Innovation and progress continues in the surgical instrument market as manufacturers improve on earlier generations or disrupt with novel ways of making surgical procedures and pre-op prep safer and more efficient. Here’s a snapshot of what some surgeons and perioperative professionals are using to improve procedural outcomes, efficiencies and reduce surgical infections. Also, be sure to check out HPN’s listing of surgical instruments and services suppliers at the end of this feature. There’s everything from powered devices to trocars, ronguers, staplers and scalpels, instrument repair services, tracking and storage technologies and more.
Assistive technology
Olympus America Inc. recently received FDA 510(k) clearance of claims that the ENDOCUFF endoscopic device, the previous iteration of its recently launched ENDOCUFF VISION, improves adenoma detection rates (ADR) during colonoscopy over standard colonoscopy. When using the instrument to assist during a colonoscopy procedure, precancerous polyps are more likely to be found reducing risk of interval cancer. “The ENDOCUFF is the first colonoscope technology to be cleared by the FDA to claim improved adenoma detection rates,” said Kurt Heine, Group Vice President of the Endoscopy Division at Olympus America Inc. A meta-analysis has determined that the ENDOCUFF results in a statistically significant and clinically relevant improvement in ADR, as compared with unassisted colonoscopy, due to its unique design which enables manipulation of bowel folds for maximized visualization of mucosa. The ENDOCUFF and ENDOCUFF VISION are distal attachments that incorporate multiple flexible arms that fold within the product during intubation so that forward movement is not hindered and then extend when the instrument is drawn backward. The devices also allow for controlled withdrawal of the colonoscope, and minimize difficulties associated with looping of the scope, and minimize risk of mucosal trauma. Olympus said peer-reviewed studies are still required to show clinical equivalency of the ENDOCUFF VISION but noted also that the material, proprietary hinge design and moment of force are identical among the two products.
For endoscopic-based urological procedures requiring a wire guide, Cook Medical’s Motion Hybrid Wire Guide is a useful alternative that does the job of two separate devices. For example, typically, when a surgeon needs to gain access to the urethra, skin or other area to place equipment, such as an endoscope, two devices — one to establish access (fixed core wire guide) and another (working wire guide/Amplatz) to facilitate placement of the instruments — are needed.
The Cook Motion Hybrid Wire Guide streamlines the entire process. “The introduction of hybrid wires may remove multiple steps from urological procedures,” explained Jean-Marc Creissel, Vice President, Urology, Cook Medical. “Hybrid wires combine the slick, kink-resistance of nitinol wires with the rigidity and control of an Amplatz-type wire. A physician can use the hybrid wire to gain access, and then continue dilating the tract and place additional devices using the same hybrid wire, which may remove the need for an additional catheter or dilator, and a second wire guide. Using a hybrid wire guide can potentially reduce the number and variety of wire guides that a facility has to stock since one wire can be used for the entire procedure.”
The Cook Hybrid Wire Guide features include a Nitinol core for kink resistance, a slick, hydrophilic-coated nitinol tip for smooth access, tungsten-filled radiopaque tip to aid in visualization during fluoroscopy, a rigid, Amplatz-like body to make device placement easier, Teflon coating for good tactile control and maneuverability, and a tapered proximal end to help accommodate scope placement.
Cutting edge solutions
Earlier this year, Ecomed Solutions launched the Sureglide cesarean scalpel, an instrument designed to reduce the risk of fetal injury caused by nicks, cuts and lacerations. These injuries occur most often to the face, cheek and ear of the fetus which are often in the line of the hysterotomy incision. In addition, the Sureglide scalpel has safety features to help protect surgeons and other staff from sharps injuries.
“The most stressful aspect of a delivery for every doctor is getting the baby out safely,” explained Sureglide Medical Consultant Dr. Andrea Wolfe, an ob-gyn practitioner based in Grand Rapids, MI, in a press release. Sureglide’s design and movement eliminates fetal exposure to the blade during a hysterotomy, regardless of uterine wall thickness or number of passes. The protected blade cuts up and away from the fetus, eliminating blade exposure to surgical staff while the ergonomically designed handle provides greater control, familiar feel and line of sight to incision, as well as raised ribs for better grip.
For surgeons who perform cataract surgery, which accounts for nearly 4 million cases in the U.S., Diamond knives by Accutome, a Halma Company, allows for consistent reproducible incisions, said Accutome Sales Manager Colin Jenkins. “Diamond knives allow for consistent reproducible incisions which have excellent wound characteristics when done by a properly trained surgeon,” Jenkins said. “This is important in having the wound seal properly to reduce the risk of an infection. The retractable safety blades can also be re-honed for smaller-size incisions. “The fact that the same blade is reused throughout a surgery day means the cutting characteristics will remain consistent versus the variability of using multiple disposable blades.”
Jenkins added that the investment — Diamond knives run between $1,000 and $3,000 — is well worth the cost, as long as the instruments are handled and maintained properly. “Though the initial price of a diamond knife is expensive, the knife can be used thousands of times, thus Diamond knives can save a facility tens of thousands of dollars over disposable blades.”
The ELAN 4 universal high speed power system from Aesculap is used for Neuro and Spine procedures as well as Oral and Maxillofacial, ears, nose and throat, and hand and foot trauma procedures.
Craig Shepherd, Senior Product Manager, Power Systems, says some of the problems that surgeons encounter when using similar drilling equipment include over-heating and lost power, change and reload complications, surgeon hand fatigue, sharps safety, and risk of contamination and infection during reprocessing. He says the ELAN 4 direct drive approach delivers smooth running properties to reduce heat and noise and can deliver ample power and torque for cutting and removing the skull bone flap during a craniotome. ELAN 4 also has an ideal motor location for improved ergonomics, even weight distribution, reduced size, and improved balance. Passive safety features automatically lock the drill when surgeons turn on the handpiece.
Shepherd described a few more features. “Having the ability to quickly change and reload the correct cutting instrument into the power handpiece is critical,” he said. “ELAN 4 simplifies these tasks by delivering on design changes requested by the customer. The uncomplicated handling and simple Intuitive Plug-N-Play assembly for all tools and attachments enables the OR team to deliver surgeon requested cutting tool changes, quickly and easily without the need for assembly tools. Universal burr length — one-tool-fits-all drill lengths — reduces the requirement for the OR team to manage multiple tools in different lengths, further simplifying the OR while reducing inventory carrying cost and shelf space offering savings potential.”
To help reduce contamination, risk for infection and readmissions, the ELAN 4 can withstand flushing and total submersion in enzymatic and disinfectant solutions, unlike other power drills. “ELAN 4 meets the highest reprocessing requirements for not only external, but internal disinfection and can be re-processed either manually, or via mechanical washer/disinfector systems,” Shepherd asserted.
The gSource Easy2Clean Kerrison Punch is another innovative tool that is also used during spinal surgery to grasp or excise tissue, degenerated disc material and bone, says Liz Ostrow, Marketing Manager, gSource. She says a common challenge that surgeons face during spinal procedures, when using a standard spinal punch, has to deal with tissue and debris that can get trapped between the instrument’s main body and sliding parts. Scraping and striking the punch against another surface to try and dislodge the material can cause damage to the instrument. There’s also a great concern about the thoroughness of cleaning and sterilizing such instruments. “The buildup and debris that is not completely cleaned and removed prior to disinfection and sterilization is not only unsanitary, it can cause infection,” said Ostrow. “The bioburden, or number of microorganisms on a contaminated item, that collects in between the main body and slider can form a hard shell which protects the microorganisms from sterilization.
“The Easy2Clean Kerrison Punch is designed to open and close easily for complete cleaning in between the main body and slider, helping to reduce the risk of infection,” Ostrow continued. “The instrument remains in one piece for easy and quick reassembly. Central Sterile personnel do not need to worry about losing or mixing up parts as all parts remain together, helping to save valuable time and ensuring instrument will function properly during surgery. Delays in OR set-up and surgery caused by damaged or unclean instruments are reduced. Also, instruments with a smooth and precise function help a surgeon perform at his/her best and reduce time in the OR, and the instrument will not need replacement as often as a standard punch, saving the facility time and money.”
The punch is available in stainless steel with a TiAIN (Titanium Aluminum Nitride) ceramic coating for added strength, increased cutting edge hardness, smoother action and reduced glare and the 2mm-6mm bite sizes contain a bone ejector inside the top slider to help remove debris caught within the bite opening.
Reposable laparoscopic instrument systems — reusable handles that that can be outfitted with a variety of interchangeable, disposable tips — are another option that facilities are adopting. Terry Belluche, Marketing Leader, Microline Surgical, says reposables can deliver high quality while lowering costs compared to disposable and reusable instruments but not all are the same. A few things to consider when comparing products include tactile feel, handle-tip connection and durability.
