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U.S. Department of Health and Human Services

MedSun: Newsletter #8, October 2006

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Newsletter #8, October 2006


FDA Statement on Coronary Drug-Eluting Stents

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In a September 14, 2006, update, the Food and Drug Administration (FDA) provided information in response to inquiries regarding the agency’s position on adverse events related to coronary drug-eluting stents. This information presented describes the current FDA position and does not represent new agency policy.

FDA has been monitoring coronary drug-eluting stents closely since they came on the U.S. market in 2003 and 2004, and will continue to do so. Recently released data suggest a small but significant increased risk of stent thrombosis in patients who have drug-eluting stents. Even though stent thrombosis occurs at low rates, FDA is keenly interested in this issue because of the potential for serious harm to patients. While the new data are of interest to FDA and raise important questions, the agency does not have enough information yet to draw conclusions. For example, it is unclear what causes drug-eluting stent thrombosis, how often it occurs, under what circumstances it occurs, and what the risk of occurrence is in a given patient.

To better understand this issue, FDA recently met with the two manufacturers of these products to discuss any information they might have regarding this issue and to get their perspectives. In addition, FDA plans to convene a public panel meeting of outside scientific experts in the near future to assist in a thorough review of all the data and to make recommendations about appropriate actions.

More information on this topic will be available in upcoming issues of MedSun News.

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Safety Information About the Alaris® Signature Edition Gold Infusion Pump Seizure

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Comments received from MedSun sites after FDA's original press release. Thanks to all who submitted comments and/or provided feedback.

What is the problem with the Alaris infusion pumps?
Some Alaris Signature Edition (also called Alaris SE) infusion pumps have a design defect that can cause over-infusion of medications into a patient’s bloodstream. Over-infusion can potentially result in serious harm or death to the patient.

The Alaris infusion pump is programmed with a touch-sensitive keypad. The keypad sometimes registers a number twice when it has been pressed only once (“key bounce”). For example, if a medication is intended to infuse at a rate of 4 milliliters per hour, key bounce might cause the number “4” to register as “44.” Thus the pump would deliver more than 10 times the intended amount of medication.

How do I know if I have one of the problem devices?
The problem devices include all Alaris Signature Edition and Alaris SE pumps with model numbers 7130, 7131, 7230, and 7231. You can find the model number on a label directly above the power cord.

What is a “seizure?”
A seizure is a regulatory action that FDA can take through a federal district court to remove an adulterated or misbranded product from commercial distribution.

Why did FDA request a seizure of the Alaris Signature Edition infusion pump?
Alaris has violated FDA’s quality system regulations several times. A February 2006 inspection found significant manufacturing and quality violations for this product line. After FDA laboratories confirmed the key bounce problem, FDA requested the seizure of all violative products at the firm’s facility. This seizure was limited to the pumps that were at the site and did not affect the distribution of any units that were confirmed not to have the key bounce problem.

Are these pumps safe to use?
FDA believes that the Alaris Signature Edition infusion pumps can be used safely by following the company’s instructions. Alaris has provided the following instructions:
•Proper Stance
When programming pumps, stand squarely in front of the keypad (ideally with the pump at eye level for best visibility) to facilitate proper depth of depressing each key.
Focus on listening to the number of beeps while programming IV pumps; each beep will correspond to a single digit entry. Unexpected double tone could indicate an unintended entry.
•Verify Screen Display
When programming the pump or changing settings, always compare the patient's prescribed therapy or the medication administration record, original order, or bar code device to the displayed pump settings for verification before starting or re-starting the infusion.
•Independent Double Check
Request an independent double check of pump settings by another practitioner before starting or changing infusions with hospital-selected high alert drugs.
Before leaving the patient's room, observe the IV tubing drip chamber to see if the observed rate of infusion looks faster or slower than expected. Adjust accordingly.

Why didn’t FDA remove these infusion pumps from health care facilities or from individual customers?
FDA did not require the removal of all Alaris infusion pumps because we are concerned that this could create a shortage of pumps within facilities, for example those that rely heavily on this model and do not have a source of replacement devices.

FDA explored all of the options in making this decision. Although not ideal, we believe that this solution best addresses the dual needs of correcting the problem and protecting patient safety.

Can I continue to use this infusion pump?
Each facility must make this decision individually based on its own inventory and needs.
In the busy hospital environment, the additional diligence needed to ensure these infusion pumps are functioning properly is not ideal. If you have the option of using other pumps until this problem is corrected, you may decide to do so. If you do not have other pumps available to you, and you decide to continue using this model pump, you should follow carefully the company’s instructions for proper use.

