Although a small component of the complex systems in intravenous (IV) therapy and associated areas, needleless systems have a huge impact on patient and health professional safety. As a result, needleless systems are recognized as a type of engineering control to prevent infection from contaminated sharps, and their use was mandated by Congress in the Needlestick Safety and Prevention Act of 2000.
The term "needleless systems" was added to the definitions [at 29CFR 1910.103(b)1]; it is defined as "a device that does not use needles for: (1) The collection of bodily fluids or withdrawal of body fluids after initial venous or arterial access is established; (2) The administration of medication; or (3) Any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps."
Even before the mandate was issued, the industry had been striving to provide solutions to improve the safety of IV therapy practice. In parallel, through a guidance document describing needle stick reporting, sharps injury prevention features, and a broader perspective on IV administration sets, the Food and Drug Administration (FDA) provided details related to needle-free/needleless connectors.2
IV therapy is used to administer saline and/or medications to patients, with up to 80% of all patients in the hospital setting receiving IV therapy.3 Based on estimates by the authors, up to one billion IV sets and more than one billion needleless sets could be used globally each year.
Needleless valves are part of the IV circuit, typically by means of a bonded connection to tubing or by providing means to connect to a standard small-bore connector. By design, they help establish a fluid conduit when accessed with a male luer connector. Although needleless valves differ from standard small-bore connectors in terms of mating surfaces and dimensions, it is recognized that similarities exist between intended uses.
During a meeting on development of the ISO 80369 series of small-bore connector standards,4 the idea of developing a standard for needle-free connectors was born. An AAMI working group subsequently was established to address this need. The working group consists of representatives from the industry, including manufacturers and thought leaders, and those with regulatory, clinical, and product management backgrounds. Although the standard is focused on U.S. regulatory environment and end use, in order to be inclusive, representation from around the globe has been added to the AAMI luer-activated valves committee as work has continued.
Innovation in needle-free connectors has progressed at a rapid pace around the globe, with commercial organizations increasingly offering solutions that not only enhance safety but also focus on delivering value to the customer in terms of infection prevention, cost effectiveness, ease of use, ergonomics, and other factors. An initial focus on IV administration sets has expanded to use in diverse fields such as hemodialysis, hemodynamic monitoring, and hazardous drug handling. Use scenarios vary widely from simple intravenous hydration, to delivery of parenteral nutrition, and to closed medication systems used in neonatal intensive care. The settings in which care is provided also are diverse; in addition to most units in hospitals, they include ambulatory surgery centers, oncology clinics, dialysis clinics, and patients' homes. The use of needleless connectors is complemented by the enormous amounts of research and data collected by regulatory bodies.
These realities have been taken into account by the AAMI working group during the development of the forthcoming standard AAMI/CN27, General requirements for luer activated valves incorporated into medical devices for intravascular applications. As a result, the scope of the standard has been limited to luer-activated valves (LAVs) for intravascular applications that typically have a female port, which normally is closed and then can be opened through the use of a luer. The working group felt that much benefit can be gained by focusing on devices that are more ubiquitous to the healthcare setting, rather than all types of needle-free connectors. In the future, enhancements to the standard or development of an associated standard can be undertaken in an efficient manner. The focus areas of the standard were divided into the following three types of requirements: 1) clinical/user, 2) performance, and 3) dimensional.
The AAMI working group reviewed the FDA Manufacturer and User Facility Device Experience database to understand the challenges faced by patients and the healthcare community. The terminology surrounding needle-free connectors also was determined to not always be consistent or clearly understood. The working group recognized that due to the timing of developing the standard and advances made in the field, efforts should focus primarily on arriving at a consensus for common terminology and requirements for LAVs, in order to provide an output that delivers value to patients, users, regulators, and industry.
The working group strongly believes that this multidisciplinary perspective will provide a platform upon which solutions can be delivered to ultimately enhance the safety and efficacy of LAVs.
AAMI/CN27 is expected to be released in late 2019 or early 2020.
© Copyright AAMI 2018. Biomedical Instrumentation & Technology May/June 2018. www.aami.org/bit
Authors
Ravi Narayanan is Global Product Manager at Nordson MEDICAL in Loveland, CO, and chair of the AAMI CNWG01 luer-activated valves committee. Email: ravi.narayanan@nordsonmedical.com.
Srinath Lingutla is Senior Engineering Manager at ICU Medical in Salt Lake City, UT, and chair for the Performance Characteristics Working Group of the AAMI CNWG01 luer-activated valves committee. Email: slingutla@icumed.com.