“Cheaply made, plastic disposable handles do not provide the palpable, physical feedback that a surgeon requires when manipulating tissue and other structures within the body,” said Belluche. “Another consideration is how the disposable tip attaches to the reusable handle. With inferior products, there is not a secure fit between the handle and the tip. Some use a ball and clevis approach, which creates a delay in the surgeon’s hand when he/she maneuvers the instrument. This is a critical issue in laparoscopic procedures where the surgeon does not have an open view into the patient’s body. [And} it must be made to withstand the rigors of decontamination, cleaning and sterilization.”
Belluche says the Microline Renew ergonomically designed handle delivers a tactile experience that allows surgeons to “feel the patient’s anatomy through the instrument.” The handles and tips also have co-axial threading for a tight connection and precise alignment, which optimizes grasping and cutting.
“The per-use, long-term costs of disposable instruments are very high over the course of hundreds, thousands of procedures,” Belluche asserted. “The situation is reversed for fully reusable devices, which are intended for multiple uses. They are typically high in quality at the start and have a low per-procedure cost, but also have higher up-front costs and their quality declines with each use as the tip wears down. Reposable instrumentation, on the other hand, can help materials managers provide surgeons with high quality devices for every procedure coupled with low per-use and long-term costs while minimizing waste. Some materials managers are opting to reprocess higher cost devices but implement reposable instruments such as scissors or graspers to trim costs on already low-cost basic endomechanical instrumentation.”
In March, Ethicon released its ENSEAL X1 Large Jaw Tissue Sealer, the next generation in advanced bipolar devices. The instrument is the first in a new generation of ENSEAL devices and, the company says studies show that it provides better sealing than LigaSure Impact device through less bleeding4, less thermal spread5 and better ergonomics.6 The ENSEAL X1 Large Jaw is compatible with the existing Ethicon GEN11 Generator and can replace other products or provide an alternative to existing Ethicon advanced bipolar devices.
For brain radiosurgery, Elekta’s Leksell Gamma Knife Icon received 510(k) clearance from the U.S. Food and Drug Administration in August 2015 and approval from Health Canada in February 2017. Susan Springer, MD, Medical Affairs Manager for Elekta says more than 1,000,000 patients have been treated with the Leksell Gamma Knife and that it has been featured in more than 2,800 published peer-reviewed journal articles. “There are several different systems used to provide radiosurgery, but Gamma Knife is the only system developed and dedicated specifically for brain radiosurgery, where precise dose targeting is especially important for preserving function and minimizing damage to healthy tissue,” Dr. Springer said. “This high level of precision makes Gamma Knife an increasingly used treatment option for patients with primary or metastatic brain tumors and other neurologic disorders such as severe facial pain (trigeminal neuralgia) and vascular malformations.
“Gamma Knife can be used as a standalone treatment for a variety of brain indications or in combination with surgery. The option of the mask and the accuracy of the Leksell Gamma Knife Icon over multi-session treatments means that larger tumors and tumors close to critical structures which may not be suitable for a single session treatment, can also be successfully treated over several sessions (known as fractionated treatment) with Leksell Gamma Knife Icon. The system’s integrated stereotactic cone beam computed tomography scanning and treatment planning software enables dosage and targeting to be automatically corrected and viewed prior to the patient’s treatment session and can be re-evaluated before each session for patients undergoing multiple treatments over time.”
Leksell Gamma Knife Icon’s frame-based immobilization option stabilizes the patient’s head during treatment. The frameless model works using Icon’s Online Adaptive DoseControl in which treatment planning software automatically adapts for patient translations and rotation shot by shot. At the operating console, it compares the planned dose to the dose about to be delivered to ensure accuracy and, if not, correct it in real time. Personalized mask fixation provides immobilization to help plan and guide treatment, and a motion management system uses infrared light to detect patient movement outside of the treatment limit to ensure that radiation is delivered to targeted areas only, not healthy tissue.
