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CarePlus™ FDA Listed

NiQ Health CarePlus™ is now listed with the US Food and Drug Agency (FDA) further enhancing patient and staff safety and providing end users with a new level of product compliance and certification. NiQ Health’s CarePlus™ product is listed as a Class 1 Medical Device Data System.

CEO Andrew Rothon said, “The FDA’s Medical Device Program protects and promotes public health by ensuring the safety, effectiveness and quality of all medical devices which now includes nurse call systems”. “This new US regulation goes beyond the national electrical certifications required in the 1960’s and 1970’s like; FCC, CE, Ctick, UL1069 and DIN certifications”. “The FDA requires all product software changes to be certified”. “This modernization of the certification process will give hospitals and aged care facility owners and managers a new level of system assurity and tested patient safety”. Further Mr. Rothon said, “This additional level of System certification (meaning both hardware and software) provides real benefits to end users”.

What is FDA listed MDDS?

The FDA’s Medical Device Data Systems (MDDS) certification focuses on all the stages in a product’s life cycle, from development and design through obsolescence. FDA monitors medical devices for continued safety once they are in use, foster medical device innovation, and provide the public with the accurate, science-based information needed to improve health.

The most significant regulatory requirement is supporting the mandatory Quality System Regulation (QSR). QSR is a safety-engineering framework intended to maximize product quality and safety.1

Hence customers choosing a FDA listed products can be assured the system meets the highest levels of patient and staff safety.

What are covered by FDA MDDS regulations?

The FDA ruled MDDS to include systems that electronically transfer, store, or display medical device data, and systems that electronically convert medical device data from one format to another in accordance with preset specifications.

Class I devices certain computer/software systems that electronically transfer, store, convert, or display medical device data; for example data from glucose meters or nurse call systems.

All devices that meet the definition of an MDDS are now classified as Class I devices. MDDS manufacturers will be required to comply with Class I device requirements, including registration, listing, labeling, Quality System Regulation, Medical Device Reporting (MDR), and correction and removal reporting requirements. The FDA clarifies that the term manufacturer includes not only traditional computer/software manufacturers but also hospital and end user who modify their systems.

The FDA gives the following guidelines on their web site

FDA examples of what is regulated by MDDS and the 501K process

Change in software or firmware

Small changes to device software – including software that is an integral part of a device or stand-alone software that constitutes a medical device in and of itself – can have pervasive effects on the safety or effectiveness of a device and trigger the need for a new 510(k) submission. Changes to device software that could affect a clinical algorithm (an algorithm that controls how software analyzes, interprets, or uses patient data) would also warrant a new 510(k).

Examples:

  • Software that plans placement of an implant based on patient case data is modified to plan placement of different implants or to plan placement based on a new patient parameter. These changes should result in a new 510(k).
  • Software for a dental operative unit is modified to allow for use of a new control feature. This change should result in a new 510(k).
  • Software for an electroencephalograph (EEG) is configured to display a generic error message when a sensor is disconnected. The software is modified to display a more specific error message that instructs the user to connect the disconnected sensor. This change does not significantly affect the safety or effectiveness of the EEG and does not require a new 510(k).
  • The software for a polysomnogram (PSG) is modified to allow for saving or printing of recorded information for post-acquisition viewing. This change does not significantly affect the safety or effectiveness of the PSG and does not require a new 510(k).

Modification impact how the device receives, transmits, or displays electrical signals or data?

While such changes may seem innocuous, most changes of this nature have the potential to significantly impact safety or effectiveness by altering data communication quality.
Examples:

  • Diagnostic software that typically displays images on a monitor in a clinical setting is modified to output the image to a portable hand-held device that can be used to view the images from any location. This change could result in new risks, such as the inability to discern certain data due to a smaller hand-held screen, lower picture resolution, or loss of data during transmission, that could significantly affect the safety and effectiveness of the software. Therefore, this change should result in a new 510(k) submission.
  • An infusion pump that was cleared with a hard-wired connection to a keyboard to input treatment parameters is modified to include wireless capability to allow for remote input of treatment parameters. This change could significantly affect safety or effectiveness by altering data communication quality, which could affect the input of treatment parameters, and should therefore result in a new 510(k).

1 www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm