MedSun: Newsletter #11, January 2007
Newsletter #11, January 2007
FDA Safety Tip: Pneumatic Tourniquet Cuffs,With a Tourniquet System
Device Description: The pneumatic tourniquet system consists of a pressure-regulated control unit, tubing, and an inflatable tourniquet cuff. The cuffs inflate with air, oxygen, or nitrogen to a preset pressure to compress the patient’s blood vessels during surgical procedures, thus ensuring a bloodless operative field. Qualified medical professionals, such as surgeons or anesthetists, use the tourniquet systems. Tourniquet systems are contraindicated for use in neonates and patients with peripheral vascular disease, thrombosis, or embolism. Both disposable and reusable tourniquet cuffs are available. Disposable cuffs are intended for single use only, and reusable cuffs are intended to be cleaned and inspected prior to their multi-use.
Crinkling, folding, and bending of pneumatic tourniquet cuffs are common occurrences whether it is a disposable single-use tourniquet or one that was intended for multiple uses. Reported Incident: A patient undergoing a total knee replacement had a pneumatic tourniquet cuff in use. Cast padding was applied to the patient’s upper thigh, beneath the tourniquet cuff, prior to covering the patient with a surgical drape. During the surgical procedure, the patient’s bleeding became uncontrolled and the pressure of the tourniquet cuff was inflated to 300 mmHg, and then to 350 mmHg. The inflation source appeared to be working properly, without any active alarms. At the end of the surgical procedure, the drapes were removed and the tourniquet cuff was noted to be crinkled and appeared to have a defect on the inside. The cuff’s rigid bladder was bent, folded, and crushed down the wrong way, thus preventing the appropriate pressures from being applied to the thigh and controlling the patient’s blood flow. The patient experienced subsequent blood loss as a result of this event.
Recommended Actions for All Pneumatic Tourniquet Cuffs:
• Tourniquet cuffs are subject to wear, tear, and deterioration, and should be inspected routinely for integrity and potential safety hazards prior to each use. The pneumatic cuff’s VELCRO® cuff closures, bladder, seams, and tubing should be inspected before applying the cuff to the patient. Physical damage to the cuff, such as rips, tears, or holes, as well as kinked or occluded tubing connecting the cuff to the instrument, may prevent the instrument from displaying the correct pressures.
• Tourniquet control units and cuffs should be checked, disassembled, and cleaned in accordance with the manufacturer’s written instructions with documentation per internal policy.
• Caution should be taken with the placement of tourniquet cuffs. The cuffs should be applied smoothly, with no wrinkles or tunneling effect, to prevent damage to the underlying skin and soft tissue. The skin should be protected by wrapping padding, with interlocking fibers that will not come apart, prior to tourniquet application.
• Inflation pressure and times are to be determined by the patient’s physician. It is important to remember that when a patient is experiencing uncontrolled bleeding at the operative site, increasing the pressure might not be the most appropriate action. Attention should be given to the tourniquet cuff to see if anything looks unusual, such as the crinkled cuff in this case.
AORN (February 2002). Recommended Practices for Use of the Pneumatic Tourniquet. AORN Journal. 75 (2).
Food and Drug Administration (April 2001). Enforcement of FDA Requirements on Reprocessing of Single Use Devices.
McEwen J., Inkpen K. (August 2002). Safety Preventing Skin Injuries. The Surgical Technologist. 218 (1):7-14. Tourniquet.org (November 2005). Tourniquet Overview.
Enforcement of FDA Requirements on Reprocessing of Single Use Devices.
JCAHO To Provide Data Management Tool
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will provide a new data management tool to all accredited hospitals by mid-year. This new tool, the Strategic Surveillance System, is designed to help identify and prioritize areas for improvement. JCAHO will provide the data management tool at no additional cost, and it will be accessible via an organization’s extranet site. The system is not a requirement for accreditation and does not require hospitals to input additional data.
The Joint Commission
JCAHO REMINDER: Field Review of Potential 2008 National Patient Safety Goals, Requirements, and Implementation Expectations
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) seeks input through January 26, 2007, on potential National Patient Safety Goals, Requirements, and Implementation Expectations under consideration for 2008.
Update to FDA Statement on Coronary Drug-Eluting Stents January 4, 2007
On September 14, 2006, FDA issued an initial statement related to concerns about adverse events related to coronary drug-eluting stents (DES). The statement noted that new data suggested a small but significant increased risk of stent thrombosis in patients who have been treated with the currently approved DES (the CYPHER® stent and the TAXUS® stent). FDA has made detection of DES thrombosis signals a priority because of the potential for serious harm to patients—even though stent thrombosis occurs at low rates. While the new data raised important questions, the Agency did not have enough information to draw conclusions. FDA announced plans to convene a public panel meeting of outside scientific experts to assist us in a thorough review of all available data and make recommendations about what actions may be appropriate, such as possible labeling changes or additional studies.
On December 7 and 8, 2006, the Circulatory System Devices Advisory Panel met in an effort to fully characterize the risks, timing, and incidence of DES thrombosis. The purposes of this meeting were: (1) to provide a forum for the presentation of clinical data relevant to the issue of DES thrombosis (both when DES are used according to their label and in more complex patients beyond their labeled indication); and (2) to address the appropriate duration of antiplatelet therapy (aspirin plus clopidogrel) in DES patients. Panel members and public speakers represented a broad spectrum of interest and expertise, including interventional cardiologists, noninterventional cardiologists, cardiovascular surgeons, biostatisticians, and the DES manufacturers.
In response to specific questions posed by FDA, the Panel had the following recommendations regarding DES when they are used in accordance with their approved indications:
• Both approved DES are associated with a small increase in stent thrombosis compared to bare metal stents that emerges 1 year post-stent implantation.
• However, based on the data available, this increased risk of stent thrombosis was not associated with an increased risk of death or myocardial infarction (MI) compared to bare metal stents. This finding may be due to (1) an insufficient number of patients in currently available studies; or (2) an increase in deaths or MIs was offset by a reduction in events associated with in-stent restenosis and additional revascularization procedures.
• When compared to bare metal stents, DES are not associated with an increased rate of all-cause mortality.
• The concerns about thrombosis do not outweigh the benefits of DES compared to bare metal stents when DES are implanted within the limits of their approved indications for use.
• Larger and longer premarket clinical trials and longer followup for postapproval studies are needed, using uniform definitions of stent thrombosis and close attention paid to patient compliance with antiplatelet therapy.
The Panel was also asked to address the broader use of DES with more complex patients and coronary lesions compared to those patients studied to support initial marketing approval. The use of a drug or device outside the FDA-approved indications is known as “off-label use.” Although FDA regulates the manufacture, labeling, and promotion of devices, we do not regulate how they are used by individual clinicians in the practice of medicine. However, FDA may take action if safety issues with any use of a device become a public health concern. We felt that DES safety associated with off-label use should be included in the Panel’s deliberations, given observations that at least 60 percent of current DES use is off-label. The Panel had the following comments and recommendations:
• With more complex patients, there is an expected increased risk in adverse events. The Panel agreed that off-label use of DES is associated with an increased risk of stent thrombosis, death, or MI compared to on-label use.
• The available data were insufficient to determine whether the increased risk in adverse events with off-label use was the same or different between the two currently approved DES.
• Data on off-label use are limited, and additional studies are needed to determine optimal treatments for more complex patients. Until more data are available, the DES labels should state that when DES are used off-label, patient outcomes may not be the same as the results observed in the clinical trials conducted to support marketing approval.
Regarding the duration of antiplatelet therapy:
• Data from several studies suggest that a longer duration of antiplatelet therapy than is currently included in the CYPHER® and TAXUS® labeling may be beneficial.
• The optimal duration of antiplatelet therapy, specifically clopidogrel, is unknown and DES thrombosis may still occur despite continued therapy.
