Disposable wipes saturated with antibacterial agents can effectively remove bacteria from surfaces, but that doesn't mean the bacteria are dead. In a study presented at the American Society for Microbiology's annual meeting in Boston last week, researchers reported that bacteria such as MRSA may remain active on a wipe and may be spread if the wipe is used on other surfaces.

"Our surveillance study highlighted the risks associated with the way decontamination products are currently being deployed," says the study's presenter, Gareth Williams, PhD, a microbiologist from the Welsh School of Pharmacy at Cardiff University in Wales. "Methods currently available to test the performance of these products may be inappropriate since they do not assess the ability of wipes to actually disinfect surfaces."

If used properly, however, the wipes can be effective, says Dr. Williams. "We found that the most effective way to prevent the risk of MRSA spread in hospital wards is to ensure the wipe is used only once on one surface," he says.

Nathan Hall

In a warning letter sent to medical device manufacturer Steris Corporation, the U.S. Food and Drug Administration notes that the company may need to seek re-approval of its System 1 sterilizer. According to the agency, the device has undergone numerous modifications since its 1989 FDA approval that may have affected its safety and effectiveness, to the point where the agency no longer considers it the same product it once approved.

The FDA's May 15 letter, which doesn't make reference to complaints or adverse patient events, does say that Steris may be required to file a new pre-market notification submission for the sterilizer. If so, the System 1 - which Steris says is used in more than 5,000 hospitals nationwide daily to sterilize more than 275 million endo- and bronchoscopes since its launch - "would be considered misbranded and adulterated," says Steris in an interim report filing with the Securities and Exchange Commission.

The company maintains that the changes it made to the device didn't warrant new pre-market notification submissions, and that the changes were made in compliance with FDA requirements. Steris continues to market, sell and support System 1 and the S-20 Steriliant liquid chemical sterilizer it uses.

"Steris Corp.'s highest priority is patient safety and we take our regulatory obligations very seriously," says spokesman Stephen Norton in a written release. "So it is important to note that the FDA has not directed customers to stop using System 1, modify clinical practices or notify doctors or patients."

Customers with questions about the warning letter or System 1 are advised to contact their Steris account manager, call its customer service line at (800) 548-4873 or visit the company's Web site for more information.

A System 1 sterilizer made news in 2002 when a Pittsburgh hospital blamed an infectious outbreak that killed one patient and sickened 15 on the device. Steris replied that the hospital was improperly using the equipment.

Dan O'Connor

The U.S. Department of Health and Human Services has released a five-year strategic plan to facilitate the adoption of a national, interoperable health information technology system.

The multi-agency directive, developed by the HHS's Office of the National Coordinator for Health Information Technology and issued June 3, lays out strategies for achieving President Bush's goal of giving most U.S. citizens access to electronic medical records by 2014. Detailing the progress that has been made since the president first set that goal in a 2004 executive order, the document "establishes the next generation of health IT milestones," says national coordinator Robert Kolodner, MD, in a statement.

The plan sets four objectives for health IT - privacy and security, interoperability, adoption and collaborative governance - and outlines strategies for achieving each one. For example, it calls for developing and implementing uniform standards for EMR security and interoperability; making EMRs more affordable; alleviating liability issues for providers and getting all stakeholders involved in the creation of a national health IT system.

Meanwhile, concerns about patient privacy and the cost of implementing EMRs continue to hamper the widespread adoption of health IT. Lawmakers and health technology experts debated those issues on Capitol Hill last week as the House and Senate considered different versions of a bill that would help providers purchase and implement EMRs and require the government to set hardware and software standards.

Privacy advocates oppose the legislation, arguing that it doesn't give patients enough control over their own records. Physicians and industry groups counter that tighter privacy controls could hinder their ability to exchange vital information with patients and other providers.

Irene Tsikitas