MedSun: Newsletter #13, March 2007
Newsletter #13, March 2007
FDA’s OIVD Begins Open Dialogue With LabNet Sites
In March 2007, the Office of In Vitro Diagnostic (OIVD) of the Food and Drug Administration (FDA) began its “open dialogue” with LabNet participants by means of telephone calls to seven LabNet sites. Dr. Steve Gutman, Director of OIVD, talked to LabNet participants, most of whom said that they were pleased with LabNet training and that they believe they understand how to report problems. At least one participant indicated a desire for more timely input from manufacturers about newly identified problems. At another site, a reporter mentioned the desire to network with other laboratories in the LabNet subproject. Other subjects that arose during these conversations were human factors concerns with in vitro diagnostic devices (IVDs) and the accuracy of IVDs when used with special patient populations. Dr. Gutman and OIVD staff encouraged LabNet sites to share these and other types of incidents with FDA. Some sites have not yet reported issues, either because products are working well, or because companies, when contacted, have provided satisfactory responses to problems identified. LabNet site representatives seemed pleased with these OIVD outreach efforts, so Dr. Gutman and his staff will contact all participants in the LabNet project over the next several months and then hold followup calls in 6 to 9 months.
National Medical Laboratory Professionals Week April 22–28, 2007
National Medical Laboratory Professionals Week, April 22–28, 2007, is a time to recognize the approximately 265,000 medical laboratory professionals and 15,000 board-certified pathologists who play a vital function in every aspect of health care. Since the development of this career group in the 1920s, the clinical laboratory science professional has played an increasingly important role in the diagnosis and prevention of disease. Today, the clinical laboratorian is a key member of a health care team.
Planning guides, posters, and promotional materials are available to assist in preparing for this annual event. For more information, visit the American Society for Clinical Laboratory Science National Medical Laboratory Professionals Week homepage.
This year’s sponsors of National Medical Laboratory Professionals Week are the American Society for Clinical Pathology, American Association for Clinical Chemistry, American Association of Blood Banks, American Medical Technologists, American Society for Clinical Laboratory Science, American Society of Cytopathology, Association of Public Health Laboratories, Clinical Laboratory Management Association, College of American Pathologists, and National Society for Histotechnology.
American Society for Clinical Laboratory Science National Medical Laboratory Professionals
More on the Breast Cancer Specific Molecular Prognostic Test
The February 2007 issue of MedSun News featured the announcement by the Food and Drug Administration (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety of FDA clearance of a first-of-a-kind medical device that determines the likelihood of recurrence of breast cancer within 5 to 10 years after a woman's initial cancer. The following details on the MammaPrint® test may be of interest to readers.
The MammaPrint® test assesses the risk of distant metastasis for female breast cancer patients under 61 years of age with Stage I or Stage II disease, with tumor size = 5.0 cm, and who are lymph-node negative. The test uses microarray technology to measure the level of gene expression of 70 genes that regulate cell cycle, invasion, metastasis, and angiogenesis. The gene expression information from these 70 genes is combined to yield a “score” that indicates whether the patient is in a “low-risk” or “high-risk” category for metastatic recurrence of cancer.
The score was developed based on an initial study of 78 patients, was then evaluated in a second study with 151 patients, and was further validated in another study using 302 patients from five different centers in Europe. High-risk patients have a 22 percent probability of distant metastasis at 5 years, compared to 29 percent at 10 years. On the other hand, low-risk patients have a 95 percent probability of not getting metastatic disease at 5 years compared to 90 percent at 10 years.
The MammaPrint® test is not intended for diagnosis, or to predict or detect response to therapy, or to select the optimal therapy for patients. A special control guidance will be issued soon by FDA to describe types of information needed for other manufacturers to offer similar FDA-cleared tests.
