Safer surgery

Sandel sharps safety products include Neutral Zone instrument drape, Hands Free passing tray, safety scalpel and safety scalpel handle.

"Overall there’s been a lot of success in implementing safety devices in the U.S., with a high level of adoption in most healthcare facilities. But one area where safety device implementation has lagged is surgery," said Perry. "When you look at our overall data, it’s clear that a large proportion of injuries occur in the surgical setting. If 30 percent of needlesticks and percutaneous injuries come from one clinical area, and that area has not shown much inclination to adopt safety devices and practices, it’s going to effect the degree to which rates can continue to decline. Thus, in our view, the major factor in the plateau of sharps injury rates over the last five years has been the lack of progress in the OR."

"As with many professionals, surgeons can be resistant to change," commented Lucy Reday, product manager, Sandel Medical Industries. She outlined several challenges in getting surgeons to adopt safety devices.

"First, the vast majority of surgeons were never trained in the use of sharps safety products (safety scalpels/handles and/or blunt suture needles) and have been clinically successful for years without them.

"Second, the vast majority of injuries involve the staff and not the actual surgeon. In addition, the historical belief has been that such incidences are a ‘part of surgery’ and therefore should be simply accepted (and potentially not reported).

"Third, many surgeons believe that changing to an engineered safety device may compromise their clinical outcomes. Historically, safety scalpels have been poorly designed relative to the surgeon’s needs and requirements – [with the] wrong weight and feel, inability to utilize their preferred choice of surgical blade, impaired visibility, etc.," said Reday.

The Change-A-Blade Safety Scalpel Handle from Sandel features a metal neck that is identical to a standard reusable scalpel. This frees healthcare facilities to utilize any #10, #11 and #15 standard blade, enabling each surgeon to keep their tool of choice. A fully retractable safety shield gives the surgeons uninterrupted puncturability and unobstructed field of vision. Change-A-Blade is weighted similar to a traditional #3 Scalpel Handle. An audible-click indicates that the safety shield is fully engaged.

The BD Beaver Safety Cataract Knife, featuring a specially designed, integrated retractable shield, is designed to minimize the risk of accidental surgical blade injuries that could occur during all phases of a surgical procedure: before use, during passing, between steps of the procedure, after use or during disposal. The integrated safety shield is easily activated by the user with just one finger, through a spring-assisted slider that provides tactile and audible feedback in both the shielded and unshielded positions. The single-use knives are essentially the same size and weight as conventional ophthalmic knives.

Suture needles are the second leading cause of needlestick injury in the U.S., accounting for 22 percent of incidents. The use of blunt suture needles, which Perry described as "sharp enough to get through internal tissue, but not sharp enough to penetrate the skin and cause a needlestick," has been endorsed by both the American College of Surgeons and OSHA. Yet resistance remains high, in part due to pre-conceptions about the devices by older surgeons who may have tried first generation blunt suture needles years ago.

"One of the reasons for the relatively low adoption of blunt suture needles has been lack of availability," said Ethicon Products Company Spokesperson Kristen Wallace. "Surgeons were looking for a greater variety of suture/needle combinations. In April 2009, ETHICON expanded the ETHIGUARD Blunt Point Needle product line by launching 30 new product codes to address this issue."

Ethicon’s Ethiguard Blunt Point Needles are made from a heat-treated, stainless steel alloy that delivers optimal strength and ductility to resist bending and breaking. The blunt point geometry allows for easy soft-tissue penetration with no more additional bleeding or patient trauma than with a conventional taper needle. Additional attributes include a ribbed and flattened body that affords stability in the needle holder for improved protection against slipping. Ethicon has also combined its Plus Antibacterial Sutures (which kill bacteria and inhibit bacterial colonization of the suture) with Ethiguard Needles to provide additional protection for both surgeons and their patients.

Also from Ethicon, DERMABOND Topical Skin Adhesive is a liquid bonding agent that holds many cuts, wounds and incisions together as effectively as stitches do. The adhesive material in Dermabond also forms a strong microbial shield to help protect wounds from bacteria that may lead to infection as they heal.

