MedSun: Newsletter #9, November 2006
Newsletter #9, November 2006
MedSun Hospitals Lend Data to Congressional Testimony
In testimony before the U.S. House of Representatives Committee on Government Reform,
Daniel Schultz, M.D., Director of the Center for Devices and Radiological Health (CDRH) at the
Food and Drug Administration (FDA), referred to feedback received from MedSun facilities in addressing the issue of reprocessed single-use devices (SUDs). Dr. Schultz noted that FDA has been actively engaged in the issue for some time, with the agency’s efforts including research, outreach, premarket review, inspections, and compliance investigations. FDA believes that, taken together, these efforts have provided and will continue to provide reasonable assurance of safety and effectiveness of reprocessed SUDs for patients.
Dr. Schultz’s remarks on MedSun during the September 26, 2006, Committee meeting included the following text:
“FDA’s Medical Product Safety Device Network (MedSun) is comprised of over 350 hospitals that have been recruited and specifically trained to identify and report device problems. The hospitals in this program are broadly representative of U.S. healthcare facilities. FDA staff talked with representatives from more than 50 of these facilities to obtain feedback on their experience with using reprocessed SUDs.
“The MedSun respondents who gave us feedback represented various occupations in hospitals, including materials management, biomedical and clinical engineering, risk management, infection control, surgical services, nursing staff, supply utilization, and equipment management. Staff being interviewed responded overwhelmingly that they view the use of reprocessed SUDs as providing a significant cost savings to their facilities and as being an environmentally sound practice.
“There was considerable variation in the devices being reprocessed at the various facilities and the degree of acceptance of this practice by individual practitioners within the facilities. None of the participants we spoke with reported specific problems with SUD-related infections, but they also pointed out that, if an infection occurred, it would be difficult to discern whether the reprocessed SUD was the cause. It also is interesting to note that the participants did not report a greater concern with mechanical problems associated with reprocessed SUDs compared to unreprocessed SUDs. In general, the participants had a favorable view of reprocessed SUDs used in their facilities. They also stated that they relied heavily on FDA oversight to ensure safety and effectiveness and to provide objective information on reprocessed SUDs.”
Applying the Swiss Cheese Model to a MedSun Report
Historically, in medicine and in other industries, accidents have been thought to be the result of individual human error, which is commonly referred to as the “person approach.” This approach views unsafe acts as those arising from atypical mental processes—such as forgetfulness, inattention, carelessness, negligence, and recklessness. Many limitations have been posed by this theory, and this approach is likely to have prevented developments toward safer health care practices.
In the early 1990s, cognitive psychologist James Reason began to analyze failures occurring within complex organizations or as part of systems. Through close examination of errors in such organizations, Reason questioned the customary person-centered model of error. He began to view accidents as imperfections in the multifunctional layers of systems, and he referred to this as the “system approach” to failure. This perspective concentrates on the conditions under which persons work and on the development of defenses to guard against errors or to mitigate their effects.
Reason portrays the system approach to failure through his “Swiss Cheese Model,” which explicates a perfect system as one with layers of defenses, barriers, and safeguards. In reality, systems are more like slices of Swiss cheese: they are characterized by many “holes” in various locations across the institution. The alignment of holes in the many layers of systems can line up and permit a trajectory for hazardous circumstances.
This Swiss Cheese Model was applied to an August 2006 MedSun report in order to analyze and better understand the system failures that led to patient harm. The MedSun report Event Description and analysis are presented below.
For additional information on James Reason’s Swiss Cheese Model, go to
Rapid Lead Screening Test Now Available at More Facilities
The Centers for Disease Control and Prevention (CDC) has found that each year more than 300,000 children under the age of 6 have blood levels that exceed 10 micrograms per deciliter, the threshold used to indicate lead poisoning. The American Academy of Pediatrics (AAP) estimates that one out of four homes with children under age 6 has lead contamination. The CDC and AAP recommend screening children who live in high-risk homes at ages 1 year and 2 years.
