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U.S. Department of Health and Human Services

MedSun: Newsletter #12, February 2007

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Newsletter #12, February 2007

Articles

Cardinal Health 303 Inc. Signs Consent Decree With FDA, Agrees To Correct Manufacturing Deficiencies

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Cardinal Health 303 Inc. (Cardinal 303), formerly known as Alaris Medical Systems, Inc., and three of its top executives have signed a consent decree for condemnation and permanent injunction related to the company’s Signature Edition (SE) infusion pumps. The infusion pumps have a design defect referred to as "key bounce" that may cause the pump to recognize a single key stroke as a double key stroke. The "key bounce" problem poses a risk to public health because of a potential overinfusion of medications.

Under the terms of the consent decree, the company has agreed to take necessary measures to ensure compliance with the current good manufacturing practice requirements and the Quality System regulation by all of its facilities that design, manufacture, process, pack, label, hold, or distribute SE infusion pumps. The decree also requires the company to retain an independent expert consultant to conduct inspections of its SE infusion pump facilities and certify to FDA that corrections have been made. FDA will continue to monitor these activities through its own inspections.

The decree was entered in the United States District Court for the Southern District of California on February 8, 2007.

Additional Information:

For more information, go to
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108840.htm

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FDA Clears Breast Cancer Specific Molecular Prognostic Test

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FDA has cleared for marketing a test that determines the likelihood of breast cancer returning within 5 to 10 years after a woman's initial cancer. It is the first cleared molecular test that profiles genetic activity.

The MammaPrint test uses the latest in molecular technology to predict whether existing cancer will metastasize. The test relies on microarray analysis, a powerful tool for simultaneously studying the patterns of behavior of large numbers of genes in biological specimens.

The recurrence of cancer is partly dependent on the activation and suppression of certain genes located in the tumor. Prognostic tests like the MammaPrint can measure the activity of these genes, and thus help physicians understand their patients' odds of the cancer spreading.

MammaPrint was developed by Agendia, a laboratory located in Amsterdam, The Netherlands, where the product has been on the market since 2005.

"Clearance of the MammaPrint test marks a step forward in the initiative to bring molecular-based medicine into current practice," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "MammaPrint results will provide patients and physicians with more information about the prospects for the outcome of the disease. This information will support treatment decisions.”

Additional Information:

For more information, go to the FDA Web site at
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108836.htm

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Custom Ultrasonics Signs Consent Decree

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Company agrees to stop manufacturing devices that wash and disinfect endoscopes until it corrects problems

Custom Ultrasonics, Inc. (CUI), has signed a consent decree of permanent injunction in which it has agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System Plus 83 Mini-flex Washer/Disinfector until it brings the methods and controls used to manufacture the devices into compliance with FDA's Current Good Manufacturing Practice requirements of its Quality System (QS) regulation. In addition, the company has agreed to develop and implement adequate written medical device reporting procedures. The consent decree was signed by Judge Timothy J. Savage and entered on January 25, 2007, in the U.S. District Court for the Eastern District of Pennsylvania.

The company's actions posed a potential public health hazard because endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients, causing life-threatening infections. FDA is not aware of any adverse events but advises health care providers using these products to discontinue using them if another option is available and to contact the firm for more information. Other options include using an alternative device or following appropriate protocols to manually wash and disinfect the device. If no alternative is available, health care providers should carefully weigh the risks and benefits of using these products.

Additional Information:

For more information, go the FDA Web site at
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108837.htm

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FDA Clears First-of-Its-Kind Suture Made Using DNA Technology

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FDA announced on February 12, 2007, that it has cleared for marketing in the United States the TephaFLEX Absorbable Suture, the first absorbable polymer suture made from material isolated from bacteria modified by recombinant DNA technology. Recombinant DNA technology uses living organisms to create chemicals that may be more difficult to produce under standard industrial methods.

"The TephaFLEX Absorbable Suture is made from material that uses the latest DNA technology," said Daniel Schultz, M.D., Director of the Center for Devices and Radiological Health of FDA.

"This approach could have broader applications for medical devices that use this novel manufacturing technology." FDA based its decision on the company's laboratory and animal testing that examined chemical composition, biological safety, and mechanical performance of the polymeric suture. The company provided data to show that the suture could be manufactured in a consistent and safe manner.

Additional Information:

For more information, go to
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108843.htm

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Critical Limb-Saving Vascular Device Cleared

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On February 9, 2007, FDA cleared for U.S. marketing a vascular shunt, a medical device that can help save the arms and legs of soldiers critically injured in combat as well as individuals in other trauma settings and emergency situations. The Temporary Limb Salvage Shunt (TLSS), made by Vascutek Ltd. (Renfrew, Scotland), was reviewed by FDA in less than 1 week because of the critical need for such a device.

"This device offers surgeons a new tool to potentially avoid the need for limb amputation following traumatic injury," said Daniel Schultz, M.D., Director of FDA’s Center for Devices and Radiological Health. "This device has been used successfully by other countries and is particularly important to serve our men and women in the Armed Forces who are seriously injured in combat."

The device works by connecting together the ends of a severed blood vessel, providing a bridge or shunt around the damaged area and restoring blood flow to the injured limb. It can be implanted on the battlefield and other remote areas to bypass damaged blood vessels and temporarily maintain blood flow to the injured limb until the patient can be transported to a surgical facility.

Additional Information:

Read the full press release at
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108841.htm

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FDA Warns MRL, Inc., of Violations of Current Good Manufacturing Practices in Manufacture of AEDs

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In a December 8, 2006, Warning Letter (CHI-2-07) from Food and Drug Administration (FDA) District Director Scott J. MacIntire, FDA officially warned the president of MRL, Inc., a Welch Allyn Company, of the inadequacy of the firm’s responses in August, September, and October 2006, to FDA Form 483, Inspectional Observations. Form 483 described the company’s automatic external defibrillators (AEDs) as adulterated and misbranded, based on FDA inspections of the Buffalo Grove, Illinois, manufacturing facility May 22 through July 20, 2006.

