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April 2010 Supplement vol. 19:05

FDA Recalls and/or Manufacturer Product Advisories and Field Corrections

Product distribution is nationwide unless otherwise specified. Contact the Home Office in Dallas for additional information. We cannot always include the serial and lot numbers affected by each recall, as both are often extensive. We also include recalls designated as COMPLETE. The “COMPLETE” designation does not guarantee that all users have been contacted – but signifies that FDA had determined that the manufacturer or supplier has completed due diligence to notify users; in addition, all recall information is significant to the repair history of the device and may: a) help clarify a past intermittent problem whose cause could not be fully explained at time of occurrence or b) provide valuable information for consideration during pre-purchase evaluations.

MEDWATCH/FDA Notifications.

1) FDA News Release: 4/20/10; FDA Obtains Consent Decree to Stop Marketing of Unapproved Sterilization System. Steris agrees to stop selling SS1 tabletop system for endoscopes, other devices. The U.S. Food and Drug Administration today announced that a consent decree has been filed against the device manufacturer, STERIS Corp. of Mentor, Ohio. The decree stops the company from distributing unapproved and misbranded devices used to sterilize heat-sensitive instruments and medical devices. It prohibits the distribution of the STERIS System 1 Processor, or SS1, a tabletop liquid chemical system marketed to disinfect certain devices, such as endoscopes, that cannot withstand steam sterilization.

As part of the consent decree of permanent injunction, STERIS has developed a transition plan and rebate program for its U.S. customers to ease the transitioning to legally-marketed alternatives. The transition plan allows STERIS to continue to support existing customers who are using the SS1, but requires these customers to obtain a Certificate of Medical Necessity to get parts, components, accessories, and service during the transition period which ends on August 2, 2011.

“FDA's oversight of medical devices helps ensure that patients are protected from unsafe or ineffective devices,” said Assistant Attorney General Tony West, who heads the Justice Department's Civil Division. “When device manufacturers fail to comply with FDA's regulations, they put patients at increased risk. As this consent decree shows, we will take whatever steps are necessary to make sure that all manufacturers are complying with FDA's regulations.”

In May 2008, the FDA advised STERIS in a Warning Letter that significant changes made to the SS1 caused the device to be adulterated and misbranded. In December 2009, the FDA sent a letter to health care facilities and infection control practitioners advising them that the agency had not cleared the current version of the SS1. The letter recommended users transition to a legally-marketed alternative.

Under the consent decree, STERIS agreed to destroy used SS1 devices, components, parts, and accessories in the company's possession within the United States by September 30, 2011. Some specified unused devices and component can, with FDA approval, be retained.

The decree was filed in the U.S. District Court, Northern District of Ohio on April 19, 2010, and is subject to court approval.

2) MEDWATCH: April 22, 2010. Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator

FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between Marcy 26, 2009 and December 15, 2009.

Reason for Recall: There is a potential for the device to unexpectedly:

  • Power Off then On by itself.
  • Power Off then NOT turn On.
  • Power Off by itself requiring the operator to turn it back On.
  • Stay powered On and not allow itself to be turned Off.

FDA COMMENTS: On March 4, 2010, the company informed customers by letter advising them to keep the device in service and to test their devices according to the operating instructions. The company stated that local service representatives are scheduling service visits within 60 days. Contact Physio-Control Technical Support at 1-800-442-1142 – option 5, Monday – Friday between 6:00 A.M. and 4:00 P.M. (Pacific Time).

3) FDA News Release April 23, 2010. FDA Launches Initiative to Reduce Infusion Pump Risks
Agency calls for improvements in device design

The U.S. Food and Drug Administration today announced a new initiative to address safety problems associated with external infusion pumps, which are devices that deliver fluids, including nutrients and medications, into a patient's body in a controlled manner.

As part of its initiative, FDA is moving to establish additional premarket requirements for infusion pumps, in part through issuance today of a new draft guidance and letter to infusion pump manufacturers. FDA is also announcing a May public workshop on infusion pump design, and launching a new Web page devoted to infusion pump safety.

“These pumps often provide critical fluids to high-risk patients, so failures have significant implications,” said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. “It is time for a more comprehensive approach than we've taken to date.”

Infusion pumps are widely used in hospitals, other clinical settings, and the home. The devices allow a greater level of control, accuracy, and precision in drug delivery, and help to reduce medication errors.

However, infusion pumps also have been the source of persistent safety problems. In the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data.

The most common types of reported problems have been related to:

  • software defects, including failures of built-in safety alarms;
  • user interface issues, such as ambiguous on-screen instructions that lead to dosing errors; and
  • mechanical or electrical failures, including components that break under routine use, premature battery failures, and sparks or pump fires.

Failures of infusion pumps have been observed across multiple manufacturers and pump types. The FDA says that many of the reported problems appear to be related to deficiencies in device design and engineering.

As part of its initiative, the FDA published draft guidance today recommending that infusion pump manufacturers begin to provide additional design and engineering information to the agency during premarket review of the devices.

Also today, the FDA issued a letter to infusion pump manufacturers, informing them that they may need to conduct additional risk assessments to support clearance of new or modified pumps.

In addition to alerting them of this intended change, the letter offers manufacturers the option of submitting their infusion pump software codes to experts at the FDA for static analysis prior to premarket review. Static analysis is a diagnostic technique that can help detect software problems early in the device development process. The agency previously invited manufacturers to make use of an open-source software safety model developed through the Generic Infusion Pump project, an ongoing collaboration with outside researchers aimed at improving pump design.

The FDA's public workshop will be held May 25-26, 2010. Participants will discuss observed safety problems, and explore opportunities to work with others, including foreign regulators, to improve the design of infusion pumps on the market or in development, in order to reduce pump malfunctions and errors. ...

The agency's new infusion pump safety Web page features basic information about infusion pumps and steps that patients and healthcare professionals can take to prevent and report safety problems, even before new or redesigned pumps are brought to the market...