While the continual sharps safety debate historically has focused on costs, liabilities, end-user protection and the types of safety-engineered devices themselves, the underlying issue continues to involve co-dependence and confusion.

Most healthcare facilities have been exposed to sharps safety education for at least a decade. And even though many of them are cognizant of safety issues and maintain some kind of patient and worker safety initiative, sharps safety still faces hurdles.

Dan Sandel, chairman and CEO of Sandel Medical Industries LLC, pulls no punches as to why he thinks sharps safety isn’t standard operating procedure in healthcare facilities yet and why it lacks enough administrative support. "Nurses may be too timid to demand it. They need to take the initiative and push it through. OSHA hasn’t really started any massive investigations yet, and the regulations are so complicated that it can be difficult for clinicians and administrators to get to the meat of them," he said. "Doctors have been resistant, too," he added. "Many feel that it’s part of their profession to be cut, as stupid as that sounds."

Take surgical scalpels, for example, where doctors have been slow to use lighter disposable safety scalpels over the heavier reusable metal ones. "Surgeons won’t touch plastic scalpels in the O.R. because they feel they’re too light," Sandel noted. A regular scalpel with the blade inserted weighs about 27 grams; a safety scalpel weighs about six grams. Based on an idea from a nurse, Sandel developed a weighted safety scalpel, which his company unveiled at the Association of periOperative Registered Nurses (AORN) Congress last year in Chicago. "It gives the physician the feel of a reusable scalpel without the potential danger of suffering a cut when changing blades," he said. But he acknowledged that safety scalpels might not be appropriate for all surgical procedures, particularly in high-risk anatomical areas.

  Photo courtesy of BD

Steven Bierman, M.D., founder, chairman and CEO of Venetec International Inc., agreed that awareness is high but implementation is mixed. "There are a large percentage of hospitals diligently adopting sharps safety devices," he said. "The recent actions of OSHA (which has cited more than 100 hospitals for non-compliance within the last year) have stepped it up a notch. People are beginning to become aware that OSHA is taking this seriously. But from my experience there is still a significant percentage of hospitals – particularly the smaller ones in rural areas – that are ignoring the law or are waiting for a push. They’re concerned about cost implications."

But the bottom line is that hospitals must have an exposure control plan in place with the intent to evaluate safety-engineering products and the records to prove when they did, what they decided and why, according to Bierman. Otherwise, OSHA will issue a citation and a fine. If the non-compliant hospital fails to respond accordingly OSHA declares it guilty of a willful violation and exponentially increases the fine. If a facility is found guilty of a willful violation and that violation results in the death of an employee, OSHA refers that facility to the Department of Justice for possible criminal prosecution. What’s not clear is the length of the statute of limitations, particularly if an injured worker contracts a disease and dies 10 years later.

"Even though OSHA has said they will inspect 2,700 healthcare facilities a lot of them are under the illusion that they’ll be passed over," said Bierman, who contracted hepatitis B from an accidental needlestick. "The law is the law.

"The key to driving sharps safety in today’s market is for providers to develop a culture of safety in their facilities from the top down and understand that no one can shirk responsibility any longer," Bierman continued. "That’s a lot to do. People need to know that. Given their resources, OSHA is doing an outstanding job. JCAHO needs to step up and enforce the standards, too. JCAHO should not accredit facilities that don’t comply with applicable laws and regulations as stated in its new 2004 accreditation standards, thereby jeopardizing Medicare reimbursement."

In fact, OSHA’s is getting more serious about enforcement. "You may not have seen a lot of OSHA people doing [sharps safety] inspections in the past but you will be seeing more now," said Melody Sands, director of OSHA’s Office of Enforcement, during a sharps injury prevention teleconference last month, sponsored by the Premier Safety Institute.

OSHA’s leaven

OSHA calls for maintaining a written exposure control plan and a sharps injury log where facilities must record and collect data on what happened, who it happened to, how it happened and why it happened, according to Gina Pugliese, R.N., vice president of the Premier Safety Institute. And it also requires annual device reviews. But it’s important to note that a reduced injury rate and no reports of employee dissatisfaction do not obviate the need for these evaluations.

