BOTHELL, Wash., July 19 /PRNewswire-FirstCall/ -- Cardiac Science Corporation (Nasdaq: CSCX), a global leader in automated external defibrillator (AED) and diagnostic cardiac monitoring devices, announced it has addressed outstanding issues with the Food and Drug Administration ("FDA") relating to the corrective AED field action announced on November 13, 2009. The FDA has issued an updated communication on this matter which may be viewed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191426.htm.

Agency to consider risks to vulnerable populations

The U.S. Food and Drug Administration today announced plans to hold an advisory panel on Dec. 14-15, 2010, to discuss several scientific issues that may affect the regulation of dental amalgam, used for direct filling of carious lesions or structural defects in teeth. The panel meeting will focus particularly on the potential risk to vulnerable populations, such as pregnant women, fetuses, and young children.

DEERFIELD, Ill, May 3, 2010 - Baxter Healthcare Corporation today announced that it will recall COLLEAGUE infusion pumps from the U.S. market pursuant to an order under its existing June 2006 consent decree with the U.S. Food and Drug Administration (FDA). Baxter will work with the FDA to ensure that the recall process provides customers appropriate alternatives for supporting patients' needs.

As previously disclosed, Baxter entered into a consent decree with FDA under which the company has been pursuing remediation of the infusion pumps. The decree permits FDA to require the recall of the pumps, and FDA has communicated to the company that it will require such a recall, with the company providing monetary consideration or replacement pumps to customers on a timeline to be determined with FDA and based on medical need. Baxter intends to work with FDA to minimize disruption to healthcare facilities using COLLEAGUE pumps. Baxter anticipates that, among alternatives to be provided to customers, the company will offer to exchange Baxter's Sigma SPECTRUM infusion pumps for COLLEAGUE infusion pumps without charge to customers.

The consent decree permits Baxter to propose alternative actions to achieve the FDA's objectives under the decree, which the company intends to do. The final nature of the recall and offer to customers remain subject to that ongoing dialogue. Once final, Baxter will notify customers and make information available on www.baxter.com.

Notwithstanding that uncertainty, the company currently anticipates that it will record a pre-tax special charge of $400 to $600 million in the first quarter for the reasonably estimable cost of the recall. The company is not otherwise revising its earnings guidance for the year in connection with the recall.

About Baxter

Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the Company's recall of its COLLEAGUE infusion pumps from the U.S. market, including expectations with respect to the implementation of the recall and the amount of the related charge. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: resolution of the final nature of the recall; future actions of the FDA with respect to the Company's implementation of the recall pursuant to the Consent decree, including any sanctions available under the Consent Decree; future actions of the FDA or any other regulatory body or government authority that could delay, limit or suspend product development, manufacturing or sale or result in seizures, injunctions, monetary sanctions or criminal or civil liabilities; product quality or patient safety issues; the financial impact of the recall; and other risks identified in the company's most recent filing on Form 10-K and other SEC filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.

The FDA unveiled the Center for Devices and Radiological Health (CDRH) Transparency Web site to provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.

Part of an ongoing effort within CDRH, across the FDA, and across the Department of Health and Human Services to enhance public communication and transparency, the new site includes features from the previous CDRH site that provided information about approved products, industry guidance, medical device safety, and adverse event reports. In addition, the new Web site features extra information displayed in a more user-friendly format.

As every BMET knows, Infusion pumps are one of the most ubiquitous, time consuming, and problem prone devices in the hospital environment.  In an effort to improve the quality and design of infusion pumps the FDA has started an initiative to improve their pre- and post-market assessment of these devices.  On April 23, 2010 the FDA issued the following letter to manufacturers of infusion pumps:

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
April 23, 2010

Dear Infusion Pump Manufacturer:

FDA’s records have identified you as the “Official Correspondent” to the Medical Device Manufacturer stated above. Please ensure that the following message is relayed to the Most Responsible Individual at the Medical Device Manufacturer.

The Food and Drug Administration (FDA) is notifying you of our intent to improve the current premarket and postmarket regulatory processes associated with infusion pumps. These actions are being taken in light of serious adverse events noted in Medical Device Reports and an increasing number of recalls involving several different types of infusion pumps. The FDA believes that this effort will help mitigate current risks and reduce future risks associated with infusion pumps.

