A sharper image of safety-engineered products

Due to the pioneering work of a handful of dedicated and determined researchers, the sacrifice and perseverance of injured clinicians — a number of whom contracted infections and diseases that didn’t quell their advocacy, and a number of suppliers who saw a market gap and worked to fill it, the healthcare industry has come a long way for sharps safety in roughly four decades.
Even so, data collection and ongoing research reinforces the idea that the industry still has miles to go.

Healthcare Purchasing News asked a variety of industry experts to look back on forward progress and offer some tips on where the industry still needs to go. Here’s what they said about noteworthy improvements and innovations in safety-designed and safety-engineered devices since the early 1980s, where there continue to be unmet needs and how current safety products could be improved.

“These products and innovations have assisted hospitals and surgical centers aiming to minimize accidental scalpel cuts, needlesticks, and other sharps hazards in the OR:

• Safety scalpel devices (e.g., single-use scalpel handles and blades that do not require disassembly, retracting scalpel blades, shielded or sheathed scalpel blades, rounded tip scalpel blades, scalpel blade removal devices) which assist healthcare workers in the operating room, emergency rooms and Labor & Delivery in avoiding injuries from contaminated scalpel blades.
• Safety-engineered syringes, needles, and IV catheters (e.g., a syringe or needle with a sliding sheath, a hinged needle guard attached to the needle hub, a syringe with a retractable needle, needless systems, and blunt cannula), which provide protection from needle-sticks.
• Sharps containment devices or specified areas of the sterile field. These devices confine and contain sharps by providing neutral zone and hands-free techniques during procedures.

“Two products which could benefit from safety-designed and /or engineering modifications are surgical needles (non -blunt) and sharp surgical instruments as justified by data from the Massachusetts Department of Public Health (Massachusetts Sharps Injury Surveillance System [MSISS]) and EPINet data. For surgical needles, modifying the surgical needle driver by adding a sheath or shield to the instrument is one potential improvement. The same sheath or shield can be added to sharp surgical instruments, such as bone hooks and Gelpi retractors. Those shields/sheaths could be made of disposable material because none is currently available.

“Sharps passing trays and disposable magnetic drapes could be improved by adding a weight chip that notifies staff when items such as instruments are not returned safely back to the passing tray or magnetic drape. The weight chip in the passing tray or magnetic drape would function like the self-service check-out stations in a supermarket. If a customer scans an item, it needs to be bagged and placed in the weighted holding bin or the customer receives an alert. The same concept could be applied to a passing tray or magnetic drape — if a sharps is not returned to the tray, an alert could be provided to the nurse or scrub technician.”

Mercedes Chavira, RN, Senior Clinical Consultant,
Professional Education and Clinical Affairs, Ansell, Iselin, NJ

• Protected Safety Scalpels/Blade Systems — These are scalpels and blade systems that either have a retractable blade or a shield to help guard the blade. These are especially important in helping protect clinicians in the passing of the scalpel or in between steps of a procedure.
• Safety Scalpel Handles — These are scalpel handles that include a sheath to help guard the blade. Such handles help to protect clinicians during the passing of the scalpel. Some models also include a feature to help disarm the blade with a hands-free technique. This is a nice option for facilities that prefer to choose their own blade, but still want to protect staff.
• Safety Blade Removers — These devices are a bit newer to the market and allow clinicians a way to remove a traditional scalpel blade from a scalpel handle in a quick and safe manner. Given that 90 percent of blades being removed from a scalpel handle are contaminated [from EPINet research in 2014], this can help clinicians guard against exposure to blood-borne pathogens.
• Cautery — Although not meant to be a safety option, some surgeons are choosing to use cautery to make cuts as an alternative to using a scalpel.
• Neutral Zones/Transfer Trays — These items provide a designated space to place instruments between steps of a procedure and help to avoid hand-to-hand passing and the associated sharps injury risk.
• Safety Syringes — These are retractable or guarded syringes used to help avoid an accidental needlestick and associated blood-borne pathogen risk.
• Blunt Suture Needles — These are suture needles with ends that are sharp enough to cut through tissue, but less likely to puncture the gloved hand of a clinician. Sharp-tipped suture needles are said to be the leading cause of percutaneous injury, causing 51 percent-77 percent of these incidents [based on CDC and NIOSH research].

Many sharp products in the healthcare field now have safety options. In that regard, the focus probably needs to be less about safety-engineered devices that don’t exist, and more about improving adoption of the devices that already exist through education/awareness, support of safety culture, enforcement of sharps safety legislation, and working with clinician input to make design improvements.”

Bob Lawrence, R&D Director, Hill-Rom Surgical Solutions

“Many ‘retooled sharps devices’ are inferior to those that are designed with safety in mind. They also, I believe, pose greater risk for injury to users. Examples include hollow-bore needles with external arms or sheaths. It’s too easy to ignore safety mechanism activation or do a work around. I believe we should universally move to passive or automatic safety-engineering safety mechanisms, thereby removing the decision or choice to activate a safety mechanism from the user.”

Karen Daley, PhD, RN, FAAN, Past President, American Nurses Association, co-chair, ANA’s Sharps Injury Prevention Stakeholder Group

“The Guarded Needle with the shroud around the needle replaces all of the various-sized vial adapters with a one-size-fits-all product. Medication withdrawal done with a Guarded Needle and injection into the IV rubber port is done safely without risking a sharps injury.

“The Ultimate Sharps Safety Station includes three safety hinges with an automatic — passive — closure mechanism. Stabilizing ribs keep the box secure while using the scalpel blade remover. Overlapping walls prevent sharps from sticking out from the standard box gap and potentially injuring personnel cleaning the OR. It also includes a built-in combination scalpel shield that serves as a neutral zone for passing instruments. It also includes a one-handed hypodermic needle recapper/exchanger for additional safety.

“The USSS passing tray includes special pockets for the scalpel blade and handle, hypodermic needles, suture needle and needle holder as well as other surgical sharps, such as Iris scissors, scissors and Trocars. The tray handle wraps all the way around the tray. The tray also includes a lowered pick-up zone in the middle so the surgeon does not need to look at the tray to pick up the sharp instrument, an adhesive tab on the bottom to secure the tray in a neutral zone for hands-free transfer per AORN recommended standards, and the ability to connect two trays for one-handed suture needle exchange between the scrub nurse or technician and the surgeon.

Mike Hoftman, President, Advanced Medical Innovations Inc., Northridge, CA