkelstein is the Dix Hills doctor who exposed thousands of his patients to blood-borne pathogen infections such as hepatitis B and C and HIV/AIDS due to his shoddy injection practices. The raid was part of a probe into whether Finkelstein caused two cases—not one—of hepatitis C.

State health authorities had believed there was one case of hepatitis C linked to Finkelstein. Investigators seized medical records and a computer hard drive from Finkelstein's Plainview medical office and are considering whether they can bring felony charges against the physician which could include second-degree assault for causing the infections, falsifying business records, offering a false instrument, and for changing or withholding records from the state Department of Health. Finkelstein has not been charged.

The search warrant made comprehensive demands for business and medical records and asked for specific patient charts for three hepatitis C patients who received pain injections on July 15, 2004.  The first of those patients was Steve Corrado, 53, a Florida man who says he has had hepatitis C for nearly a decade. Corrado’s medical records confirm Finkelstein knew of Corrado's diagnosis as far back as 1999.  Two patients who received injections following Corrado - Raymond Bookstaver of Hicksville and a 66-year-old unnamed Syosset man - say they developed hepatitis C following treatment from Finkelstein. The three men's disease strains share the same genotype of 1B; however, the diseases have not yet been genetically linked.

The Health Department did not learn of Corrado's records until November when it concluded the hepatitis passed from Bookstaver to the Syosset man. That conclusion was incorrect, according to an attorney representing Bookstaver and Corrado who said, "To me, Steve Corrado is the known hepatitis C patient who saw Finkelstein that day and was potentially the first link in the chain of contamination." The state Department of Health is also reviewing Corrado's medical records and told the DA’s office about him, said spokeswoman Claudia Hutton.

Health authorities said they were frustrated by what they believed was Finkelstein's reluctance to turn over records and expanded the investigation to include over 10,000 patients. Corrado, now on disability, said he began receiving injections from Finkelstein in the mid-1990s after a work injury left him with debilitating back pain. In 1999, Corrado said he became ill, was diagnosed with hepatitis C, and immediately called Finkelstein, with whom he had become close.  "He told me it was probably all of the tattoos I got in the '70s," Corrado said. In a July 20, 1999, medical document, Finkelstein notes Corrado's diagnosis: "Hep C x 20 years."  Five years later, on July 15, 2004, in a procedure that ended at noon, Finkelstein injected Corrado with medications and dyes. About 35 minutes later, Bookstaver was injected with the same four medications: Triamcinolone, a steroid; lidocaine, and bupivacaine, both local anesthetics; and ketorolac, an anti-inflammatory drug. The Syosset man was injected with the same combination at 1 p.m.

Finkelstein’s treatment practices came under scrutiny after it was found that Finkelstein was reusing syringes on multiple patients.

Nevada Hepatitis C Outbreak Tied to Las Vegas Clinic. Thousands Now At Risk for Hepatitis, HIV

Thu, 28 Feb 2008 00:00:00 -0800

Hepatitis C and other blood borne diseases now threaten thousands of people in Nevada, thanks to the unsafe way anesthesia was administered at the Endoscopy Center of Southern Nevada in Las Vegas. At least six people who received treatment at the Endoscopy Center of Southern Nevada have already tested positive for Hepatitis C, but health officials in the state have urged another 40,000 to be tested for the virus, as well as HIV.

Hepatitis C is a blood disorder that is transmitted through blood-to-blood contact. Hepatitis C for the most part is asymptomatic and often leads to chronic, and long-term infection resulting in approximately 70% of those infected developing liver disease. Hepatitis C is a risk factor for liver cancer and can lead to the need for a liver transplant. HIV is the virus that causes AIDS, and is transmitted through the exchange of bodily fluids, including blood-to-blood contact.

The Endoscopy Center of Southern Nevada Health has been under investigation since early January, after health officials learned of three people who had been diagnosed with Hepatitis C. According to the Southern Nevada Health District, a total of six people contracted Hepatitis C after being treated at the Endoscopy Center of Southern Nevada. Five of them were treated the same day in late September; the sixth is believed to have been infected in July, the district said. The Southern Nevada Health District investigation revealed that “unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients,” the statement said.

The Hepatitis C virus may have been spread when clinic staff reused syringes and used a single dose of anesthesia medication on multiple patients, the district said. A syringe would become contaminated by the backflow of blood when patients with a blood-borne disease were injected with medication, health officials said. That syringe, in turn, would be reused to withdraw medication from a different vial. That vial could become contaminated and result in infection.

The Southern Nevada Health District said that the unsafe practices had been in place for several years at the Endoscopy Center of Southern Nevada, and may have put others at risk. About 40,000 patients who received injections of anesthesia at the clinic will be told of the potential exposure in letters arriving next week. Anyone who received anesthesia at the clinic from March 2004 to Jan. 11 should be tested for the virus, along with Hepatitis B and HIV. The Southern Nevada Health Districts patient notification will be the largest of its kind in the country.

