GE HealthCare is correcting certain Carestation devices due to the risk that they may not provide effective ventilation when used in volume control ventilation mode, according to a medical device recall notice from the US Food and Drug Administration (FDA). 

In these systems, effective ventilation can be achieved in pressure control ventilation or pressure control ventilation volume guarantee modes—or with manual ventilation. 

If this issue occurs, GE HealthCare notes that it will be apparent to the Carestation user through observation and multiple alarms. The inflated bellows, visible through transparent glass, will stop moving, and an audible alarm and visual “Unable to Drive Bellows” message will alert the user. Additional alarms, including apnea, EtCO2 low, MVexp low, RR low, and TVexp low, will also alert the user to inadequate ventilation.

The use of the affected product may cause serious adverse health consequences, including failure of ventilation resulting in hypoxia and death.  

A spokesperson with GE HealthCare says the company is working with hospitals to address the issue and ensure continued device use. “Patient safety is our top priority. After identifying a potential issue with certain Carestation anesthesia delivery systems that may impact effective ventilation in one specific mode of ventilation, we are providing hospitals with instructions to follow to continue use of their devices,” the spokesperson says. “We will be correcting all impacted systems. There have been no reports of patient injury as a result of this potential issue.”

Intended use of the Carestation is to provide monitored anesthesia care, general inhalation anesthesia, and/or ventilatory support to a wide range of patients (neonatal, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics by a clinician qualified in the administration of general anesthesia.

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type.

The affected product names are Carestation 620/650/650c and 750/750c Anesthesia Systems. 

Customers in the US with questions about this recall should contact GE HealthCare Service at 1-800-437-1171.  

ID 249615353 © Thanee Hengpattanapong | Dreamstime.com

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The researchers found that Masimo Patient State Index (PSi), a SedLine parameter derived from electroencephalographic (EEG) data, was statistically significantly associated with dexmedetomidine dosage, and, along with another EEG metric, “better captured changes in brain state from dexmedetomidine and has potential to improve the monitoring of dexmedetomidine sedation.”

The researchers noted that while anesthesia induced with dexmedetomidine may more closely resemble natural sleep compared to other sedatives, which makes it particularly appropriate in procedures like DISE, its effects on the brain are inconsistent, which has limited its usage.

Better sedation assessment—an improved understanding of its impact and corresponding EEG changes—could help support more widespread adoption of the drug. The researchers sought to compare and evaluate several methods of assessing sedation in such a scenario. Regarding the choice of EEG markers, they noted that “Previous EEG markers, such as the bispectral index, have been unable to determine differences elicited with dexmedetomidine, thus motivating the discovery of novel EEG markers associated with changes in brain state seen with dexmedetomidine sedation.”

They enrolled 51 patients undergoing DISE, for the diagnosis and possible treatment of obstructive sleep apnea, who were sedated with dexmedetomidine and continuously monitored using Masimo SedLine. The concentration of the drug in their bloodstream was determined using a pharmacokinetic model. The concentration levels over time were recorded alongside the values derived from four methods of assessment, two metrics and two analyses: 1) the Richmond Agitation-Sedation Scale (RASS), 2) the SedLine Patient State Index (PSi), 3) spectral edge frequency (SEF95), the frequency below which 95% of total EEG power was contained, and 4) the correlation dimension (CD), a type of fractal dimension used to assess the complexity of a system. To evaluate the efficacy of these methods, the researchers compared them both against dexmedetomidine concentration and against each other.

Comparing the assessment methods to dexmedetomidine concentration, the researchers observed that RASS scores decreased with increasing dexmedetomidine concentration but noted that, “Overall, the RASS score was least able to capture the brain state changes seen with dexmedetomidine, suggesting other metrics for titrating dexmedetomidine sedation may be of greater value.” They found that PSi, SEF95, and CD all decreased statistically significantly with increasing dexmedetomidine concentration, “a clear dose-dependent decrease with an inflection point.”

Comparing the methods to each other, they found that PSi, SEF95, and CD all decreased statistically significantly with decreasing RASS score, most notably at deeper levels of sedation, suggesting that this is when they may be most beneficial.

