“An MDDS is a device that is intended to transfer, store, convert from one format to another according to preset specification, or display medical device data,” according to the rule. “An MDDS acts only as the mechanism by which medical device data can be transferred, stored, converted or displayed. An MDDS does not modify the data or modify the display of the data. An MDDS by itself does not control the functions or parameters of any other medical device. An MDDS can only control its own functionality. This device is not intended to provide or be used in connection with active patient monitoring. Any product that is intended for a use beyond the use (or functions) identified in this final classification rule is not an MDDS and is not addressed by this rule.”
The final MDDS rule will apply to “all manufacturers,” the FDA says. Critically, this includes hospitals, health care facilities or any other organization that does any of the following:
- Makes any modifications to the MDDS that are outside the parameters of the original manufacturer’s specifications for the device, for purposes of the user’s clinical practice or otherwise for commercial distribution.
- Purchases hardware or software and modifies it to transfer, store, convert or display medical device data for clinical use.
- Develops in-house software with an intended use consistent with an MDDS.
- Develops an in-house system, using multiple components of devices, that has an intended use consistent with an MDDS.
- The rule does not apply to electronic health record (EHR), personal health record (PHR), computerized physician order entry (CPOE), e-prescribing or word processing systems. Laboratory information systems and picture archiving and communication systems (PACS) are not medical device data systems either.
- An MDDS can covert data to the HTML; PDF; or Health Level Seven International, or HL7, data formats. However, “an MDDS may not otherwise convert, alter, modify or interpret the data that is received from a medical device,” the FDA said.
- Devices that transfer information for the purpose of information exchange, or that can generate or manipulate data on their own, are not considered medical device data systems.
- Such devices as glucose monitors, blood pressure cuffs and active patient monitors are not MDDS. These are Class III devices because they directly support and sustain a patient’s life; as such, they remain subject to stricter regulatory control, as well as to premarket approval.
- Devices intended for use by people who are not health care professionals (data entry clerks, for example) count as MDDS, though the FDA reserves the right, “if, through normal reporting mechanisms or otherwise, FDA determines that the use of these devices by someone other than a health care professional poses an unreasonable risk of illness or injury.”
