According to Medtronic’s website, Medtronic is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world.

PPAHS asked Medtronic to answer the questions that we posed to manufacturers of continuous monitoring devices. PPAHS questions are in blue.

Medtronic’s answers are below in green (provided July 30, 2018). These answers have been prepared by Kathie Niebel (Regulatory Affairs, Medtronic).

All links were accessed August 7, 2018.

Parameters Monitored

What physiologic parameters of the patient does your device monitor?

The Capnostream™ 20p bedside monitor and Capnostream™ 35 portable respiratory monitor from Medtronic continuously measure and monitor:

Partial pressure of CO2 during the breathing cycle

▪ Respiratory rate (RR)

▪ Oxygen saturation (SpO2)

▪ Pulse rate (PR)

What evidence is there that your device provides a reliable and early indicator of deterioration of the patient’s condition or decline?

The devices also offer Smart Alarm Management™ algorithms, including the Integrated Pulmonary Index™ algorithm (IPI), a numerical value that incorporates etCO2, RR, SpO2, and PR into a single number between 1-10, offering clinicians an integrated indication of the patient’s respiratory status.

The Joint Commission Sentinel Event Alert #49 states that pulse oximetry may be used to monitor oxygenation.1 Capnography may be used to monitor ventilation. Clinicians should be taught not to rely on pulse oximetry alone because pulse oximetry can indicate adequate oxygen saturation in patients who are experiencing respiratory depression, particularly if supplemental oxygen is being used – thus the value of using capnography to monitor CO2 ventilation.1

Continuous monitoring of oxygenation and ventilation are two key factors used to help identify respiratory compromise in its early stages. With Microstream™ technology, you can measure both, so you can focus on what you do best: help save lives.2-5 Microstream™ technology delivers—

Effective sampling from both nares and the mouth — even at low tidal volumes — with the Smart CapnoLine™ Plus sampling line with exclusive Uni-junction™ technology

etCO2 samples are unaffected by the presence of other gases (i.e., O2, N2O, He, or inhaled anesthetics) due to unique CO2-specific IR wavelength molecular correlation spectroscopy technology

Click here to see the advantages Microstream™ technology brings to capnography monitoring.

Best Clinical Usage

What is the target population for your equipment?

Microstream™ technology is designed for efficient use:

▪ Across the continuum of care

For both intubated and non-intubated patients

For virtually all patient populations – from neonate to adult

Is there a patient condition, clinical unit, or area that you believe that your device provides an earlier indication of patient deterioration vs. your competitors?

Respiratory compromise — incidents of respiratory insufficiency, failure, and arrest — is a genuine threat to patients and health systems.6 A 2016 analysis of 44,551 acute respiratory events revealed a mortality rate of 39.4%.6 Another analysis expects cases of respiratory compromise to increase 31% by 2019.7 Those trends must be reversed — and they can be. Because addressing respiratory compromise begins with detecting it. And that’s what capnography is engineered to help clinicians do.

Continuous monitoring of oxygenation and ventilation are two key factors used to identify respiratory compromise in its early stages. With Microstream™ technology, you can measure both, so you can focus on what you do best: help save lives.2-5

Microstream™ technology measures end-tidal CO2, respiration rate, and apnea more accurately and reliably than other technologies and sampling lines.8-10† That’s because it’s engineered to deliver9†:

Effective sampling from both nares and the mouth — even at low tidal volumes — with the Smart CapnoLine™ Plus sampling line with exclusive Uni-junction™ technology

Highly accurate etCO2 samples that are unaffected by the presence of other gases (i.e., O2, N2O, He, or inhaled anesthetics) due to unique CO2-specific IR wavelength molecular correlation spectroscopy technology

Click here to read the white paper on how accurate capnography is highly dependent on quality sampling lines.

Reducing Adverse Events and Patient Deaths

Have your customers experienced a reduction in serious adverse events (“near misses”) or patient deaths using your device? This may be evidenced by a reduction in use of naloxone, decreased transfers to the ICU, reduction in length of stay, etc.

Candler/St. Joe’s in Savannah, GA had a 100% reduction in adverse events with no events in 11+ years post-implementation (2012 data).11-12 Wesley Medical Center in Wichita, KS experienced a 31% rate of severe adverse events prior to Microstream™ monitoring. By year three post-implementation, Wesley experienced a 1.5% incidence rate.13-14 Bellin Hospital in Green Bay, WI experienced an 85% decrease in emergent Narcan administration.15

Watch a short video to learn what Dr. Maddox has to say about the economic impact of reducing adverse events. In the interview, Dr. Maddox explains that in five years, the facility experienced an internal rate of return of 83%, with a cost savings of $1.8 million over and above the cost of the capnography technology. And he feels capnography helped save lives.16

Patient Satisfaction

How is your device connected to the patient?