• The labeling for both approved DES should include reference to the ACC/AHA/SCAI PCI [American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions/Percutaneous Coronary Intervention] Practice Guidelines, which recommend that patients receive aspirin indefinitely plus a minimum of 3 months (for CYPHER® patients) or 6 months (for TAXUS® patients) of clopidogrel, with therapy extended to 12 months in patients at a low risk of bleeding.
Following this meeting, FDA has been carefully considering the new data presented at the meeting, the opinions from public speakers, and the Panel’s deliberations and recommendations.
We will be working closely with the manufacturers of both approved DES and other DES still under study to incorporate appropriate modifications to labeling and changes to pre- and postapproval studies. Additionally, we will continue to work with professional societies, consumer organizations, and health care providers to provide physicians and patients with the most updated information as quickly as possible.
FDA Approves Novel Device That Prevents or Reduces Brain Damage in Infants
The Food and Drug Administration (FDA) today approved a first-of-a-kind medical device for the treatment of babies born with moderate to severe hypoxic-ischemic encephalopathy (HIE), a potentially fatal injury to the brain caused by low levels of oxygen. The Olympic Cool-Cap system is designed to prevent or reduce damage to the brains of these patients by keeping the head cool while the body is maintained at a slightly below-normal temperature. The Cool-Cap is manufactured by Olympic Medical Corporation of Seattle, Washington.
“This approval brings new hope to parents of the approximately 5,000–9,000 babies each year who are born in the United States with moderate to severe hypoxic-ischemic encephalopathy,” said Dr. Daniel Schultz, director of FDA’s Center for Devices and Radiological Health. “Until now, there has been no effective treatment for these infants other than supportive care. Up to 20 percent of them died, and 25 percent suffered permanent disability because of neurological deficits.”
The Olympic Cool-Cap treats the patient by maintaining a steady flow of water at a selected cool temperature through a cap covering the infant’s head. The system, which consists of a cooling unit, a control unit, temperature probes, and a water-filled cap, was found safe and effective in a study with 234 infants with moderate to severe HIE. At 18 months of age, there were fewer deaths and fewer severe cases of neurodevelopmental disability in the cooled group compared with the control group.
As conditions of the approval, Olympic Medical Corporation will set up a patient registry to collect information on device usage and to track treatment outcomes; organize a training and certification process for all operators of the device; and restrict use of the device to patients who meet the eligibility criteria defined by the original study.
FDA Patient Safety News Now Available Online
“FDA Patient Safety News” (PSN), a monthly video news show for health professionals, presents timely information on new product approvals, recalls, and safety alerts, and offers important tips on protecting patients. Find out more about this show, read the complete stories, and watch or download the video at http://www.fda.gov/psn. Although some items covered on PSN may have already appeared on the MedWatch Web site, many of these videos and demonstrations are especially useful to educators in health care facilities and academic institutions. Please send any comments, questions, or suggestions about the program to PSNews@fda.gov.
Patient Safety News
FDA Patient Safety News Mailing List
DS-X Lessons Learned
The Device Safety Exchange Is Expanding
For the first time, Device Safety Exchange (DS-X) Web site access is expanding to allow non-MedSun Representatives at MedSun facilities to participate. New participants will be issued a password that will provide them access to the DS-X Web site, but not to the MedSun Reporting Site.
The DS-X Web site provides a forum for discussing device safety-related questions and sharing device safety success stories across the MedSun community. The Web site affords the opportunity to submit, as well as reply to and comment on, stories and questions.
Some examples of recent questions posted to the DS-X site are:
• What are the Top 10 device problems reported to FDA? In the answer to this question, a spreadsheet outlines the top reported device problems for each of the past 4 years.
• What is the risk associated with the use of cell phones in the hospital environment? In the answer to this question, multiple respondents share their view of the problem and offer suggestions for mitigating it.
If you know of an interested party at your facility who would like access to this resource, please contact us at firstname.lastname@example.org.
Updated January 1, 2007