More than 16 years ago the Centers for Disease Control and Prevention announced that safety-engineered sharps devices could prevent an estimated 62 to 88 percent of sharps-related injuries.1
Are healthcare facilities proving them right?
“In 2000, it was reported that there was an estimated 600,000 to 800,000 needlestick [and other percutaneous] injuries (NSIs) in the U.S. each year,” said Ron Stoker, Executive Director, the International Sharps Injury Prevention Society (ISIPS), referring to the Needlestick Safety and Prevention Act (NSPA),1 an update to the Occupational Safety and Health Administration (OSHA)’s Bloodborne Pathogens Standard. “More recent estimates indicate that 384,000 NSIs occur each year in the U.S. I believe the estimates are low.”
“Zero Needlesticks — the Only Acceptable Goal” describes the mission of ISIPS, which Stoker said aims to reduce the number of accidental NSI and other sharps injuries by promoting greater adoption and proper use of safety-engineered products and services.
Stoker believes most healthcare providers are compliant with the requirements of the OSHA Bloodborne Pathogen Standard but not all are on board. “There are pockets that are not totally compliant. One example is safety scalpels. One estimate puts only 5 percent to 15 percent conversion to safety scalpels, leading to unimproved scalpel-injury rates, with even worse rates in some settings,” he said. “Seventy-six percent of injuries from non-safety scalpels are to personnel other than the original user of the device, including surgical attendants and nurses.
“Manufacturers should be encouraged to use innovation and clinical trials to protect healthcare workers (HCWs) better,” he added, underscoring that industry plays a key role.
“Some of the reasons that surgeons and other physicians are not converting to safety scalpels include lack of user friendliness, no ambidexterity in design, weak blades that bend, awkward safety activation, and weight and balance issues,” he asserted. “There is still a need for greater innovation in product design.”
On a more positive note, Stoker did point to some of the newer safety-engineered products available that he thinks could have a significant impact on reduction of NSI and other sharps injuries.
“In the safety-scalpel arena, I have been impressed with the PenBlade,” said Stoker. “I feel that their design meets most of the criteria that I would place on evaluating safety scalpels. However, since the vast majority of surgeons are not using safety scalpels, it is prudent to reduce the potential of scalpel injuries in other work-practice areas and by using other innovative products. Neutral zones, passing trays, etc., can assist. Since many scalpel injuries occur when removing scalpel blades from holders, a scalpel-blade—removal system, such as the Qlicksmart BladeFLASK and BladeCASSETTE, might be helpful.”
Stoker said safety-product trends on the development horizon include “totally passive designs not requiring the clinician to push a button or snap something into place. This is critical, since many safety-engineered devices with manually activated safety features have been associated with almost 11 times more sharps injuries than safety-engineered devices with automatic or passive safety features.”
Michael Sinnott, MD, MBBS, FACEM, FRACP, Managing Director, Qlicksmart Pty. Ltd., believes, “A good culture of staff safety is a prerequisite to patient safety. It is a basic human right of all workers, including doctors and nurses, to be safe at work.” Qlicksmart single-handed surgical-blade removers are passive, automatic safety devices that “keep operating-room staff, and downstream staff, safe from surgical-blade injuries, especially when the surgeon refuses, for patient-safety reasons, to use a safety scalpel.”
Sinnott explained how one facility was able to reduce injuries using Qlicksmart products. He said a regional hospital in Melbourne, Victoria, Australia, reviewed a blood and body-fluids exposure in the operating room and identified a needle counter as contributing to the injury. A new surgical-blade—removal system, the BladeCASSETTE and BladeSINGLE, was implemented to minimize the risk of sharps injuries, including removing, containing, and disposing of used surgical blades. Since the hospital began using BladeCASSETTE and BladeSINGLE, approximately two years ago, there have been no reported sharps injuries to staff when removing used surgical blades.
MYCO Medical, Cary, NC, is the U.S. master distributor for the Qlicksmart line of safety products.
Patty Taylor, BA, RN, Vice President, Professional Education and Clinical Affairs, Ansell, agrees with Stoker’s view that more work needs to be done to prevent sharps injuries. “Healthcare workers are still being injured. It is our collective responsibility to work toward safer working environments through education, development, and implementation of safer products. Engineered safety devices can prevent many injuries, especially if surgeons and other workers are involved in choosing to use them.”
