What's The Difference? FDA or MDDS? Plenty!

What’s the Big Deal About FDA Clearance? Plenty! The benefits will rock your world!

We all know the importance of having vitals measurements automatically downloaded to our EMR system. The simple benefits: time savings and error elimination. But we all want more—we want outcome improvements! That’s why we need a vitals integration solution that delivers the advantages of FDA Clearance.

The fundamental difference between the MDDS (Medical Device Data System) and Integrated Clinical Software with FDA Clearance boils down to what they can do with the data.  MDDS are not required to get pre-market clearance from the FDA, so their software is narrower in scope to avoid the complicated scrutinizing and precision-oriented process of FDA clearance, inspections, and audits.  The trade-off is that MDDS software is limited in its functionality to transferring, displaying, and converting the data into standard formats like HL:7 for simple, basic integration.  On the other hand, an FDA cleared system is able to not only engage in the data transfer, but may also utilize analytics, data interpretation, alerts, thresholds, and other clinically relevant feedback from the data and is able to engage in true, comprehensive “patient monitoring.”

What does this mean to you as a clinician?   Tiffany Hafner, Director of Nursing at the Lodge Health and Rehabilitation Center is one of the many clinical leaders feeling the increased scrutiny by CMS and referral partners on preventable hospital readmissions in Long Term Care.  Her organization, Greystone Health Network, has implemented Medline's CareConnection FDA cleared Integrated Clinical Software and is reaping the benefits from both the clinical tools and the direct integration with her EMR, PointClickCare.

“Now that the vitals arrive in PointClickCare within minutes, our nursing team has the option to use those most recent vitals to administer meds. In addition, we’re finding that our ability to intervene and prevent a hospital readmission has vastly improved.  We are all so much more confident of the measurement and documentation accuracy. I’m no longer seeing a temperature entered at 986°F because someone missed a decimal while entering data. We are human—we make mistakes, but when a resident’s health is at stake, we need this kind of technology to ensure the best care.”

If your facility shares Greystone’s concerns, then you’ll want to embed the benefits of connecting your medical devices through an Integrated Clinical Software with FDA clearance rather than a system that only holds MDDS certification and is limited to the most basic and confining data transfer.  Integrated Clinical Software delivers not only data transfer (like an MDDS) but also offers more advanced features like predictive analytics for early warnings on patient’s conditions, alerting when patient readings are out of range or trending negatively, and allowing facilities to set measurement thresholds and trending preferences for their patients in the system.  An example of leveraging the value of information from an FDA cleared integration is CareConnection’s SMART*Reports used by Directors of Nursing and Nurse Practitioners to identify at risk residents and trigger proactive intervention.   

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Whats The Difference between FDA and MDDS? Plenty! Whats The Difference between FDA and MDDS? Plenty! (619 KB)



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