The researchers conclude, “Complex EEG metrics such as PSi and CD, as compared to RASS score and SEF95, better capture changes in brain state from dexmedetomidine and have potential to improve the monitoring of dexmedetomidine sedation.”

Study lead authors Lichy Han, MD, PhD and David Drover, MD, Perioperative and Pain Medicine at Stanford University, commented, “This study provides one more step in the journey to understanding SedLine processed EEG parameters that can guide sedation levels. This work helps clinicians use SedLine as an objective measure reflecting how the brain is responding to this important sedative, dexmedetomidine.”

Through the combination, SunMed aims to create a leading manufacturer wholly dedicated to airway management and operative care with a more comprehensive offering for practitioners, serving as a one-stop source for the highest-quality consumable respiratory and anesthesia medical products that support the best outcomes for patients. 

The respiratory and anesthesia consumables business of Vyaire, which Vyaire purchased from Becton Dickinson in 2018, encompasses leading airway management and operative care technology, including AirLife oxygen therapy and VitalSigns anesthesia circuits.

Terms of the SunMed acquisition of the Vyaire business unit were not disclosed.

“We are pleased to officially welcome Vyaire’s respiratory and anesthesia consumables team into the SunMed family and are excited by the promising opportunities created by the joining of two great businesses,” says Hank Struik, CEO of SunMed. “As we bring our people together, we are confident in the highly complementary nature of our platforms and in our ability to strengthen our manufacturing capabilities and ensure our customers reliable and predictable supply of the most trusted respiratory and anesthesia consumables. Together, we will be even better positioned to drive innovation, using our combined expertise and industry-leading engineering capabilities. Our mission will continue to be focused on improving quality of life and setting the standard of care.”

Major players operating in the market are focusing on adopting growth strategies such as product awareness, which is expected to drive the global anesthesia market growth over the forecast period. For example, on Jan. 24, 2022, GE Healthcare demonstrated its products and solutions at the Arab Health 2022 held at the Dubai World Trade Centre.

Increasing product approval from the U.S. FDA is also expected to boost the growth of global anesthesia device market over the forecast period. For instance, on July 27, 2022, Ambu Inc., a medical device company, announced that Ambu aScopeTM 5 Broncho, a family of single-use, sterile bronchoscopes, received 510(k) regulatory clearance from the U.S. FDA.

Industry professionals are also focused on growth strategies, like product launches of key market players of anesthesia devices. This in turn is expected to drive growth of the global anesthesia device market. As another example, on Feb. 16, 2022, Mindray, a global developer, manufacturer, and supplier of medical devices, announced the launch of a new platform that elevates traditional anesthesia in the Perioperative Environment, the A8 and A9 Anesthesia Workstations.

Regarding product types in this space, the Anesthesia machine segment is expected to dominate the market. For example, in December 2021, MDoloris Medical Systems, a global company of objective analgesia/nociception monitoring during anesthesia and in intensive care, and Mindray, a global company in developing and providing advanced medical devices and solutions, announce the CE Mark and upcoming launch of the Mdoloris ANI-MR module, which is developed to help clinicians effectively measure the analgesia nociception level and show on the digital display.

Among regions, North America is expected to hold a dominant position in the global anesthesia devices market over the forecast period, owing to increasing number of growth strategies by key market players in the region.

Key players operating in the global anesthesia devices market include GE Healthcare, Spacelabs Healthcare., Septodont Inc, Draegerwerk AG & Co. KGaA, Beijing Aeonmed Co., Ltd., HEYER Medical AG, ORICARE, Inc., Philips Healthcare, Becton Dickinson and Company,  Getinge AB., 3M, General Electric, SunMed, Teleflex Incorporated and Ambu A/S.

The Getinge Flow-c and Flow-e anesthesia systems are intended to provide inhalation anesthesia and control the ventilation of patients who have no ability to breathe. These systems can also support the breathing of people with limited ability to do so themselves. It is used for patients ranging in age from newborns to adults and operated by trained anesthesiologists in hospital setting

If the on/off switch breaks, the suction unit will not work to remove fluids such as phlegm, blood, or stomach content from the patient’s mouth and/or airways. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

This issue could cause a delay during a procedure or in between procedures if the anesthesiologist needs to find another way to suction fluids. Additionally, if the suction device is not working for a longer period of time, these fluids could block a patient’s breathing. The risks of such a blockage may include:

• Choking;
• Inability of oxygen to get into the blood;
• An infection in the lungs that prevents oxygen from getting to the blood;
• Brain injury caused by lack of oxygen to the brain;
• Death

There have been 21 complaints, no injuries and no deaths associated with the use of this device. Roughly 64 devices that were distributed between June 2, 2020 to Feb. 15, 2022 have been recalled.

“Premier awarding Getinge this contract is an important milestone for our anesthesia product line. This is the first time we are able to provide Premier members access to Flow Family Anesthesia machines at a contract rate,” says Patricia Fitch, president, North America, following the awarded contract.

Getinge’s Flow family technology provides personalized anesthesia to cover the needs of all types of surgeries and patients. Premier is a healthcare improvement company uniting an alliance of approximately 4,400 U.S. hospitals and health systems and more than 225,000 other providers and organizations.

Getinge worked closely with clinicians to develop these anesthesia machines designed to facilitate personalization with patient safety in mind. With an intuitive interface, emphasis on ease of use, smart design, and a high level of automation, the Flow Family brings personalized anesthesia delivery and smooth workflow to the operating room. 

“Easier access to Flow Family Anesthesia machines means that Premier members benefit from our innovative technology while providing personalized anesthesia to all their patients, but especially to their most challenging patients, neonates and the morbidly obese,” says Fitch.

Every detail of the machines has been meticulously designed to help ensure optimal care with high efficiency. The Flow-e and Flow-c come equipped with the MAC Brain indicator. This unique technology visualizes the difference in agent concentration between the lungs and target organ, the brain.² The reliability of the data places anesthesiologists in control, allowing planning and delivery of more efficient agent dosing.

All models in Getinge’s Flow Family include O₂Guard, the world’s first active hypoxia prevention system.^3,4 O₂Guard automatically overrules the settings and increases the flow of oxygen if the inspired oxygen level drops below 21%, minimizing the risk of hypoxia in challenging patient types.⁴ These innovations provide a smart workspace that makes work more manageable in the busy OR environment.  

Read more about Getinge’s Flow-e and Flow-c anesthesia machines.

References

• Above 1 year of age – see indications for use
• Hendrickx JFA, De Wolf AM, De Hert S. O2, anybody? Eur J Anaesthesiol. 2015 Jun;32(6):371-3.
• Hypoxic guard systems – how safe are they? An interview with Dr Jan Hendrickx, Aalst Belgium, MX-6295, Rev03.
• De Cooman, S, Schollaert C, Hendrickx JFA, et al. Hypoxic guard systems do not prevent rapid hypoxic inspired mixture formation. J Clin Monit Comput. 2015 Aug;29(4):491-7.

“SuperNO2VA Et brings a new standard to the way surgeries can be performed for patients,” says Steven H. Cataldo, MD, director of anesthesiology at CareMount Medical and director of anesthesia services at Yorktown Center for Specialty Surgery in New York. “With this technology, we are able to rethink how and where we operate, with decreased risks, procedure times, and associated costs. Even high-risk patients can have reduced recovery times, providing them a safer and better overall care experience.”

The mask is designed to maintain airway patency while delivering precise and consistent oxygenation to patients during deep sedation procedures, which helps reduce hypoxemia and hypoventilation. SuperNO2VA Et provides continuous patient oxygenation before, during, and after surgery, which allows more patients to have procedures under sedation.

“At Vyaire, we are committed to imagining new possibilities in the ways we can support breathing,” says Gaurav Agarwal, CEO of Vyaire. “SuperNO2VA Et does just that by removing some of the tangible risks of deep sedation through proprietary airway management technology and real-time clinical measurements to reduce complications. Through this innovation, we envision reducing the need for general anesthesia and the associated complications, including extended procedure times, hospital stays, and their burdens on healthcare systems.”

SuperNO2VA Et reduces hypoxemia by 75% and airway intervention by 65% compared to the current standard of care.[1,2] It also allows for effective pre-oxygenation and rescue ventilation without the need for additional equipment. The mask eliminates the use and associated costs of a separate mask, endotracheal tube, laryngoscope, and intubation, according to the company.

