To better understand your perspectives about safety scalpels, Outpatient Surgery Magazine and the International Sharps Injury Prevention Society (ISIPS) jointly conducted a survey of 186 operating room clinicians. Among other key findings: the discovery that 60% of respondents reported safety scalpels were not being used at their facility, despite their being encouraged to do so by OSHA. Why is that, and what might help drive that change?

Why bother with safety scalpels?
More than a decade has passed since the landmark 2000 Needlestick Safety and Prevention Act was signed into law. Since that time, many hospitals, clinics and medical institutions have become compliant with the revised OSHA Bloodborne Pathogens Standard that was influenced by the legislation.

Although most hospital departments have embraced the standard and have almost entirely converted to such safety products as safety needles, lancets, butterflies and introducer catheters, the operating room is one prominent segment that has struggled with compliance. In particular, many operating room workers continue to use standard conventional scalpels rather than adopting a safety scalpel.

Scalpel injuries represent an estimated 7% to 8% of all sharps injuries. But apart from frequency, it is the severity of scalpel blade injuries that is perhaps of greater concern, as they can be deeper and more dramatic than needlestick injuries, and can cause life-changing and life-threatening injuries.

In 2005, it was estimated that less than 5% of the reusable scalpels used were safety scalpels. A more recent 2010 estimate indicated that less than 15% of the acute-care market for reusable scalpels had converted to the use of safety devices.

Additionally, the Outpatient Surgery/ISIPS survey discovered that OR technicians endured 3 times the number of scalpel injuries than surgeons, and nearly 5 times as many as nurses and assistants.

Furthermore, almost half of the respondents have witnessed a scalpel-related injury — with more than 80% of them having reported the incidents. And while less than 10% of the respondents indicated that someone else had injured them with a scalpel, only 2% admitted to injuring someone with a scalpel.

Why the resistance?
So, if scalpel-related injuries are anything but infrequent, why aren't more surgical facilities using safety scalpels? The survey provided some compelling results that may help reach some conclusions.

It's a logical first assumption that surgeons simply aren't aware of the legislation, mandates and standards that implicitly advocate safety scalpels and therefore aren't compelled to consider their adoption. But when 96% of respondents indicate that they're indeed aware of OSHA requirements, and another 64% verify awareness of the 2000 Needlestick Safety and Prevention Act (with yet another 11% indicating awareness of nearly a dozen more guidelines), the "I didn't know" assumption quickly loses merit.

What about OSHA? Although 60% of respondents indicated that no safety scalpels were being used at their facility, about 95% said that their facilities had never been cited or fined for non-compliance. (The remaining 5% weren't sure.) Additionally, OSHA mandates that facilities document instances of surgeons' complaints about not being able to use safety scalpels in their Exposure Control Plans. However, survey respondents said that they were documented only 45% of the time.

Then there are surgeons' hard-to-shake feelings about safety scalpels, born from trial (and error?) and perception (which is of course reality). Here are some telling write-in responses from our survey:

• "Our general surgeon has used safety scalpels at other facilities and has been injured by them, so refuses to use them here."
• "It's very difficult to get surgeon buy-in to use scalpels. We have trialed 6 different ones and still no acceptance by surgeons."
• "Of the 16 sharps exposures we've had over a 2-year period and 20,000 cases, one [might] have been prevented with a safety scalpel."
• "Our physicians have been very resistant. We have trialed several, but none have been acceptable to our docs."
• "Precision is not as good."
• "The biggest challenge is the quality of the product. It needs to look and feel the same as the regular metal handles."
• "The blade is not as sharp and isn't always appropriate. For example, in arthroscopic knee surgery, the safety scalpel shield blocks the depth to which the surgeon can go."
• "I have trialed several different safety scalpels at our facility and cannot get the physicians to accept any of the trialed ones."
• "My staff and surgeons think they are cumbersome, not user friendly and are more dangerous than the regular scalpel."
• "Surgeons are the hindrance. They are not accepting of the safety scalpels."
• "They have cumbersome handling parts or pieces, which interfere with the physician's job."
• "We still have more control over the disposal blade when it is removed from the reusable handle with another instrument than with the safety devices. The devices that cover up the blade lead to more careless handling."
• "Safety scalpels are too light and need to be weighted to feel more like a metal one for surgeons' comfort and confidence level."
• "My physicians hate them."

Evaluating the evaluators
Along with gaining critical feedback about their products, medical device manufacturers and distributors encourage clinical evaluations of their products to promote brand and product awareness. In that regard, respondents indicated that they were quite aware of safety scalpels, with nearly 82% reporting to have evaluated them.

Perhaps to the chagrin of those same manufacturers and distributors, when asked why an evaluated safety scalpel was ultimately not chosen for continued use, an overwhelming 84% said that the surgeons didn't like the general feel. And when the problems weren't about the general feel, 52% cited specific problems with weight, balance or line of sight.

Likewise, evaluators were also turned off by some of the very features that are supposed to make a safety scalpel safe. If a cumbersome activation method wasn't the problem (as it was for nearly 35% of respondents), then it was difficulty with the safety sheath (as it was for slightly more than 25%).

Evaluators that didn't opt to use safety scalpels cited other factors such as cost (27%) and administrative/contractual conflicts (just more than 6%), and opinions ranging from not believing safety scalpels were actually safer (less than 18%) to not seeing a need to change products (less than 13%).

The perfect safety scalpel
Beauty is in the hands of the beholder and in the hands of those that hand it to them. According to the survey, there's a significant likelihood that surgeons would use safety scalpels if they met at least 2 conditions: availability and usability. But as the evaluators have been nearly unanimous in illustrating, the latter is the more critical factor — and most safety scalpels fall short.

So exactly what features and attributes would make the ideal safety scalpel? Along with questions about materials (safety scalpels are generally available with either plastic or metal handles), the survey inquired about preferred tactile and operational qualities.

In simplest terms, surgeons don't care much about how a safety scalpel works — just as long as it does work without them having to radically adjust to handling the device. This is why more than 53% would demand the same weight and balance as a traditional non-safety scalpel, and more than 47% would require ambidextrous operation.

Those matters would likely apply to any type of redesigned scalpel, but safety scalpels introduce a new dimension. For example, more than 68% of surgeons don't want their line of sight obstructed by a safety shield. Likewise, 58% would need single-handed operation of the safety mechanism, while another 45% would expect a blade that could be easily concealed without having to look at it.

Nurses and assistants — who would be responsible for handling the safety scalpel both before and after its use — also had strong opinions of what would make an ideal safety scalpel.

Whether projecting their preferences for blade cartridges that are safe to assemble or remove (73% and 74%, respectively) or for blade cartridges that are easy to assemble or remove (67% and 66%, respectively), nurses are not unreasonable in their desire to have scalpels that will not injure them or complicate their duties.

Yet another crucial assumption for why safety scalpels aren't more widely used can be considered in the context of buying power. After all, how much influence do facility managers actually have with medical product selection and purchasing? According to the survey, quite a lot. Nearly 68% said they had either significant or some influence for decisions of medical products that include safety scalpels — while slightly more than 6% indicated that they had very little or no influence on these types of decisions. Still, you can lead a surgeon to the safety scalpel, but you can't make him use it.