Under the rule IT companies now need to register healthcare hardware devices that transmit data and this can be a small blood pressure device or a larger imaging devices. The Class 1 rule is for devices that don’t affect a patient’s care, like an automated IV machine as an example that dispenses medications and reports data as that’s a higher classification.
This is the FDA’s attempt to certify that data is being sent properly and hopefully without software bugs (if all are found). All vendors with devices that report data are now required to register with the FDA. Medical records, PHRs and CPOE systems are not included in the rule. Health care providers must report deaths or serious injuries that MDDS products may have caused or contributed to so if the software/hardware fails, a registry of those occurrences has begun.
Medical billing and Workflow software, modems, laptops tablets can all fall under the MMDS rule and with those items mentioned this gets interesting as billing and workflow software integrate right along with medical record software so this is a big vague and the article even lists communication protocols too, so my guess would be that everyone who creates some type of software that could somehow integrate with a devices or other software that integrates with a device could fall under this provision. If in doubt, register I think <grin>.
The products must be tested before marketing and of course that’s not an issue as that’s part of the development stage and I’m sure in time more criteria will develop on how they are tested, mark my words on that one. Items like the “pill bottle” would be an example of a class 1 device as it’s reporting data. If nothing else the FDA will be more aware of everything that’s floating around out there today, and there’s a lo tof it! BD
A new U.S. Food and Drug Administration rule went into effect April 18 that regulates how hardware manufacturers can introduce new mobile medical devices for use by health care providers.
The rule was promulgated by the FDA's Center for Devices and Radiological Health, which oversees regulations for companies manufacturing, repacking, relabeling or importing medical devices in the United States. The FDA division also regulates electronic products that emit many forms of radiation, including lasers, X-ray systems and ultrasound equipment.
The new MDDS (Medical Device Data Systems) rule classifies most health care IT devices as Class 1 or low-risk medical devices.