News Briefs: Week of March 21-25

March 23, 2011 06:05 pm News Staff

This roundup includes the following news briefs:

Gen-Probe Recalling Tests

Gen-Probe Inc. has initiated a Class I recall of three tests(www.fda.gov) -- AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium tuberculosis Complex Culture Identification Test, and AccuProbe Mycobacterium avium Complex Culture Identification Test.

A Class I recall(www.fda.gov) indicates that exposure to a product could cause serious adverse health consequences or death. The FDA said in a March 17 safety alert that affected products may contain tube components that are partially empty or empty of solution, which could lead to false-negative results.

The products were distributed from October 2008 through December 2008. Gen-Probe is recommending that customers discontinue using the identified lots(www.fda.gov). The manufacturer recommends that customers who used these batches and obtained negative results notify the referring physician about the possibility of false-negative results.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch program(www.fda.gov).

Car Seat Recommendations Updated

The American Academy of Pediatrics, or AAP, has updated its recommendations(www.aap.org) for child car seats. The new policy, which was published online March 21 and will appear in the April issue of Pediatrics, includes the following recommendations:

  • keep toddlers in rear-facing car seats until age 2 or until they reach the maximum height and weight for their seat;
  • most children should ride in a belt-positioning booster seat until they have reached 4 feet 9 inches tall and are between 8 and 12 years of age; and
  • children should ride in the rear of a vehicle until they are 13 years old.

The AAP previously advised that infants and toddlers should ride in rear-facing car seats until they reach the limits of those car seats, but it also cited age 12 months and a weight of 20 pounds as constituting the minimum threshold for allowing children to ride front-facing. As a result, many parents turned car seats forward when their child reached his or her first birthday.

However, a 2007 study(injuryprevention.bmj.com) (abstract) in Injury Prevention showed that children younger than age 2 are 75 percent less likely to die or be severely injured in a crash if they are riding in a rear-facing seat.

H&P Recalls Povidine Iodine Prep Pads

H&P Industries Inc. is recalling all lots of its povidine iodine prep pads because the products may be contaminated with the bacteria Elizabethkingia meningoseptica.

The pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin before surgery. H&P said in a March 15 news release(www.fda.gov) that use of contaminated pads could lead to life-threatening infections, especially in at-risk populations such as neonates and immunosuppressed or surgical patients.

The recalled pads were distributed under the following brand names:

  • Cardinal Health,
  • Medical Specialties,
  • VHA,
  • Triad,
  • Triad Plus,
  • North Safety and
  • Total Resources.

Customers interested in returning the product may call H&P at (262) 538-2900.

Adverse reactions associated with the use of the product should be reported to the FDA's MedWatch program(www.fda.gov).

AAFP Postpones Introduction of Draft Bylaws Revision

The AAFP has decided to postpone introduction of a draft revision of the organization's Bylaws, which was originally intended to be introduced during the 2011 Congress of Delegates, until the 2012 COD.

The AAFP Task Force on Bylaws Revision was charged by the Board of Directors with updating and modernizing the Bylaws to better reflect the current needs of the Academy and to simplify and organize the Bylaws. In the process, the task force moved most operational and procedural issues to a separate document titled "Rules and Procedures," according to a communication from AAFP Vice Speaker John Meigs Jr., M.D., who is chair of the task force.

Although the draft revision of the Bylaws was ready for review in January, a review draft of this second rules and procedures document was still a work in progress. Consequently, the task force decided to move the introduction of both draft documents to 2012 so members would have sufficient time to review and comment on them. Moving the introduction also provides members with an opportunity to informally discuss and comment on the drafts during the 2011 COD in Orlando.

Newly Unemployed Can't Find Health Insurance

An estimated 9 million working-age adults became uninsured during the past two years after they lost their jobs, according to the Commonwealth Fund 2010 Biennial Health Insurance Survey(www.commonwealthfund.org).

According to a March 16 Commonwealth Fund news release(www.commonwealthfund.org) on the survey, the unemployed have great difficulty finding affordable health care. In fact, 71 percent of adults who tried to buy individual coverage in the past three years, or 19 million people, either found it difficult or impossible to find a plan that fit their needs or that they could afford.

Some individuals also were turned down or charged a higher price for coverage because of a pre-existing condition.

House, Senate Leaders Still Cannot Agree on FY 2011 Budget

Nearly six months into the current fiscal year, Congress still has not approved a final budget for fiscal year 2011, forcing lawmakers to rely on a series of continuing resolutions to keep the government running.

President Obama signed the latest continuing resolution on March 18. The measure will fund the federal government through April 18 at levels slightly below those of fiscal year 2010.

House and Senate leaders continue to insist that they expect to reach an agreement on a final budget before adjourning for a two-week recess on April 18, thus avoiding a government shutdown. Nevertheless, some House Republicans continue to oppose any spending bill that does not include language that would defund the Patient Protection and Affordable Care Act.

Triad Alcohol Pads Prompt Another Recall

Eli Lilly and Co. is advising consumers to not use alcohol prep pads made by the Triad Group that were included in black starter kits for teriparatide injection, which is marketed as Forteo, and distributed from March 2008 to June 2009.

Triad announced in January that it was recalling all lots of its alcohol prep pads, alcohol swabs and alcohol swabsticks because the products may be contaminated with the pathogen Bacillus cereus.

Lilly said in a March 17 news release(www.fda.gov) that its starter kits were updated in June 2009, and the new blue bags do not include alcohol prep pads.

Lilly is requesting that physicians examine their inventory of starter kits and remove and discard Triad Group alcohol prep pads in the black bags. The company also asked that physicians inform patients who may have received those starter kits to discontinue use of the pads.

Triad's recall has prompted several recalls(www.fda.gov) similar to Lilly's because medications were packed with the pads.


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