MHA Society for Purchasing & Materiel Managers

FDA asks company to recall medical devices

The Food and Drug Administration on May 2 issued a formal request that Shelhigh Inc. recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns. On April 17, U.S. Marshals seized all medical devices and components at Shelhigh’s facility in Union, NJ, after the FDA found significant deficiencies in the company’s manufacturing processes.

According to the FDA, the company declined to perform a voluntary recall at that time. The agency recommends that doctors and hospitals consider using alternative products.

The Shelhigh devices include pediatric heart valves, tube-like devices for blood flow (conduits), surgical patches, dural patches to aid in tissue recovery after neurosurgery, annuloplasty rings to help repair heart valves, and arterial grafts.

"Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. For more information, see the FDA news release.

[ via AHA News Now ]

OIG report examines pricing, supply of intravenous immune globulin

Just over half (56%) of the intravenous immune globulin (IVIG) sold to hospitals and 59% of the IVIG sold to physicians by the three largest distributors in the third quarter 2006 were priced below Medicare payment amounts, according to a report issued April 30 by the Department of Health and Human Services’ Office of Inspector General. The blood plasma derivative is used to treat patients with poorly functioning immune systems.

The finding is an improvement from the previous three quarters when just 23% and 4% of the IVIG sold to hospitals and physicians, respectively, was priced below Medicare payment rates. OIG said the change appeared to be due to manufacturer price increases early in 2006 that were not reflected in increased Medicare payments until third quarter.

In 2005 and the first quarter of 2006, physicians and distributors reported serious problems with IVIG availability, which they said were related to Medicare payment rates and the fact that payment rate updates lag behind drug prices by two quarters under the Average Sales Price methodology. The OIG notes that additional factors also drive the difficulties with IVIG pricing and availability, including off-label use, coding and plasma industry economics.

[ via AHA News Now ]