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FDA to Reclassify Device Software


February 8, 2008

The Food and Drug Administration has published a proposed rule to reclassify the regulatory status of certain software used with medical devices. The rule would affect medical devices used in provider organizations and in patient homes.

The software, called a Medical Device Data System or MDDS, currently is classified as a Class III medical device--the most stringent and expensive regulatory classification--and must receive pre-market approval from the FDA. Now, FDA proposes to reclassify the software as Class I, the least stringent classification.

The FDA, in the proposed rule published Feb. 8 in the Federal Register, identifies a Medical Device Data System as a device intended to provide one or more of the following services:

“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 interrogates a ventilator every 15 minutes and transfers information about patient CO\ levels 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, this would include software that stores historical blood pressure information for later review by a healthcare provider;

“The electronic display of medical device data, without altering the function or parameters of connected devices. For example, this would include software that displays the previously stored electrocardiogram for a particular patient; or

“The electronic conversion of medical device data from one format to another format in accordance with a preset specification. For example, this would include software that converts digital data generated by a pulse oximeter into a digital format that can be printed.

“Examples of medical device data systems that would be used in the home are systems that periodically collect data from glucose meters or blood pressure devices for later review by a healthcare provider.

“Medical device data consist of numerical or other information available from a medical device in a form suitable for processing by computer. Medical device data can represent many types of information (e.g., clinical values, alarm conditions, error messages).

“MDDS are not intended or designed to provide any real time, active, or online patient monitoring functions. Medical device data systems can deliver and store alarm data but do not have the capability to display, create, or detect alarm conditions, or to actually sound an alarm. In particular, a MDDS can record the fact that an alarm sounded, but cannot by itself sound an alarm in response to patient information.

“Medical device data systems cannot create alarms that are not already present from the connected medical devices. By themselves, MDDS do not provide any diagnostic or clinical decision making functions.

“Medical device data systems can transmit, exchange, store, or retrieve data in its original format or can be used to convert the medical device data from one format to another so that the arrangement or organization of the medical device data is in accordance with preset specifications.”

Full text of the proposed rule is available at gpoaccess.gov.

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