"OSHA cannot tell you exactly what you need to do in an annual review, except that the intent of the review is to make sure the devices you are using remain appropriate, control the hazard and reduce the risk to workers," she said. "The intent is that you would not choose a device and keep using it year after year despite employee complaints and documented ongoing problems with the device. Nor does it mean you evaluate every device on the market every year. It’s an ongoing process that must be outlined in written form and followed. The precise type of annual review (and what data will be reviewed and by whom) and what devices are evaluated, if necessary, should be outlined in your exposure control plan."

Furthermore, "the annual review could be as simple as a review of injury data (including data by device) and a discussion of this data at a safety or infection control-related meeting, with documentation of discussion, findings and recommendations in the minutes," she continued. "This annual review then, might include documentation of your sharps injury data reviewed and mention of any considerations in the annual review (e.g., feedback from staff on acceptance of current device, etc). If injuries are identified, they need to be assessed to determine if the injury is from the device or perhaps some other issue, like overfilled disposal containers. If no injuries have occurred with a particular device or injury rates are reduced, it may be determined that a review of a new device is not needed. However, if there is an increase in injuries from a specific device and all the injuries occur during activation of the safety mechanism, it might indicate the need to evaluate a different device."

"This standard is very performance-oriented," said OSHA’s Sands, "and not a specification standard. It’s designed to help employers make the standard work for them.

"The importance of having an exposure control plan can’t be overstated," Sands added. That plan should include program management information, such as the methodology for annual reviews, device selection and frontline worker input. It should be facility-specific and depend on the types of risks, review of institutional-based injury data, types of procedures performed, patient populations and other considerations.

"Do you have to look at absolutely everything on the market? That’s up to the facility to determine," Sands noted. "Do you have to look at all your devices every year? No, especially if what you have is working. Otherwise, you should look for replacements."

But Sandel contended the OSHA regulations may be too complex. "We asked nurses at an O.R. managers conference why they weren’t evaluating and buying safety-engineered products," he said. "They told us that when they take the issue to the committees no one understands the regulations and consequences of what’s going on. You can spend 20 hours going through the maze of information out there before you get to the bottom line." As a result, Sandel commissioned a risk management professional to summarize the regulations into five easy-to-understand risk assessment/protection bulletins. "They’re like Cliffs Notes," he added. "They instruct you on what the regs are, what to do about them and how to conduct a study." Sandel has been actively involved in AORN’s Patient Safety First initiative and is a featured speaker at the upcoming Congress in San Diego.

Bierman pointed out that frustrated healthcare workers can contact OSHA anonymously to report any perceived unsafe conditions without fear of repercussions or job loss.

In addition to government regulations, decertifications and payer pushback, Poulos noted that a "groundswell of healthcare worker activity stemming from employee dissatisfaction to the point of disruption of business" will emphasize the seriousness of this issue, particularly during a nursing shortage.

"I think we all know what needs to be done," said Denise Cardo, M.D., director of the Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention, during a nationwide sharps injury prevention teleconference sponsored by the Premier Safety Institute last month. "Our main efforts should focus on how it can be done. We cannot do it by ourselves."

Being typecast

While sharps safety awareness may be reaching an all-time high, debate over the preferred types of safety-engineered devices remains in the early stages. However, some key definitions have emerged. Professional organizations like the National Association for the Primary Prevention of Sharps Injuries (NAPPSI) delineate between primary and secondary sharps safety devices. Basically, primary prevention-oriented safety devices don’t have needles or sharps; secondary prevention-oriented safety devices sport needles or sharps with safety-engineered shielding.

"NAPPSI’s philosophy is ‘no needle, no risk,’" said Brad Poulos, executive director. "It’s just like the primary prevention for pregnancy is abstinence." Because clinicians can’t always eliminate the needle or sharp they may have to turn to secondary prevention technology.

"NAPPSI recognizes that you get the maximum safety benefit by combining primary and secondary prevention," said Bierman, who serves as NAPPSI’s president.