For more information, go to
CMS Recognizes Joint Commission Accreditation for Clinical Laboratories
On February 26, 2007, the Centers for Medicare & Medicaid Services (CMS) of the U.S. Department of Health and Human Services granted the Joint Commission continued deeming authority under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The CMS designation means that laboratories accredited by The Joint Commission are deemed as meeting both CLIA and Medicare certification requirements. CMS found that Joint Commission standards for laboratories are equal to, or more stringent than, the CLIA condition-level requirements. The Joint Commission began evaluating laboratory services in 1979, and since 1995, clinical laboratories surveyed using Joint Commission standards have been judged by CMS as meeting or exceeding CLIA requirements. The Joint Commission evaluates and accredits nearly 2,000 organizations with laboratory services, including approximately 3,300 CLIA-certified laboratory sites, providing an assessment of a laboratory’s compliance with state-of-the-art standards.
The Joint Commission
By: Jill Marion, BSE, Patient Safety Staff
What Is KidNet?
KidNet is a specialty network of the Medical Product Safety Network (MedSun). It is focused on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric intensive care units (NICUs and PICUs).
What Are the Goals and Objectives of KidNet?
KidNet Goal: To enhance pediatric patient safety associated with medical device use in the clinical setting by healthcare professionals’ recognizing, reporting, and understanding of medical-device related adverse events.
Increase the number and quality of signals for adverse events associated with devices used in pediatric patient populations
•To identify, understand and share postmarket device safety issues relevant to pediatric patient populations with KidNet participants, FDA, and the pediatric clinical community.
•To utilize the KidNet community as an interactive venue or real-time ‘laboratory’ to validate and understand device-related adverse event signals identified by FDA and KidNet participants.
Who Can Participate in KidNet?
MedSun facilities interested in reporting adverse events involving devices used in NICUs or PICUs including reports of:
•Patient, family member, or healthcare provider death or serious injury, or those that represent ‘potential for harm, ‘near miss’, or ‘close call’ events
•Problems with devices indicated for use with neonatal or pediatric patients that fail or don’t perform as intended
•Problems with devices without pediatric indications for use that fail or don’t perform optimally because of anatomic or physiologic differences between adults and children (i.e. sizing, fit affects delivery of therapy).
Pediatric MedSun Success Stories (2006-2007):
Neonatal PICC Catheter: A minor injury was experienced by a critically ill NICU patient when the dual lumen PICC catheter was noted to be leaking and required immediate removal and replacement. CDRH/FDA followup with the firm identified that the firm had begun an investigation to address the increasing trend of PICC complaints. The investigation concluded that the source of the leak was use error and the sales force is reenforcing the instructions for use with their customers.
Infusion Pump: A report described an adverse event with 15cc of air noted in the lipid syringe and halfway down the tubing of an infant‘s IV lipids. The lipids had infused too fast and the facility’s clinical engineering department found that the syringe had a dent/defect in it. CDRH/FDA follow-up with the firm indicated that the firm identified a manufacturing defect, which is being addressed.
Syringe Pump: A pediatric patient was found holding a syringe of medication, while standing in the patient’s crib. The syringe of medication had been properly placed in the syringe pump, even though the patient was able to pull on the tubing, reaching the syringe and removing it from the pump. CDRH/FDA follow up with the manufacturer indicated that although the event was the only reported issue of this type; a lock box was created to prevent this issue from reoccurring.
Infant Warmer: An infant warmer had an upgrade kit issued following a manufacturer investigation in September 2006. After that upgrade, a MedSun user facility reported an event of the bed platform falling approximately 1 foot and tilting sharply, as a patient was being repositioned on the bed. CDRH/FDA followup with the firm indicates the firm identified the cause for the reported problem, resulting in a recall.
Prospective KidNet Timeline:
•KidNet Web-based orientation May 17, 2007 3:00 p.m. EDT
•KidNet data collection begins June 1, 2007
•New hospital group orientation June 25, 2007 Annapolis, MD
(KidNet reporters welcome) July 13, 2007 San Diego, CA
•Educational Audioconference: August/September 2007 3:00 p.m. EDT
“Improving Patient Safety By (specific date to be Reporting Problems With announced with Medical Devices” replays available)
•KidNet participant roundtable October 18, 2007 3:00 p.m. EDT to discuss and obtain feedback on reported events and safety issues of concern – via Webcast or audioconference
Prevent Dangerous Hemodialysis Catheter Disconnections
By Shirley A. Zeigler, R.N., CRNP, M.S.N.