Lead poisoning in children typically results from drinking water from corroding plumbing, and inhaling or ingesting dust from deteriorating lead-based paint. Symptoms of lead poisoning include headaches, stomach cramps, fatigue, memory loss, high blood pressure, and seizures. Lead poisoning in children has been linked to learning disabilities and developmental delays. A test is now available that can provide immediate results on lead levels in children and adults at thousands of places nationwide, including health clinics, mobile health care units, and doctors’ offices. Broader availability of and easier access to this test mean lead exposure can be detected and treated earlier, before the damaging effects of lead poisoning occur. The LeadCare® II Blood Lead Test System measures lead in blood samples using a finger stick or taking a blood sample from a person’s vein, and gives results in as little as 3 minutes. The rapid result means a second sample for further testing can be obtained quickly, if needed, thus reducing the need for a followup visit.
The U.S. Department of Health and Human Services is allowing use of the LeadCare® II Blood Lead Test System, made by ESA Biosciences of Chelmsford, Massachusetts, at more than 115,000 certified point-of-care settings because the company proved to the U.S. Food and Drug Administration (FDA) that the test is simple and accurate, and that it poses very little risk of harm to a patient. The test was previously only available for use in certain laboratories, and patients often times had to wait several days or more to receive their results. Doctors have said that it is sometimes difficult to reach patients to give them their results or to discuss treatment options when such patients have elevated blood lead levels.
Rapid Lead Screening Test Q&A
What does the LeadCare® II Blood Lead Test do?
The test measures lead in blood samples taken from a patient in a doctor’s office or clinic and gives results in as little as 3 minutes. If the test indicates an elevated lead level, a second sample can be obtained for further testing before the patient leaves the facility. Furthermore, if the result indicates high levels of lead, doctors and patients can begin discussing treatment options immediately.
Is this a new test?
FDA had already cleared this lead screening test for use by certain hospitals, private laboratories, and large physician practices capable of performing moderate and high-complexity testing. There are approximately 35,000 such facilities in the United States. This meant that other doctors had to send their samples to these facilities and wait for results. Doctors have expressed concern that many patients who might be affected by lead poisoning did not return for followup testing. FDA has broadened access to this test by granting a Clinical Laboratory Improvement Amendments (CLIA) waiver, which gives manufacturers approval to market a test to doctors’ offices, clinics, and other health care sites, in addition to hospital laboratories. An already approved or cleared test can qualify for a CLIA waiver if the manufacturer demonstrates that the test is so simple and so accurate that health care professionals without conventional laboratory training can use it in minimally regulated laboratories.
What are the benefits of this test?
Making the LeadCare® II blood test available more widely makes testing more convenient for both patients and doctors. Patients learn their test results right away, and followup testing, if needed, can be done on the spot. Doctors do not have to locate hard-to-reach patients to give them their test results or to discuss treatment options with them if they have elevated blood lead levels. FDA’s expansion of this test bolsters ongoing efforts to reach populations at greatest risk for lead poisoning, particularly young children with inadequate access to medical care. Health care professionals can now screen many more people for exposure to lead, including inner city residents and minority groups who may live in areas with deteriorating lead-based paint and corroded plumbing.
Is this test effective in screening patients for lead poisoning?
This test is very effective for screening. As with blood lead tests performed in laboratories, initial test results showing lead levels higher than 10 micrograms per deciliter need to be confirmed with additional laboratory blood tests.
Where will the test be available?
This CLIA waiver expands availability of the LeadCare® II blood test to more than 115,000 doctors’ offices, clinics, and other sites nationwide.
Office of In Vitro Diagnostic Device Evaluation and Safety Web site
FDA Tissue and Cell Pilot Project: A Special Collaboration With the Medical Product Safety Network (MedSun) Project
This month marks the 1-year anniversary of the FDA’s Tissue and Cell Pilot Project. Currently, 95 hospital staff members at 31 hospitals across the country have been trained to be on the lookout for and to report on adverse events involving biologics; 35 reports have been submitted.
CDC FAQs About Tissue Transplants
In a continuing effort to educate the public and to ensure the safety and well-being of cell and tissue implant patients, the Centers for Disease Control and Prevention (CDC) updated the online information on its “About Tissue Transplants” Web page on September 1, 2006. The following excerpted frequently asked questions (FAQs) provide recommendations on testing of individuals who received tissues from two companies named in indictments this year alleging illegal harvest, sale, and implantation of human tissues.
On October 26, 2005, the CDC and the U.S. Food and Drug Administration (FDA) recommended that recipients of tissues recovered by Biomedical Tissue Services (BTS) be tested for evidence of infection with HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis. (For more information about BTS, see “In Brief” on page 2.) On
August 30, 2006, CDC and FDA made the same recommendation for testing of recipients of tissues recovered by Donor Referral Services.
What tests should be performed and how often? There are no set guidelines on how this testing should be done for tissue recipients. CDC thus recommends that clinicians follow the postexposure followup testing recommendations that are used for occupational exposures to HIV, HBV, or HCV, as described in the Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis, available at http://www.cdc.gov/ncidod/dhqp/gl_occupational.html. The following recommendations can be used for all recipients who have normal immune systems. For those who have very weakened immune systems because of immune system suppressing medications, other tests might be indicated.
Patients who had tissue implanted more than 6 months ago should be offered the following tests: HIV antibody, antibody to hepatitis B core antigen, antibody to hepatitis C virus, a nontreponemal syphilis test (e.g., RPR or VDRL), and a treponemal syphilis test (TP-PA or any ELISA test). If all of these tests are negative, it is very unlikely that the recipient will contract any of these diseases from an implanted tissue that was potentially contaminated, and no further followup testing is necessary.
Patients who had tissue implanted less than 6 months ago can be offered the same series of tests as above immediately, but should also be retested 6 months after the tissue was implanted. If earlier diagnosis of HBV and HCV infection is desired, testing for hepatitis B surface antigen (HBsAg) and HCV RNA may be performed. If negative, testing for anti-HBc and anti-HCV should be performed at least 6 months after the tissue was implanted. Again, if all of these tests are negative 6 months after the tissue was implanted, it is very unlikely that the recipient will contract any of these diseases from an implanted tissue that was potentially contaminated, and no further followup testing is necessary.
How were these infectious diseases selected? HIV, hepatitis B and C, and syphilis are the infectious diseases for which potential tissue donors must be tested.
What if one of the screening tests is positive? It is important to remember that these initial tests are screening tests, and, hence, positive results do not always mean that the patient has been infected. Patients who have a positive result for any of these tests should undergo confirmatory or supplemental testing. Clinicians who have questions about confirmatory or supplemental testing should contact a clinician with expertise in infectious diseases.
CDC FAQs About Tissue Transplants
Recommendations for Postexposure Prophylaxis
FDA Forms Task Force on Human Tissue Safety
In an effort to strengthen its comprehensive, risk-based system for regulating human cells and tissue, the U.S. Food and Drug Administration (FDA) has formed the multidisciplinary Human Tissue Task Force (HTTF). An August 30, 2006, FDA announcement noted that senior officials from FDA’s Center for Biologics Evaluation and Research and the Office of Regulatory Affairs will lead the HTTF. The task force will assess the effectiveness of the implementation of the tissue regulations established in 2005, and will review recent findings that some tissue recovery establishments have violated Federal rules governing tissue recovery. This task force will help FDA explore additional means to strengthen its approach to ensuring that tissue recovery firms follow required practices to prevent transmission of communicable diseases.
FDA Forms Task Force on Human Tissue Safety
ACCE Healthcare Technology Foundation Reports
Clinical Alarms Improvement Needed
Clinical alarms that warn hospital personnel of patient problems are not as effective as they could be because of an unacceptable number of false and nuisance alarms, the complexity and number of alarms in the patient care environment, inadequate training of hospital staff, and a lack of alarm system standardization. These are among the findings reported in the first educational white paper published by the Healthcare Technology Foundation of the American College of Clinical Engineering (ACCE). A task force headed by Tobey Clark, Director of Instrumentation and Technical Services at the University of Vermont, and Yadin David, Director of Biomedical Engineering at Texas Children’s Hospital, surveyed clinical alarm use in January 2006 with 1,327 respondents, most of them registered nurses. False and nuisance alarms were largely seen as a significant problem that occurs frequently, disrupts patient care, reduces trust in alarms, and causes caregivers to sometimes disregard them.
The white paper also includes a review of clinical alarm-related literature, analysis of adverse event data (with many such reports found on the FDA MAUDE adverse event database), and summaries of forums held at national meetings. Task force members suggest that medical device manufacturers, clinical engineers, clinicians, risk managers, and standards agencies work together on alarm system design, improved integration into the clinical environment, standardization, and user training to increase the effectiveness of clinical alarms. At the same time, they caution health care organizations and clinicians to recognize the limitations of alarm systems and use them only as a tool in the overall assessment of patient condition.
The full text of the paper, entitled “Impact of Clinical Alarms on Patient Safety,” can be seen at the Foundation’s Web site.
Home Medical Devices and Hospital Stays,
The ACCE Foundation addresses questions that individuals who use apnea monitors, infusion pumps, or other medical devices at home may have if they need to be hospitalized and are confused about whether their devices can accompany them. A new brochure from the Healthcare Technology Foundation attempts to clarify this and other issues confronting patients who are facing hospital stays. The brochure, which was published as part of a public education outreach, notes that most hospitals have rules about bringing medical devices to the hospital from home, but that hospital admissions staff will work with patients to determine whether an individual’s device can be safely used in the hospital.
AHRQ WebM&M Looks at the Safety Transformation Within the Veterans Health Administration
The September 2006 “Perspectives on Safety” in the Agency for Healthcare Research and Quality (AHRQ) WebM&M focuses on the notable safety transformation at the Veterans Health Administration within the U.S. Department of Veterans Affairs (VA).
In an interview with WebM&M Editor Dr. Robert Wachter, James P. Bagian—physician, mechanical engineer, and two-time space shuttle astronaut—describes the life experiences that prepared him for his position as Director of the VA National Center for Patient Safety and the path to improvement at the VA. From an early age, Dr. Bagian, the 2001 winner of the American Medical Association’s Nathan S. Davis Award for outstanding public service in the advancement of public health, was interested in “trying to do things the most effective way.” This attitude continued in medical school, where, based on his understanding of device designs and metallurgical properties, he many times suggested alternative surgical techniques to his professors. In addition to his medical training, his engineering education and the leadership skills he developed at the National Aeronautics and Space Administration inform Dr. Bagian’s attitude toward safety improvement. On arrival at the VA, Dr. Bagian concentrated on changing the institutional culture, one that varied considerably from that of the “high reliability” aerospace world.
He stressed the importance of having a staff who could analyze problems and devise feasible solutions that were user-friendly and that produced tangible results, all in a context in which employees felt safe enough to speak the truth.
In “What Can the Rest of the Health Care System Learn From the VA’s Quality and Safety Transformation?,” Ashish K. Jha, M.D., M.P.H., of the Harvard School of Public Health and the VA Boston Healthcare System, discusses the lessons learned from the VA experience and analyzes the most important modifications—those to decisionmaking, data collection and feedback, performance contract incentives, and the electronic records system—that account for the remarkable improvements in the VA health care system.
For the full interview with Dr. Bagian, go to
What Can the Rest of the Health Care System Learn From the VA’s Quality and Safety Transformation?
Joint Commission Resources QI Online Offers Tips on Reducing Bed Entrapment Risk
From January 1, 1985, through January 1, 2006, the U.S. Food and Drug Administration (FDA) received 691 reports on hospital bed entrapment—including 413 deaths—from long-term care facilities, hospitals, private homes, and other settings. Individuals most vulnerable to entrapment are elderly patients and residents who are incapacitated to some degree. Risk of entrapment increases when the bed moves up and down, and when a gap is present between the mattress and headboard or footboard, common in older “legacy beds” with new mattresses.
In light of the recent release of the FDA’s final report on the risks of bedrail entrapment, QI Online responded to these questions: How do Joint Commission standards address issues related to reducing the risk of bedrail entrapment, and how can organizations maintain compliance with those standards as they relate to this safety issue?
To diminish the risk of bed entrapment, organizations should: Use FDA guidelines to conduct a risk assessment on existing beds and replacement beds to determine the risk potential from mattresses and the suitability of various bedside rail systems for their patient populations; and retain information on patient assessment and bed evaluations for patient safety committees.
The September 6, 2002, Joint Commission Sentinel Event Alert — Issue 27 - identified these strategies for reducing the risk of injuries and/or death from bed entrapment: Orient and train staff on bedrail entrapment dangers; reevaluate beds for entrapment potential; assess patients/residents for risk of entrapment, including physical, mental, behavioral, or medication impairment; provide more frequent observation of patients/residents with risk factors for entrapment; and provide information to patients/residents and/or their families on the purpose and potential dangers of bedrails, and train them according to their needs as appropriate to the care provided.
September 6, 2002, Joint Commission Sentinel Event Alert
Hospital Bed System Dimensional and Assessment Guidance To Reduce Entrapment
Clinical Guidance for the Assessment and Implementation of Bed Rails
Hospital Bed Safety
Updated November 1, 2006