Preventing infection, increasing efficiencies
Many surgical procedures will also require some amount of hair removal from the patient first. But any hair clippings left behind can also potentially increase risk of infection. Stephen Placeway, Senior Manager, Product Marketing, Infection Prevention, BD, explains. “Hair clippings, which contain the same pathogenic bacteria as skin, can be left behind on patients, linens and the OR floor. Hospital-acquired infection outbreaks have been traced to organisms isolated from hair or scalp.”1, 2
To try and reduce the risk, clinicians have used tape, adhesives and mitts to try pick up the hair left behind on skin and linens. However, those methods may not be the best way to accomplish the task. “There is evidence associated with the risk of bacterial cross-contamination with adhesive tape,” asserted Placeway. “Adhesive products have also been shown to strip skin and cause micro-abrasions, increasing the risk of infection. There is also a population of patients who will exhibit an allergic response to the adhesives from tape.”
The ClipVac hair removal system, a vacuum-assisted surgical clipping device, provides a safer alternative and serves as another tool that can be used in the fight against hospital-acquired infections. “A small, portable vacuum with a latex free single use vacuum tip and filtered reservoir attaches to the BD surgical clipper to create a complete hair removal system,” Placeway explained. “ClipVac captures hair clippings as the hair is cut right at the source. An average of 98.5 percent of the clipped hair and debris are captured by the filter for easy disposal, thereby eliminating the risk of cross-contamination associated with adhesive tape cleanup. A recent study3 compared the removal of hair using standard surgical clippers with surgical tape vs. clippers fitted with the ClipVac hair removal system. The results demonstrated a statistically significant time savings — an average 40 percent faster, an 85 percent reduction of microbial contamination, and was highly effective in reducing the dispersion of contaminated hair fibers within the areas adjacent to the skin-prep site vs. clipping followed by tape cleanup.”
Safe, dependable fluid collection/management systems are also vital pieces of surgical equipment to consider. Jason Pfeiffer, U.S. Sales Manager, SERRES Inc., manufacturer of single-use surgical suction bag systems with reusable canisters, says when Massachusetts General Hospital in Boston (Harvard Medical School’s teaching hospital) sought a solution to the reliability and safety concerns it was having with their old system, they decided to install the SERRES product in all 60 of their ORs.
“We were able to eliminate product malfunctions which previously caused surgical disruptions, system shutdowns and vacuum line contaminations caused by leaks, spills and breakages during and after surgical procedures,” Pfeiffer explained. And because the sturdy, reusable canisters and vacuum tubing does not interact with fluid and air molecules, staff does not have to change or replace the canisters and connect or reconnect vacuum tubing before and after each case — just install and remove the used suction bag and replace it with a new one. “SERRES suction bags have one port on the lid making the selection process for patient tubing connection simple and error-free,” Pfeiffer said. “This design improves OR efficiency, turnover times and reduces downtime between cases by eliminating confusion and incidents which lead to wasted OR time, delays and ultimately wasted OR resources and dollars. The Mass General conversion has been functioning at 100 percent efficiency for 8-plus months now with no reports of product failures, leaks, spills or system shutdowns.
“Inventory management efficiency is also dramatically improved with a standard SERRES case: 144 or 216 suction bags vs. the competition case: 40 canisters/bags,” continued Pfeiffer. “Four times more product is shipped, stored and stocked with SERRES as our design is extremely compact and efficient. SERRES also reduces the amount of SKU’s in the ordering system up to 80 percent which simplifies the supply chain and inventory management requirements. Currently MGH is ordering three SKU’s to supply their PeriOp Department and handle surgical suction system needs with SERRES.”
References:
1. Dineen P, Drusin L. Epidemics of postoperative wound infections associated with hair carriers. Lancet. 1973;2(7839):1157-9.
2. Mastro TD, Farley TA, Elliott JA, et al. An outbreak of surgical-wound infections due to group A streptococcus carried on the scalp. N Engl J Med. 1990;323:968-72.
3. Edmiston CE Jr, Griggs RK, Tanner J, Spencer M, Seabrook GR, Leaper D. Perioperative hair removal in the 21st century: Utilizing an innovative vacuum-assisted technology to safely expedite hair removal before surgery [published online June 30, 2016]. Am J Infect Control. doi: 10.1016/j.ajic.2016.03.071.
4. Preclinical test of distal tip bleeding (ENSEAL® vs Impact-LF4318) in thick porcine mesentery base (p<0.001). (C2169).
5. . Preclinical testing on porcine carotids (ENSEAL® vs Impact-LF4318) that measured mean max lateral thermal damage via histology (p=0.005). (C2155)
6. (C2114).
Valerie J. Dimond | Managing Editor
Valerie J. Dimond was previously Managing Editor of Healthcare Purchasing News.