How does Alaris intend to fix the problem?
In an August 15, 2006, letter, Alaris informed its customers that it will provide a warning label for the pumps and a permanent correction for the key bounce problem once it is available. The company is developing a system to make the keypad less sensitive to “key bounce.” Once the firm provides assurance that the key bounce issue has been corrected, and performs and documents all necessary testing (i.e., design validation, process validation, document control, change control) to meet the requirements in the quality system regulations, the information shall be reviewed by the FDA. If the submission is complete and accurate, the FDA will clear the device for manufacture by the firm. The firm can also retrofit the devices that are currently on the market with the correction.

You can contact Alaris directly to learn how the company intends to correct the malfunction in your pumps. Call the Alaris SE Call Center at 877-552-4922. The call center is staffed from 6:00a.m. to 5:00p.m. (Pacific Time).
For more information, see Cardinal Health’s Alaris SE Pump Recall Information

Is FDA prohibiting Alaris from servicing these pumps for problems other than key bounce?
No. Alaris is responsible for deciding whether or not to service these pumps. The FDA seizure did not require Alaris to stop their routine servicing of the Signature Edition pumps.

What should I do if my Alaris infusion pump needs to be serviced for a problem other than key bounce?
We understand that some facilities need service on their pumps and do not have many options available to them. We encourage you to work closely with Alaris to find out what service they will and will not provide at this time, and how and where they recommend you obtain service.

How do I contact FDA?
If you need FDA to help explain the information listed above, e-mail DSMICA@cdrh.fda.gov or call 800-638-2041 (8:00 a.m. to 4:30 p.m. Eastern Time).

Additional Information:

For more information, see Cardinal Health’s Alaris SE Pump Recall Information

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MedSun Provides Another Source of Customer Feedback for Hospital Crib Manufacturer HARD Manufacturing Co., Inc.

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It’s pretty simple for HARD Manufacturing, America’s leading maker of hospital cribs: “If you don’t listen—and react—to what your customers are saying about your product, you don’t stay in business. That’s the biggest source of innovation, a customer’s saying, ‘Hey, can you do this?’,” says HARD Manufacturing President William N. Godin.

The company seeks that customer feedback after every purchase, calling customers 1 month and then a year after the sale. It seeks feedback through consultations with doctors and nurses. And now MedSun provides another source of valuable input.

It was through the MedSun program that HARD became aware that some customers felt the need for more concise and visible instructions on raising and lowering the sides and ends of cribs. Years ago, HARD responded to the needs of medical professionals who raise and lower crib sides multiple times during a day by designing their cribs to meet Federal OSHA standards and minimize the possibility of repetitive strain and other injuries. But parents are interacting more frequently with their children while they are in the crib, and the parents may not fully understand how to raise and lower the sides of the cribs. This may be one reason why HARD customers have requested improved instructions on how to raise and lower the sides.

To address customers’ requests, HARD will now supply each crib with a laminated card featuring simplified instructions, in easy-to-understand language, for the proper operation of the sides and ends. Additional labels will also be attached to the rails, explaining how to lower the sides using the lift-then-squeeze handle, and how to lift them using two hands. The Consumer Product Safety Commission mandates that two distinct motions must be used to lower a crib’s sides. More than 40 years ago, HARD designed the Johns Hopkins Handle, which must be lifted, then squeezed, before a crib side can be lowered.

“We want parents and caregivers to know how to properly lower the sides for maximum access to kids—and how to properly raise them for the peace of mind a secured crib provides,” Godin said. All of the new labels will be available free of charge to facilities with HARD cribs by calling 800-873-4273.

HARD’s cribs already feature a number of health, safety, and comfort innovations. Please visit our Web site to learn more about these features: http://www.hardmfg.com. “The product just continually gets better and some of the reason for that is input from customers and patients,” Godin said. “We’re glad to add the MedSun system as a partner in our efforts to provide a high quality product.”

Note from MedSun: MedSun staff send a copy of incoming reports to the appropriate product manufacturers with the reporter’s contact information and location so the manufacturers may be informed of what is reported to the program that concerns their products. This process ensures that manufacturers and FDA regulators can both work on what steps may be necessary to ensure the safety and effectiveness of the medical products. The process also assists MedSun sites with their fulfillment of the Safe Medical Devices Act requirements to send reports of serious injury and death to manufacturers.

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FDA Approves First Totally Implanted Permanent Artificial Heart for Humanitarian Uses

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The U.S. Food and Drug Administration (FDA) today approved the first totally implanted artificial heart for patients with advanced heart failure involving both pumping chambers of the heart under the Humanitarian Use Device (HUD) provisions of the Food, Drug and Cosmetic Act. The AbioCor® Implantable Replacement Heart, made by Abiomed, Inc. (Danvers, MA), is intended for people who are not eligible for a heart transplant and who are unlikely to live more than a month without intervention. In clinical studies, this product was shown to prolong the life and improve the quality of life for critically ill patients.

