FDA, CDC Tackle Duodenoscope Reprocessing Issues

In the wake of several superbug outbreaks that were traced to cross-contamination by difficult-to-clean duodenoscopes, the U.S. Food and Drug Administration has issued new recommendations for the manufacturers of reusable medical devices.

In the new guidance, the agency, which has been criticized for failing to conduct stronger oversight, addresses safety labeling and reprocessing instructions as well as the technical feasibility, thoroughness and clarity of those instructions. The FDA also recommends that manufacturers consider potential reprocessing challenges early on in the design stage. "Manufacturers will be expected to conduct validation testing to show with a high degree of assurance that their cleaning and disinfection or sterilization instructions will consistently reduce microbial contamination," the agency warns.

Meanwhile, the Centers for Disease Control and Prevention, which recommends bacterial culturing as a means of ensuring that duodenoscopes are thoroughly cleaned, has issued guidance on proper culturing protocols.

Jim Burger

An End to CON Regulations in North Carolina?

North Carolina lawmakers are considering a bipartisan bill that would exempt surgery centers and gastroenterology procedure rooms from certificate of need regulations, freeing same-day care facilities to be built without first receiving permission from the state.

House Bill 200 was recently referred to 3 subcommittees for review in advance of a possible vote in the state's general assembly.

Republican Rep. Marilyn Avila says the cost differential between the care provided at hospitals and at surgery centers is one of the driving forces behind the proposed bill. The bill's aim, she says, is not to eliminate hospitals' abilities to perform procedures, but to exercise control over the expense of health care.

Julie Henry, spokeswoman for the North Carolina Hospital Association, says the general assembly is endorsing the cherry-picking of privately insured patients from the state's hospitals. "Just 24% of hospital patients in our state are privately insured," she says. "The remainder are uninsured or covered by government-funded programs that don't fully reimburse for the cost of care."

Ms. Henry says opening the door to carve-outs will reduce hospitals' ability to fulfill their mission to care for everyone in local communities and jeopardize a healthcare model that is focused on the value, not volume, of care delivered.

Says Ms. Avila, "We're very cognizant of concerns that hospitals have, and believe we have taken care of them."

According to the bill, surgery centers must agree before they are built that 7% of their total revenue will consist of Medicaid cases. They must also report the number and type of uninsured cases they host to the state health department. Proposed facilities in rural counties with populations less than 100,000 would need written support and transfer agreements from all local hospitals.

"Our goal is to provide better, accessible and affordable health care for the citizens of North Carolina," says Ms. Avila. "I know discussions will be ongoing."

Daniel Cook

Minimally Invasive Magnetism

Magnetically driven laparoscopic instruments may provide an easier, more effective approach to the minimally invasive surgery, their creators claim.

The local magnetic actuation (LMA) technique employs internal and external units containing strong magnets. The use of magnetism to move and position tools inside the abdomen allows the use of smaller instruments, more precise control and a higher transmission of mechanical power than the "chopstick" approach of traditional laparoscopes, the researchers say.

The internal unit containing the surgical tool is small enough to fit through the 0.25- to 0.5-inch ports used during surgery, according to their report in IEEE Transactions on Robotics. The external unit is placed on a patient's abdomen and provides the mechanical power to the tools. The first instrument to use this approach was a magnetic organ retractor about the size of a pen.

Pietro Valdastri, PhD, an assistant professor of mechanical engineering at Vanderbilt University and director of the school's Science and Technology of Robotics in Medicine Lab, along with a team of graduate students, designed the magnetic instruments.

Kendal Gapinski

InstaPoll: Does Your Staff Wear Protective Eyewear?

Do your surgical team members balk at wearing safety goggles or eyeshields in the OR, complaining that they distort their vision or make them feel too hot? Tell us in this week's InstaPoll.

Last week we asked what your facility does when forecasters predict severe weather. Here's how 154 respondents to the poll deal with Mother Nature:

Do you have an inclement weather policy?

  • If we anticipate bad weather, we'll push our cases back to have a late start time. 30%
  • If the county or state closes roads, we close, too. 33%
  • If all our patients cancel, then we'll close. 28%
  • No, the weather's gorgeous here year-round. 9%

Dan O'Connor

News & Notes
  • More nurses are adding degrees Enrollment in the nation's RN-to-BSN educational programs increased 10.4% last year, while practice-focused nursing doctoral programs saw a 26.2% bump, according to survey data from the American Association of Colleges of Nursing. MSN program enrollments rose 6.6%, entry-level BSN programs 4.2% and research-based doctoral programs 3.2%.
  • Mold recalls lactated Ringer's Aspergillus kanagawaensis is a non-toxic, non-invasive mold, but you don't want it floating in your lactated Ringer's. A customer who reported seeing its dark particles floating in an IV bag has led Hospira to recall 1 lot of the solution. Packaged in 3,000 mL bags, lot 40-008-JT was distributed between June and September 2014 and has an expiration date of April 1, 2016.
  • AORN guidelines on the go AORN has partnered with Denver-based healthcare software maker MyRounding to create "myAORNguidelines," an easy-to-use interface for mobile electronic devices that provides portable access to the organization's standards as well as a paperless method of collecting data on and analyzing compliance with those standards. It's scheduled to be available for subscription this summer, starting with modules on hand hygiene, preoperative patient skin antisepsis, cleaning and care of surgical instruments and sterilization.
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