This is not the first time an outbreak of Hepatitis was blamed on medical practitioners who reused syringes or reused multidose vials of anesthesia on more than one patient. Late last year, the New York State Department of Health warned thousands of people treated by Long Island anesthesiologist Harvey Finkelstein that they were at risk for Hepatitis C, B and HIV. Finkelstein also was known to reuse syringes. At least one person is known to have contracted Hepatitis C as a result of Finkelstein's unsanitary practices, and another six patients tested positive for the disease, although it is not absolutely certain that the virus was the result of Finkelstein's treatment. Another six tested positive for Hepatitis B.

LASIK Surgery - Depression Link To Be Studied by FDA

Tue, 26 Feb 2008 00:00:00 -0800

LASIK surgery - a procedure that can sometimes lead to life-altering complications -- has caught the eye of federal regulators. When patients undergo vision-correcting laser eye surgery—such as LASIK—they sign a release form with an extensive list of risks. However, researchers and former patients say a potential complication is not mentioned: depression leading to suicide. In response to patient complaints, the US Food and Drug Administration (FDA) plans to organize a large, national study to examine the relationship between LASIK complications and quality of life issues, including psychological problems such as depression.

Malvina Eydelman, an ophthalmologist with the FDA's Center for Devices and Radiological Health, says the limited clinical data "failed to suggest significant problems following LASIK surgery." Confirming that the FDA wants a broad and systematic review, she said, "We also noted that quality of life issues related to LASIK had not been evaluated consistently and there were few reports of well-designed studies." While frustration and sadness can result from any unsuccessful surgery, when left with constant eye pain or permanently impaired vision, the response can be severe. For instance, Colin Dorrian, 28, a patent lawyer and aspiring medical student from Philadelphia committed suicide last summer, six years after LASIK surgery left him with visual distortions. The surgery was conducted at a LASIK center in Canada that has since closed. "If I cannot get my eyes fixed, I'm going to kill myself," he wrote in a note police found, adding, "I have other problems like most people do. But this is something else.
As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it."

Laser eye surgeons who treat patients with complications say they do come across cases of depression, but don't believe LASIK complications are the root cause, arguing that patients who exhibit depression after the procedure were likely depressed or psychologically troubled beforehand. "There's no cause and effect," said Dr. Steven Schallhorn, the former head of the Navy Refractive Surgery Center in San Diego and an expert on permanent visual distortions from LASIK. Christine Sindt, an optometrist and associate professor of clinical ophthalmology at the University of Iowa in Iowa City, has encountered the psychological effects that patients experience when they have trouble seeing. "Depression is a problem for any patient with a chronic vision problem," she said. In the case of post-LASIK patients, depression is compounded by remorse, "It's not just that they lose vision. They paid somebody [who] took their vision away," she said. Dr. Alan Carlson, a laser eye surgeon at the Duke Eye Center in Durham, built his career on correcting the vision of patients at high risk of complications and said people at risk of depression or anxiety are generally not good LASIK candidates.

In 2006, the FDA began to look into LASIK complications and quality-of-life issues and determined more research was needed.  A task force including representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study to be conducted by laser eye surgeons across the country. The FDA is also planning a public meeting to discuss experiences with LASIK devices since their introduction to the U.S. market.

Heart Attacks Late at Night, on Weekends More Likely to be Fatal

Fri, 22 Feb 2008 00:00:00 -0800

Late night or weekend heart attacks might be the most dangerous. New research has found that hospital patients who suffer cardiac arrest at night or on the weekend are less likely to survive than those who have a heart attack during weekdays or weekday evenings. The study was not conducted to determine why this is occurs; however, it's likely that staffing patterns, procedure access, and other systemic issues may explain the difference in outcomes. "Hospitals simply don't work the same at night as they do during the day," explained study author Dr. Mary Ann Peberdy, an associate professor of internal medicine and emergency medicine at Virginia Commonwealth University in Richmond. "There is enough data out there to suggest that this may be a process issue that is at least contributing, and probably contributing substantially."

According to the Institute of Medicine, up to 98,000 preventable in-hospital deaths occur annually in the US; the rate of medical errors is higher at night. Earlier studies also reported that heart attacks treated on a Saturday or Sunday are more deadly than those attended to during the week and Canadian researchers found that strokes treated on the weekend are deadlier than those treated on a weekday.

The immediate cause of poor survival on nights and weekends may be one of timing where there is either a delay receiving critical procedures or in diagnosing the cardiac arrest. "We're literally talking about a difference in seconds, which makes a significant impact," said Beth Mancini, associate dean of Undergraduate Nursing Programs at the University of Texas at Arlington. "It's time for hospitals to look critically at their processes." Mancini is one of the "mothers" of the database used in this study, which is published in the February 20th issue of the Journal of the American Medical Association.