The etCO2 sampling line is connected to the Capnostream™ 20p bedside monitor or Capnostream™ 35 portable monitor. The sampling line is placed on the patient’s face with the nasal prongs gently placed in the patient’s nares, and the oral scoop is placed right over the

What patient feedback have you had regarding use of your device? Have there been any patient recommendations for improvement? Have these recommendations been included in your device design.

When the patient and their loved ones understand that capnography monitoring ensures their own safety when sedated, they are more likely to comply. Medtronic offers a plethora of patient education resources to help you ensure their safety. Visit www.VerifyEveryBreath.com or utilize the patient education flyer available in both English and Spanish. Click one of the below links to download your free copy today.

English

Spanish/Español

Alarm Fatigue

Does the monitor alarm at the bedside only or is it centrally monitored?

The Capnostream™ 20p bedside and Capnostream™ 35 portable monitors alarm at the bedside with many alarm settings for thresholds and delays that the institution can adjust to their specific needs. Both monitors offer connectivity to remote central monitoring solutions.

Have clinicians using your device experienced an increase in the number of alarms sounding? Identify the number or percentage of alarms in terms of criticality.

Due to the proliferation of monitors designed to provide clinicians with more physiologic information and improve patient safety, the number of alarms encountered by clinicians has risen proportionally. It is estimated that 85 to 99 percent of alarms do not require an intervention.17-18

Microstream™ technology features the Smart Capnography™ family of algorithms is designed to help you reduce nuisance alarms and focus on actionable alarms—

The Smart Alarm for Respiratory Analysis™ algorithm (SARA) is engineered to reduce insignificant or “nuisance” alarms by 55%.10

Smart Breath Detection™ (SBD) algorithm screens out low-amplitude “non-breath” etCO2 excursions (snoring, talking, etc.)

Nellcor™ SatSeconds alarm management calculates duration and severity of events to distinguish between minor desaturations and serious hypoxemia

What advice do you provide your customers to help distinguish between actionable and non-actionable alarms?

Medtronic offers strategies and solutions to help you focus on actionable alarms, optimize clinical workflow, and most importantly, ensure patient safety. There are three key steps to reduce alarm fatigue—

Step 1: Manage Default Alarms

The Joint Commission cited that common causes of alarms include setting the alarm thresholds “too tight,” and default alarms not adjusted to individual patient needs.17-18

Click here to download your free copy of the clinical white paper, “3 Steps to Reducing Alarm Fatigue and Improving Patient Safety.”

In 2015, AAMI released a compendium to help hospitals manage alarms. AAMI released a compendium to help hospitals manage alarms. To see their recommendations visit: http://s3.amazonaws.com/rdcms-aami/files/production/public/FileDownloads/HTSI/Alarms/Alarm_Compendium_2015.pdf

Step 2: Patient Education

Another cause of alarms is the patient removing a monitor sensor. Too often, patients aren’t properly instructed about why they are being monitored. Click here to view the Patient Education Website, www.VerifyEveryBreath.com.

Download your free Patient Education Flyer copy:

English

Spanish/Español

Step 3: Staff Education

A clear knowledge of the operation, alarm features, and limitations of monitors by the clinicians using the monitor is a key to assessing and understanding causes of alarms, and taking steps to reducing alarms. Medtronic offers comprehensive, free training to ensure your success.

Contact your local Medtronic representative today to learn more or to get started.

Interoperability – Does your device interface with other technologies, such as EHR or other monitoring devices?

Both the Capnostream™ 20p bedside monitor and Capnostream™ 35 portable monitor offer a connectivity options. Consult your institution’s EMR representative to find the best connectivity solution as the Capnostream™ monitors connect to most EMR systems.

Additionally, the Capnostream monitors provide connectivity with hospital data systems including the Vital Sync™ virtual patient monitoring platform. This solution permits regular, real-time transfer of data from the monitor to hospital patient data systems. It transfers the measurement data, instantaneous CO2, etCO2, FiCO2, respiratory rate, SpO2, and pulse.

There are many data infrastructure options. Consult your local representative to find the best connectivity solution as the Capnostream™ monitors connect to most systems.

A software solution, called Profox™* software, can be installed on your PC to download patient data from the Capnostream™ 20p bedside monitor and Capnostream™ 35 portable respiratory monitor, analyze and format the data, and produce a report tailored to your individual needs.

The combination of the Vital Sync™ virtual patient monitoring platform and Microstream™ capnography can help you:

Make timely, well-informed clinical decisions based on near real-time data at breath-to-breath, heartbeat-to-heartbeat resolution

▪ Implement and automate proven clinical protocols using CDS apps

View patient information remotely and receive updates and alerts on any web-enabled device

Learn more about the Vital Sync™ virtual patient monitoring platform.