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"Another potential cause for low adoption is physician education," continued Wallace. "The practice of using sharp needles starts during residency training. Exposing surgeons to the benefits of blunt suture needles early on may impact adoption. The recommendation of universal adoption from industry advocates such as the American College of Surgeons (ACS) can help to lead the discussion."

Having a "champion" surgeon to lead sharps safety efforts can also be a big help, said Pugliese. "There are many new safety scalpels that perform equally to the reusable scalpels and samples from a variety of different suppliers need to be evaluated by the surgeons. Regarding blunt suture needles, the elegant research done by the CDC on their efficacy was published in 1997 and surgeons reported no interference with surgical procedures. I believe this is a matter of re-introduction of these devices in the OR and again, a champion surgeon."

Perry noted that along with safer devices, work practices that can reduce either the use of sharps or the risks associated with them must also be implemented. For example, employing a "no-hands passing" or "neutral zone" technique for transferring scalpel blades among members of the surgical team is an important practice that’s currently being heavily promoted to help reduce the risk of injury.

According to David Skinner, vice president, Daniels Sharpsmart Inc., "OR teams are acutely aware of the ‘neutral zone’ and instrument hand-off risk, yet transfer injuries are still too frequently reported. Daniels’ Bladesmart receiving device was designed by OR staff and develops further the neutral zone principle enabling safer transfer of scalpels, suture [needles] and other sharp objects."

The Z-Friction Instrument Drape from Sandel is a flexile non-skid bright orange material that serves as a noticeable neutral zone on the sterile field, the Mayo stand or back table. Sandel’s Hands Free Transfer Tray facilitates non-hands passing of scalpels and instruments on the sterile field. Sandel’s Stretch-A-Tray expands to accommodate instruments in a variety of shapes and sizes.

Disposing of risk

The final risk for injury during the lifecycle use of a needle or other sharps occurs during, and after, disposal of the device. Well-designed sharps containers placed in strategic locations, when combined with best practices, can help protect healthcare workers, patients and visitors from accidental needlesticks.

"The challenge is incorporating engineered passive safety features in a user-friendly design, in a compact wall space at an affordable cost point," said Skinner. "Even with extensive use of sharps safety devices, 6-9 percent of sharps injuries are container-related, i.e. via deposition, protrusion, bounce-out or penetration. These are caused primarily by sharps containers with small openings, point-first deposition, insensitive trays, and thin walls or closures."

Sharpsmart’s larger access, sensitivity, passive overfill protection, pre-assembly, tamper-proof closure, strength, and bracketry are the product of five years of engineered clinical research. These passive safety features work 24/7 to protect staff, are independent of contractor intervention, and have significantly reduced sharps injuries (SI) in peer-reviewed studies, according to Skinner.

Debra Gillmeister, director of healthcare services marketing for Stericycle Inc., described how the "vertical drop" design of Stericycle Bio Systems containers allows for simple, single-handed disposal of a wide variety of sharps, even including winged-steel "butterfly" needles that are often hard to get fully inside of a container due to their attached flexible tubing.

Stericycle’s Sharps Disposal Management Service, in which service technicians provide regularly scheduled, pro-active change-out of the Bio Systems reusable containers, can help alleviate challenges associated with in-house management of disposable sharps containers. "If you’ve got a disposable container, those containers [often] don’t get changed out until they’re full, and that really creates an opportunity for needlesticks," explained Gillmeister. "I’ve been in facilities where I’ve walked into the soiled utility room and twelve disposable containers are lined up against the wall – they’re not even in the receptacle that they’re supposed to go into – with needles sticking out of the tops of them, because nobody wanted to change the containers out. So that is a real issue."

The Stericycle program helps ensure best practice for sharps disposal, from making sure the right sized containers are installed in the most appropriate locations at the proper height according to NIOSH guidelines, to selecting the most suitable style of container for a particular area. For example a "hamper top" lid that accommodates larger sharps and medical devices may be preferable in the OR, suggested Gillmeister.

In an independent study of 52 Stericycle customer facilities, 100 percent of respondents indicated a significant decline in disposal needlesticks, with 77 percent averaging 0 to 1 per year, which Gillmeister attributes to the proactive change-out of containers by Stericycle employees as well as user-friendly container designs.

"In a recent study involving 28 U.S. hospitals, Daniels Sharpsmarts, when compared to non-user hospitals, were associated with significantly less Total SI; an 81 percent reduction in Container-associated SI; and a 23 percent reduction in Inappropriate-disposal SI," said Skinner.

Not to be overlooked is the positive environmental impact achieved with reusable containers.

Stericycle's Sharps Management Service includes pro-active change-out of containers.

"Disposable sharps containers add plastic and cardboard to a hospital’s sharps waste stream," said Skinner. "In two recent U.S. studies, one of 11 hospitals and another of 103 hospitals, reusable Sharpsmarts reduced the sharps waste stream by 4-6 tons per 100 occupied beds. In addition, Sharpsmart efficiency resulted in staff having to exchange 30-50 percent less containers."

A Carbon Footprint Calculator posted on the Stericycle website, www.stericycle.com, helps facilities gauge the impact of their activities on the environment. Because the Stericycle containers can be reused up to 600 times, a significant amount of plastic and cardboard is diverted from landfills, thus reducing carbon dioxide emissions.

"An average 200-bed hospital using our system would have diverted 13,180 pounds of CO2 from the atmosphere per year," Gillmeister illustrated. Using the calculator we learn that’s the equivalent of 679 gallons of gasoline, or 249 propane tanks. According to a running total on the Stericycle website, "overall since the Bio Systems container has been in existence we’ve kept more than 69 million containers out of landfills," she said.

Improving compliance

Just because a facility provides healthcare workers with sharps safety devices does not ensure that the safety mechanisms will always be activated. The clinician may be rushed and either forget or for some reason consciously choose not to activate the safety feature, or they might think the safety mechanism was activated when it wasn’t.

Trauger emphasized the role that "passive" safety devices such as B. Braun’s Introcan Safety IV catheter can play in improving sharps safety compliance. Whereas "active" sharps safety devices require the user to do something to engage the safety mechanism in order to protect the needle, passive devices provide automatic needlestick protection without a change in technique.

For example, with B. Braun’s Introcan Safety IV Catheter, described Trauger, "the needle tip is always protected, from the time it’s removed from the catheter hub to the time it’s disposed."

Because truly passive devices cannot be bypassed, they not only serve to protect caregivers administering treatment, but also employees, patients and visitors who could potentially come in contact with an exposed needle downstream after the procedure is completed.

Passive safety devices continue to grow in popularity as hospitals grapple with ways to improve compliance and reduce needlestick injury rates, acknowledged Pugliese. "Hospitals that have adopted safety devices in all situations where there is a potential exposure to blood and still experience needlestick injuries often see the injuries as a result of non-activation of the device. So compliance with activation is still an issue and what is influencing many hospitals to select devices with a ‘passive’ activation feature where the needle is covered automatically as part of the use of the device, such as retractable needles."

While Trauger estimated that 70 to 80 percent of the IV catheter market is currently using an active safety device, "the passive safety market is growing faster than any other segment within the IV catheter market."

The use of passive safety devices may indeed provide an added safeguard, but Perry provided this caveat, "there are applications where HCWs need to control the activation of the safety feature. The most common example is giving incremental doses, as is done in anesthesia. A device with a safety feature that automatically engages when it is withdrawn from a patient would not be appropriate for this type of procedure. We think there’s a need for choice in the marketplace; no one kind of safety feature will fit all clinical applications."

"Also, it’s important to note that very few safety devices are truly passive – that is, the safety feature engages after use without requiring any additional action on the part of the user. Devices are sometimes marketed as ‘automatic’, but in fact usually require that the user do something to engage the safety mechanism," she said.

Cautioned Trauger, "some products are marketed as passive, however if the safety mechanism can be bypassed, the product is not a truly passive safety device."

Another benefit of the B. Braun Introcan Safety IV Catheter is its ease of use. Featuring a Universal Bevel design that accommodates a variety of insertion angles, the B. Braun Introcan Safety allows for easy, comfortable catheter insertion resulting in improved outcomes as well as reduced risk. "The other way to reduce needlestick injuries is to reduce the number of IV catheters being used or reduce the number of insertion attempts a clinician performs on a patient," Trauger explained. "Ultimately, it’s a best practice model consisting of safer products, informed caregivers and consistent processes that will help drive down needlestick injuries and reduce IV complications."