Posted by: Steve in Untagged on
Jul 23, 2008
The American Red Cross has been under a court order for the past 15 years to improve the way it handles the nation’s blood supply. Since 2003, the Red Cross has been fined more than $21 million for failing to do so. Yet critics of the organization claim the Red Cross is still not doing enough to make sure donated
blood is safe. Now, frustrated at the Red Cross’ apparent unwillingness or inability to do its job, federal regulators are said to be considering filing criminal charges against the organization’s board members.
The list of fines assessed against the American Red Cross over the past several years is long. Just this past June, the Food & Drug Administration (FDA) fined the organization $1.7 million after the agency found that the Red Cross had washed six units of red blood cells with hypertonic saline solution. Sterile normal saline solution should always be used for this purpose. The defective red blood cells were transfused to three patients in 2006 and 2007 at three Red Cross chapters in the Northeast and Southeast.
The June fine followed another in February, when the FDA ordered the Red Cross to pay $4.6 million after the agency discovered 113 incidents in which the organization collected blood from an ineligible donor, failed to undertake proper testing, or shipped the collected blood at wrong temperatures.
In September 2006, the Red Cross was penalized $4.2 million for non-compliance with federal and FDA regulations concerning the collection of blood products. In that incident, the fine was levied for the American Red Cross’s “failure to comply with requirements under Federal laws and FDA regulations relating to the collection of blood products.” The FDA said that the fines were “assessed under an amended 2003 consent decree that called for significant financial penalties when” the American Red Cross “fails to comply with FDA regulations and consent decree provisions designed to ensure the safety of the nation’s blood supply.”
The 2003 consent decree required the American Red Cross to “establish clear lines of managerial control over a newly established comprehensive quality assurance system in all regions; enhance training programs; and improve computer systems, records management, and policies for investigating and reporting problems, including adverse reactions.” Between the conception of the consent decree and the September 2006 fine, the FDA levied another $5.7 million in fines against the American Red Cross.
Despite the consent decree and subsequent fines, apparently not much has improved at the American Red Cross. According to The New York Times, the FDA has become so frustrated over the situation that in January, agency commissioner Andrew von Eschenbach attended a meeting of the Red Cross board of directors. The commissioner warned meeting attendees that they could face criminal charges for their continued failure to bring about compliance.
The Red Cross controls 43 percent of the country’s blood supply. According to FDA records, some of the safety lapses at the Red Cross that resulted in fines put patients in danger, and exposed them to diseases like hepatitis, malaria and syphilis. Despite repeated incidents, the FDA says the Red Cross has failed to investigate the results of its mistakes, so no one knows for sure if any of the incidents resulted in patient injuries.
Posted by: Steve in Untagged on
Jul 23, 2008
Dearth of Pediatric Medical Devices Puts Children at Risk
Monday, July 21st, 2008
According to Ziyad Hijazi, chief of pediatric cardiology at Rush University Medical Center, and other doctors, children receive worse treatment in the United States, and have even died, because pediatric
medical devices are not approved. Hijazi travels annually with two or three children ad their families to Jordon for heart operations where medical devices not approved for use in the United States are available.
Hijazi implanted an amplatzer muscular VSD to close a hole between the lower chambers of the heart in a child from Massachusetts. The device was manufactured by Minneapolis-based AGA Medical and was available for nine years in Jordan before finally being approved in the US in 2007. Hijazi said over 90 percent of the medical devices he uses on children are “off-label”–approved by the U.S. Food and Drug Administration (FDA) for other uses, such as adult use. “We take responsibility as physicians for using unapproved devices on kids,” he said.
In the years 1989-2000, only one stent—a device that props open heart vessel walls—was appropriate for pediatric use, said Thomas Forbes, director of cardiac catheterization at Children’s Hospital of Michigan in Detroit. “In the ’90s, we lost lives in the cath lab. Patients have died on the table because we were using stents that were made for adults and weren’t flexible enough,” Forbes said. Having to use adult-sized devices on children can be the difference between “potentially dangerous care and very good care,” he said. Three stents can be modified for pediatric use; none are approved for such use in the US, Forbes said. Other pediatric specialists voice similar complaints, saying they either use devices approved for adults or hand-make their own.