According to the warning letter, deficiencies in the MRL responses included, but were not limited to, failure to: establish and maintain procedures for device design verification; maintain complaint files; keep a list of maintained databases for collecting failure data; validate data analysis databases for their intended uses; track and trend data according to a statistical methods; complete nonconforming manufactured product reports; file replacements for lost documents in a timely manner; and validate corrective and preventive actions.

The warning letter also directed MRL to investigate and determine the causes of the violations and to take prompt actions to correct the violations and bring the products into compliance.

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Safety Tips

FDA Safety Tip: External Defibrillators With “Hands-Free” Capabilities, Preventing Defibrillator Cable and Connector Malfunctions

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Problem Descriptions: Many reported malfunctions with external defibrillators, particularly those with “hands-free” configurations, indicate failures in the cables and their connectors. These failures were not discovered during routine functional tests but only when an attempt was made to use them on a patient. The failure to deliver possible life-sustaining electrical energy to the patient’s heart in a timely manner may contribute to an adverse event.

In brief, a defibrillator is a device that delivers an electrical shock of energy for defibrillating (restoring normal heart rhythm to) the atria or ventricles of the heart or for terminating other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. There are two basic patient contact configurations, the paddles and the hands-free. With the paddles, the health care professional or device user holds the wired contact paddles on the patient while the shock is delivered through them to the heart. With the hands-free configuration, disposable pads connect to the defibrillator unit by a cable and connectors to deliver energy to the patient. The hands-free terminology refers to the fact that the user’s hands are not needed to hold the pads in place when the shock is delivered from the defibrillator power unit.

Reported Incidents: The Medical Product Safety Network (MedSun) has received several adverse event reports describing external defibrillator malfunctions attributable to cables and their connectors. These failures are not product- or source-specific but occur across defibrillator manufacturers. Summaries of several of these reports follow here.

•On one occasion, a nurse tried to attach the hands-free pad to the hands-free interface cable. It would not attach. The nurse found that the defibrillator hands-free electrode cable end was broken and would not align with the connector of the external multifunction electrode pad. The interface cable had to be replaced. It was believed that the twisting motion used during removal of the test load (testing done daily) put stress on the connector, causing the break.

•In another case, a nurse was unable to defibrillate a patient using the hands-free pads and interface cable. A switch was made to the paddles-cable, and defibrillation was achieved. A second defibrillator was later requested, and it also failed to work in the hands-free mode but did work when the paddles were attached. The last self-test on the original defibrillator unit had been performed the day before the failure, but the last time the pad interface cable was tested with this defibrillator was about a month before. The underlying causes of the hands-free failure were that the staff was unaware that an audible click would confirm the proper seating of each connector, and they were unable to recall (seeing) a system or momentary error message on the unit’s display.

•In a third instance, a patient was brought into the ER with no vital signs present. The ER staff attempted to defibrillate using the hands-free pads, but the device failed to operate. A second unit was tried [with the same pads], and it also failed. Paddles were brought in, but they would not plug into the defibrillator. Finally, a defibrillator from another unit was brought in and it worked. The original defibrillator was inspected by Biomedical Engineering staff, and it was discovered that the hands-free cable had a pin that had broken off in the defibrillator connector. This prevented the other pads (cable) that were tried from making proper connection and also damaged the paddle’s connector so it would not work in another unit.

Recommendations: Cables and their connectors are often the source of hands-free defibrillator failures. The following recommendations are designed to assist user facilities and staff in minimizing these types of occurrences during both testing and patient defibrillation.

•Perform a functional test of the defibrillator at least once a day or per the facility’s or manufacturer’s protocol.
-Be sure to test the unit on battery power only.
-Be sure that all accessories such as ECG electrodes, lead wires, hands-free pads, cables, and paper are present.
-Check for expiration dates on disposable products such as electrodes and hands-free pads.
-Keep records of these tests.
-Report within the facility any failures including mechanical faults such as bent or broken connector pins and/or cables, and electrical malfunctions such as open circuits or failure to deliver selected energy level.

•Include testing with an external test load with the interface cable.
-Keep the hands-free interface cables plugged into the test load as a protective measure when the device is not in use, if feasible. This measure can reduce the wear and tear from the frequent attaching and detaching of the connectors and the cables. The other ends of the cables can be connected to the defibrillator, if your facility’s protocol allows.

•At no less often than once every 6 months, test to ensure that the system will reliably produce the maximum energy level that will be used on patients.

•Keep in mind that the interface cables (and other included wires) are subject to various mechanical bending and twisting during use.
-Functionally testing and repositioning the cables to simulate actual use conditions may be helpful for early detection of connection issues that may cause intermittent opens/shorts.

•Be sure that the cables and connectors are positioned within easy reach of device users. Overreaching and stretching during a code event may lead to pin bending/breaking and/or incomplete mating of the pins or no connection.

•Train all device users to check the display screen and/or to listen for an audible clicking sound. These are feedback mechanisms from defibrillators that confirm positive connections. Look for possible messages that may indicate a connection has or has not been established.

•Provide the most current instructions for use with each defibrillator model during daily testing and preventive maintenance procedures, including any manufacturer’s suggested checklists.

•Provide adequate staff training according to the user facility’s policies and procedures.

•Provide the manufacturer’s technical support and emergency contact phone numbers near the defibrillator for easy contact if the device does not operate properly.

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Updated February 1, 2007

Return to MedSun: Medical Product Safety Network

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