Taylor described Ansell’s efforts to contribute to the pool of safety-engineered sharps-injuries—protection products. “In the past, surgeons were reluctant to implement the use of safety scalpels, because the handling characteristics were not similar to their traditional #3 reusable scalpel handle,” Taylor explained. “Ansell resolved this issue with the launch of the SANDEL Change-A-Blade, a disposable safety-scalpel handle. The Change-A-Blade matches the weight of a #3 handle, allows surgeons to use their preferred blade, gives the ability to change blade throughout the procedure as needed, and maintains complete visibility of the blade when in use.”
Sharps injuries are not just the surgeon’s problem. Assisting staff are in danger, too, as Taylor pointed out. “One-fourth of suture-needle injuries and more than one-half of scalpel injuries occur when an instrument is passed from one person to another during a surgical procedure.” Ansell’s Hands-Free Transfer Trays, and neutral zones such as the Z-Friction Drape and SharpsRink, facilitate hands-free passing, minimizing the risk of sharp injuries to the surgical team, by providing a designated area for placement and retrieval of sharps.
Passive is the name of the game. B. Braun complies with the NSPA by offering automatic, passive infusion catheters. No extra steps in inserting, deployment, or removing the catheters means no added chances of injury.
Cheryl Wozniak, Product Director, Vascular Access Systems, believes that Introcan Safety IV catheters offer clinicians the best of both worlds, because it provides fully automatic, passive needlestick and blood-exposure protection. “From needle removal to disposal, the Introcan Safety IV Catheter protects clinicians by means of a passive safety device that is activated automatically. Designed specifically to help eliminate accidental NSI, no extra steps are required and the safety features cannot be bypassed. The Introcan Safety family of infusion catheters is the only brand to feature truly automatic, passive needlestick protection and an option for automatic, multi-access blood control.”
B. Braun’s latest advancement, Introcan Safety 3 Closed IV Catheter, “takes the same passive safety-engineered NSI protection found in Introcan Safety and adds additional automatic protection from blood exposure,” related Wozniak. “For safety and convenience, Introcan Safety 3’s unique multi-access blood-control septum is designed to minimize blood exposure during needle removal and each time the catheter hub is accessed.”
“Needlestick injuries generate significant direct, indirect, potential, and intangible costs, possibly increasing over time,” said Taylor. “Further, economic efforts directed at preventing occupational exposures and infections, including provision of safety-engineered devices, may be offset by the savings from a lower incidence of NSIs.”
Julie Sawyer Montgomery, President, U.S. Infusion Systems, Hospira, added “Hospira is committed to bringing technology to our customers and is passionate about providing the smartest solutions to help support their intravenous (IV) access initiatives. With more than 350,000,000 peripheral IV catheters placed annually in the U.S. and an estimated 385,000 to 800,000 NSIs and sharps injuries occurring annually in all settings, Hospira recognizes the need to help reduce the risk of blood exposure and NSIs. Using equipment that helps reduce the risk of NSIs and other blood exposure is an important step in helping to prevent the transmission of bloodborne viruses to healthcare personnel.”
Hospira’s latest safety-focused technology is Supercath 5. “Our Supercath 5 safety IV catheter is aligned with the NSPA’s goal to help further reduce HCWs’ exposure to bloodborne pathogens.2 Montgomery outlined the safety features of Supercath 5. “Supercath 5 is equipped with a number of safety features designed to facilitate a safer IV placement, including a side-notched introducer needle that provides visual confirmation of blood-vessel entry; an advancing tab that helps facilitate one-hand insertion and compliance with ‘no-touch’ contamination protocols; a retractable and fully encased needle protection that helps reduce risks posed to HCWs from inadvertent needlesticks; a patented integral blood-control valve that creates a physical barrier to minimize exposure to bloodborne pathogens; and an active system that provides clinician control to engage the safety mechanism when the IV catheter is successfully seated in the vein.”Owen Mumford’s Unistik capillary sampling solutions are a line of safety devices that permanently retract after blood sampling, to protect against accidental NSI, said Casey Pflieger, Director of North American Marketing, Owen Mumford Inc.
“All products within the Unistik family feature a built-in safety mechanism to help protect against sharps injuries, cross-contamination, and infection. These sterile, single-use safety devices permanently retract after sampling, safely protecting the HCW from the used lancet or blade. Additionally, these devices are designed to maximize comfort for the patient. Unistik products combine enhanced quality of care and safety, for a sampling experience patients and healthcare professionals can appreciate.”