Engineering/Design

Did the design of your device include input from human factors engineers, clinicians, or hospital biomedical department? If so, what was that input and how did it affect the marketed version of your device?

Yes, we put clinicians and patients at the forefront of product development. Our products and services are designed and validated to meet the highest standards possible. As a result, Microstream™ technology is reliable and easy to use.

Recalls

Have there been product recalls of this equipment? If yes, when, what were the key safety issues, and what was the resolution?

Yes. Date of letter: April 15, 2016; Description of letter: Class I Recall of Capnostream™ 20 and Capnostream™ 20p battery packs. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a voluntary recall for the battery pack used in Oridion labeled Capnostream™20 and Capnostream™20p patient monitors. The scope of this recall included battery packs that were manufactured between April 2014 and February 2016. The recall included battery packs shipped with the monitors and spare replacement parts purchased separate from the monitor. Customers were notified by letter. Customers were requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected devices. Replacement batteries are supplied to customers upon response to the recall letter. For additional information please see FDA website link: https://www.fda.gov/Safety/Recalls/default.htm

Training

What training, on-going staff education, equipment troubleshooting, and other assistance do you provide your customers to ensure their use of your device is kept up-to-date and state of the art in terms of high quality patient care delivery?

Our Microstream™ capnography solutions include the following at no additional charge:

Dedicated education

▪ In-service support

▪ Troubleshooting experts

Install Base

In North America, approximately how many patients are monitored each day using your monitoring equipment?

More than 80,000,000 patients have been safely monitored with Microstream™ technology.19

Equipment Usage

Approximately what are the percentages that your equipment is being used in:

a. ICU

b. PACU

c. Med-surg

d. Pediatrics

e. General care floor

f. Telemetry or step down units

g. During conscious sedation or MAC (Monitored Anesthesia Care)

h. In healthcare facilities other than at a hospital hospital (e.g. ambulatory surgical settings, surgical centers, outpatient clinics that provide endoscopy capabilities)

i. ______ (pls provide details)

Microstream™ capnography monitoring is engineered for accuracy and ease-of-use, across many areas of care. It offers clinicians real-time alerts to respiratory compromise, so they can intervene early and help save lives.

Equipment Costs (approximates are acceptable)

What is the cost per patient per day to monitor with your equipment? Is there a specific ICD 10 code or bundled payment code which applies to your device?

The average cost of a FilterLine™ sampling line is between $10 and $15 per patient.

Quality measures are becoming increasingly important as they become tied to potential payment models, and we know that patients may increasingly consult publicly available hospital quality information to decide where to pursue care.

Reimbursement Coding

Capnography devices are typically not separately reimbursed in a hospital setting under ICD-10-PCS; instead they are reimbursed under a bundled Diagnosis-Related Group (DRG) payment methodology. There may be some isolated cases when capnography is separately coded when performed outside the OR. For example, in the ICU the physician may assign a separate code when the physician personally interprets the values; it may be paid together with hospital and critical care codes. The CPT code is 94770. To learn more, click here to download the Advanced Monitoring Parameters Reimbursement Guide.

Quality Measures

The Centers for Medicare & Medicaid Services (CMS) implemented pay-for-reporting (P4R) and pay-for-performance (P4P) programs focused on the hospital inpatient and long-term care settings. CMS evaluates performance using quality measures.

There are three specific ways you may tie capnography to quality measures—

1. PSI #90: Composite Measure Patient Safety for Selected Indicators—This measure (may be most applicable to you) includes postoperative respiratory failure and pulmonary embolism. Capnography is recognized as the fastest method for detecting changes associated with ensuing respiratory failure. There are several composite measures included in PSI #90 as a weighted measure.

2. Patient Safety Indicator (PSI) #04: Death Rate Among Surgical Inpatients with Serious Treatable Complications—capnography may improve postoperative outcomes in situations that could have otherwise been fatal.

3. Ambulatory Surgical Center (ASC)- 4: Hospital Transfer Admission—capnography may be used to recognize changes in respiratory status and as an early indication of airway compromise.

Have your customers seen a return on their investment? (please specify parameters for measuring ROI)

We’re committed to partnering with you to overcome clinical and economic challenges. And part of that commitment includes industry-leading advancements like Microstream™ technology.

A 2016 analysis of 44,551 acute respiratory events revealed a mortality rate of 39.4%.6 Another analysis expects cases of respiratory compromise to increase 31% by 2019.7

A study concludes with the following mean costs of adverse respiratory events in procedural sedation20:

  • • Prolonged apnea: $394
  • • Mild desaturation: $463
  • • Severe desaturation: $529

Routine use of capnography monitoring may:

✓ Reduce the cost per gastrointestinal endoscopy procedure by $8520

✓ Generate an average annual cost avoidance of $304,23420

Help avoid a cost of around $53,502 per episode of respiratory failure, according to HealthGrades estimates.22

Capnography monitoring can help you continue to save lives and reduce costs by mitigating respiratory adverse events. 21

Read a White Paper about the Economic Value of Capnography.