"But you should strive for primary prevention devices whenever practical and exhaust those possibilities first," Poulos added.

Secondary prevention-oriented safety devices can be further defined by their safety mechanism. It’s either active or passive. In general, an active safety mechanism requires the end user to push a button or do something to engage or trigger the shielding to work. By contrast, a passive safety mechanism engages or triggers that shielding automatically without any intervention by the end user – like automatic seat belts in cars.

When sharps safety emerged as a bellwether issue on the national scene in the early 1990s, most participating product manufacturers developed and marketed secondary prevention devices with active safety mechanisms as alternatives to traditional sharps. Very few offered secondary prevention devices with passive safety mechanisms or even primary prevention devices with no needles or sharps attached.

Because these devices tended to cost at least twice as much as traditional sharps, clinicians conducted numerous studies that evaluated their performance in preventing injuries as well as operating properly and ease-of-use. Not surprisingly, most studies demonstrated favorable results in preventing injuries, particularly when the clinicians were trained to use them and the devices worked as they were intended. However, some studies on both active and passive devices cast doubts when the device malfunctioned, the clinicians failed to activate it, they weren’t paying attention or they simply weren’t motivated to use it at all.

"No one can pay complete attention in the healthcare marketplace every time they do a procedure," Bierman said. "No one is that good. If a gurney flies by carrying a bloody patient you’re probably going to divert your attention to look and become distracted from what you were originally doing. And even if the operator is perfect the device itself may not be. These devices do have malfunctions. Pushing a button, as easy as it seems, is less than perfect, too. That’s why the most effective sharps safety devices are primary prevention devices followed by passive secondary prevention devices."

  Scapel-Time-out from Sandel

Poulos concurred. "We emphasize passive safety devices. In theory, if you use the device as intended there should be no user error and no risk for injury because the safety mechanism automatically activates. Today, you cannot start an I.V. without exposure to a needle. Injections for the flu can be needleless. Catheter securement devices can be needleless, too. So why not use something that avoids sharps altogether? After that, why not use most foolproof technology available?"

Added Bierman: "Every manufacturer knows that whenever you add a step to a process or procedure you increase the likelihood of non-compliance. Yet even when you have a passive safety device people still get needlesticks regardless of the device malfunctioning. There’s no such thing as a perfect device because it will be used by imperfect humans. And these nurses are working at 100,000 miles an hour."

Good parenting may be necessary

Rather than assume responsibility for their sharps safety program, many facilities merely want to pass the buck and take the painless and easy way out.

"Everybody wants somebody to tell them what to do – what to buy, what to use," Pugliese said. "That’s not how it works and that’s not what OSHA will do. It’s what works best for you."

Sandel stressed the need for some behavioral modification. "People are going to make mistakes anyway," he said. "They’ll daydream, get distracted or not pay attention. Using a safety device won’t matter. You need to change behavior and encourage time outs. Providing access to more safety devices that remind people about this will help them in the long run."

But Pugliese disagreed. "It’s not enough to simply provide the devices," she said. "You have to make sure that the end users activate the devices so that the safety features are engaged. When you don’t engage the safety mechanism you run the risk of getting stuck. You have to determine which device works the best for those workers in those clinical areas performing those clinical procedures."

NAPPSI’s Poulos echoed the need for individual choice. "Aside from weighing costs versus risks, it really gets down to practicability and physician technique," Poulos said. "What makes sense is for facilities to let the clinicians decide what products to use – primary or secondary, active or passive. A clinician in San Francisco may face different challenges than one in Oklahoma City, as would a clinician at a teaching hospital versus a suburban community hospital."

Pugliese also dismissed the active vs. passive debate as only part of the process. "When deciding between active vs. passive features you have to make sure that you’re not interfering with the procedure itself and how it’s performed," she said. "You need to evaluate all the options and all the considerations that go with engaging the devices. Passive is only one of those considerations."HPN

Because the sheer volume of information about sharps safety and needlestick prevention can be overwhelming we searched and sourced the World Wide Web for the most noteworthy and useful sites online. Check out the following Web sites so you can get up to speed quickly.

Noteworthy Associations