The Unistik product family includes Unistik 3 Side-Activated Safety Lancets, Unistik Touch Contact-Activated Safety Lancets, and Unistik TinyTouch Heel Incision Devices. “Unistik 3 and Unistik Touch safety lancets are designed with Comfort Zone Technology, a proprietary feature that includes eight raised dots on the patient end of the device that stimulate nerve endings and help to mask the pain stimulus of the lancet,” explained Pflieger. “Unistik TinyTouch heel-incision devices are designed to deliver a smooth, tightly controlled incision, to minimize tissue trauma during routine newborn blood panels and other neonatal blood tests.”
Patrick Yi, Founder and CEO, described MediPurpose’s safety devices for prevention of NSI. “SurgiLance safety lancets are single-use fingerstick devices used for the collection of blood from the fingers of adults and children. They are designed to protect HCWs from accidental NSIs due to exposed needles. The SurgiLance safety lancet’s passive safety mechanism automatically activates after the device is used, requiring no action on the part of the user. Before use, the needle is safely enclosed in a protective housing. When activated, the internal needle is exposed momentarily to prick the patient’s finger before it automatically retracts into the housing. The HCW is therefore never exposed to the needle, before or after use. After activation, the single-use device cannot be used again, thus preventing cross-contamination from one patient to the next.
Although more expensive than regular lancets, which are used only at home, SurgiLance safety lancets protect both HCWs and patients from NSIs and cross-contamination. They are also much easier to use, increasing the productivity of the HCW. Safety lancets are now routinely used in almost every healthcare facility in the U.S.”
BD Medical offers their customers a Sharps Safety Assessment of their facility to identify products and procedures where safety-engineered products should be used. Bruce Culleton, MD, MBA, Vice President of Worldwide Medical Affairs for BD Medical—Medication & Procedural Solutions, noted, “BD partners with our customers to provide education and training in addition to products. BD fully supports the NSPA by having frontline workers involved in the evaluation and selection process of safety-engineered products, and provision of education and training related to these products. Studies have shown that the use of safety-engineered devices, along with education and training, has had a positive impact in reducing NSI, compared to the use of the device alone.”
Culleton recounted a customer’s experience with the BD Eclipse needle that demonstrated the effect training and education can have on results. “A hospital in Amsterdam was able to demonstrate that the use of the BD Eclipse needle and an interactive workshop led to the highest reduction in the number of self-reported NSIs compared to a workshop alone or no intervention.3 This study further reinforced earlier studies that indicated proper use of safety-engineered devices, along with training and education, was highly effective in preventing NSIs.4
“BD offers a broad portfolio of safety-engineered products—injection, infusion, blood collection—that help healthcare facilities comply with the NSPA,” continued Culleton, adding, “BD Medical offers a portfolio of safety-engineered products with retracting, shielding, pivoting, and sliding technology, because one safety technology may not meet all clinical needs. The safety devices are designed to protect the HCW by keeping their hand or fingers behind or away from the needle while activating the safety mechanism. The different safety devices provide clinicians audible and/or tactile feedback when the safety mechanism is engaged.”
BD also offers catheters with blood control, which eliminates or reduces the clinician exposure to blood and bloodborne pathogens during catheter insertion. “BD Sharps Collectors are also part of the engineering controls that are used for the disposal of contaminated needles,” added Culleton.
A surgeon’s first line of defense against exposure to bloodborne pathogens is gloves. Sheila Mays, RN, BSN, CASC, Executive Clinical Nurse Consultant, Mölnlycke Health Care, explained how double gloving with the Biogel Puncture Indication System reduces risk. “Hospitals must consider and implement ‘appropriate commercially available and effective safer medical devices’ that will reduce occupational exposure.2 Double-gloving is an example of a work-practice control that reduces the risk of exposure to patient blood by as much as 87 percent when the outer glove is punctured.5 The volume of blood on a solid suture needle is reduced by as much as 95 percent when passing through two glove layers, reducing viral load in the event of a contaminated percutaneous injury.”5
A puncture to the Biogel glove is visually indicated. “The Biogel Puncture Indication System provides a clear, fast, and large indication of a glove breach, which is a break in aseptic technique.”
Mays cited facts from an observational study that analyzed the clinical consequences of surgical-glove perforation during surgery, as measured by incidence of surgical-site infections (SSIs). “The study found that, where no surgical antimicrobial-prevention measures were put in place, glove perforation during surgical procedures increased the risk of SSIs by 9.8 percent.6 The authors noted that the most effective method for lowering the frequency of glove leakage is through double-gloving, particularly with the use of indicator systems.”