Companies often focus on adult-sized devices because the market is bigger. Also, heart diseases in children, are likelier to be congenital and rare; in adults they are more likely to be progressive, and common.
Meanwhile, a law signed late last year provides financial incentives to companies for making devices for children; however, those companies must also track patients at their own expense. “It’s a paperwork nightmare. They have to commit resources and follow these patients forever,” Forbes said. There are other issues and some solutions, for instance a significant tax credit for research and development in this area, but that is not being discussed, Federici said. Richard Ringel, a pediatric cardiologist at Johns Hopkins Hospital, said he is awaiting the next innovation in cardiovascular medicine: Stents that dissolve inside the body “… do you think Johnson & Johnson is going to be interested in doing this for babies? No, they want to do it for (adult) coronary patients because the numbers are so much larger,” Ringel said.
“Development (of pediatric devices) is time-consuming, there are regulatory hurdles, and how do you recoup your investment? The math generally does not work,” said Edwards Chairman and Chief Executive Michael Mussallem, who is president of AdvaMed, who added that it comes down to economics and physicians are just used to getting by with what they have.
Posted by: Steve in Untagged on
Jun 26, 2008
Two RNs were honored recently by The Daily Record as top category winners as part of its annual Health Care Heroes program.
The Baltimore legal publication, which honors healthcare professionals in six categories, recognized nearly two dozen local RNs or RN teams in its awards program.
The late Marie Harkowa, RN, CHPN, was honored as the Nurse Hero Top Winner.
Harkowa, who died Nov. 15, 2007, after a seven-year battle with ovarian cancer, served as hospice supervisor and manager of Shore Home Care and Hospice, Easton, Md.
Marlene Cochran, RN, Franklin Square Hospital Center, Baltimore, earned the Volunteer Hero Top Winner. Cochran has doubled enrollment since becoming president of the hospital's auxiliary since 2005.
In the Health Care Professional category, Deb Kirkland, RN, of Lifebridge Health, Baltimore, was named a winner.
The Nurse Hero winners honored were Viki Anders, RN, CRNP, Johns Hopkins University, Baltimore; Marlene Clements, RN,CRNP, Franklin Square Hospital Center; Susan Erlandson, RN, Howard County General Hospital, Columbia, Md.; Barbara Herron, RN, Target Hearts Exercise Program; Mary Lindenmuth, RN, Levindale Hebrew Geriatric Center and Hospital, Baltimore; and Clola Robinson-Blake, RN, Northwest Hospital Center's Cancer and Infusion Therapy Center, Randallstown, Md.
More than a dozen RN finalists also were recognized. Patricia Isennock, RN, CHES, Franklin Square Hospital Center, was a finalist in Community Outreach, while Lucy Shamash, RN, St. Joseph Medical Center, Towson, Md., and Mary Ann Straughn, RN, Kaiser Permanente, Rockville, Md., were Health Care Professional finalists.
In the Nurse Hero category, the honorees included Denise Choiniere, RN, and Trisha Fronczek, RN, MSN, University of Maryland Medical Center, Baltimore; Sherry Councell, RN, Shore Health System; Terri Dashiell, RN, Northwest Hospital Center; Carol Perry, RN, The Breast Center at Franklin Square Hospital Center; Sharon Powell, RN, U. of Maryland School of Medicine and U. of Maryland Medical Center, Baltimore; Jean Seiler, RN, Heart Aware Program at St. Joseph Medical Center; the surgical unit nurses at Shore Health System; and Terri Zeman, RNC, Janice Colbert, LPN, Paula Fiorucci, RN, and the OB nurses at Franklin Square Hospital Center. The finalists in the Volunteer Hero category included Marian Muth, RN, MS, St. Joseph Medical Center.
