Medical Device Daily Washington Editor

Baxter Healthcare (Deerfield, Illinois) reported another Class I recall of more than 4,000 of its Colleague line of infusion pumps.

Baxter said in a statement reporting the recall that it had “identified a processing anomaly related to buffer overflow that occurs in specific situations,” which was implicated in “reports of 16 serious injuries that are associated with this issue at nine U.S. customer accounts.”

The devices lock up when all three infusion lines are operative and a healthcare professional uses a command that creates additional demands on the user interface, such as implementing an override on dose limits. The interruption of infusion could lead to injury or death, hence the Class I recall.

The recall affects 4,500 units that the firm put into distribution between May 14 and June 20, but single-line pumps and upgraded triple-line pumps are not affected by the glitch and are not subject to the recall.

In the company’s statement, Peter Arduini, president of Baxter’s infusion unit, said that the company had identified the error “early on in our U.S. remediation process and have taken decisive action to replace these pumps and correct the situation to the satisfaction of our customers.”

Erin Gardiner, a spokeswoman for Baxter, told Medical Device Daily that the injuries were “either an elevation or depravation of blood pressure.”

The company said all customers with these pumps have been notified and the affected devices removed from use.

“Within two weeks we identified the problem and were able to move all the devices,” Gardiner said.

In July 2005 the FDA issued a Class I recall of the company’s Colleague pumps because of a design problem involving a clocking circuit that disrupted internal communications in some devices (MDD, July 22, 2005).

On June 29, 2006, FDA reported that it had inked a consent decree with the firm for violations of good manufacturing practice regulations. The agency dealt Baxter warning letters in 1999 and 2001 for problems in its corrective and preventive action (CAPA) procedures, and a subsequent pair of inspections, conducted in September 2000 and June 2002, both disclosed CAPA problems as well as lack of management control over operation at the company’s Round Lake, Illinois, plant.

Gardiner said that although the company validated the software for the Colleague units, “[t]his particular clinical scenario was not replicated in the simulator testing.” However, she could not say whether the fix needed only more system memory in the infusion pumps or required a rewrite of the software.

Gardiner said that Baxter’s engineers “have identified the root cause” and have decided on “a way to correct it,” and that the company is in touch with FDA on the correction. Baxter will ship non-upgraded triple channel and upgraded single channel pumps to replace the recalled units.

Class I recalls are the most serious, described by FDA as incurring “a reasonable chance that the product will cause serious health problems or death.”

CMS publishes final ASC rule

The Centers for Medicare and Medicaid Services has published the final rule for the revised payment system for ambulatory surgical centers (ASCs) “to better align payments for similar services furnished in a hospital outpatient department (HOPD) or a physician’s office,” according to an agency statement.

Acting CMS administrator Leslie Norwalk said in a statement that the new payment schedule “will promote the goals of quality and efficiency in care furnished to people with Medicare in ambulatory surgical centers.” She said that the tweak will assist CMS in its efforts to eliminate “financial incentives for choosing one care setting over another, thus assuring that patients’ needs come first.”

CMS anticipates that it will pay out nearly $3 billion in calendar year 2008 to 4,600 or so ASCs that provide Medicare services. The final rule will increase the number of procedures reimbursed to ASCs by 790.

In CMS’s view, the procedures in question do not demonstrate significant safety risk when performed in outpatient clinics as compared to hospital outpatient centers.

The Medicare Modernization Act of 2003 requires that the revised ASC payment system be budget neutral, and the change to the set of covered procedures for ASCs was prompted by a report by the Government Accountability Office that disclosed that procedures performed in ASCs typically run about 65% of the cost of the same procedure in a hospital outpatient setting.

The revised payment scheme will pay separately for radiology services, drugs and biologics that are part of the treatments in question. CMS will also pay for brachytherapy performed in an outpatient clinic for treatment of prostate cancer and will boost payment for services that incur “high device costs, which ensures that the ASC payment system includes the same payment for an implantable device” as when the procedure is performed in a hospital.