† Based on a comparison between Smart CapnoLine™ Plus sampling line, Respironics, and Salter Labs sampling lines.

1 Safe use of opioids in hospitals.” The Joint Commission Sentinel Event Alert. Issue 49. 8 August 2012. The Joint Commission. https://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf. Accessed 06/06/2018.

2 Metzner J, Posner KL, Domino KB. The risk and safety of anesthesia at remote locations: the US closed claims analysis. Curr Opin Anaesthesiol. 2009;22(4):502–508.

3 Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011;106(5):632–642.

4 Patail B. Veterans Health Administration. In: Infusing Patients Safely: Priority Issues from the AAMI/FDA Infusion Device Summit. Oct. 5, 2010:12.

5 McCarter T, Shaik Z, Scarfo K, Thompson LJ. Capnography monitoring enhances safety of postoperative patient-controlled analgesia. Am Health Drug Benefits. 2008;1(5):28–35.

6 Andersen LW, Berg KM, Chase M., et al. Acute respiratory compromise on inpatient wards in the United States: Incidence, outcomes, and factors associated with in-hospital mortality. Resuscitation. 2016;105:123–129.

7 Agarwal SJ, Erslon MG, Bloom JD. Projected incidence and cost of respiratory failure, insufficiency and arrest in Medicare population, 2019. Abstract presented at: Academy Health Congress; June 2011; Seattle.

8 Maddox RR, Williams CK, Oglesby H, Butler B, Colclasure B. Clinical experience with patient-controlled analgesia using continuous respiratory monitoring and a smart infusion system. Am J Health Syst Pharm. 2006;63(2):157–164.

9 Colman Y, David U. Comparison of Capnography Filter Lines for Nose and Mouth Breathing of End Tidal Carbon Dioxide Sampling With and Without Supplemental Oxygen. STA Annual Meeting Abstracts; January 2009.

10 Hockman S, Glembot T, Niebel K. Comparison of capnography derived respiratory rate alarm frequency using the SARA algorithm versus an established non-adaptive respiratory rate alarm management algorithm in bariatric surgical patients. Resp Care. 2009 Open Forum Abstract; December 2009.

11 Danello SH, Maddox RR, Schaack GJ. Intraveneous infusion safety technology: return on investment. Hosp Pharm. 2009;44(8)680-687,6962.

12 Maddox R. Clinical Experience with Capnography Monitoring for PCA Patients. APSF Newsletter Winter 2012.

13 Fox D, Wencel M. Integral Role of Respiratory Therapists in a Comprehensive Pain Management Program using End Tidal CO2 Monitoring. 2011 AARC Congress. Respir Care. 2011;56:1636.

14 Fox D, AARC Webcast—etCO2 Monitoring: Riding the Wave, April 2013.

15 Weber P. High risk patient protocol: preventing respiratory complications. 2011 AARC Congress. Respir Care. 2011;56:1636.

16 Maddox R. Personal interview. http://www.rtmagazine.com/2012/07/respiratory-care-departments-take-a-lead-role-in-postoperative-monitoring/. Accessed 12/6/2017.

17 Graham KC, Cvach M. Monitor alarm fatigue: standardizing use of physiological monitors and decreasing nuisance alarms. Am J Crit Care. 2010;19(1):28-35.

18 The Joint Commission. Medical device alarm safety in hospitals. Sentinel Event Alert. April 8, 2013; issue 50. Available at: http://www.jointcommission.org/assets/1/18/SEA_50_alarms_4_5_13_FINAL1.PDF.

19 Based on Microstream™ Sampling Lines Sales Tracings from 1995 to 2017 Report. Analyzed 7 August 2017.

20 Saunders R, Erslon M, Vargo J. Modeling the costs and benefits of capnography monitoring during procedural sedation for gastrointestinal endoscopy. Endosc Int Open. 2016;4(3):E340–51.

21 Jopling M, Heard L, Kofol T, Warner E. Evaluating the cost-effectiveness of capnography monitoring in procedural sedation: a gastroenterology (GI) suite cost-avoidance model. Gastrointestinal Endoscopy. 2015;81(5S):AB193.

22Health Grades Patient Safety in American Hospitals Study. March 2011. Available at http://patientsafetymovement.org/wp-content/uploads/2016/02/Resources_Reports_Patient_Safety_in_American_Hospitals_Study.pdf.

This Guide is moderated by the Physician-Patient Alliance for Health & Safety. The statements and opinions expressed in this guide are solely those of the manufacturer’s representative and of any health experts cited. Such statements and opinions do not represent the opinion of the Physician-Patient Alliance for Health & Safety, its staff or its board of advisors.