FDA: Use blunt suture needles to prevent sticks

Agency issues safety alert with OSHA, NIOSH

An alert from the U.S. Food and Drug Administration puts new clout behind the push for surgeons to use blunt suture needles to close fascia and muscle and to reduce sharps injuries in the operating room.

In a joint publication, the FDA, U.S. Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) said they “strongly encourage health care professionals to use blunt-tip suture needles as an alternative to standard suture needles when suturing fascia and muscle to decrease the risk of needlestick injury.”1

The document echoes a joint safety bulletin issued by OSHA and NIOSH in 2008, urging the use of blunt suture needles. OSHA inspectors have been visiting ambulatory surgery centers, among other outpatient facilities, in Florida, Georgia, Alabama and Mississippi as part of a special emphasis program.

The operating room has lagged behind the rest of the hospital in implementing safer practices, despite a 2005 statement from the American College of Surgeons advocating “universal adoption of blunt suture needles as the first choice for fascial suturing.”

In fact, an analysis of sharps injuries at 87 hospitals around the country showed that sharps injuries actually rose by 6.7% in the OR between 1993 and 2006 while they declined by 31.6% elsewhere in the hospital.2

Blunt suture needles could reverse that trend. Using blunt suture needles cuts the risk of glove perforation and needlestick by more than half, according to a Cochrane review of 10 randomized controlled trials.3

“We hope [the FDA alert] will bring refocused attention to the issue and we’ll start seeing an increase in uptake of blunt suture needles,” says Jane Perry, MA, associate director of the International Healthcare Worker Safety Center at the University of Virginia in Charlottesville. “It will give not just safety advocates, but manufacturers of safety needles, a good tool to educate their customers.”

‘Change has to be mandated’

There’s already a mandate for hospitals to address sharps safety in the OR. It’s the Bloodborne Pathogen Standard, the same rule that governs the rest of the hospital. But surgeons have balked at using safety-engineered devices, and hospitals have been reluctant to push the issue.

Ramon Berguer, MD, FACS, chief of surgery at Contra Costa Regional Medical Center in Martinez, CA, has been a longtime advocate for sharps safety in the OR. The alert is a tool for awareness, but Berguer urges hospitals to follow it up with stronger policies.

“I think change has to be mandated, once it’s supported by data. Otherwise the speed of change is just too slow,” he says. “We’re talking about saving lives, saving money. There’s a human and a financial component to this.”

The alert notes that the cost of following up on a sharps injury ranges from $376 to $2,456. (See article on post-exposure prophylaxis below.) An estimated 80,000 sharps injuries occur in the OR each year. “Numerically, suture needles account for the majority of sharps injuries in the operating room and the solution is quite simple,” Berguer says.

Surgeons need to try the newer blunt suture needles, which have improved greatly in recent years, he says. “The quality is exactly the same as any other suture needle you use. They’re called safety tip needles because they’re really not blunt, they’re just much less sharp,” he says. “You need to get used to the increased force. If there’s a lot of scarring, they won’t penetrate the scar, but by and large they can be used routinely.”

Sending a strong message

When Peter Lurie, MD, MPH, was deputy director of Public Citizen, a Washington, DC-based advocacy group, he asked the FDA to label suture needles with a suggestion to use blunt suture needles, when possible. Now, as senior adviser in the FDA’s Office of Policy and Planning, he says the joint alert serves as a strong message.

The alert also was part of the Viral Hepatitis Action Plan issued by the U.S. Department of Health and Human Services. “We’re hoping that hearing it from multiple sources will be mutually reinforcing and will lead to uptake in the market,” he says.

“Our attempt here is to be forward-looking and to remind hospitals and health care organizations of the existence of these products and to recommend their use whenever clinically appropriate instead of the conventional product,” he says.

The alert also reminds “user facilities” and manufacturers to report “adverse events” to the FDA, such as needlesticks that involve possible bloodborne pathogen exposure. (See story page 88.)

Lurie hopes professional organizations will help spread the word for hospitals to switch to blunt suture needles. For example, the Association of periOperative Registered Nurses (AORN) has created a sharps safety tool kit (http://www.aorn.org/Secondary.aspx?id=20852#axzz1xmbVAiRW).

“Back in 2002, I thought there was enough data to take some action [related to suture needles],” says Lurie. “The data now are consistently stronger.”

References

1. Food and Drug Administration. FDA, NIOSH and OSHA Joint Safety Communication: Blunt-Tip Surgical Suture Needles Reduce Needlestick Injuries and the Risk of Subsequent Bloodborne Pathogen Transmission to Surgical Personnel. May 30, 2012. www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm305757.htm. Accessed on June 14, 2012.

2. Jagger J, Berguer R, Phillips EK, et al. Increase in sharps injuries in surgical settings versus nonsurgical settings after passage of national needlestick legislation. J Am Coll Surg 2010; 210:496–502.

3. Parantainen A, Verbeek JH, Lavoie MC, Pahwa M. Blunt versus sharp suture needles for preventing percutaneous exposure incidents in surgical staff. Cochrane Database of Systematic Reviews 2011, Issue 11. onlinelibrary.wiley.com/doi/10.1002/14651858.CD009170.pub2/abstract

Updated PEP will use new HIV drugs

Lower toxicity means better compliance

Changes in post-exposure prophylaxis (PEP) are on the horizon. New, less toxic (but possibly more expensive) drugs are part of the regimen proposed in draft guidelines by the Centers for Disease Control and Prevention.

Improvements in HIV treatment will finally influence the follow-up of bloodborne pathogen exposures – but viral load will not be a determining factor.

Although health care workers who sustain a sharps injury may feel relieved if the HIV-positive source patient has a low viral load, the guidelines will likely not recommend a different regimen in those cases, says David Kuhar, MD, medical officer with CDC's Division of Healthcare Quality Promotion. "If you're exposed to a patient with an undetectable viral load, HIV can still be transmitted," he told HEH.

Kuhar presented draft guidelines at the June meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). Final guidelines are expected by late 2012 or early 2013.

No confirmed cases of occupational transmission of HIV in health care workers have been reported since 1999. However, reporting of cases to CDC is not mandatory. There are two to three cases of possible occupational transmission each year, says Kuhar.

"We don't have enough information to know if [they were] occupationally acquired or not," he says. While safety devices and PEP have lowered the risk of transmission, "I think it would be a shame if the message taken from [the lack of confirmed cases] was that occupational transmission was not happening anymore," he says.

Timeliness of PEP will be emphasized in the updated guidelines, Kuhar says. Based on animal studies, "there is some consistency that delaying post-exposure prophylaxis even by a number of hours increases the risk of transmission," he says.

Hospitals could have the three drugs available in a starter pack to make it easy for health care workers to begin PEP, he says. The new drug regimen will include emtricitibine, tenofovir and raltegravir. They will likely cost about $1,500 to $2,000 for a month's supply, he says.

At a 72-hour follow-up visit after the start of PEP, an occupational medicine or infectious diseases physician could check for side effects and reevaluate the PEP based on information about the source patient or exposure, Kuhar says. Because the newer drugs have lower toxicity, health care workers may be more compliant with the PEP regimen, he says.

If the source patient is known to be resistant to some HIV drugs, occupational health professionals should consult an HIV expert, he says.

Editor's note: PEPline (the National Clinicians' Post-Exposure Prophylaxis Hotline) provides expert advice from 9 am to 2 am, EST, at 888- 448-4911.