Medical Devices

Identifying an MDDS

What is an MDDS?

The Federal Register notice provides the following definition of a medical device data system:

§ 880.6310 Medical device data system. -- (a) Identification.

  1. A medical device data system (MDDS) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:
    1. The electronic transfer of medical device data;
    2. The electronic storage of medical device data;
    3. The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or
    4. The electronic display of medical device data.
  2. An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.

In practice, a medical device data system (MDDS) is a medical device intended to provide one or more of the following functions:

  • The electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices. For example, this would include software that collects output from a ventilator about a patient's CO2 level and transmits the information to a central patient data repository.
  • The electronic storage and retrieval of medical device data, without altering the function or parameters of connected devices. For example, software that stores historical blood pressure information for later review by a healthcare provider.
  • The electronic conversion of medical device data from one format to another in accordance with a preset specification. For example, software that converts digital data generated by a pulse oximeter into a digital format that can be printed.
  • The electronic display of medical device data, without altering the function or parameters of connected devices. For example, software that displays the previously stored electrocardiogram for a particular patient.

MDDS include the following, provided the intended use is consistent with the MDDS regulation:

  • Any assemblage or arrangement of network components that includes specialized software or hardware expressly created for a purpose consistent with the intended use in the MDDS regulation;
  • Products specifically labeled (per 21CFR 801) by the manufacturer as an MDDS, provided such products do not provide additional functionality.
  • Custom software that is written by entities other than the original medical device manufacturer (for example, hospitals, third party vendors) that directly connects to a medical device, to obtain medical device information,
  • Modified portions of software or hardware that are part of an IT infrastructure created and/or modified for specific MDDS functionality. For example, when modifying software (writing and compiling software source code), the modified portion is considered MDDS.

What is Not an MDDS?

  • General-purpose IT infrastructure used in health care facilities that is not altered or reconfigured outside of its manufactured specifications. Modifications within the off-the-shelf parameters of operation are still considered general IT infrastructure and not MDDS. For example, components with the following functions by themselves are NOT considered MDDS if they are used as part of general IT infrastructure even though they may transfer, store, display or convert medical device data, in addition to other information:
    • The electronic transfer of medical device data;
      • Network Router
      • Network Hub
      • Wireless access point
    • The electronic storage of medical device data;
      • Network Attached Storage (NAS)
      • Storage area network (SAN)
    • The electronic conversion of medical device data from one format to another in accordance with a preset specification;
      • Virtualization System (ex: VM Ware)
      • PDF software
    • The electronic display of medical device data.
      • Computer Monitor
      • Big screen display
  • Networks used to maintain medical devices to see which systems are running or malfunctioning, or other similar uses that do not meet the definition of medical device under 201(h) of the FD&C Act.
  • Standard IT software that is not specifically sold by the manufacturer as a MDDS, which may have MDDS functionality such as reading serial numbers, barcodes, UDI or other data from a medical device, but is not used in providing patient care.
  • Off the shelf passive network sniffing software that is generally used to monitor any network performance by reading TCP/IP packets on a network if this software is not intended to connect directly to a medical device.

 

Page Last Updated: 07/08/2014
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