On October 7, 2016, the FDA updated its safety information regarding medical device misconnections. Medical device misconnections may occur when one type of medical device is mistakenly attached to another type of medical device that performs a different function. Because these connectors are easy to use and may be compatible with different medical devices, users can mistakenly connect unrelated systems to one another. This may cause medication or other substances to be delivered through the wrong tubing into the incorrect area of the body. These errors are sometimes called tubing misconnections, wrong route errors, catheter misconnections, or Luer misconnections and can result in patient injury or death. For examples of potential misconnections, see FDA, Medical Devices, Examples of Medical Device Misconnections, which includes case studies of errors and how to correct or prevent them.
Patients in health care settings receive food, medication, and other therapies through a variety of devices, or delivery systems, such as syringes, catheters, and tubing sets that connect to each other. Connectors are the parts of devices that attach tubing, catheters, and syringes to other medical devices.
Medical devices are often packaged together in tubing sets or co-packaged with another device (e.g. feeding set and enteral feeding tube). These sets comprise all the parts needed to use the tubing for its intended purpose, including the connectors that attach tubes to the other parts of the set or to other devices.
In a typical hospital setting, several different types of medical devices, each with their own connections, may be in use at the same time on a single patient. In specialized settings, such as intensive care units (ICUs), cardiac care units, or emergency departments, patients may require dozens of different devices at once.
Devices that need to connect to each other are also used in the home setting, and other environments beyond professional health care facilities. Patients may have to use these devices for the duration of an illness, recuperation, long-term care, or throughout their lives.
Device misconnections can occur for many reasons. The similar design of many connectors and widespread use of connectors with similar sizes and shapes can cause confusion. Misconnections can also be due to human error, arising from conditions such as multiple connections on one patient, poor lighting, lack of training, time pressure, fatigue, or high-stress environments.
Manufacturers and health care facilities have tried many methods to prevent device misconnections, including color-coding, labels, tags, and training. However, these methods alone have not effectively solved the misconnection problem because they are not consistently applied, nor do these methods physically prevent the misconnections.
Soon, the way devices connect to each other may be changing, greatly reducing the risk for misconnections. New design standards are being developed for tubing connectors for high-risk medical applications (e.g., enteral, respiratory, neuraxial), so that unrelated devices cannot connect with each other.
The FDA is working with standards organizations, federal partners, professional societies, advocacy groups, patients and other stakeholders to reduce the chance of medical device misconnections. The FDA continues to address this issue through participating in international consensus standards development, developing draft and final guidance, evaluating medical device adverse event reports about medical device misconnections, and communicating with patients and other stakeholders to understand the impact of new connector designs.
See the FDA Safety Communication
For additional information, see FDA, Medical Devices, Reducing Risks through Standards Development for Medical Device Connectors
See also Medical Law Perspectives October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment
See also Medical Law Perspectives June 2014 Report: Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability
See also Medical Law Perspectives April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory