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CMS surveyors assessing protocols to reduce tubing misconnections

Premier Communications

SafetyShare® newsletter brought to you by the Premier Safety Institute®

Gina Pugliese, RN, MS, editor

April 5, 2013


CMS surveyors assessing protocols to reduce
tubing misconnections

The Centers for Medicare and Medicaid Services (CMS) is advising its surveyors to determine what steps organizations are taking to prevent Luer or tubing
misconnections while the long awaited international standards are being developed that will specify unique connectors for each system/application, such as,
IV, enteral, or epidural. These designed incompatibilities would make it easy to make the
correct connection and difficult or impossible to make the
wrong connection.

Misconnections result in serious injury and death
Misconnections of tubing that link patients to medical devices continue to result in serious injury and death. Examples of misconnections that have
resulted in death include:

  • Enteral feeding tubes connected to trach tube or ventilator in-line suction catheter
  • Epidural tubing connected to IV tubing
  • Oxygen tubing connected to a needleless IV port
  • Blood pressure tubing connected to IV catheter
  • Pulsatile anti-embolism stocking connected to IV heparin lock

Good news and bad news –

the standard Luer connector

Medical devices must have the ability to connect to related tubing and accessories – the standard “Luer” connector1 makes this possible. However,
because the Luer connector is a standard size and is used on such a broad range of medical devices and products, it allows functionally dissimilar tubes or
catheters to be connected together. Depending on the acuity level, a patient may have as many as 40 different tubing lines connected to devices, with many
of the fluids and tubings being similar colors, increasing risk for misconnections.

International standards intended to reduce risk

An international standards committee, led by ISO2 and AAMI3 with participation by FDA, suppliers and the healthcare community, is
developing standards that limit the use of Luer fittings to specific devices and design other connectors that are incompatible with Luer connections for
the remaining devices. In January 2011, the ANSI/AAMI/ISO4 small bore connectors standard (80369-1
general requirements) 
was released, the

first in a seven-standard series

to give manufacturers guidance on preparing for remaining standards. Each standard
will focus on connectors for a specific clinical application and the
remaining six
standards will be released as they are completed beginning in 2014 with a phase in period for product development and implementation guided by the FDA and
existing state legislation, such as


Interim solutions to reduce risk

Until international standards are finalized and new products with unique connectors are on the market, CMS is reviewing the steps that healthcare
facilities have in place right now to reduce the risk of tubing misconnections. CMS notes that the FDA tubing and Luer misconnection website
has been updated with tips, images, and information for healthcare providers and manufacturers of devices that use small bore connectors that can be used
for educational programs and action plans to prevent misconnections. Examples of actions that can be taken by providers to reduce risk include:

  • Investigating and changing to devices recently developed with alternative connector designs that may reduce the likelihood of misconnections of
    incompatible lines;
  • labeling all tubes and connections at the time they are established and re-checking as part of staff hand-off process;
  • tracing all lines back to their origins before reconnecting devices; and
  • educating non-clinical staff and visitors not to reconnect lines, but to seek clinical assistance instead.

Reporting tubing misconnections to FDA

CMS surveyors are asked to encourage healthcare facilities to report misconnections to the FDA as part
of the FDA’s user facility reporting requirements, even if an adverse event did not occur. Increased awareness and analysis of these errors by the FDA,
including corrected errors, can lead to improvement in patient safety.

Providing leadership to reduce tubing misconnections

The Premier healthcare alliance has taken a leadership role in preventing tubing misconnections beginning in 2003 in collaboration with suppliers,
regulatory and non-governmental organizations. Visit the Safety Institute’s website for tools, resources and



1. Luer connector
is a conical fitting with a taper and the luer connection consists of male and female counterparts that are joined together either by a push and twist
(luer slip) or screw-in threaded (luer lock) fitting to form a secure, yet detachable leak-proof connection.
2. ISO: International Standards Organization
3. AAMI: Association for the Advancement of Medical Instrumentation
4. ANSI: American National Standards Institute


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