Better products, better breathing

Nov. 20, 2017

When Brad Bullen, Global Sales Product Line Manager, Core Products, Nova Biomedical, began his respiratory care career working in hospitals, he said blood gas analyzers — devices that measure the blood’s oxygen and carbon dioxide levels and other components — were often housed in a facility’s laboratory where the staff was capable of addressing complexity and compliance issues. Responsibilities would also vary depending on a hospital’s size and location. When employed by a small, New England provider, he said maintenance and quality control (QC) activities were the responsibility of those working in the respiratory care department, which was time-consuming and burdensome.

Brad Bullen

“This would often take two to three hours per day if the analyzer was behaving,” recalled Bullen. “If QC failed or a parameter was uncalibrated, this required additional time away from the bedside or more importantly a delay in critical analysis. Working as a therapist, I understood the need for quality control but it was something I disliked executing because of the time involved. This seemed outside of my typical clinician responsibilities and was something I executed begrudgingly.”

Today’s respiratory technologies — blood gas analyzers, ventilators, nebulizers, scopes, monitoring devices and other equipment and supplies — provide clinicians with advanced alternatives that are a lot smarter, safer and more intuitive than their predecessors.

“In this day and age when practitioners are constantly being asked to do more with less, industry needs to step up with technology that makes that possible,” Bullen said.

Acing the analysis

Nova Biomedical’s STAT Profile Prime blood gas analyzer, developed by respiratory therapists, addresses the common pain points that end users would experience.

“Analyzer downtime was at the top of our list and something I experienced nearly every day when working clinically,” said Bullen. “The Prime design incorporates a unique component cartridge design. We have separated our consumables into our MicroSensor Card, and Calibrator and QC Cartridges. This allows the clinician to optimize the value/life of each of the consumables minimizing waste and maximizing value. Cartridge based systems that have little to no maintenance allow clinicians to focus on what we are passionate about — patient care.”

The built-in Clot Block technology also cuts costs and increases caregiver efficiency since there is no need to change out paks/consumables, a requirement of some analyzers. “This is not only expensive but this action will often require significant downtime associated with hydration and calibration of the new consumable. When a clot is introduced into the Prime it is a 30 second back flush, short calibration and the analyzer is up and running at full capacity.”

STAT Profile Prime blood gas analyzer from Nova Biomedical

The QC process is also fully-automated and compliant with current regulatory guidelines, which were updated in 2016. “To meet these guidelines Prime incorporated what is called TQM or Total Quality Management. TQM offers clinicians a hands-off approach to QC. This incorporates automated liquid quality control which is analyzed at set frequencies depending on the hospital and SQM (Supplemental Quality Monitoring) which monitors the status of all analytical components providing sample-to-sample accuracy between QC intervals,” explained Bullen, noting that it also comes with a comprehensive encrypted data connectivity solution at no additional cost.

“The STAT Profile Prime and its unique design has brought to market an incredibly simplistic analyzer that is both cost effective as well as easy to use,” said Bullen.

The switch to single-use

As they become available, providers are embracing single-use devices and making them a staple for performing a variety of surgical and diagnostic procedures. This seems logical considering the many advantages they offer compared to reusables, especially flexible scopes, which are complicated, time-consuming and expensive to reprocess.

“As far as bronchoscopes are concerned, risk of cross-contamination and lack of availability are the two biggest issues facing respiratory [clinicians] and the patients they care for,” said Jason Cronwall, Senior Market Manager, Ambu. “Published studies demonstrate the risk of cross-contamination [when using a reusable bronchoscope] is from 0.6 percent to 4.6 percent. The aScope 3 single-use bronchoscopes are sterile, thereby eliminating any risk of cross-contamination and infection. Also, they are immediately available when clinicians want to care for the patient rather than when a reusable bronchoscope becomes available.”

The single-use aScope 3 by Ambu

Cronwall says more than 1,500 hospitals in the U.S. have adopted the technology, which one study shows has a 0 percent risk of causing infection,1 for regular use in intensive care units, operating rooms and emergency departments. “By implementing aScope these facilities have eliminated bronchoscope reprocessing costs, eliminated the risk of infection by bronchoscope cross-contamination, eliminated the capital purchase and repair costs for reusable bronchoscopes, and provided clinicians with a readily available bronchoscope to bronch patients when they need it rather than when the scope has been reprocessed and prepared for use.”

In late October, another single-use respiratory product hit the scene: Inscope Direct, the first disposable laryngoscope by Inscope Medical Solutions with integrated, controllable suction to clear away secretions and provide a clear and steady view of the airway during trauma intubation. The tool eliminates the need for a yankauer suction catheter, has a built-in LED light source, connects to standard suction tubing, is compatible with wall suction and powered portable suction, and has a MAC 3.5 blade size that fits most adults.

Inscope Direct disposable laryngoscope by Inscope Medical Solutions

“Inscope Direct was born out of a real-life need following an incident where a founding physician had to treat a patient with life-threatening injuries, but struggled through the intubation process by juggling multiple pieces of equipment to clear the airway and pass the breathing tube,” said Inscope Medical Solutions Co-founder and CEO Maggie Galloway. “Every second is critical in emergency situations, and we knew there just had to be a better way.”

Protecting ventilated patients

For adult patients who are ventilator-dependent, the ThermoFlo HN, a heat and moisture exchanger (HME) from Arc Medical, Inc. is a safer, more efficient and cost-effective delivery system compared to heated humidifiers, says the company’s President Hal Norris.

Regardless of which delivery system one chooses, they should be able to provide a minimum of 30 mg H2O/L of delivered gas at 30°C, according to Clinical Practice Guidelines from the American Association for Respiratory Care (HMV 2.0). “ThermoFlo HN delivers the minimum even at high-minute ventilation,” said Norris. And according to current infection control guidelines, condensation from the patient circuit should be considered infectious waste and disposed of according to hospital policy using strict Universal Precautions, a process that clinicians needn’t worry about when using the Arc device. “Using ThermoFlo HN, the circuit is dry and poses no risk to the staff,” Norris added.

ThermoFlo HN from Arc Medical, Inc.

In addition to being guideline-compliant, the product promotes greater efficiency, safety and savings. “Nebulization can be completed without removing the HN device; it is not necessary for the RCP to return to work with the device after the neb treatment has begun,” said Norris. “The device allows for therapeutic levels of drugs to pass through while continuing to humidify the patient. There is no disconnection and no twisting the device from HME to Aerosol. The patient is only disconnected once per day to change HN.”

The ThermoFlo HN can also reduce use of heated water bath systems significantly. “Heated humidification uses water that is expensive and heavy to ship. HN provides humidification to more than 95 percent of all adult ventilator dependent patients from intubation to extubation. Daily cost for using HN is less than $3.00 per day. Daily cost for heated humidification ranges from $7.00 to more than $10.00 per day.”

And they’re dependable. “The FDA MAUDE [Manufacturer and User Facility Device] database for heated humidifiers shows more than 500 malfunctions reported annually,” said Norris. “Our entire line of HME devices has had only two in 10 years.”

Carlos A. Urrea, MD, MPH, Vice President, Medical Affairs, Hill-Rom Corp., noted that more than one million patients suffer respiratory complications after surgery, with atelectasis — lung collapse — the most common.

“This is because general anesthesia and mechanical ventilation impair pulmonary function. In addition, breathing may be impacted by the patients’ pain or if they experience a lot of secretion in the lungs,” Urrea said. “Advancement of medical knowledge to identify and address these complications is constantly evolving. The challenge has been that traditional therapies for atelectasis depend on patients’ ability to inhale and exhale, and the effort required to do so may be more than what a post-surgical patient can accomplish. Therapies intended to expand the lungs and help remove secretions have proven effective for these conditions. Evidence shows that such techniques may hold the key to the reduction of post-surgical pulmonary complications, in some cases by as much as 50 percent. Such therapies can take place immediately following surgery.”

Hill-Rom Corp.’s MetaNeb System

Hill-Rom’s MetaNeb System expands the lungs by alternating cycles of continuous positive expiratory pressure (CPEP) and continuous high frequency oscillation (CHFO) combined with aerosol delivery. “First, CPEP works to expand the lungs; then, CHFO therapy mobilizes retained secretions in the patient,” Urrea explained. “The cycles are alternated and repeated twice over a period of ten minutes.”

The MetaNeb System also integrates well with concomitant therapies, delivers three different therapies for mechanically ventilated or non-ventilated patients. It acts as a nebulizer if needed and is able to provide supplemental oxygen when used with compressed oxygen.

“The MetaNeb System can treat — and in some cases, prevent — complications through consistent lung expansion, secretion clearance and aerosol delivery,” Urrea said, noting that facilities looking for a good ROI (and who isn’t) should consider the long term benefits. “Implementation of the MetaNeb System carries an upfront investment that may give healthcare administrators pause; but data2 shows that such an investment may be offset by lower costs for respiratory therapist time per patient, which may result in comparable or even lowered expenditures for both therapies.”

All circuits are closed

Ventilated patients, particularly those who are intubated more than 48 hours, are at increased risk of developing ventilator-associated pneumonia, a hospital-acquired condition that puts hospitals at risk too – financial risk and poor patient satisfaction scores. Considering that VAP rates remain unchanged, perhaps there’s a need to underscore the importance of best practices and products designed specifically for lowering risk.

