CMS in their MLN newsletter (10/4/18) reminded clinicians about availability of new enteral products that meet industry standards and a 3/8/13 surveyor memo about changing to alternative connector devices to reduce risk.
GEDSA position statement on the FDA’s 9/7/18 Letter to healthcare providers.
Misconnection of tubing used to link patients to medical devices or medical devices to each other is an underreported medical error, which has the potential to result in serious injury or death. Errors involving various types of tubing and catheters misconnections have been reported for over 40 years and despite warnings of the risks and guidelines to prevent them, they continue to occur.
The problem Medical devices used in hospitals must have the ability to connect to related tubing and accessories – the standard “luer” connector made this possible. However, because the luer connector is a standard size and is used on such a broad range of medical devices and products with totally different functions, the risk for tubing misconnections is great.
A patient, for example, may be connected to several devices used to administer fluids through a vein; deliver feedings via a tube to the stomach; monitor blood pressure; and administer oxygen via mask or cannula. This collection of devices, all of which may include luer connectors, poses a risk of tubing misconnection especially in a busy clinical environment where stress, fatigue and distractions are common.
Tubing misconnections that may lead to severe illness or death
- Connection of a feeding tube or nasogastric (NG) tube accidentally connected to an intravenous (IV) line – delivers liquid feeding into the bloodstream causing death.
- Tubing from a blood pressure accidentally connected to IV line–delivers air under pressure into the bloodstream causing an air embolism and death.
- IV fluids accidentally connected to the inflation cuff on an endotracheal breathing tube causing it to burst with fluid leaking into the airway resulting in airway obstruction.
|New!! Webinar Dec 4, 2018 On Demand: Implementing ENFit Enteral Feeding System
Faculty: Debby Kasper, Premier; Mark Antonino, FDA; Michael Cusak GEDSA; Amy Monroe, McLaren Health Care; Gina Pugliese-moderator, Premier.
The solution – Collaboration to develop standards
Experts agree that the best solution to prevent tubing misconnections is to change the design of the connectors so only devices that should be connected are able to be connected and those devices that should not be connected are incompatible.
In 2008, an international initiative led by the Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization for Standardization (ISO) began to develop international standards for small bore connectors (diameter < 8.5 mm) that require unique connectors for each device category. These new unique engineering designs would make it difficult or impossible to make the “wrong” connection or a tubing misconnection on incompatible device that serves a completely different function. More details about this effort are available on the AAMI small-bore connection website.
The standards The first international standard, ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications: Part 1 General requirements was published in 2011 and provides the framework for a unique connector for six device categories/applications. The standard ISO 80369-20:2015, Part 20: Common test methods – specifies test methods to support small-bore connectors’ functional requirements. Both standards are recognized by the FDA.
Status on international design standards for small bore connectors
- Enteral devices (feeding tubes, formula delivery): ISO 80369-3:2016 was published in July 2016 and FDA recognizes this standard.
- Enteral devices that meet this standard are available and identified by the tradename ENFit®.
- More information on products, implementation tools, FAQs, case studies and training at www.StayConnected.org
- Neuraxial devices (spinal, epidural catheters): ISO 80369-6:2016, was published in March 2016 and FDA recognizes this standard.
- Neuraxial devices that meet this standard are being made available and are identified by the tradename NRFit®.
- More information at www.StayConnected.org
- Blood pressure and limb tourniquet cuffs/devices: IEC 80369-5:2016 was published in March 2016
- Breathing or respiratory systems such as anesthesia machines and ventilators used to facilitate a patient’s breathing: In process
- Intravascular or hypodermic devices: ISO/FDIS 80369-7 standard is being finalized
- Urethral and urinary devices: Planned
Stay Connected is a program designed to facilitate the transition to new, safer connectors that ensure compatibility and consistency while reducing the likelihood of tubing misconnections. Stay Connected is organized by the Global Enteral Device Supplier Association (GEDSA) in partnership with leading industry organizations. GEDSA invites everyone to stay connected as the tubing connectors are introduced through a three-phase communications program – Aware, Prepare, and Adopt – to ensure a successful transition to safer connectors. Resources include design standards, transition checklists, products, frequently asked questions, case studies, and training videos. Visit StayConnected.org.
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