A Medical Device Daily

FDA notified healthcare professionals of a Class 1 recall of Abiomed's (Danvers, Massachusetts) AB5000 circulatory support system, a product that supplies power to disposable blood pumps used to support the left and/or right sides of the heart.

The FDA said that the computer may shut down (stop pumping) without an alarm and this defect may cause serious injuries or death. These products were manufactured and distributed between May 2003 and December 2009.

At the start of the recall, FDA said the company phoned their customers and followed up with a letter dated Jan. 27, 2010. The sales representatives delivered the letter at the time the product repairs were carried out.

The company declined to comment on the warning letter to Medical Device Daily.

FDA warns on counterfeit surgical mesh

Counterfeit flat sheets of polypropylene surgical mesh, used in the repair of hernias and chest wall defects, are being marketed in the U.S., labeled with the C. R. Bard/Davol (Murray Hill, New Jersey/Warwick, Rhode Island) brand name, according to the FDA.

These products are not Bard-manufactured products. Healthcare professionals and facilities should carefully examine all manufacturers' polypropylene surgical mesh products for their lot numbers and anything unusual that might indicate they are counterfeit.

"The warning is of particular significance to healthcare professionals and their patients with surgical mesh implants, as well as hospitals and surgical centers, operating room medical professionals and staff, and purchasing and risk managers," the FDA said, noting investigations showed several sizes and lots of counterfeit flat sheet polypropylene surgical mesh are not manufactured by C.R. Bard.

To date, four product sizes have been identified as counterfeit by the FDA and the company: Bard Flat Mesh 2"x 4" Lots 48HVS036 and 43APD007; Bard Flat Mesh 10"x 14" Lots HUSD0629 and HURL0336; Bard Flat Mesh 3"x 6" Lots 43HPD027, 43HPD032; HUSG0540, Lot 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011 and 43IPD038; and Bard Flat Mesh 6" x 6" Lot 43FQD327.

The FDA said patients should contact their surgeon if they experience problems that they think might be related to surgical mesh.

Davol is a subsidiary of C.R. Bard.

Senate approves $138B spending bill

After months of wrangling, the Senate last week approved a $138-billion spending bill that would extend jobless benefits, help states pay for Medicaid and continue a bundle of tax measures designed to stimulate the economy.

The measure — which must still be reconciled with a version passed in the House — also extends tax cuts for college tuition, the program that helps laid-off workers keep their job-based health insurance, and tax breaks for research and development that have long been important to the nation's high-tech industries.

In addition, the bill delays a threatened 21% cutback in the payments doctors receive for treating Medicare patients.

"Extending these tax cuts and the critical safety-net programs in this bill will give businesses the tax certainty they need to move forward and families the support they need to make ends meet," said Sen. Max Baucus (D-Montana), chairman of the Senate Finance Committee.

The measure was approved 62 to 36, with six Republicans voting in favor.

One Democrat, Ben Nelson of Nebraska, voted no.

The Republicans voting yes were Christopher Bond of Missouri, Lisa Murkowski of Alaska, David Vitter of Louisiana, George Voinovich of Ohio, and Susan Collins and Olympia Snowe, both of Maine.

The bill includes $25 billion in new Medicaid funds to help financially hard-pressed states pay for healthcare for the poor. California is projected to receive at least $1.7 billion.

FDA to formally recognize equipment standard

The 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; Arlington, Virginia)/FDA International Conference on Medical Device Standards and Regulation, which took place in Reston, Virginia last week.

"We will not only recognize the third edition of the standard, but we will also recognize all collaterals and all particulars," Herman told attendees.

The third edition of 60601-1 offers general requirements for basic safety and essential performance of medical electrical equipment. It also contains requirements for reliable operation to ensure safety. CDRH hopes to publish notice of the recognition in the Federal Register by June, Herman said. Once the notice is published, users will have three years to transition to the third edition and the related collaterals and particulars, Herman added.

The standard already has been recognized and harmonized in Europe for the last several years, said Charles Sidebottom, director of corporate standards for Medtronic (Minneapolis) and secretary of IEC/Sub Committee 62A, which developed the standard.

Sidebottom, who is chair of AAMI's board of directors, says that the subcommittee has been working with CDRH staff to get the standard recognized since well before it was even published. "For us that is a real big deal that the agency formally announced recognition of the whole collection of standards," he said.

AAMI had adopted its own version of the standard with national deviations called ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD), which includes original IEC text where U.S. modifications are introduced for easy comparison of requirements, as well as a number of the collateral and particular standards.

The CDRH recognition comes as a new amendment to 60601-1 is under development, which includes some changes to the original standard.

One of the proposed changes focuses on extending the scope of 60601-1 to include medical software systems. The amendment includes a definition of medical software systems and associated technical requirements.

The amendment also aims to streamline the application of risk management. It clarifies how a manufacturer should apply the standard's requirements when evaluating residual risk, Sidebottom said during a presentation at the conference. When there are specific requirements with specific acceptance criteria, compliance is "presumed to establish acceptable risk," Sidebottom added. The amendment also revises how to establish alternative risk controls or test methods.

The amendment clarifies the definition of essential performance to more fully explain the process for identifying essential performance and mitigating the risks associated with its loss or degradation, said Sidebottom. "Essential performance is performance other than that related to basic safety," he said. "In many cases, differentiating between basic safety and essential performance is not that important because the standard says both have to be maintained. However, in some cases it is important to draw that distinction so the standard needs to be clearer about how the manufacturer should go about identifying the essential performance."

The amendment is expected to be published in August 2013.