Patients 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. Medical devices are often packaged together in tubing sets or co-packaged with another device. These sets comprise all the parts needed to use the tubing for its intended purposes, 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 ICUs, cardiac care units, and/or emergency departments, patients may require dozens of different devices at once.
Devices that need to connect are also used in the home setting and in other environments beyond professional healthcare facilities. FDA’s Center for Devices and Radiological Health www.fda,gov/MedicalDevices regulates these devices, however, the regulatory authority alone is not enough to ensure that devices are safe and effective when used in the home.
For more information on safety of devices in the home, go to view the proposed rule “Declaration of Labeling for Home-Use Medical Devices” published October 17, 2016, in the Federal Register www.federalregister.gov on page 71415.
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. This may cause medication or other substances to be delivered through the wrong tubing into the incorrect area of the body which can result in patient injury or death.
Device misconnections can occur because:
- The design of many connectors are similar in size and shape and the widespread use of similar connectors
- Human error can arise from multiple connections on one patient
- Professionals in the field are not trained properly and may experience time pressure to treat the patient or experience fatigue while working
Manufacturers and healthcare facilities have tried many methods to prevent device misconnections such as using color coding, labels, tags, and training. However, these methods have not effectively solved the problem mainly because they are not consistently applied.
The FDA, in working with the standards community, federal partners, professional societies, advocacy groups, and the medical device industry, is taking action to reduce the likelihood of medical devices not being correctly connected.
These actions include the development of standardized connector designs for specific medical applications intended to physically prevent connections with devices used for other medical applications.
FDA continues to address the issue by participating in international consensus standards development, developing draft and final guidance, evaluating medical device adverse event reports, and currently, FDA is communicating with patients and other stakeholders to understand the impact of new connector designs.