(Article reprinted from Nursing2007, Volume 37, Number 3, p. 70)
Ten minutes after a patient began receiving a hemodialysis treatment, his venous blood line separated from the catheter. Shortly after the venous blood line was clamped, the patient complained of shortness of breath. His respirations were labored at a rate of 28 to 32 breaths/minute. He was immediately placed on his left side in Trendelenburg’s position, started on 10 liters/minute of oxygen by face mask, and transported to the hospital. Despite these measures, he died of an air embolism.
What went wrong?
An implanted or nonimplanted hemodialysis catheter can be used as a “bridge” device until the patient’s arteriovenous graft or native fistula is ready to be used. If the hemodialysis catheter inadvertently separates from the venous blood line, the patient can suffer an air embolism or quickly lose a large amount of blood.
When a catheter separates, the hemodialysis machine’s alarm doesn’t always go off. Its venous pressure monitor triggers an alarm when the venous blood line falls below the limit set by the user.
A patient can lose 200 to 250 mL/minute of blood when a catheter separates. The rate of blood loss varies depending on the rate at which the blood is being pumped through the hemodialysis machine.
The Food and Drug Administration (FDA) has received adverse event reports describing hemodialysis catheters that have separated, leaked, cracked, torn, or broken, leading to infection, air embolism, blood loss, additional surgery, or death.
What precautions can you take?
Follow these steps to reduce the chances of hemodialysis catheters separating and to lessen the harm if they do separate:
•Know and follow your facility’s policies and procedures for managing catheters and blood line tubings used for hemodialysis.
•Read the manufacturer’s instructions carefully before initiating treatment. Use and care for the catheter according to the manufacturer’s device labeling.
•Inspect equipment for damage before initiating hemodialysis.
•During hemodialysis, monitor catheters and arterial and venous blood line tubing for cracks, tears, and breaks of the catheter hub or luer connection. Remember, alarms may not sound if a catheter separates from the venous blood line.
•Use luer connections or tape with hemodialysis catheters and tubing as specified by your facility protocols.
•Use the indicated vascular access site only for hemodialysis.
•Make sure the catheter site remains visible during treatment. For example, remove sheets and blankets if necessary.
•When a hemodialysis catheter separates from the blood line tubing or the integrity of the catheter is compromised in any other way, follow your facility’s policy for preventing air embolism and infection, including clamping the line immediately.
•If a catheter separates, monitor the patient for signs and symptoms of hypovolemia and air embolism: shortness of breath, chest pain, altered level of consciousness, agitation, tachycardia, tachypnea, and hypotension. Then intervene if required.
•Fill out your facility’s adverse event report. If faulty equipment was involved, also report it to your facility’s biomedical engineering department.
Article reprinted from Nursing2007
Prevent Fires When Using Oxygen Cylinder Regulators
FDA has received 12 reports of oxygen cylinder regulators that spontaneously ignited and burned during emergency medical use or routine equipment checks, causing burns and property damage. A recently published article by Robert A. Fischer, R.N., M.S.N., a nurse-consultant at the Center for Devices and Radiological Health (CDRH), in Nursing2007 [37 (1): 20] discussed such fires. To read this article, see additional information below.
After a recent, very destructive, oxygen cylinder regulator fire, one in which a firefighter received second-degree burns, the National Institute for Occupational Safety and Health (NIOSH) and CDRH commissioned an extensive forensic analysis by an independent test laboratory of oxygen cylinder regulators. The resulting laboratory report stated that “any leakage [around damaged seals], especially slow weeping leaks, increases the probability of flow-friction ignition of this seal.” The FDA and NIOSH believe improper use of damaged gaskets/washers on the regulator was a major factor in both the ignition and severity of this particular fire.
