

Sepsis management
Take action to reduce the deadly toll of sepsis.
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Early detection and management of sepsis patients is critical to improving survival and reducing the economic burden of sepsis.
Edwards Lifesciences hemodynamic monitoring solutions offer advanced pressure- and flow-based parameters to help you detect sepsis early, guide treatment evaluation, and comply with NQF/CMS bundle requirements.

Severe sepsis and septic shock management bundle measure (NQF #0500)
The Centers for Medicare & Medicaid Services (CMS) now require hospitals participating in inpatient quality reporting (IQR) Program to collect data for the severe sepsis and septic shock: management bundle measure (NQF #0500).5 With the implementation of this measure, CMS will be able to gauge if care of severe sepsis and septic shock patients is improving. Compliance with this measure will determine payment starting fiscal year 2017.5
Solution to help you make proactive clinical decisions
The 6-hour bundle includes dynamic assessment of fluid responsiveness with either a fluid bolus or a passive
Early recognition is critical for timely intervention
Hospitals that follow the CMS sepsis bundle guidelines have shown significantly lower mortality rates for patients diagnosed with severe sepsis and septic shock.

Initiating advanced hemodynamic monitoring

Noninvasive ClearSight finger cuff
The ClearSight finger cuff offers access to continuous noninvasive blood pressure, as well as advanced hemodynamic parameters that provide valuable insight to help guide your detection of fluid responsiveness and make more informed volume administration decisions.
ClearSight finger cuff parameters
The following parameters can help guide your detection of fluid responsiveness help you make more informed volume administration decision.

The Center for Medicare and Medicaid Services (CMS) required reporting begins with the 3-hour bundle for patients with severe Sepsis

View the sepsis bundle guidelines overview
Request a printed copy of the sepsis guidelines poster
Hemodynamic monitoring during the 3-hour bundle
Edwards’ ClearSight finger cuff or FloTrac sensor can be used to measure flow-based parameters continuously prior to, during, and after the fluid administration portion of the 3-hour bundle.

Noninvasive ClearSight Finger Cuff
The simplicity of the ClearSight system gives you access to automatic, up-to-the-minute hemodynamic information for a broader patient population, including elderly or obese patients in whom an arterial catheter would not typically be placed.

Minimally-invasive FloTrac Sensor
The FloTrac sensor has been chosen by clinicians more than any other minimally-invasive volume management solution to monitor over 2.5 million patients worldwide.*
FloTrac sensor parameters
The following parameters can help guide your fluid administration decisions, serce as a an accurate marker of patient status on the Frank-Starling curve as well as help monitor and optimize oxygen delivery (with fluid and inotropic in combination with SaO2 and hemoglobin).

Edwards oximetry central venous catheter
The following parameters can help provide real-time assessment of oxygen delivery and consumption.

The Center for Medicare and Medicaid Services (CMS) required reporting continues with the 6-hour bundle for patients with septic shock
The 6-hour bundle includes dynamic assessment of fluid responsiveness with a passive leg raise or fluid challenge as noted below. In a recent CMS educational program, it was noted that a dynamic assessment requires more than these passive maneuvers. To calculate percent volume responsiveness, cardiac output or stroke volume must be known in advance and after these maneuvers.

View the sepsis bundle guidelines overview
Request a copy of the sepsis bundle guidelines overview
Learn more about shock management
6-hour bundle and dynamic assessment of fluid responsiveness

Noninvasive ClearSight finger cuff
The parameters from the ClearSight system can help guide your detection of fluid responsiveness and help you make more informed volume administration decisions.

Minimally-invasive FloTrac sensor
For A-line patients, the FloTrac sensor measures flow-based parameters continuously before and after a passive leg raise or fluid challenge.

Edwards oximetry central venous catheter
Meet reassessment requirements with one device by utilizing Edwards oximetry central venous catheter for measurement of continuous ScvO2 and CVP.
With the costs of treating sepsis patients rising, your hospital cannot afford to wait.
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The sepsis bundle guidelines as presented above were published by CMS on August 4, 2014 and are presented for informational purposes only. This information does not constitute reimbursement or medical advice. Edwards makes no representation or warranty regarding this information or its completeness, accuracy or timeliness. It is not intended to make a recommendation regarding clinical practice. Laws, regulations, and payer policies concerning reimbursement are complex and change frequently; service providers are responsible for all decisions relating to clinical services, coding and reimbursement submissions. Accordingly, Edwards strongly recommends consultation with CMS, payers, reimbursement specialists and/or legal counsel regarding guidelines, coding, coverage, and reimbursement matters.

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- Rhee, Chanu, et al. “Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014.” Jama, vol. 318, no. 13, 2017, p. 1241., doi:10.1001/jama.2017.13836.
- Alliance, Sepsis. “Sepsis Fact Sheet.” Sepsis Alliance, 2019, www.sepsis.org/wp-content/uploads/2019/02/Screen-Shot-2019-07-24-at-10.38.57-AM.png. Accessed May 2020
- Dugani S, Kissoon N. Global advocacy needed for sepsis in children. 2017/06/01. Journal of Infection. 10.1016/S0163-4453(17)30193-7.
- Kumar, Anand, et al. “Duration of Hypotension before Initiation of Effective Antimicrobial Therapy Is the Critical Determinant of Survival in Human Septic Shock*.” Critical Care Medicine, vol. 34, no. 6, 2006, pp. 1589–1596., doi:10.1097/01.ccm.0000217961.75225.e9.
- U.S. Department of Health and Human Services, HHS Press Release. “Largest Study of Sepsis Cases among Medicare Beneficiaries Finds Significant Burden." HHS.gov, U.S. Department of Health and Human Services, 14 Feb. 2020, www.hhs.gov/about/news/2020/02/14/largest-study-sepsis-cases-among-medicare-beneficiaries-finds-significant-burden.html.
- Centers for Medicare and Medicaid Services, CMS to Improve Quality of Care during Hospital Inpatient Stays. Available at: www.cms.gov. Accessed March 21, 2016.
- qSofa.org.
- Hospital IQR Specifications Manual Version 5.1.
- Report to Congress: Medicare and the Health Care Delivery System, June 2015.
- National Quality Forum. NQF Revises Sepsis Measure. Available at www.qualityforum.org. Accessed March 21, 2016.
- Mayr FB, et al. Proportion and cost of unplanned 30-day readmissions after sepsis compared with other medical conditions. JAMA 317.5 (2017): 530-531
Important safety information
See Instructions For Use (IFU) / Directions For Use (DFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
Important safety information
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
See Instructions For Use (IFU) / Directions For Use (DFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
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