Addressing the Misconnections Issue
There is very little room for error in the ICU, as the patients there are often critically ill and on life support. If a critical event is not detected and corrected in the ICU, it will affect patient outcomes and may even cause their death. Studies have therefore been conducted to get insights into errors in the ICU. One such study finds that events can be classified as a result of human error in 70.3% of the researched cases, while in 29.7% of the cases the trouble was due to mechanical errors.
Despite these two clear classifications, misconnections seams to often be the result of a mixed occurrence. A mechanical error or malfunction of the equipment is enhanced by the patient’s movement and an accidental disconnection of medical Luer tubing connection occurs. As most traditional Luer connections and stopcocks look the same, people (patients, family members and overtasked nurses) can inadvertently connect the wrong tubes together causing a misconnection.
The Common Causes and Results of Misconnections
- Universal design of Luers and many other small-bore connectors
- Widespread use of Luers and other small-bore connectors with the same size opening
- Increasing complexity of medical treatments that require numerous medical devices with Luers and other small-bore connectors
- In specialized settings such as the ICU, even more extensive use of Luer-connected devices is required
- Human error which can be caused by a variety of conditions, such as: poor lighting, lack of training, time pressure, or fatigue
The FDA has also reported several case studies of accidental misconnections. Below are two examples:
- Feeding tube erroneously connected to the trach tube – An infant in the pediatric intensive care unit had both a feeding tube and a trach tube. The feeding tube was inadvertently placed in the trach tube and milk was delivered into the infant’s lungs, resulting in the infant's death.
- Epidural tubing erroneously connected to IV tubing – An anesthetist and a midwife mistakenly connected an epidural set to the patient’s IV tubing, which delivered epidural medicine to the IV which resulted in the patient's death.
New regulations to avoid misconnections - ISO 80369
The healthcare industry has started addressing the issue of misconnections by creating new regulations and standards, which are expected to be adopted in 2016 and 2017. The medical device manufacturers and medical practices are making preparations and changes accordingly.
The purpose behind ISO 80369 and its upcoming changes to the health field is to improve patient safety while making operation easier for staff. The standard is a unilateral collaboration between healthcare providers, manufacturers, industry organizations, and regulatory agencies. ISO 80369 sets new regulations for medical devices with small-bore connectors to help prevent scenarios where patient lives are put in danger from misconnections between these medical devices.
On January 11, 2016, California passed a new law (HB 1867) that prohibits 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."
By creating universal standards for small-bore connectors that include sufficient differences between connectors for different purposes, the risk of misconnections is eliminated, increasing patient safety and improving the quality of medical care will be the final result.
What is ISO 80369?
In 2009, an international committee comprised of manufacturers, clinicians, and regulators, including the FDA, set out to solve the problem of small-bore connector hazards. In collaboration with the International Organization for Standardization (ISO) and the Association for the Advancement of Medical Instrumentation (AAMI) they created a new standard for medical devices with small-bore connections – ISO 80369.
The FDA has announced that it is considering recognizing the ISO 80369 standards. A new transition era has begun, at the end of which it is expected that the new standards will eventually be adopted internationally by the medical device industry.
Upcoming Changes from ISO 80369
ISO 80369 contains several standards for medical device compliance that affect a variety of healthcare services and applications.
Here are three important standards to be aware of:
- ISO 80369-3 Connectors for Enteral Applications – The committee concluded that the proposed Enfit connector design is applicable for both adult and pediatric applications. California’s deadline for enteral application connectors that don't fit into a connector other than the type it was intended for is July 1, 2016
- ISO 80369-6 Connectors for Neuraxial Applications – This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used with epidural devices, pain pumps and their administration sets, as well as with regional anesthesia catheters and needles. ISO 80369-6 is being implemented. California’s deadline for epidural application connectors is January 1, 2017.
- ISO 80369-7 Connectors with 6% (Luer) Taper for Intravascular or Hypodermic Applications – This part of ISO 80369 defines the Luer fitting and other minor changes to dimensions previously undefined in the old standard, ISO 594-1 and 594-2. Luers made to the ISO 80369-7 standard will connect to Luers made to the ISO 594-1 and ISO 594-2 standard, but not vice versa.
It is expected that the FDA will release new compliance requirements by early 2017 based on the current guidelines outlined in ISO 80369.
Preparing For ISO 80369
Elcam Medical has taken a proactive approach to the implementation of the new ISO 80369 standard regulations and is in the process of implementing the standard drafts well in advance, allowing our customers to prepare themselves for the upcoming change. We invite you to view our current offering.
Elcam also offers the Safe2 Rotator These medical devices prevent accidental disconnections, are one of the leading causes of misconnections when patients or medical staff accidently reconnect tubing to the wrong connector.
As Luer connector misconnections are an under-recognized, but common dangerous events. The objective of the new ISO 80369 Standards, which are gradually being implemented, is to prevent these adverse events so crucial to patient safety.
December 18, 2017
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