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Stephanne Hale on Patient Safety


Improving Patient Safety: Preventing Tubing Misconnections
In a recent Novation survey of hospital providers titled “Tubing Misconnections Standards,” about 88 percent of respondents indicated that they had a policy in place to report a tubing misconnection event involving the delivery of an incorrect substance or utilization of an incorrect delivery route to a patient. Tubing misconnections are a serious patient safety issue, one that can be fatal, and one that is believed to be seriously underreported. Also referred to as Luer misconnections, small bore misconnections, or wrong route errors, tubing misconnections occur as a result of connecting a medical device from one delivery system to another delivery system that serves a completely different function. Based upon root-cause analysis and industry review of reported misconnection events, the Luer appears to be a contributing factor in many instances as the Luer allows therapeutically dissimilar devices to be easily connected.  Examples of reported adverse events involving the Luer include connection of a feeding tube to a tracheostomy tube; delivering milk into an infant’s lung and a peripheral intravenous (IV) route connected to an automatic blood pressure cuff; delivering air to the bloodstream.  Both misconnection events resulted in the patient’s death.

In March 2013, the Centers for Medicare & Medicaid Services (CMS) issued an immediate communication to state and regional office training coordinators, survey and certification staff and staff managers regarding the issue. The memo provided information to surveyors on what to look for and questions to ask healthcare personnel during a misconnection investigation regarding variables contributing to the cause of the error.  Additionally, questions regarding tubing misconnections and prevention steps are allowed during routine survey visits. In the event that the Luer or a similar connector is implicated in the cause of the adverse event, the surveyor should determine whether the facility has taken actions to ensure systems are in place to prevent recurrence of this type of adverse events.

In addition to investigating possible causes of misconnections and prevention methods, the March memorandum communicated to surveyors, that they may encourage [health care] facilities to report misconnection issues to the Food and Drug Administration (FDA), even in the absence of an adverse event and reporting of such events should be in accordance with the procedures establishes by the facility. Research suggests that tubing misconnections and medical errors in general are believed to be seriously under reported and for various reasons including the perceived threat of sanctions, malpractice suits, stigma related to professional identity and reputation and fear. Learning from tubing misconnection errors can be productive and not necessarily punitive, therefore, despite actual or perceived seriousness of consequences, transparency in healthcare is vital to identifying recurring problems and creating a culture of patient safety and reporting of such events should be encouraged.

There is work currently underway by an international working group to address this patient safety issue from a policy perspective. In 2009, California Senate Bill 158 was passed, requiring state manufacturers to adopt a series of standards for preventing device misconnections. The initial bill, passed by the state legislature, required adoption and implementation of new device standards by manufacturers and hospitals by January 2013; that deadline has since been extended to January 1, 2016.  Actual language from the bill mandates that “a health facility is prohibited from using an intravenous connection, epidural connection, or enteral feeding connection that would fit into a connection port other than they type it was intended for, unless an emergency or urgent situation exists and the prohibition impairs the ability to provide health care.”

The group that is developing the small bore misconnection standards consists of clinicians, manufacturers and regulators, including the U.S. Food and Drug Administration (FDA), the International Organization for Standardization (ISO) with the Association for the Advancement of Medical Instrumentation (AAMI), members of the medical device industry and Novation.  Collectively, the group is developing the 80369 series which will require small bore connector designs involving the Luer to be specific to the applications they were intended for and not a universal fit.

In January 2011, AAMI adopted the standard ANSI/AAMI/ISO 80369-1:2010, which provides general requirements for small bore connectors for liquids and gases, with additional standards being developed for application-specific designs as follows:

  • 80369-2 — Small bore connectors for liquids and gases in health care — connectors for breathing systems and driving gases
  • 80369-3 — Small bore connectors for liquids and gases in health care — connectors for enteral applications
  • 80369-4 — Small bore connectors for liquids and gases in health care — connectors for urethral applications
  • 80369-5 — Small bore connectors for liquids and gases in health care — connectors for limb cuff inflation applications
  • 80369-6 — Small bore connectors for liquids and gases in health care — connectors for neuraxial applications
  • 80369-7 — Small bore connectors for liquids and gases in health care — connectors with 6% (Luer) taper for intravascular or hypodermic application

To address those anticipated concerns, education efforts are beginning to take place regarding tubing misconnections and the new standards. Recently, an informative panel discussion was held during the recent Health Care Supply Chain Conference (HSCA) in Washington, DC. The panel was comprised of subject matter experts from Novation, the Joint Commission, US Food and Drug Administration, Centers for Medicare and Medicaid Services, AAMI, Premier, Collaborent Health-Global Enteral Device Supplier Association (GEDSA) as well as the co-chairperson for the AAMI/ISO Technical Advisory Group (TAG) involved in the development of the ISO standards. The group discussed development of the standards, a tentative timeline for implementation and supply chain implications for healthcare providers. Awareness efforts are also being developed by a collaborative group that includes AAMI and other partners and will be led by the Joint Commission. The group is developing an awareness campaign addressing the need for change by developing tools and resources to disseminate timely and appropriate information. The group hopes to facilitate rapid adoption of the new global standards while minimizing disruption to the supply chain and clinical practice while maximizing patient safety.

Frequently Asked Questions

Stephanne Hale, Sr. Clinical Manager, Sourcing Operations at Novation, provides clinical expertise and insight into the bid process for healthcare and supply chain quality and safety. She is responsible for developing educational resources and tools that address clinical efforts for the hospital members that Novation serves.

Prior to Novation, Hale was a Patient Care Manager for one the nation’s leading palliative care organizations where she had responsibility for the clinical program. Her clinical experience includes liver-kidney transplantation and traumatic neuro-rehabilitation primarily at Baylor University Medical Center, Dallas. Her background also includes experience in sales and marketing as a National Nurse Clinician for a major manufacturing and distribution company.

Hale holds a bachelor’s degree in nursing from Baylor University as well as both an MBA and MHA from Texas Woman’s University. She is currently pursuing a Ph.D. from TWU where her research efforts are dedicated to promoting health and improving lives with evidence-based practice interventions and evaluation.
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