Updated Information on Reducing Risks Associated with Medical Device Misconnections

• Background
• Medical Device Misconnections
• Reducing Risks
• The FDA’s Role

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.

Examples of Medical Device Misconnections page, which includes case studies of errors and how to correct or prevent them.

Device misconnections can occur for many reasons, including:

• The similar design of many connectors and widespread use of connectors with similar sizes and shapes.
• Human error, arising from conditions such as multiple connections on one patient, poor lighting, lack of training, time pressure, fatigue or high-stress environments.

Reducing Risks through Standards Development for Medical Device Connectors page.

medical device adverse event reports about medical device misconnections;

Communicating with patients and other stakeholders to understand the impact of new connector designs.

For additional information, see FDA Activities.