A Medical Device Daily

The Centers for Medicare & Medicaid Services last week issued a proposed rule to enhance the enrollment standards for durable medical equipment, prosthetics and orthotics suppliers (DMEPOS). The proposed rule is intended to protect Medicare and its beneficiaries from dishonest or low quality suppliers.

The rule would include five new standards and the strengthening of seven of the 21 existing standards suppliers must meet.

“The proposals represent the next step in Medicare’s ongoing efforts to ensure its beneficiaries continue to have access to high quality products and services at appropriate prices, while protecting them and the program from unscrupulous suppliers,” said CMS acting administrator Kerry Weems. “In addition to meeting the enrollment standards, all DMEPOS suppliers are required to obtain accreditation from one of ten accrediting organizations announced in November 2006.”

Proposed requirements and deadlines for obtaining accreditation are as follows:

• Suppliers in the DMEPOS competitive bidding areas must be accredited before CMS can contract with them as winning bidders.

• New suppliers, who apply to the National Supplier Clearinghouse (NSC) for a supplier number before March 1, must be accredited by Dec. 31. The NSC is the organization that issues DMEPOS billing numbers and maintains information about all suppliers enrolled in Medicare, CMS noted.

• New suppliers who apply for a supplier number on or after March 1 must be accredited before they can get a supplier number.

• All other suppliers must be accredited by Sept. 30, 2009.

The enrollment standards would affect all DMEPOS suppliers, CMS said.

The proposed rule was published in the Jan. 25, Federal Register. Comments will be accepted until March 25, and a final rule will be published later this year, the agency noted.

Baxter recalls nine heparin vial lots

Baxter Healthcare (Deerfield, Illinois) said it is recalling nine lots of heparin sodium injection 1000 units/ml 10ml and 30ml multi-dose vials.

Heparin is a prescription, injectible blood thinner. The 1,000 units/ml multi-dose vials are primarily used for hemodialysis and cardiac invasive procedures.

The company said it began recalling the lots Jan. 17 as a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product. Baxter said it is investigating these reports to identify the cause of the increase in allergic-type reactions.

According to the company, adverse patient reactions have included: stomach pain or discomfort; nausea; vomiting; diarrhea; decreased or low blood pressure; chest pain; fast heart rate; dizziness; fainting; unresponsiveness; shortness of breath; feeling heart beat strong or fast; drug ineffectiveness; burning sensation; redness or paleness of skin; abnormal sensation of skin, mouth or lips; flushing increased sweating; decreased skin sensitivity; headache; feeling unwell; restlessness; watery eyes; throat swelling; thirst; and difficulty opening mouth.

Baxter said it has not observed a significant increase in adverse event reports occurring with any other of its heparin presentations.

FDA recalls all AM2 heparin/syringes

FDA reported a nationwide recall of all lots of heparin and saline pre-filled flush syringes made by AM2 PAT (Angier, North Carolina).

The agency said two lots were contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

AM2 makes the syringes under the brand names Sierra Pre-filled and B. Braun. They are sold in fill sizes of 3ml, 5ml and 10ml and syringe sizes of 6ml and 12ml.

Consumers and healthcare facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately, FDA said. Health care facilities should quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. The agency also recommends consumers let their health care providers know that they have been exposed to syringes recalled by FDA.

Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections, according to FDA.

The company voluntarily recalled these products on Jan. 18 after confirming bacterial contamination in some user samples.

Birth control patch linked to VTE

FDA has approved additional changes to the label of the Ortho Evra Contraceptive Transdermal Patch made by Ortho McNeil Pharmaceuticals (Raritan, New Jersey), a division of Johnson & Johnson (J&J; New Brunswick, New Jersey) to include the results of a new epidemiology study that found users of the patch at higher risk for venous thromboembolism (VTE), serious blood clots, than women using birth control pills. VTE can lead to pulmonary embolism.

The changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) for J&J. The patch was studied in women ages 15 to 44. These recent findings support an earlier study that said women in this group were at higher risk for VTE.

Ortho Evra is a prescription patch that releases the estrogen hormone ethinyl estradiol and the progestin hormone norelgestromin through the skin into the blood stream. Women using the patch are exposed to about 60% more estrogen than with use of birth control pills containing 35 micrograms of estrogen. And higher levels of estrogen may increase the risk of side effects, including VTE.