To view precautions that can be taken to avoid explosions, cylinder ruptures, and fires from oxygen cylinder regulators, see additional information below.
Nursing2007 discussed such fires and was featured by CDRH at
To view precautions that can be taken to avoid explosions, cylinder ruptures, and fires from oxygen cylinder regulators, go to
Changing Medical Technology and Its Effect on Health Care Costs
A new paper in the Kaiser Family Foundation series Snapshots: Health Care Costs examines the ways in which changes in medical technology can affect health care costs. Health care experts frequently point to the development and adoption of medical technology as key factors in the rapid rise in health care spending in the United States. Some observers argue that new medical technology accounts for one-half or more of real long-term spending growth. Snapshots is a series of regular online publications that address the issue of national health care costs.
The term medical technology can refer to procedures, equipment, drugs, medical devices, and administrative support systems used to track patient information. The Foundation paper discusses why medical technology is considered one of the most important factors in rising health care costs. Even if an advance in medical technology is less costly than the current approach, the new technology may extend treatment to a greater number of patients or may add to rather than replace existing treatment, thus adding to overall health care costs. The paper studies some of the key factors that can influence the development and adoption of new technology, including consumer demand and insurance coverage. In addition, it raises policy issues such as whether consumers and insurers receive adequate value for money spent on new medical technologies and how medical technology costs can be contained.
How Changes in Medical Technology Affect Health Care Costs
DS-X Lessons Learned
Emergency and Disaster Relief Preparedness
By Yadin David, M.Sc., Ed.D., PE, CHSP, CCE
Edited By Jill Marion, FDA Patient Safety Staff
After the multiple natural disasters in the United States over the past several years, particularly those in the Southern region, staff of Texas Children’s Hospital in Houston decided that they needed a more focused, comprehensive plan to handle emergencies in the future. They decided to overhaul their existing disaster plan, changing it into a global emergency preparedness program. The global emergency preparedness program would be designed to improve resource planning and allocation during extreme conditions with a goal of sustaining the level of care the hospital could deliver under disaster circumstances. The program would consist of two distinct plans rather than the existing single plan. The two plans would be composed of protocols and procedures to be used during an emergency to aid in disaster relief. One of the two plans would be medical device-specific, and the other a broader, hospital-wide plan.
Expanding and Updating the Existing Plan
To initiate the process of expanding and updating the hospital’s disaster plan into the global emergency preparedness program, Lynn Sessions, Director of Risk Management, appointed Yadin David, Director of Biomedical Engineering, and a multidisciplinary team of hospital personnel that included risk managers, facility engineers, information technology professionals, security employees, and telecommunication managers, to review the existing disaster preparedness plan. The focus of the new program was on sustaining clinical operations and on training staff to function under changing circumstances and abrupt curtailment of otherwise normal conditions.
The global emergency preparedness program documents everything from patient evacuation to the location of flashlights, radios, and scrubs, to placement of emergency power sources for charging medical devices. Administering an emergency preparedness plan is very demanding and occurs in a chaotic environment. Technical, clinical, and administrative leaders are often required to make decisions “on the fly.” Thus, to make the administration of such a plan successful during a disaster, there must be a well-planned strategy, trained staff, and collaboration of multiple teams with clear “buy-in” from all parties. To this end, the team met monthly with clinicians and hospital administrators to review the plan updates. The plan that was developed focused on the potential impact of hurricane conditions. (Hurricane season in Texas is between June and November.)
The hospital-wide plan provides guidance and recommendations on development and structure of multiple departmental-level command centers that are separate from the main hospital command center. It describes electronic and human communications protocols as well as how to maintain an asset inventory. The medical device-specific plan not only encompasses all the actions included for the hospital-wide plan, but also includes tracking of machines and their power requirements, and critical information on which devices must continue to function to support patients. Details on these plans are discussed in the following section on implementation of the plans.
