October 30, 2007   Download print version

Fire-related patient load lands on UCSD’s Hillcrest burn unit  

City hospital in Brooklyn reviews care of a boy, 12

Participants left uninformed in some halted medical trials

FDA issues early communication about an ongoing safety review of Aprotinin injection

Influx of medical students creates concern; Enrollment increase
means resident training needs to expand

Getinge contracts with GE Healthcare and Premier

More than 700 healthcare facilities respond to Cardinal Health
patient safety grant challenge

Fire-related patient load lands on UCSD’s Hillcrest burn unit             

The tenacity with which the 18-bed the burn unit at the University of California, San Diego (UCSD) Medical Center in Hillcrest (CA) has tackled the strains of an unprecedented fire emergency has once again made the hospital a hub of media attention, this time for treating victims of the devastating fires this week. Recognized as the only specialized burn unit in the San Diego and Imperial counties, the hospital has treated many of the area’s fire victims. To date, the unit has treated 47 fire-related injuries due to surface or inhalation burns. Currently, there are eight patients in critical condition and 10 in rehabilitation. Nineteen out of the 20 other patients that were previously in critical care have been upgraded to the hospital’s general ward. Laura Everett, an administrative assistant, described last week in the burn unit as “chaotic, but in control.” Burn Unit Charge Nurse Janine Dubina, like all of the staff, underwent a harrowing week dealing with crisis conditions in the unit. Living between Lakeside and Ramona, she had to evacuate early in the week, but still came to work ready and able. Most patients came in during the first two days of the fire, and while new cases have tapered off for the moment, Dubina said she expects the number of patients to increase as the weeks progress. She said that more people will likely start trickling in now that the fires have died down and residents are returning to their normal routines like after 2003’s Cedar Fires, the disaster that put the burn unit in the national spotlight.  

The current patients’ burn degrees range from 20-90 percent, some of them being treated for inhalation as well as surface burns. Although response efforts brought victims in quickly enough to be intubated before any internal swelling choked off their airways, some patients’ bodies have swelled so much internally that removal of intubation tubes is now impossible. Dubina said that one of the major health concerns from the fires is smoke inhalation. Having burned through many commercial and residential developments, smoke is rife with plastics, paint and other chemical pollutants that can cause lung damage. Smaller particles in the air farther away from the fires can be more hazardous than the smoke and ash closer to the fires themselves. In order to protect patients and staff from the outside air, high-efficiency particulate air filters are stationed near the unit’s doors, and indoor air quality is checked daily to ensure a sterile environment.

Lasting impressions from the Cedar Fires pushed the county to make sure that the same mistakes would not be repeated. For instance, the implementation of a reverse-911 program saved many more lives last week, allowing people to evacuate properly and be informed ahead of time of the disaster. The hospital also now has a better-developed relationship with Cal Fire, allowing for stronger lines of communication, Dubina said. “For everyone that complains about UCSD running disaster drills, this is the reason we knew what to do,” she said. The staff prides itself on a strong sense of camaraderie, a bond that staff members said helped strengthen their team’s efficiency when patients began to piling up at the burn unit. Many nurses and doctors  ignored orders to evacuate their homes, instead coming in to work 12-hour shifts and occasionally overtime, just to make sure the unit wasn’t left short-handed. On Oct. 21, the unit was graced with extra nurses, according to registered nurse Jami Lewellen. “Night shift nurses stepped outside and smelled smoke on the air, they just knew to come in,” she said. Even students from UCSD who normally volunteer at the hospital came to help, retrieving any extra equipment or blood that was needed, even though campus had shut down for the week. (UCSD Guardian) To read the original article see THIS LINK

City hospital in Brooklyn reviews care of a boy, 12

Officials at Kings County Hospital Center said yesterday that they were “closely examining” why doctors there failed to detect a drug-resistant staph infection in a 12-year-old Brooklyn boy who died this month. The boy, Omar Rivera, was given only allergy medication at the hospital and was then sent home, a lawyer for the boy’s family said yesterday. A hospital spokeswoman, Hope Mason, confirmed that Omar was treated at the hospital shortly after midnight on Oct. 13. She said that the hospital would look into “what more could have been done to detect the infection at that time.” Omar was pronounced dead at Brookdale University Hospital and Medical Center in Brooklyn at 10:25 a.m. on Oct. 14, city officials said. School officials have said that Omar, a student at Intermediate School 211 in Canarsie, was sick and stayed home from school on Oct. 9. On Oct. 9 or 10, his mother, Aileen Rivera, took him to a clinic, First Medcare, on Flatlands Avenue in Canarsie, said the family’s lawyer, Paul B. Weitz.