Another study, which analyzed the cost of managing occupational exposure to blood and bodily fluids, found an average cost of $1,687 per exposure. Related costs include laboratory testing, treatment, pharmacy costs, and administrative costs.7 “Although double-gloving increases the initial cost of gloves used,” said Mays, “it reduces the incidence of occupational exposure and related expenses.” Check out Mölnlycke’s double-gloving cost calculator tool, to understand total cost of surgical gloves and potential cost savings from implementing a standard double-gloving protocol.
Disposing of sharps safely
Taking the appropriate safety precautions does not end on the operating table. Sharps must be properly disposed of to prevent injuries as well—not only to surgical staff and other clinicians but other HCWs, including environmental services staff that can come into contact with sharps when cleaning.
Maria Lyubelsky, Senior Manager of Sharps Management Service explained how Stericycle Inc.’s sharps-disposal service exceeds compliance with the NSPA. “The NSPA regulates occupational exposure to bloodborne pathogens. The Act seeks to further reduce HCWs’ exposure by requiring employers to have sharps procedures. Decades ago, Stericycle created a program to dispose of that waste properly, the Sharps Management Service, that goes beyond NSPA standards and helps healthcare facilities manage this waste stream.”
Lyubelsky related a disturbing anecdotal experience from Ann Marie Pettis, University of Rochester, who said that, before there was a formal solution in place, she recalls using empty, open-top orange juice cartons and open mayonnaise jars to dispose of sharp objects because, “There was no other alternative.”
Stericycle’s lid design, such as a vertical-drop container, supports HCW safety by allowing them to see when the container is filled, helping to reduce sharps injuries and related infections. “Stericycle’s technicians proactively exchange full containers for clean ones, reducing staff handling and helping to avoid overfilling,” said Lyubelsky. The containers also are closeable, puncture-resistant, leak-proof, and display warning labels.
“The cost of a proactive sharps-management system more than justifies investigative and treatment costs for injuries, which can range from $375 to $2,500 per needlestick” said Lyubelsky. “These tangible costs do not factor in costs for reputation and HCW stress if exposure occurred during patient care.8
1. Centers for Disease Control and Prevention. Needlestick Safety and Prevention Act. http://www.cdc.gov/sharpssafety/pdf/Neelestick%20Saftety%20and%20Prevention%20Act.pdf.
2. Tatelbaum MF. Needlestick Safety and Prevention Act. Pain Physician. 2001;4(2):193-195.
3. van der Molen HF, Zwinderman KAH, Sluiter JK, et al. Better effect of the use of a needle safety devices in combination with an interactive workshop to prevent needle stick injuries. Safety Science. 2011; 49:1180-1186.
5. Berguer R, Heller PJ. Preventing sharps injuries in the operating room. J Am Coll Surg. 2004;199(3):462-467.
7. O’Malley EM, Scott RD 2nd, Gayle J, et al. Costs of management of occupational exposures to blood and body fluids. Infect Control Hosp Epidemiol. 2007;28(7):774-782.
8. Wolters Kluwer Health: Lippincott Williams & Wilkins. Sharps’ injuries have major health and cost impact for surgeons. ScienceDaily. April 2, 2013. www.sciencedaily.com/releases/2013/04/130402101144.htm.
SHARPS PRODUCT SPOTLIGHTS
Unistik Touch Contact-Activated Safety Lancets
Owen Mumford is proud to introduce a new value-priced offering, Unistik Touch safety lancets. The contact-activated design is intuitive and easy to operate in just 3 simple steps. Featuring Comfort Zone Technology, Unistik Touch is designed to help reduce pain for a more comfortable blood sampling experience.
MYCO Medical is a leading NMSDC Diversity Certified supplier of Surgical Blades, Disposable and Reusable Safety Scalpels, OR Sharps Safety Devices, and Safety Infusion and Blood Collection devices. Visit us at www.mycomedical.com, or call 1-800-454-6926.
The Biogel PI Micro Indicator Underglove is a thinner synthetic glove, specifically designed to enhance tactile sensitivity while double-gloving.
• Can be worn alone or as part of the Biogel Puncture Indication System
• Recommended for use with the Biogel PI Micro overglove to create a thinner, more comfortable double gloving system