FDA has seen an increase in the number and severity of infusion pump recalls. Analyses of MDRs have revealed device problems that appear to be a result of faulty design. Between January 1, 2005 and December 31, 2009, FDA received over 56,000 MDRs associated with the use of infusion pumps. Of these reports, approximately 1% were reported as deaths, 34% were reported as serious injuries, and 62% were reported as malfunctions.

The most frequently reported external infusion pump device problems are: software error messages, human factors (which include but are not limited to use error), broken components, battery failure, alarm failure, over infusion and under infusion. In some reports, the manufacturer was unable to determine or identify the problem and reported the problem as “unknown”. Subsequent root cause analyses revealed that many of these design problems were foreseeable and, therefore, preventable.

We have evaluated and analyzed a broad spectrum of external infusion pumps across manufacturers and concluded there are numerous, systemic problems with device design, manufacturing, and adverse event reporting. We believe these types of problems are preventable. To address these device problems, manufacturers may need to conduct additional risk assessments of new products or changes to products currently being marketed.

Given the concerns involving software errors, we offer, on a voluntary basis, a static analysis of your software for a new or changed infusion pump. The analysis can help manufacturers identify potential defects earlier in the product development cycle and support validation of the software. This analysis can be performed in conjunction with or in advance of a premarket submission for that device. We believe this action can facilitate the development of safer infusion pumps while reducing costs to manufacturers. For further information, please contact Mr. Richard Chapman, Division of Electrical and Software Engineering, Office of Science and Engineering Laboratories at (301) 796-2585 or Richard.Chapman@fda.hhs.gov.

We strongly recommend external infusion pump manufacturers meet with the Agency early in the device development process to discuss submissions regarding new infusion pumps or changes to existing devices. For further information, please contact Mr. Anthony Watson, Director, Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation at 301-796-6296 or Anthony.Watson@fda.hhs.gov.

FDA believes these actions, early communication between the FDA and infusion pump manufacturers, and additional actions being announced by the agency today will result in safer and more effective infusion pumps. We look forward to working with you on this important public health issue.

Sincerely,

Jeffrey E. Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration

Additional information on this initiative can be found here

The U.S. Food and Drug Administration today announced that it will change the way its expert panels review and discuss data and information during public hearings on medical devices under review for premarket approval, effective May 1, 2010.

The changes were prompted by an increasing number of medical device advisory panel meetings in recent years. In 2008, there were 10 panel meetings covering 14 major topics. In 2009, there were 17 meetings on 20 topics, and 2010 is on track to surpass those numbers, according to the FDA’s Center for Devices and Radiological Health (CDRH).

The FDA announced that it will begin implementing a requirement that device manufacturers provide readily available information in certain premarket applications on pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use. Very few devices are developed or assessed specifically for use in pediatric patients, those 21 or younger at the time of treatment or diagnosis. This effort will provide a better understanding of which devices developed for use in adults should be assessed or modified for use in pediatric populations. The requirements, contained in the Food and Drug Administration Amendments Act of 2007, will also improve the agency's ability to track the number of approved devices for which there is a pediatric subpopulation who could benefit and the number of approved devices labeled for use in pediatric patients.

"This requirement allows the agency to collect information that will help us better assess public health needs for medical devices that can be used for pediatric populations," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health.

Under the 2007 legislation, manufacturers must provide certain pediatric information, if readily available, with each premarket approval application or supplement, humanitarian device exemption request, or product development protocol. Manufacturers now must include a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure. Manufacturers also must include the number of affected pediatric patients. If the manufacturer does not submit such information, the FDA may not approve the application until the required information is provided.

By ALICIA MUNDY and JARED A. FAVOLE

WASHINGTON—When medical-equipment makers like Philips Electronics NV, Siemens AG and General Electric Co. need approval for some new devices, they don't always have to start at the Food and Drug Administration. They can pay companies to do the reviews, which are then routinely approved by FDA officials most of the time.

Now this third-party outsourcing program has come under fire at the FDA, and the agency is weighing whether to end it. Agency officials question the quality of the reviews and whether they have served the program's original purpose: saving U.S. taxpayers money.

The U.S. Food and Drug Administration (FDA) will formally recognize the electrical equipment standard IEC 60601-1/Ed.3:2006.

Carol Herman, director of standards at the FDA's Center for Devices and Radiological Health (CDRH), made the announcement during the Association for the Advancement of Medical Instrumentation (AAMI)/FDA International Conference on Medical Device Standards and Regulation, which took place in Reston, VA, March 9-10.