"This device represents a significant advance in artificial heart technology and holds promise for critically ill heart patients who are not candidates for heart transplants due to age or other medical conditions," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA.

"We hope today's approval will encourage the continued development of potentially lifesaving technologies for critically ill patients."

The AbioCor system consists of: a 2-pound mechanical heart that takes over the pumping function of the diseased heart, which is removed during the implantation procedure; a power transfer coil that powers the system across the skin and recharges the internal battery from the outside; and a controller and an internal battery, which are implanted in the patient's abdomen.

The controller monitors and controls the functioning of the device, including the pumping rate of the heart. The internal battery allows the recipient to be free from all external connections for up to 1 hour. The system also includes two external batteries that allow free movement for up to 2 hours. During sleep and while batteries are being recharged, the system can be plugged into an electrical outlet.

In order to receive the artificial heart, in addition to meeting other criteria, patients must undergo a screening process to determine if their chest volume is large enough to hold the device. "The National Heart, Lung, and Blood Institute (NHLBI) is proud to have supported the research which led to this development," said Elizabeth G. Nabel, M.D., Director, NHLBI, National Institutes of Health. "It represents a major technological advance and will benefit people in critical need."

Devices approved under the HUD provisions are those intended to treat conditions or diseases that affect fewer than 4,000 people a year in the United States. Similar to the Orphan Drug Act, the HUD provisions were designed to encourage development of innovative medical devices to treat rare conditions. These provisions allow medical devices to be approved for market if they demonstrate safety and probable benefit.

FDA based approval on the company's laboratory and animal testing and on a small clinical study of 14 patients conducted by Abiomed. The study showed that the device is safe and has likely benefit for people with severe heart failure whose death is imminent and for whom no alternative treatments are available. In some cases, the device extended survival by several months, allowing the patients to spend valuable time with family and friends. In two cases, the device extended survival by 10 and 17 months, respectively, and one patient was discharged from the hospital to go home.

"FDA recognizes that not all patients who are eligible will choose this option, but for many patients faced with death, the chance to have additional time with family and friends—however limited—is a chance they are willing to take," said Schultz. "We believe it is important to make the latest technology available as soon as possible and give patients and families complete information about the risks and benefits so they can make an informed choice."

FDA is requiring the company to provide a comprehensive patient information package to patients and families that clearly describes the risks as well as the probable benefits of the device and explains what patients should expect before, during, and after surgery. The patient and physician materials are available on the company's Web site at http://www.abiomed.com/.

To further refine and improve the use of this artificial heart technology, Abiomed will continue to do additional laboratory studies and will also conduct a postmarketing study of 25 additional patients. The postmarket study was recommended by the Circulatory Systems Devices Panel, a part of the agency's Medical Devices Advisory Committee.

Additional Information:

The patient and physician materials are available on the company's Web site at

For more information on HUDs, visit

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Research on Physician Disclosure of Medical Errors to Patients

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In two articles in the August 14/28, 2006, issue of the Archives of Internal Medicine (Arch Intern
Med. 2006: 166:1585-1593 and 1605-1611), University of Washington researcher Thomas H.
Gallagher, M.D., and his colleagues reported on findings of a mailed survey to 2,637 U.S. and
Canadian physicians (response rate 62.9 percent) of their attitudes toward physician communication of medical errors to patients.

“Choosing Your Words Carefully: How Physicians Would Disclose Harmful Medical Errors to Patients” describes wide variation in the type and amount of information that respondents are willing to disclose. Researchers noted that both the nature of the error and the physician’s specialty affect disclosure. Further, they concluded that disclosure standards and training are necessary in order for physicians to meet patient expectations and to fulfill their professional obligations.

In “U.S. and Canadian Physicians' Attitudes and Experiences Regarding Disclosing Errors to Patients,” the researchers reported that though the physicians work in differing malpractice environments, respondents from both countries had similar experiences and mixed feelings about disclosure of medical error. The authors recommend that the medical profession address obstacles to transparency within its culture.

Additional Information:

The findings from this study are discussed in an August 17, 2006, article in The Seattle Times

The findings from this study are discussed in a September 9, 2006, editorial in The New York Times

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DS-X Device Safety Exchange, a MedSun Program

DS-X Lessons Learned

Question of the Month with Comment

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How long must hospitals retain copies of MedSun or MedWatch reports submitted to the FDA?

From FDA: Per 21 CFR Part 803.18(c), if you are a user facility, you must retain a medical device reporting (MDR) event file relating to an adverse event for a period of 2 years from the date of the event. If you are a manufacturer or importer, you must retain an MDR event file relating to an adverse event for a period of 2 years from the date of the event or a period of time equivalent to the expected life of the device, whichever is greater. If the device is no longer distributed, you still must maintain MDR event files for the time periods described in this paragraph.

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Updated October 1, 2006

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