jueves, 12 de febrero de 2015

CDRH Industry: FDA Actions to Reduce Misconnections of Medical Devices

The FDA posted final guidance on Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications, which provides recommendations to manufacturers, FDA reviewers, and others involved in manufacturing devices that use small-bore connectors for enteral feeding. This guidance also provides guidance for those submitting or reviewing premarket notification submissions [510(k)s] for these types of devices.
The final guidance recommends that:
  • Devices with connectors that are part of, or form connections to, enteral feeding tubes conform to AAMI/CN3:2014 (PS) Part 3. However, conformance to the standard is not a requirement.
  • Manufacturers design and test enteral connectors based upon AAMI/CN3:2014 (PS) and AAMI/CN20:2014 (PS) to ensure that each proposed enteral connector is physically incompatible with non-enteral devices.
  • Manufacturers of enteral connectors that do not meet AAMI/CN3:2014 (PS), also known as proprietary connectors or transition connectors, continue to design and test the devices based upon the AAMI/American National Standards Institute (ANSI)/International Organization for Standardization (ISO) 80369-1 standard “Small-bore connectors for liquids and gases in health care applications — Part 1: General requirements.
The final guidance also includes recommendations for:
  • Connector materials
  • Inadequacy of color-coded and labeled connectors
  • Side ports, transition connectors, adapters, and syringes
  • Labeling
  • Usability and human factors testing

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