At First Medcare, Weitz said, doctors noted that Omar had one or two pus-filled boils on his buttocks, diagnosed an infection and prescribed an antibiotic, amoxicillin, along with ibuprofen. A manager at First Medcare said she could not comment on the case because of privacy laws. Late on Oct. 12, Weitz said, Omar still had a high fever, so his mother took him to the emergency room at Kings County, a city-run hospital in East Flatbush, with one of the city’s busiest emergency rooms. Mason said she was not allowed to disclose who had treated Omar. Whoever it was, said Weitz, decided that Omar had an allergic reaction to ibuprofen and gave him Benadryl. Weitz’s account of Omar’s treatment at Kings County was reported yesterday in The New York Post. Blood tests done after Omar’s death determined that he was infected with the bacterium methicillin-resistant Staphylococcus aureus, or MRSA, health officials said. A determination on whether MRSA caused Omar’s death is not expected for several weeks. A student at another school in the metropolitan region, Trinity Elementary School, in New Rochelle, came down with an MRSA infection, but school officials said yesterday that the child was recovering. Custodians at the school were doing special cleaning before today’s classes, the officials said. (The New York Times)

Participants left uninformed in some halted medical trials

When Congress passed a bill last month requiring makers of drugs and medical devices to disclose the results of clinical trials for all approved products, advocates of greater study disclosure applauded the move. But a provision that would have mandated disclosures for another group of products never made it into the final version of the bill. It would have covered products tested on patients, but dropped before marketing. “Trial sponsors can still choose to keep information about some trials confidential, creating serious ethical concerns,” said Dr. Deborah A. Zarin, the director of ClinicalTrials.gov, a Web site run by the National Library of Medicine. Many experts said the recent Congressional debate underscored a troubling fact: some patients in clinical studies never learn about test results. The problem may be particularly relevant to those implanted with medical devices that stay with them long after a trial is over. For manufacturers and researchers alike, “there is a tremendous incentive to go on, to forget about the old and move on to the new,” said Drummond Rennie, a deputy editor at The Journal of the American Medical Association.

There are no data available for the number of patients who participate in studies of drugs and medical devices that never make it to the marketplace, though it is likely that the number runs into the thousands. A product may not reach the market for a variety of reasons; it may not perform well in trials, for example, or it may be rejected by regulators. Although researchers conducting clinical studies are not required to disclose test results to study participants, they must alert patients taking part in a test to emerging product dangers. Companies also have to keep promises made to regulators at the time a trial began, like agreements to follow the health of study patients. Such promises are often required to get approval to begin trials in the first place. But researchers and manufacturers do not always fulfill even those minimal requirements. And such failing may be particularly acute in trials of implanted devices, since those products remain inside patients. In August, for example, the Food and Drug Administration sent a warning to Boston Scientific after investigators discovered the company’s diligence in following up with patients faltered around the time it dropped a product under development. The product being tested was an experimental stent intended to prevent the rupturing of an aneurysm in the major abdominal artery. Among other things, agency investigators found that Boston Scientific, which halted development of the stent last year after a study showed it frequently fractured, had neglected to tell patients in that trial about the problem’s scope.

Because of loopholes in the recently passed Congressional bill, device makers like Boston Scientific will still have discretion whether to publicly reveal the results of studies like that of the failed stent. Under the law, device producers will have to report such “premarketing” studies and their results to the F.D.A. But that data will remain in a confidential “black box” until a product is approved; if a device is rejected or dropped, a company will not have to disclose those results or even publicly acknowledge that the trials occurred. Device makers lobbied against mandating disclosure for failed products, arguing that releasing such data would be confusing to patients and would give away valuable information to a company’s competitors about devices under development that might succeed in subsequent trials. “Such disclosures could have the unintended consequence of eliminating many small device makers from the marketplace,” Stephen J. Ubl, chief executive of the Advanced Medical Technology Association trade group, testified before Congress in June. The new bill does allow for a mechanism under which the secretary of the Health and Human Services Department could release trial data about unapproved products if a public health issue exists, but such moves would be argued case by case. “This was a disappointment,” said Dr. Steven E. Nissen, the chairman of the cardiology department at the Cleveland Clinic, who helped draft the House version of the bill. (The New York Times) To read the original article see THIS LINK
 

FDA issues early communication about an ongoing safety review of Aprotinin injection

The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Aprotinin Injection (marketed as Trasylol), a drug used to control bleeding during heart surgery. Last week, FDA was notified that a Canadian research group stopped a study on Trasylol because the drug appeared to increase the risk for death compared to the other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The data also suggested that fewer patients receiving the drug experienced serious bleeding events.

This most recent data support the results from other comparison studies of Trasylol. The comparison studies were discussed at a September 2007 joint meeting of FDA’s Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees. FDA anticipates further review of the risk and benefits of Trasylol, which may result in additional labeling or other regulatory action. FDA will work with the sponsor of the recently terminated study to evaluate the data fully. In the meantime, FDA recommends that healthcare providers review the risks and benefits of Trasylol outlined in the label and in the Early Communication about an Ongoing Safety Review, and discuss the information with their patients. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery. Trasylol is marketed by Bayer Pharmaceuticals Corp., Leverkusen, Germany. Full text of the Early Communication about an Ongoing Safety Review can be found at http://www.fda.gov/cder/drug/early_comm/aprotinin.htm.

Influx of medical students creates concern; Enrollment increase
means resident training needs to expand

Enrollment is increasing sharply at medical schools across the country, a trend that’s expected to help the nation combat a worsening shortage of physicians. But it’s also focusing attention on the need to expand the other half of the physician pipeline: residency programs. “If you don’t increase the second stage of the education process, you don’t end up with more practicing physicians,” said Edward Salsberg, director of the Association of American Medical Colleges’ center for workforce studies. A record number of students enrolled at medical schools this fall, including those in Houston, Salsberg’s group reported recently. But the higher numbers also mean more training positions in hospitals will be needed after those students graduate in four years. The enrollment jump was largely in response to the AAMC’s appeal to the nation’s 126 medical schools last year to increase class size by nearly one-third by 2015. This year’s increase to about 17,800 first-year students represents an 8 percent increase since 2002, the group’s benchmark year. Medical schools in Houston are contributing to that increase.

The University of Texas Medical School at Houston enrolled 230 first-year students this fall, up 12 percent from 206 students in 2002. And Baylor College of Medicine plans to increase its first-year class to 200 by 2011, a 19 percent increase over the 168 students in 2002. “We think the gradual increase will allow us to accommodate people and not affect their education,” said Dr. Stephen Greenberg, Baylor’s dean of medical education. Because the UT Medical School has added seats in recent years, enrollment will remain stable for the next few years, said Dr. Judianne Kellaway, assistant dean of admissions. But the number of applicants, which already has outpaced the increase in class size, is expected to continue to rise. Nearly 3,700 aspiring physicians applied this year, 5 percent more than last year. Though medical school enrollment is on the rise, increasing the number of residency positions is arguably more difficult. That’s mainly because programs in most states depend largely on funding from the federal government through Medicare, and that funding has remained static for the past few years. State funding in Texas, however, is improving. The Legislature this year approved an increase to $63 million for residency programs, the highest level ever and more than double the $25 million appropriated last year. Some state money could go toward a new neurology residency program at the UT Medical School here. Dr. Dong Kim, chairman of the department of neurosurgery, said seven positions could be approved by January. Until then, the university offers residency in every specialty except neurology, he said.

Like the rest of the country, Texas does not have enough physicians to keep up with a growing population that demands more specialty services. It ranked 42nd in the country for its patient-to-resident ratio in 2005, with 194 patient-care physicians per 100,000 residents, according to the American Medical Association. Lately, however, more doctors have applied for licenses in Texas, likely because of new limits in medical malpractice lawsuits that make it more appealing for physicians to practice here. The number of residency positions available in Texas climbed to 7,260 slots during the 2005-06 school year, an increase of about 4 percent in two years, according to the Accreditation Council for Graduate Medical Education. That’s far fewer slots than other populous states; New York, for example, had more than twice as many residents that year, partly because the state secured nongovernmental funding. Without enough positions for its graduates, Texas could lose physicians-in-training to other states.  Nationwide, the number of residency slots is increasing at a similar rate. About 115,100 positions were available across the country during the 2005-06 school year, the ACGME reported. There's good reason to keep graduates in Texas for training, according to the Texas Medical Association, which represents physicians and medical students. The group reported that physicians who complete both medical school and residency here are nearly three times more likely to stay in the state to practice. (Houston Chronicle) To read the original article see THIS LINK
 

Getinge contracts with GE Healthcare and Premier

Getinge USA, Rochester, NY, has entered into an agreement with GE Healthcare to service GETINGE washer/disinfectors and steam sterilizers in more than 200 facilities that contract with GE Healthcare to provide a host of asset management services, the company has announced. Getinge USA also has been awarded a contract with Premier Inc., one of the nation’s largest healthcare purchasing networks, to offer detergents and cleaners to 1,700 hospitals and more than 47,000 other healthcare sites. Getinge AB is a manufacturer and distributor of advanced infection control equipment, medical systems and extended care products for OR, ED, ICU, sterile processing and life science applications. For more information, see THIS LINK.
 

More than 700 healthcare facilities respond to Cardinal Health patient safety grant challenge

More than 10 percent of the nation’s healthcare facilities are seeking grants from Cardinal Health through a $1 million fund set up by the company to help improve patient safety. Company officials said more than 700 hospitals, health systems and community health clinics responded to their announcement in August about the grant program, which is the largest and first of its kind in the private sector. To support initiatives that enhance patient safety and quality of care, Cardinal Health will grant up to $50,000 per facility to fund new and innovative programs that establish or implement creative and replicable methods to address challenges in providing quality patient care and to help drive improvements. The company expects to fund up to 40 of the 730 grant requests.

In selecting grant recipients, Cardinal Health’s selection committee will look for: projects that respond to a clearly identified, high priority safety issue; projects that apply new thinking and approaches to development of solutions; collaborative programs; demonstrable and sustainable measures to assure that improvements hold up over time; model programs that can be replicated at other organizations. To be eligible for funding, facilities must be designated as 501(c)(3) by the IRS and were required to submit a letter of intent to submit a proposal by October 12. Approximately 100 to 150 institutions will be asked to submit a full proposal, with grants announced in March 2008.