The HALYARD Health Turbo-Cleaning Closed Suction System

“To help protect patients and caregivers, a closed ventilator circuit is often recognized as a best practice in the prevention of VAP,” said Jamie Handler, Director of Marketing, North American Core Devices, Halyard Health. “The HALYARD Turbo-Cleaning Closed Suction System, which features technology from BALLARD trach care, is the only catheter that retracts within a unique, isolated and vacuum-sealed turbulent cleaning chamber, reducing potential for bacterial colonization within the circuit and helping to reduce the risk of VAP in ventilated patients. Compared to standard closed suction systems, the Turbo-Cleaning Closed Suction System’s turbulent cleansing action results in an 89 percent cleaner catheter tip, which may help reduce the risk of VAP. Additional features to reduce the risk for contamination and protect caregivers from exposure to bodily fluids include a one-way lavage port, designed to prevent ‘sprayback’ and a hinged valve to isolate the catheter tip and help prevent inadvertent lavage.”

Helping babies breathe better

Neonatal ventilation has evolved considerably as well, says Ed Coombs, Director of Marketing, Intensive Care, Draeger, particularly when it comes to monitoring tidal volume accurately and compensating for airway leakages.

Draeger Evita Infinity V500 ventilator

“Today, technology has improved to allow for a volume-guarantee approach which has improved patient outcomes in terms of more stable CO2 values, less IVH, and less incidence of lung injury,” said Coombs. The Draeger Evita Infinity V500 ventilator incorporates closed-loop technology systems such as SmartCare/PS and APRV with AutoRelease. SmartCare has been shown to reduce the length of stay on a ventilator and overall time in the ICU. APRV with the AutoRelease feature can track and correlate settings based on the patient’s individual needs.

“The prioritized alarm system reduces nuisance alarms and provides for early warning messages to clinicians alerting them to acute changes in the patient,” Coombs continued. “These unique features provide for a safer environment for the ICU patient and helps streamline the work of respiratory therapists and nurses.”

Additional features of the Evita Infinity V500, also available for adult and pediatric patients, include comprehensive data points that can integrate with most commercially available EMRs and a secure biomed web-connection for troubleshooting, repair and maintenance.

Timely detection of respiratory depression

Opioid-related injuries and deaths are causing a national stir not only in America’s neighborhoods but in our healthcare institutions. Post-surgical patients have the highest risk of suffering opioid-induced respiratory depression (OIRD). “Post-operative patients at risk for obstructive or central sleep apnea are particularly vulnerable to undetected respiratory depression,” said John Zaleski, PhD, CAP, CPHIMS, Chief Analytics Officer, Bernoulli.

Tens of thousands of OIRD events occur annually with billions of dollars lost on a problem that could be addressed successfully if effective surveillance technology is used, according to Zaleski and published research.

“Current practices for monitoring patients receiving opioids are neither adequate nor comprehensive for early intervention,” Zaleski asserted. “The most common practices include visual spot checks by clinical staff and responding to alarms by physiologic devices. Clinicians won’t always be present when respiratory depression occurs. Pulse oximeters and capnographs are often set to pre-determined thresholds, which can cause false alarms. In truth, spot checks can leave patients unmonitored 96 percent of the time, leaving them vulnerable to advanced deterioration. In addition, neither method consistently identifies gradual deterioration; only that respiratory depression is already in progress.”

Bernoulli’s Respiratory Depression Safety Surveillance technology

Earlier this year, Bernoulli rolled out the Bernoulli Respiratory Depression Safety Surveillance (RDSS), a solution they say can attenuate those problems. Specific features include:

  • Connectivity to the hospital’s existing fleet of pulse oximeters and capnographs from a wide range of vendors including Medtronic, Masimo and others
  • Remote, centralized, continuous monitoring of patients at risk of respiratory depression, helping clinicians to quickly recognize respiratory distress and respond to signs of patient deterioration
  • Comprehensive real-time data to provide active patient monitoring, eliminating the exclusive reliance on individual device alarms to inform clinicians regarding the patient’s condition
  • Bernoulli’s exclusive RDSS analytics with multi-variable thresholds—adjustable by the hospital—to identify, clinically actionable events while significantly reducing the overall number of alarms communicated to clinicians, which can result in the risk of alarm fatigue.
  • Integration with mobile clinical communication tools to deliver the right alarms and alerts to the right nurse, respiratory therapist or care team member at the right time.

References

  1. (C.J. Terhesen J. Kovaleva L. Ehlers “Early Assessment of the Likely Cost Effectiveness of Single-Use Flexible Video Bronchoscopes” PharmacoEconomics Open (2017) 1: 133. doi:10.1007/s41669-017-0012-9).
  2. Contact Hill-Rom for data.
About the Author

Valerie J. Dimond | Managing Editor

Valerie J. Dimond was previously Managing Editor of Healthcare Purchasing News.