The current study, the most comprehensive of its kind, analyzed survival rates for 86,748 adults who suffered cardiac arrest events in one of 507 hospitals participating in the American Heart Association's National Registry of Cardiopulmonary Resuscitation. Survival was divided into hourly time segments, with day/evening specified as 7 a.m. to 10:59 p.m., night as 11 p.m. to 6:59 a.m., and weekends as 11 p.m. Friday to 6:59 a.m. Monday. Overall survival was 14.7 percent for nights/weekends, and 19.8 percent for weekdays. Although individuals do undergo physiological changes at different times of the day, the authors ruled out most of these changes. There were no survival discrepancies in the emergency department and trauma services.

"Emergency departments are one of the only places in the hospital that are typically staffed the same 24 hours a day and also have attending senior-level physicians available 24 hours a day," Peberdy said. "[Other areas of] the hospital often have doctors-in-training who respond to the cardiac arrest. That suggests this may be a process issue." There may be other such process issues. For instance, in one hospital, Mancini said, certain doors are locked at night, taking it longer to get a patient to a defibrillator. Even physician fatigue at the end of a shift could play a role. "This paper really needs to go to hospitals, and the people who run them," Peberdy said

Long Island's Mercy Medical Center Faces Scrutiny Following Patient Deaths

Mon, 11 Feb 2008 00:00:00 -0800

Mercy Medical Center, a Long Island, New York hospital, is facing tough questions after a doctor there charged that the deaths of several patients were caused by medical mistakes made by a Physicians Assistant (PA) employed by the hospital. The physician has claimed that the administration at Mercy Medical Center disciplined him after he contacted health officials about the patient deaths. The ensuing investigation into the Mercy Medical Center deaths have many wondering if Mercy Medical Center is looking to profit by having non-MDs, like PAs, handle surgical procedures.

The New York State Department of Health recently confirmed to the New York Times that it was investigating Mercy Medical Center. "We are investigating a series of deaths at Mercy Medical Center that raise questions about appropriate patient care and quality of care," Claudia Hutton, spokeswoman for the Health Department, responded.

The investigation at Mercy Medical Center was spurred by complaints from Anthony Colantonio, MD. Colantonio alleges that a PA has improperly inserted catheters, chest tubes, and pacemakers into patients, resulting in the deaths of several people. In one case, the PA placed a central venous line in the chest of a 19-year-old woman after she arrived at the ICU for breathing problems. The PA punctured her lung and then inserted a chest tube in an effort to inflate the lung. A chest surgeon was not called into correct the problem until 48 hours later. Despite surgery on the woman's collapsed lung, she died about 12 days later. Another patient, a 65-year-old man, developed an infection from an improperly placed catheter and died last July. A 64-year-old woman died in August, about two weeks after the attempted placement of a vein catheter. The PA allegedly punctured her neck, filling it with blood. In another case, a woman died a week ago after the PA "wrongly inserted" a pacemaker.

Colantonio complained to several health and law-enforcement agencies that the PA did not receive permission to insert the catheters. Colantonio advised the state Office of Professional Medical Conduct (OPMC), the Health Department’s disciplinary arm, that the PA practiced "with little or no supervision," used "poor judgment," and had "substandard technical skills." Colantonio said for months he warned top medical officials at Mercy that the PA "was a disaster waiting to happen." "In my opinion, those patients were assaulted," he said. In response, Mercy Medical Center brought Colantonio up on disciplinary charges, alleging he has "problems with interpersonal relationships" in the ICU and his complaints are "disruptive."

The PA involved was licensed in 1996 and worked at Mercy for nearly four years. A hospital spokesperson told the New York Times that “there have been no instances in which the actions of a physician assistant have been material to the death of a patient at Mercy."

PAs require a bachelor's degree, including two years of classroom and clinical training, and must pass a national certifying exam. PAs are certified to perform many of the tasks an MD can, including taking medical histories, performing physical exams, and ordering and interpreting lab or X-ray tests.

Not all of the deaths at Mercy Medical Center have been related to the PA’s mistakes. Recently, doctors at Mercy Medical Center told a young woman that cancer was detected in her left breast. The woman underwent a double mastectomy on May 25th and died May 26th of complications from the surgery. She did not have cancer; according to the State Department of Health. Rather, Mercy Medical Center’s lab mixed up her test results. In October, the Health Department concluded Mercy Medical Center took proper “corrective action”.

The Institute of Medicine of the National Academy of Sciences in 1999 concluded that medical errors killed 44,000 to 98,000 people a year in the U.S.