Implementing the New Emergency and Disaster Relief Preparedness Plans
This new global emergency preparedness program was first implemented during Hurricane Rita in 2005. Afterward, staff involved with implementation of the plans at Texas Children’s Hospital met to identify unanticipated issues that arose during the disaster and ways to reduce the likelihood that such issues would be repeated in future disasters. The following are items of interest from the final global emergency preparedness program:
Issue: Difficulty tracking device problems via a central command center.
Strategies To Resolve the Issue:
•Keep an up-to-date inventory that includes optional power sources (such as a source of batteries and power source longevity), along with a listing of communications assets (handheld radios, paging towers, pagers, etc.). Make sure that the inventory reflects where and with whom the communication devices are located.
•Establish a priority listing of how to reallocate these assets to high-emergency areas. Track the devices so they can be recommissioned and returned to the owners after the disaster. Supply additional batteries to support telecommunication devices and generators for charging systems for batteries.
•Maintain peer networks that can share lessons learned on this and other issues.
Issue: Difficulty locating communication devices and supporting open communication channels.
Strategies To Resolve the Issue:
•Establish departmental-level command centers that are separate from the hospital command center. These centers focus on the coordination of service and equipment support needs.
•Maintain a constant flow of information between the department-level command centers and department staff. Establish clear communication protocols (for example, telephone triage) and train staff on protocol compliance.
•Post a white board in all command centers. Keep a list of staff that are onsite, their needs, the problems they face, and staff responsible for dealing with identified problems. The board must be updated continuously to be an effective tool, and that information can be used later to determine lessons learned.
•Designate, when other communications are not reliable, one physical runner to be in charge of relaying information from the hospital command center to the department command centers, and from the departments back to the hospital command center. Have forms prepared for such an event.
•Make sure that the command center structure is planned for communications coordination (for example, bank of radios, wired and wireless telephones, local TV station, computers), that the command center is in a protected location, and that its entrance is easily accessible and near elevators.
•Make sure that TV systems can be deployed throughout the hospital to pass information to patients and their families.
Issue: Difficulty in knowing the impact of power loss on various device systems and in maintaining device operations.
Strategies To Resolve the Issue:
•Develop a matrix rating the probability and extent of impact on the function of various systems (commercial power, bedside monitors, central suction, etc.) that may be lost when a particular system fails. When the commercial power is lost, for example, it is important to consider which medical devices will be affected and how this problem could be resolved (switch to emergency generator, batteries).
•Keep track of critical devices, like infusion pumps, their electrical power needs, their battery types, and battery longevity. Plan for power-charging rotation.
•Maintain a list of devices that must continue to function to support patient care.
•Meet with vendors to review their ability to provide supplies, equipment, and expertise to support the hospital during a disaster.
•Establish a backup plan with hospitals located outside the potential disaster area. (Note that during Hurricane Rita, Texas Children’s Hospital was unable to receive deliveries of radios from the regional FedEx warehouse, but it was able to get them from a hospital in Seattle through another route.)
Issue: Maintaining personnel hygiene and staff morale.
Strategies To Resolve the Issue:
•Require staff to store at work a personal hygiene package that includes a change of clothes and basic hygiene items.
•Because the hospital may not be able to feed everyone, the personal hygiene package should include bottled water and nonperishable food.
•Staff will need to rest, so identify housing areas within the hospital that could be designated as male only and female only, and then assign staff to specific areas.
•Establish and communicate a plan for meal distribution to staff.
•Ahead of emergencies, have all staff members designate themselves as members of teams with specific functions in order to avoid confusion during the emergency. For example, staff should be identified in terms of those who are willing to stay at the hospital for the duration of the emergency and those who will not stay but will provide relief to those who do.
•Keep track of damages that occur during the disaster by making digital photographs for use when making insurance claims later.
By developing a more comprehensive emergency preparedness program, the Texas Children’s Hospital has improved the level of resource allocation and so can sustain the care the hospital delivers during a disaster situation. By continuing to evaluate the program, to train staff, and to capture lessons learned after disasters occur, the hospital intends to continually improve this plan.
For FDA tips on using home medical devices under disaster conditions, go to
Updated March 1, 2007