Some sections of the standard could be adopted as early as fourth quarter 2014. Manufacturers are committed to launching the new connectors with minimal disruption to supply and clinical practice, and to working through existing inventory. A phase-in period for product development and implementation will be guided by the U.S. Food and Drug Administration (FDA) and state legislation.
by Kyle Steele, New Product Development Engineer
The Luer connector has for decades been one of the most common types of small-bore (less than 8.5 mm) connectors used in hospitals and other healthcare facilities to link or join medical devices, components and accessories for the purpose of delivering fluids or gases. A typical patient can be connected via tubes/catheters and Luers to several delivery systems – vascular, enteral, respiratory, epidural or intrathecal – to receive medication, nutrients, fluids and gases. Connections are also made to provide limb cuff attachments, wound pressure treatment, or draining the body’s fluids. But just as the Luer’s simple and universal design has allowed for ease of use in diverse patient care applications permitting connection between unrelated patient delivery systems that have different intended uses, so too has it made possible the inadvertent connection of wrong systems by health care providers, with detrimental and fatal consequences to patients. The problem is well documented. The U.S. Food and Drug Administration, The Joint Commission, the Institute for Safe Medication Practices, the United States Pharmacopeia, and the ECRI Institute have all received reports of misconnection errors.
The effort to minimize these system misconnections, also called Luer misconnections or wrong-route errors, has been approached in the past by some manufacturers using color coding with their connectors. Others have developed proprietary alternative connectors and product designs that are incompatible with Luer connectors, such as for intravenous delivery systems which are frequently involved in misconnections. Proprietary connectors are also widely found in blood pressure systems where the safety concern of delivering air through an IV or an Enteral Port is present. These efforts have not proven successful in eliminating the problem. What was needed was a design change, and correlating standards, that would make misconnections between unrelated delivery systems, medical devices and accessories highly unlikely.
The need for a universal standard has been emphasized by the Association for the Advancement of Medical Instrumentation (AAMI), “Without an international industry standard for small-bore connectors, manufacturers would have to attempt to test against all proprietary designs for different applications to ensure that their connector is incompatible with any other connector on the market. Healthcare organizations would have to purchase multiple systems across the continuum of care – without a standardized mechanism for testing and evaluation to prevent misconnections between them. Such a scenario could create confusion and put patients at higher risk.”
Initiating a Universal Standard
In 2009, an international group of manufacturers, clinicians and regulators including the U.S. Food and Drug Administration, collaborated with the International Organization for Standardization (ISO) and the Association for the Advancement of Medical Instrumentation to reduce the frequency of small-bore connector hazards. To this end, the group initiated the development of a new standard known as ISO 80369.
The AAMI was charged with organizing technical committees and working groups to produce the ISO 80369 standards, and recommend practices and technical information reports for medical device compliance to these standards.
ISO 80369 is divided into seven sections. The first section (Part 1) identifies the general requirements for small-bore connectors, and the following six identify specific requirements for connectors falling into one of the following general application areas: Part 2) breathing and driving gases, Part 3) Enteral (feeding tube) applications, Part 4) Urethra and urinary, Part 5) Limb cuff inflation or non-invasive blood pressure, Part 6) Neuraxial applications, and Part 7) Intravascular or hypodermic applications. Other standards may be added later, if warranted by patient safety risk and clinical need.
The first of these standards, 80369-1, was published in January 2011. It provides general requirements for small-bore connectors for liquids and gases in healthcare applications. It also establishes a framework for testing connectors to ensure non-interconnectability of unrelated delivery systems. International standards for non-Luer-compatible, delivery system-specific connections have since been under development. Each additional standard in the series focuses on connectors for each of the remaining six specific clinical applications, which will be released as they are completed.
The adoption of ISO 80369 as an international standard for small-bore connectors will ensure compatibility and consistency that influences several patient-care factors: a) Standardized connections across the healthcare delivery systems; b) Greater ability for manufacturers’ devices to integrate, while making it difficult, if not impossible, for unrelated delivery systems to be connected; and c) Less likelihood of therapy interruption due to connector incompatibility or unavailability.
Design Methodology
The system required to approve the ISO 80369 standards is a methodical and tedious process of coordinating and integrating data and testing from participant manufacturers, clinicians and regulators. The procedure involves participation in repetitive committees, including the following actions: a) Post-committee completion of a CD, then sending out for review and feedback; b) Addressing and incorporating feedback, in committee, then conducting usability testing with actual molded connectors; c) Sending out another revision as a DIS (Draft International Standard) for final review and vote; d) if approved, submitting the standard to the members as an FDIS (Final Draft International Standard); e) Sending the standard to ISO for review and approval. Each of these steps takes considerable time for review, comment and incorporation into the final standard. This procedure is necessary to ensure that connectors for unrelated patient delivery systems are incompatible.
The new small-bore tubing connector designs are dimensionally driven. The design methodology is based on human-factors engineering and computer- aided design (CAD) analysis to reduce the likelihood of misconnections. The proposed unique designs for the connectors go through a rigorous process to ensure they connect only to the proper mating connector. It was proposed that the materials used to make these connectors have a minimum hardness value to prevent inter-connectibility when force fitted. Proposed designs are validated through hands-on usability testing to confirm that they meet their intended purpose of preventing the connection of a medical device from one delivery system to a device of another delivery system. Analysis of design drawings and physical force-fit testing are used to verify that connectors that are supposed to connect do so securely, while connectors that should not join are physically prevented from doing so.
Challenges are an inherent factor in the process. There is a chance that connectors defined by different subcommittees may mate with one another, and analysis and testing will need to be done to avoid this, along with usability testing for each system.
The procedure of developing any ISO standard is a very deliberate and time-consuming process, and ISO 80369 is no different. Once a standard is established, then implementation will take additional time.
Federal and State Mandates
As of February, 2014, there are no federal mandates regarding small-bore connectors for manufacturers or healthcare organizations.
Effective January 11, 2016, a California law (HB 1867) will prohibit general acute care, acute psychiatric and special hospitals from using an epidural, intravenous or enteral feeding connector that fits into a connection port other than the type for which it was intended. The AAMI expects that all medical device manufacturers and suppliers will comply with the new California law, and develop modified products that incorporate the new connectors and phase out products with old connectors.
The FDA has announced that it is considering recognizing the ISO 80369 standards. If the FDA does recognize them, it will provide guidance to manufacturers regarding the timeline for devices currently on the market to come into compliance – but typically three to five years.
The European Union (EU), and other international regulatory bodies, have their own requirements for acceptance of the standards. Foreign medical device manufacturers wishing to sell product into United States markets, however, would need to comply with the ISO 80369 standards.
The ISO 80369 committees are all engaged in varying amounts of progress. Most have significant work to be done to finalize connectors for their specific market.
Once the standards are approved, there will be a transition period marked by stages. That approach is under development and will be communicated by manufacturers with advanced warning so that all parties can prepare for the changes in the market.
The changes for the new standard connectors will roll out by delivery system. Manufacturers will incorporate the new connectors into their existing offerings where applicable. The introduction will include developing and executing a coordinated joint communications plan, identifying each unique connector with a common name to be used by all suppliers of devices for each respective delivery system.
Beginning in 2014, manufacturers of breathing systems and driving gases, enteral, urethral, limb cuff inflation, and neuraxial and urethral devices will need to redesign their products to accept the new small-bore connector standards as they are approved. Enteral feeding devices (ISO 80369-3), Intravascular or Hypodermic (ISO 80369-7) and Limb Cuff Inflation (ISO 80369-5) are the ones likely to be among the first to be released, expected as early as fourth quarter 2014. The enteral devices that will be impacted include feeding tubes, administration sets and syringes.
Manufacturers are prepared to launch new connectors with minimal disruption to supply and clinical practice. There will be a phase-in period for product development and implementation guided by the FDA, and existing state legislation (i.e. California). The standard generally allows 3 years to manufacturers for new product adoption of the new connector standards and five years for adoption into existing devices. However, these timelines are influenced by state legislation.
ISO 80369-7 states that the existing Luer connector will be maintained only for vascular access in the form of intravascular and hypodermic applications.
Patient Safety
The unique driving force about the ISO 80369 standard that is pushing the unilateral participation and collaboration by so many different manufacturers, health care providers, organizations and regulatory bodies is squarely focused on patient safety. These medical devices, and the small-bore connectors that facilitate their application, are used to interface directly with patients in hospitals and health care facilities.
From the device manufacturer, to the health care provider, and to the patient, it is a win-win situation of improved and safer medical care.
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