Put to the Test: Safety Scalpels in Action

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Which safeguarded sharps would your surgeons really want to use?


To find out how far safety scalpels have come, we visited the chief of surgery at a busy metropolitan hospital and asked him to evaluate the design and construction of 10 different scalpels. He tested the safety features of each, offering his views on which ones made a difference to him and which might get them into your surgeons' hands for good.

A usable product
"A surgical scalpel is the simplest of designs. There are no moving parts," says gastrointestinal surgeon Kenric M. Murayama, MD, chief of the department of surgery at Penn Presbyterian Medical Center and professor of surgery at the University of Pennsyl-vania School of Medicine in Philadelphia. "Once you add moving parts, you compromise the structure and consequently the feel of the instrument. Then it's not as sturdy or as robust."

That's the core of most physician-users' objections to safety scalpels, he says. "I don't think they're opposed to safety-engineered devices. It's about the feel and the ease of use." For a tool with such a central and sensitive role in surgery, the way it fits the hand and whether its safeguards are simple and intuitive enough that they don't slow or impede use are no small concerns.

While safety scalpels have not become the standard of instrumentation among the 924 physicians at the 317-bed Presbyterian Medical Center, Dr. Murayama says they were at his previous hospital, where his daily experience with them highlighted the importance of seeking user input when evaluating and selecting the devices. "The people who design safety scalpels often aren't the ones who are using them every day," he says.

The best designs, he says, feature an easy-to-understand, single-handed operation with no extra steps. The fingers should remain well behind the blade at all times during activation, which should be the last thing done before an incision is made.

Handle on the situation
Perhaps the most common complaint that surgeons have lodged against safety scalpels is that they don't feel like the conventional scalpels they're used to. Several manufacturers may offer a solution in reusable stainless steel handles with removable, disposable, self-contained blade cartridges. Dr. Murayama tried out two of them.

"I don't know how durable the blade is, but I do like the way it feels," he says. "Aside from the plastic cartridge, it feels like a traditional handle," with not only the shape but also the weight and balance of a conventional scalpel.

Once you load a cartridge onto the handle, you can slide the transparent plastic housing back and forth, single-handedly with a finger, to expose or cover the blade. "It's pretty easy," says Dr. Murayama. "The safety mechanism works quite well."

The retracted shield doesn't make the overall profile of the handle bulkier or more cumbersome, he says. As an added benefit, you can't unload the blade if it's exposed, preventing the possibility of injuries during removal. He warns, however, that fingers pushing hard to cut tissue might inadvertently press on the activation switch, causing the shield to slip.

"These hybrid reusable-disposable products have a good feel," he says, noting that he could see them being accepted as default choices in an OR, with some conditions. The cartridge has to be easy to load: Some products operate more intuitively than others. It should remain rock-solid stable once it's loaded, without even the slightest amount of jiggle.

Cartridge removal should be a safe process. One of the cartridges Dr. Murayama tested had a removal switch that was separate from the shield-slide switch to prevent its inadvertent release. With the other, however, he expressed concerns that the shield might slide and the blade might stab during removal. That cartridge was packaged with a protective tab that you must remove before exposing the blade. Reattaching the tab would eliminate the risk of a removal injury, but there's no guarantee that would always be done, he warns.

Lastly, be careful that you don't accidentally discard reusable handles along with the single-use cartridges, he says, which is a frequent hazard of hybrid products.

A place for plastic
The venue in which your physicians perform surgery might influence which safety scalpels they find suitable. For example, there may be a place for plastic-handled single-use safety knives in office-based surgery, says Dr. Murayama. Hospitals and surgery centers have the shelf space to store a wide range of multi-piece devices, the staff to deliver trays of instruments to ORs and the sterile processing capabilities to efficiently turn around reusable parts. But office-based facilities that opt for all-in-one, disposable safety scalpels can reduce the number of items they need to stock, simplify preparations for a case and possibly even save on their supply budgets.

The pre-loaded products offer safety in their disposal as well as in their use. "The advantage of disposable is that when you're done, you close it and put it right into the sharps container, with no blade removal needed," says Dr. Murayama.

A plastic-handled single-use scalpel incorporates 1 of 2 types of safety mechanisms: either a retractable shield covers the blade, or a retractable blade is withdrawn into the handle. In the eyes of many surgeons, the retractable shield makes for a more substantial instrument.

The retractable-shield scalpels Dr. Murayama trialed resembled the non-safety disposable blades his surgeons often used. "Weight-wise, this doesn't feel as robust (as a metal-handled scalpel). It's a little bit light. For a disposable device, that's an advantage. But there's not the same tactile feel," he says. "A scalpel doesn't necessarily have to be heavy, just substantial enough that it doesn't accidentally fling out of your hand during a case."

Despite complaints that the retractable shield creates a bulkier handle, an obstruction between the fingertips and the blade and between the blade and the tissue, Dr. Murayama says that the flat, transparent shield didn't make the scalpel's handling much more cumbersome. A sliding shield's ability to securely lock into both the open and closed positions with an audible or tactile click is a very useful quality, he says. A scalpel without a click means an errant finger might inadvertently move the shield half-open or half-closed, potentially obstructing a procedure or risking injury.

If a physician feels the single-use, plastic-handled scalpels with retractable shields are a bit light, he may reject the ones with retractable blades as unacceptable for surgery. "This feels more like a kit component for a central line insertion or an emergency bedside procedure," says Dr. Murayama, testing out the blades that withdraw into lightweight plastic handles. "It's not going to be strong enough or robust enough for regular use in the OR."

With scalpels, he says, technique is based on feel. "You want to feel some weight when you put it down to the skin. Like with a kitchen knife, you feel you have more control over it." Without that, you lose some amount of tactile sensation, even with a handle that's textured for improved grip.

Ophthalmic scalpels are available with safeguards, too. The lightweight, pencil-shaped handles are plastic and single-use, and incorporate easily sliding retractable shields that securely click into place to surround or expose the blade. Dr. Murayama sees a safety advantage in the mechanism that employed a switch on the handle that operated the shield, keeping the fingers behind the blade, as opposed to the mechanism that required the fingers to directly push the shield up or down. "If you slip, you could cut your finger on the blade while operating the safety mechanism itself," he says.

Another product featured a textured barrel to shield the blade. "You could work it single-handedly while operating," but holding the handle in 1 hand while sliding the shield with the other seemed easier, he says.

Successfully introducing safety scalpels to your physicians and to your facility depends on equal parts numerical data and emotional appeal, says Dr. Murayama. "Surgeons will listen to administrators armed with data on how many sharps injuries happen every year," as well as the potential consequences of those injuries and how they might be prevented. While prevention may require them to adopt alternatives to their preferred tools, he says, "are safety scalpels really that much less usable that we're going to sacrifice everybody else's safety by not using them?"

Useful Safety Scalpel Features

We asked 25 surgeons to rate which safety scalpel design features matter most to them.

Simple, self-evident operation

  • Very useful: 52%
  • Somewhat useful: 32%
  • Not useful: 16%

Single-handed operation of safety mechanism

  • Very useful: 52%
  • Somewhat useful: 28%
  • Not useful: 20%

Ambidextrous operation

  • Very useful: 48%
  • Somewhat useful: 28%
  • Not useful: 24%

Reusable metal handle with changeable blade cartridge

  • Very useful: 45.8%
  • Somewhat useful: 37.5%
  • Not useful: 16.7%

Retractable blade withdraws into handle

  • Very useful: 16%
  • Somewhat useful: 28%
  • Not useful: 56%

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