• Reprocessor crackdown.
• Reuse reminder.
• Second time's the charm.
• Needle safety nationwide.
• Clean it up.
• Comments, please.
• BBA relief falls short.
• Watch the heavy lifting.
• Attention, CS directors:
• Needle safety now!
• Pain relief.
• Finally!
• Measures of success.

The FDA cited commercial reprocessor Alliance Medical Corp. Dec. 27 for several violations at its Apopka, Fla., facility. At issue were "serious breaches of good manufacturing practices and quality control," as well as concerns about worker training. Alliance CEO Rick Ferreira says the Phoenix-based company is cooperating with the FDA to remedy the problems. He notes that the Apopka facility is used only for decontamination, removing gross soil from medical instruments before they're sent to Phoenix for further processing. The FDA's warning letter seems to indicate its intent to take a close look at the whole reprocessing industry.

This article first appeared in the February 2000 issue of Materials Management in Health Care.

A notice in the Federal Register reminds that comments are due March 3 (not March 9, as reported here last month) on the FDA's proposed scheme for determining risks involved in reuse of single-use medical devices. The document is posted at www.fda.gov/cdrh/reuse.

This article first appeared in the February 2000 issue of Materials Management in Health Care.

New Jersey passed a safe needle law Jan. 4, when Gov. Christine Whitman signed a bill the state legislature had rewritten at her request. The law requires health facilities to use safe needle systems within 12 months. New Jersey is the fifth state to pass such a law, and similar legislation has been proposed in 19 other states plus the District of Columbia, according to the University of Virginia Health System's International Health Care Worker Safety Center.

This article first appeared in the February 2000 issue of Materials Management in Health Care.

Congress is debating the Health Care Worker Needlestick Prevention Act, which currently has 162 cosponsors and the backing of worker groups such as the Service Employees International Union. As of January, the House and Senate bills (HR 1899; S 1140) were in subcommittee, where they'd been for six months.

This article first appeared in the February 2000 issue of Materials Management in Health Care.

The FDA has posted the names of sterilants and high-level disinfectants cleared through the 510(k) process for use in reprocessing reusable medical and dental devices. The list of 17 products, current as of Jan. 28, is posted on the Web at www.fda.gov/cdrh/ode/germlab.html.

This article first appeared in the February 2000 issue of Materials Management in Health Care.

If your hospital is interested in reprocessing disposable medical devices, the FDA wants to hear from you. The agency's plans to tighten oversight of reuse are on track for start-up in spring/summer, says divisional director Tim Ulatowski. Following a public meeting last month, the FDA posted its model for risk assessment and device categorization on the Web and is accepting comments until March 9. "Reprocessing and Reuse of Single-Use Devices Risk Categorization Scheme" is at www.fda..gov/cdrh/reuse, or check the CDRH Web site's index under "reuse." ASHCSP leaders attended the meeting and will post information at www.ashcsp.org. The association also plans to file comments with the FDA.

This article first appeared in the January 2000 issue of Materials Management in Health Care.

Despite President Clinton's signature on the bill restoring $17 billion in Medicare funding, many hospitals still face financial trouble. The AHA will seek more relief from previous BBA cuts in this year's session of Congress, says AHA (www.aha.org) president Dick Davidson. Among other features, last year's package restored $3.9 billion over five years in the outpatient prospective payment system and created a three-and-a-half-year transition to the outpatient PPS.

This article first appeared in the January 2000 issue of Materials Management in Health Care.

OSHA (www.osha.gov) released a proposed ergonomics standard that would require most U.S. employers to develop a plan and take steps to improve worker safety. It immediately sparked a debate: Business groups worry about costs and question the gains in worker safety, while labor groups are pushing for more help for those at risk of injury.

This article first appeared in the January 2000 issue of Materials Management in Health Care.

How well are your medical devices holding up under the strain of sterilization and reuse? The Association for the Advancement of Medical Instrumentation issued new standards and a technical information report on biodegradation and cytotoxicity of medical devices. Biological Evaluation of Medical Devices Supplement 2 offers guidance on limits for ethylene oxide residues. The standards describe test methods for cytotoxicity, identification of potential degradation products, and tests for identifying degradation in polymeric medical devices. To learn more, go to www.aami.org.

This article first appeared in the January 2000 issue of Materials Management in Health Care.

OSHA's updated bloodborne pathogens directive, issued to compliance officers Nov. 5, tightens requirements for health worker safety, including the use of safety devices. The agency held a teleconference to discuss the new provisions with industry executives and confirmed the Nov. 5 effective date (you read it right--it was last month!), saying they want hospitals to move forward aggressively to improve safety, no matter where they are in their plans now. OSHA is still deciding whether to revise the regulatory standard, officials say. The directive is at www.osha.gov.

In the same vein the National Institute for Occupational Safety and Health is urging stepped-up efforts to reduce needlestick injuries among health care employees. NIOSH recommends better engineering controls as part of a comprehensive program, eliminating needle devices if safe and effective alternatives are available, and evaluating safety devices to see which are more effective and acceptable. The alert is at www.cdc.gov/niosh.

This article first appeared in the December 1999 issue of Materials Management in Health Care.

Hospitals hurting from severe cuts imposed by the Balanced Budget Act of 1997 will get some relief. After much wrangling, Congress passed the Balanced Budget Refinement Act before adjourning for the year. The bill restores $16 billion over five years in Medicare and Medicaid cuts. The administration restored another $1 billion, for a total of about $17 billion, of which more than half will go to hospitals and health systems.

This article first appeared in the December 1999 issue of Materials Management in Health Care.

The FDA (www.fda.gov/cdrh) issued its proposed strategy on reuse Nov. 1 (a day late). The plan, which subjects single-use devices to more scrutiny, will have far-reaching effects (see Behind the News, ). Every hospital involved in reuse should be aware of the risk stratification being proposed, and key hospital personnel should view a tape of the agency's November satellite conference for firsthand information, says Carol Peterson, R.N., a perioperative nursing specialist with AORN.

This article first appeared in the December 1999 issue of Materials Management in Health Care.

The Joint Commission on Accreditation of Healthcare Organizations issued for public comment several proposed core performance measures that will permit comparisons among hospitals. They cover five areas: acute myocardial infarction, heart failure, pneumonia, pregnancy and related conditions, and surgical procedures and complications. The measure sets are posted at www.jcaho.org.

This article first appeared in the December 1999 issue of Materials Management in Health Care.

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