Understanding the point of sharps safety momentum through the years

Concerns about sharps injuries bubbled to the surface of professional discourse in the early 1980s even as some may trace it back to the mid-1970s. Those concerns spawned two nearly parallel developments joined at the hip.

A specialty market segment debuted on one side, driven as much by extensive market research and incident recording as market share, which witnessed the explosive growth of safety-engineered medical devices, including needles, catheters, scalpels, trays and collection/disposal containers. The other side saw an activist movement fomented by clinicians and administrators that demanded the creation of and access to safety-engineered products designed to prevent occupational exposure to blood and body fluids. Their actions led to the landmark passage of the federal Needlestick Safety and Prevention Act of 2000, following a wave of state-passed sharps safety-oriented regulations.

Clinician-researchers, such as epidemiologist Janine Jagger, PhD, and occupational health physician June Fisher, PhD, advocated the need for better-designed safety-engineered devices to protect healthcare workers. Jagger, who serves as Professor of Research of Internal Medicine and Infectious Diseases at the University of Virginia School of Medicine, founded the International Healthcare Worker Safety Center and the Exposure Prevention Information Network (EPINet). Fisher, who serves as Associate Clinical Professor of Medicine at the University of California at San Francisco, Senior Scientist at the Trauma Founding at San Francisco General Medical Center, and Lecturer in the Department of Mechanical Engineering at Stanford University, directed the Training for the Development of Innovative Control Technologies (TDICT) Project, which now is part of the International Safety Center, the successor to Jagger’s organization.

Both helped design safety-engineered devices, the former patenting a number of devices and the latter leading co-design educational programs that produced relevant products and useful healthcare worker feedback.

Clinician connection

During the late 1990s, a number of registered nurses who experienced needlesticks and subsequently seroconverted to HIV, brought passionate activism to the cause. Names featured prominently in lectures, media reports and trade shows, included Lynda Arnold, Lisa Black, Karen Daley and Mary Magee, who finally revealed her name in 2011 — 24 years after her needlestick.

While changing a patient’s IV line, Magee accidentally stuck herself, according to a story in the San Francisco Chronicle (Dec. 10, 2011) (www.sfgate.com/news/article/Nurse-who-contracted-HIV-with-jab-sheds-anonymity-2394068.php) “Magee’s accident occurred before dawn, in the 11th hour of a 12-hour shift,” wrote Chronicle reporter Erin Allday. “She removed a needle from a patient’s IV and, exhausted and working in the dark, she jabbed the needle through an IV bag and into her hand.”

In 1999, as Karen Daley was dropping a butterfly needle into a sharps container she was stuck by a hypodermic syringe jutting out of the top of the container. In October 1997, Lisa Black was using a needle and syringe to clear the IV line of blood of a patient with end-stage AIDS when the patient jerked his arm, leading to the needle sliding out of the port and sticking her left hand. In September 1992, Arnold was starting an IV line for a known AIDS patient when he jerked his arm just as Arnold was withdrawing the needle from the patient’s arm and forcing it into her left palm.

Lynda Arnold recounted these stories, as well as useful observations and tips in her Nurses.com column in 2000 (for background, search for “Lynda Arnold” on the website).

Diagnosing from data

During the last three decades, data collection and analysis about sharps injuries along with the availability and quantity of safety-engineered medical/surgical devices may have mushroomed and contributed to controlling and reducing the number of device-related accidents and injuries, but there remains room for improvement, according to Amber Hogan Mitchell, DrPH, MPH, CPH, President and Executive Director, International Safety Center (ISC), League City, TX.

Mitchell shared ISC’s latest available EPINet data (2016) exclusively with Healthcare Purchasing News in late April for this story. At press time, the data were in the process of being published and released as “International Safety Center Exposure Prevention Information Network (EPINet) Report for Needlestick and Sharp Object Injury, 2016” and “International Safety Center Exposure Prevention Information Network (EPINet) Report for Blood and Body Fluid Exposures, 2016.” Access to ISC’s EPINet surveillance tool can be found here: http://internationalsafetycenter.org/use-epinet/.

“According to our EPINet data, we have seen a tremendous decline in injuries occurring from blood collection devices, which indicates that advances in safety for those device types are showing effective protection, especially the push-button retracting design,” Mitchell told HPN. “Injuries from disposable syringes (26.5 percent) and suture needles (24.6 percent) are still remarkably high. For needles in syringes, insulin and 24/25 gauge needles are the highest frequency injury report types. More needs to be done to not just institute the use of sharps injury prevention devices, but also to activate the safety mechanism. According to EPINet, 30.2 percent of injuries are occurring from devices with safety features. However 60 percent indicate that they did not activate the safety feature.”

Mitchell’s last observation offers a sobering assessment and leads to what should be an obvious conclusion.

