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Building a compliant sharps exception ­process


November 1, 2012

Building a compliant sharps exception ­process

Properly documenting instances where safety devices are unavailable or inhibit patient care provides the basis for your annual evaluation

In November 2000, the Needlestick Safety and ­Prevention Act (NSPA) was passed by the federal government. The act, which was adopted by OSHA under its Bloodborne Pathogens standard several months later, requires employers to identify, evaluate, and implement safer medical devices, and to keep a sharps injury log in an effort to reduce the number of healthcare workers that were being exposed to bloodborne pathogens from accidental sharps injuries.

Since then, medical device manufacturers have come forward with a number of safety ­mechanisms for a wide range of needles and sharps that have ­drastically reduced injuries to healthcare workers. The Center for Disease Control's (CDC) estimates that about 385,000 sharps-related injuries occur annually, although OSHA estimates needlestick injuries are as high as 800,000 each year. Data from the Exposure Prevention Information Network, run by the University of Virginia health system, ­indicates that sharps-related injuries in nonsurgical hospital settings decreased 31.6% from 2001 to 2006, following ­implementation of the NSPA.

OSHA's adoption of NSPA requires all facilities to use safety mechanisms whenever possible. However, there may be some instances where safety devices are detrimental to patient care, or a safety device has not been manufactured for a particular piece of ­equipment. Most phlebotomy, hypodermic, and IV ­needles used in healthcare have either passive or active s­afety mechanisms that cover the needle or retract the ­needle to prevent injury, but there are certain surgical ­instruments and longer needles that pose problems, says Bruce Cunha, RN, MS, COHN-S, manager of employee health and safety at Marshfield (Wisc.) Clinic.

"All along the way we keep finding that there are ­certain procedures and certain devices where there just are no safety needles that will work," he says.

In these instances, healthcare facilities need to develop a sharps exception process whereby they can ­appropriately document reasons why healthcare workers cannot use a safety device, and then use that list as part of their annual evaluation for new devices.


Common safety snags

Listed below are a number of devices and circumstances in which there are no safety devices on the ­market, or the available safety devices inhibit patient care:

  • Needle length. Many sharps exceptions revolve around needle length, Cunha says. Typically there are no ­safety devices on the market for needles ­longer than 1-1/2 inches. Orthopedic surgeons ­often need to use 2- to 3-inch needles for knee aspirations on heavier patients. In those instances, Cunha provides a cone device that surgeons can use to cover the needle after the procedure in order to prevent injury.
  • Blunted suture needles. These needles are only good for suturing fascia, which probably only makes up 20%-30% of procedures, Cunha says. In other cases, exceptions need to be granted for the use of regular suture needles, even though the majority of needlesticks occur during blind suturing procedures.
  • Cervical injections. This procedure requires a needle that extends to reach certain areas. Although there are safety needles available, many physicians have said the flip-cap safety gets in the way, Cunha says.
  • Very small needles. 30-gauge half-inch needles are used by ophthalmologists for removal of cataract ­sutures and the flip-cap or accordion safety devices can get in the way.
  • Botox®. Many primary care physicians have ­begun administering Botox and complain that the ­safety needles leave some medication in the syringe, says Kathy Rooker, president and safety officer of ­Columbus Healthcare and Safety Consultants in ­Canal Winchester, Ohio. Being wasteful is not a viable reason for an exception, Rooker says. Instead, facilities should try out a variety of Botox safety needles. "Because you're working around the eye, bring some oranges in and try the safety devices out on ­oranges and document how they work," she says.
  • Dermatology scrapings. Dermatologists perform skin scraping by using a double-edged razor that is ­broken in half and then bent. "We have yet to find a ­commercial safety device that is flexible enough to bend and do the scraping," Cunha says.
  • Preloaded medications. Rooker says she has seen many preloaded medications that come with a ­non-safety needle. Facilities need to check with the manufacturer to verify there is not a safety ­needle available, and then document the exception if necessary with a ­signature or letter from a company representative.
  • Acupuncture. As you might expect, acupuncture safety needles don't exist.
  • Surgical safety scalpels. This can be a particularly contentious area because surgeons can be very picky about the instruments they use in relation to how they affect dexterity.
  • "Physicians really have a thing about the handle and the feel, and when it comes to a surgeon, I have a hard time saying, 'You can't do that, you need to use this other device,'" Cunha says.
  • Safety officers should still give surgeons ­different options to try in order to transition them to ­safety scalpels, but ultimately you cannot make them switch. Instead you can institute "no pass zones" in the surgical room, a protocol that requires surgeons to set the sharps on a tray instead of handing them to someone. Facilities should also make them use a blade box, Rooker says, which is a safer option ­compared with manually removing the blade.
  • "If I have a surgeon that is defiant and says, 'I'm not going to do it,' then I say, 'Then your staff is not ­removing the blade,'" Rooker says. "If you insist on putting yourself at risk, then you need to get a blade box, and that's the best I can do in some instances."

Strength in numbers

One of the primary rules for any sharps exception process should be that if one physician can use the safety device, so can the other physicians performing the same procedure. In other words, you cannot grant special ­requests simply because an employee doesn't like a safety device. You need to document specific reasons why it's ineffective or unsafe for patient care, Cunha says.

"We basically had to say, 'If someone else is using it for the same procedure, then you can't have an exception,'" he says.

Instead, Cunha offers to reeducate and train those physicians who are struggling with the safety device, or find a different brand or style that is more comfortable for them.

When possible, healthcare workers should have ­options, Cunha says, although it may require some coordination with your purchasing department. For example, Marshfield Clinic offers three types of IV safety needles so employees have a choice to use the brand or style they prefer.


Preparing for your annual review

Ultimately, this sharps exception list should be used as the basis for your annual sharps review. At the beginning of each year, safety officers should review the list and see whether there are any new products available that staff can test. This provides an opportunity to use safety devices when possible, and also provides documentation for OSHA inspectors who want to know why you aren't using safety needles for certain procedures.

"We're really at the mercy of these companies that are making the safety devices, but you need a process where you can document," Cunha says. "If OSHA comes in, I can say here's our exception list and here's why we're doing this."

During the annual review, remember that OSHA does not require you to use a specific needle and brand simply because it is available, Rooker says. The purpose of the annual safety device evaluation is to test new devices to determine whether they are effective and conducive.

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