By Jack Saladow
November marks the 10th anniversary of the Needlestick Safety and Prevention Act, which requires healthcare providers to use needle-free or needle-protected devices where available to reduce the risk of accidental needlesticks. While movement to these products was already underway, the legislative mandate heightened needle safety awareness and fostered the development of new safety-focused needle technology for the U.S. market.
Key among these developments was the introduction of needleless luer-activated valves (LAVs). Today there are more than 15 brands of LAVs on the market, which are accessed via the luer tip of a syringe or the distal male luer connector of an IV set. The valves can utilize either positive, negative or neutral displacement technology—as well as split-septum design. While this technology ensures healthcare worker safety by preventing needlesticks, the past decade has demonstrated that certain aspects of the design could actually put patients at risk of catheter-related bloodstream infections (CRBSIs).
Numerous published reports and studies have concluded that the inherent design and utilization of LAVs in healthcare delivery may be associated with increased rates of patient CRBSIs. In addition, this past July the Food and Drug Administration (FDA) began requiring nine LAV manufacturers to conduct a post-market surveillance studies on positive displacement needleless valves to assess whether they may be associated with a higher rate of device-associated bloodstream infections than other types of needleless connectors, and to assess the factors that may contribute to a possible increased risk. Specifically, the FDA is asking manufacturers to address the question: "Are there patient demographics, comorbidities/serverity of illness, or device cleaning practices for which placement of your positive displacement connector for central line access increases patients risk of bloodstream infections compared with other needleless connectors?"(1)
This initial FDA action will aid the market to better understand what role a specific LAV design may play in the increased incidence of BSIs. However, it is clear that all LAVs, regardless of design, are continually exposed to bacteria. If they are not disinfected consistently and reliably prior to each access, LAVs can provide a direct path to a patient’s bloodstream for any bacteria residing on the port. Therefore, if used improperly, LAVs carry an increased risk of BSIs.
BSIs and Health Policy Today
Bloodstream infections are considered preventable events, and as such, in October 2008, the Centers for Medicare and Medicaid Services (CMS) ceased reimbursing providers for the care and treatment of a BSI acquired while a patient was under their care. Numerous private insurers have adopted similar reimbursement policies.
These actions, along with increased tracking and reporting requirements, have heightened the focus on reducing the risk of BSIs and other avoidable complications. Numerous published research studies have focused on the reduction of CRBSIs through best practice process bundling and new product innovation for central line maintenance. A landmark study conducted by Peter Pronovost, MD, PhD, FCCM, medical director at the Center for Innovation in Quality Patient Care at Johns Hopkins Medical Center in Baltimore, showed that the incidence of CRBSIs could be cut by two-thirds if hospital personnel followed a five-step insertion checklist.(2)
Despite the increased awareness, hospital-acquired BSIs remain a major issue for the healthcare system today. The Centers for Disease Control and Preventions (CDC) estimates there are a minimum of 250,000 incidents of catheter-related bloodstream infections (CRBSI’s) annually in the United States. The implications and costs of a bloodstream infection are considerable:
- The average cost to treat a BSI ranges from $36,441 to $91,733(3)
- BSIs have been reported to increase hospital stays, on average, 20 days
- Patients who acquire a BSI are at risk for increased mortality, an estimated 19 percent of patients die from their infections(4)
In addition, a survey conducted by the Association for Professionals in Infection Control and Epidemiology (APIC) indicated that the majority of respondents agreed with the statement: "Despite the evidence demonstrating that many, if not most, CRBSIs can be prevented through consistent application of best practices and the financial penalty imposed by CMS and many private insurers, CRBSIs are still a persistent problem for many healthcare institutions."(5)
According to the survey, institutions should take the following steps in order to reduce the improper procedures that cause CRBSIs:
- The need for additional education and resources to prepare for the successful prevention of CRBSIs
- Additional focus by hospital administration on the issue
- Stronger monitoring of compliance with best practices for the prevention of BSIs and holding clinical staff accountable to these practices
The Disinfection Challenge
Because their surfaces are not covered, LAVs are exposed to bacteria through both touch and airborne contamination that occurs in normal everyday use. As such, clinicians are required to swab to disinfect the valve prior to use. Historically, most facilities find this practice to be inconsistent, at best. While significant attention has been placed on the improved maintenance of lines in the delivery of care, the disinfection of ports prior to use has, until recently, totally relied on internal education programs, such as "scrub the hub" campaigns. These campaigns attempt to raise awareness and focus nursing attention on proper disinfection of LAVs prior to use. Unfortunately, they offer no new tools to assist clinicians in improving their practices. The current requirement of a 15-second scrub followed by a 30- to 60-second dry time is effective when followed, but is often unrealistic in a time-compressed environment.
Improving compliance and gaining consistent and reliable disinfection of LAVs continues to elude the great majority of healthcare facilities. Relying on clinicians to comply with prescribed practices alone will not win the battle—think about handwashing. However, today’s practices can be enhanced—or even made easier—with the help of additional technology. Process improvement can be achieved through the combination of improved technology and clinical education.
LAV Disinfection Technology Advances
A new technology, disinfecting port protectors, has recently been developed to aid healthcare providers in the overall improvement of port disinfection practice with the goal of reducing the rate of CRBSIs. In June 2009, Ivera Medical, a San Diego-based medical device company, introduced the Curos® Port Protector which is the first protector to disinfect and protect LAVs against exposure to touch and airborne contamination. The patented Curos Port Protector is a small, easy-to-use disinfection cap designed to securely twist onto all currently available LAVs.
The device is designed to:
- Disinfect and protect luer-activated ports, eliminating the need to swab LAVs. For the first time, this technology provides facilities with consistent and reliable disinfection of their LAVs no matter who performs the procedure.
- Act as a visible and auditable tool by which the facility can monitor and measure compliance with disinfection protocol. The high visibility green color demonstrates compliance at a glance and provides an additional safety layer by negating any confusion with other ongoing therapies.
- Minimize cost by reducing unnecessary packaging waste (Curos has only a small foil seal to discard prior to use).