“Despite sharps injury prevention features being available for decades, injuries from disposable syringes, sutures and scalpel blades are still high,” she said. Mitchell urged the industry to continue “to develop new ways to inject, close skin and cut. She suggested new technologies for drug delivery, such as microneedles, patches, etc.; for closing skin, such as adhesives, zipper closures, staples, etc.; and better and safer designs for both single use and reusable scalpel blades.

“Evaluating devices that eliminate the needle altogether tend to be the best control technologies,” she insisted. “This includes considering alternatives for sutures for skin closure and alternatives to delivery of medications/therapeutics using hypodermic needles.”

Karen Daley, PhD, RN, FAAN, Past President, American Nurses Association, wholeheartedly agrees.

“We remain too limited in the number of available safety-engineered sharps devices within ORs, an area where we know the number of injuries have increased in recent years,” Daley said. “Semi-automatic — such as retractable — and automatic/passive safety-engineered sharps devices represent the most noteworthy safety design advances for sharps injury prevention. Improved safety-engineered disposal systems also represent a major advance since we know the disposal process poses a significant risk to users.”

Lake Forest, IL-based Stericycle recognizes the need for safer disposable mechanisms.

“Many healthcare workers would agree that to help reduce injuries, safer product design, development, training and implementation must all be considered for safer devices,” said Alex Napier, Senior Marketing Manager, Healthcare Compliance Solutions. “Stericycle takes this one step further with the belief that proper disposal methods for sharps can also reduce needlestick injuries. Stericycle employs a specially designed, reusable sharps container with a translucent base that allows one-handed disposal so staff can easily discard sharps and see when the container is filled and needs replacing. Using these containers can allow staff to easily and safely dispose of sharps, helping to reduce needlestick injuries.”

Nina Morales, Marketing Assistant, Viscot Medical LLC, East Hanover, NJ, cited a 2016 statement by the American College of Surgeons that suture needles represent the No. 1 cause of sharps injuries in the OR. “I don’t believe enough has been addressed to make them safer,” she noted.

“Additionally, many facilities already implement double gloving practices, but there seem to be mixed results on the effectiveness of reducing sharps injuries,” Morales observed. “It may be poignant to design a better surgical glove altogether, something specific to sharps.

Morales also points to the effectiveness of the “hands-free technique” for healthcare workers passing instruments within a “neutral zone” as a proven sharps safety tactic.

Nurses sustain about 15 percent of sharps injuries in the OR even though they are not likely holding or even using the device, according to research cited by Mercedes Chavira, RN, Senior Clinical Consultant, Professional Education and Clinical Affairs, Ansell, Iselin, NJ. “This means injuries are occurring with hand-to-hand passing of devices, inside the operative field during the use of an instrument by the surgeon, from devices left on surfaces or floors and from devices that are not safely contained in a sharps disposal container,” she said. “Protecting the health and wellness of surgical teams is essential to staff safety, patient safety and the fiscal viability of the healthcare organization.”

Chavira uses analysis of publicly reported sharps injury surveillance data from the Massachusetts Department of Public Health (Massachusetts Sharps Injury Surveillance System [MSISS]) and the International Safety Center (Exposure Prevention Information Network [EPINet]) to show that OR employees sustain more injuries from contaminated sharp surgical needles and sharp surgical instruments. These employees have a higher risk for occupational exposures to blood-borne pathogens than any other department in healthcare settings — an average of 40 percent of all sharps injuries occur in the OR, she stated. Suture needles were the most common cause of percutaneous injury in the OR, involved in up to 43 percent of such injuries, she quoted from reported research.

Bob Lawrence, R&D Director, Hill-Rom Surgical Solutions, recognizes how certain safety practices can allow for the responsible use of traditional products.

“Some medical device companies have thought very creatively about options for those facilities or physicians that want to use traditional sharps and support safety for their staff,” Lawrence said. “Examples of this are neutral zone mats and transfer trays, as well as products that help safely remove blades from scalpel handles.”

ISC’s Mitchell notes that “injuries from disposable syringes and sutures are the most frequent, in part because they may be used the most frequently, but also because there is still a good deal of improvements left to be done,” she said. “For syringes, since compliance with activation of the safety feature is not ideal — 60 percent of injuries are from devices with safety features that have not been activated — better and safer designs need to be developed. This may include ones that are more intuitive for users and don’t require the user to do too much more than they would normally do when using an old non-safety device.”

But exposure to infections isn’t limited to punctures or cutting, according to the latest EPINet data, and spills over to personal protective equipment.

“Splashes and splatters from blood and body fluids (non-sharps injuries) continue to pose an enormous risk, especially to the eyes (64.9 percent),” Mitchell said. “Better engineering personal protective equipment (PPE) is as important as engineering the medical devices themselves. Since compliance with PPE use during mucocutaneous exposures is much lower than desired, healthcare institutions should continue to focus on measuring and preventing these exposure types.”