“As the company inspired and empowered to elevate the quality of breathing, SuperNO2VA Et is an obvious yet critical piece of our innovation strategy and evolution,” Agarwal says. “We will continue to bring new-to-world technology to market to advance breathing solutions on behalf of customers and patients.”

References

1. Bai Y., Xu Z., Chandrashekar M., et al. Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial. Eur J Anaesthesiol. 2019;36(9):633-640.
2. Dimou F., Huynh S., Dakin G., et al. Nasal positive pressure with the SuperNO2VA Et device decreases sedation-related hypoxemia during pre-bariatric surgery EGD. Surg Endosc. 2019;33(11):3828-3832.

Within the last year, Medovate has achieved CE mark regulatory approval covering five devices in its SAFIRA range: an infusion driver, a foot pedal, a luer syringe, the NRFit syringe, and a palm operator. These latest product range additions are intended to further improve patient safety and offer greater control to anaesthetists.

The NRFit syringe provides a second option to the universal Luer connection syringes with which the system was originally introduced. It is recognized that Luer connectors carry the potential for medical tubing misconnections, which can lead to incidences of wrong route administration of medicines and gases. The UK-based National Health Service issued a Patient Safety Alert in 2019 to recommend and support the safe transition from the Luer connector to NRFit for the delivery of regional anaesthesia.

With the provision of a new palm operator, Medovate hopes to offer anaesthetists more versatility and choice, company officials say. The palm operator uses the same colour coding as the original foot pedal operator, which remains a key part of the product range for the infusion and aspiration of anaesthetics. The palm operator is ergonomically designed to fit under a surgical glove, within the palm of a hand. The addition of a hand operator product to the SAFIRA range offers regional anaesthetists’ greater choice when using SAFIRA.

According to Medovate’s technology director of Alan Finnerty, “Medovate is dedicated to improving patient care. The extension of our CE certification to include these new devices is a significant milestone for the company, and testimony to the focus and commitment of the team. It also consolidates our unique offering to patients and anaesthetists across the globe, with safety remaining a top priority.”

So far, SAFIRA has been launched in the United States, Australia, and New Zealand. And, in June, it became available across Europe via Medovate’s distributor partner Vygon with both syringe options, Luer and the new NRFit. Further regulatory approvals for the palm operator are expected throughout 2021, which will enable the full SAFIRA product range to be made available in the United States and additional key markets as further distributors are appointed.

The partnership will highlight the provision of Ultrasound Guided Regional Anesthesia and how the SAFIRA (SAFer Injection for Regional Anesthesia) can be used in conjunction with Konica Minolta Healthcare Americas’ range of ultrasound solutions. 

SAFIRA is a Class II medical device set to transform regional anesthesia around the world by making it a one-person procedure. It puts control of the injection in the hands of the anesthesiologist freeing up their assistants to carry out other tasks. The device also helps to improve patient safety by reducing the risk of nerve damage as it prevents injection above 20psi. 

The introduction of ultrasound guidance in regional anesthesia was first explored by anesthesiologists in the mid-1990s and since then technology advancements have led to an increase in ultrasound by anesthesiologists.

Ultrasound guidance offers a range of important practical advantages for nerve blockade such as visualization of the anatomy and more informed guidance for the needle pathway avoiding structures that might be damaged by the needle. It also reduces the likelihood of inadvertent needle trauma to unintended structures and ensures the continued visualization of the local anesthetic solution. Together, the two technologies present a best practice solution in delivering regional anesthesia.

“We are excited to be partnering with Konica Minolta Healthcare Americas, a world leader in ultrasound technology,” says Chris Rogers, sales and marketing director at Medovate. “The company has a strong focus on creating value through innovation—an ethos that fits with Medovate’s core focus on realising the benefits of clinician-led innovation. We are looking forward to raising awareness of ultrasound guided techniques for regional anesthesia.”

Recent publications, including a joint statement by the American Society of Regional Anesthesia and Pain Management (ASRA) and the European Society of Regional Anaesthesia and Pain Therapy (ESRA), have recommended regional anesthesia be considered whenever surgery is planned for a suspected or confirmed COVID-19 patient. This is because it preserves respiratory function and avoids aerosolization and the potential for transmission of COVID-19 compared to general anesthesia. 

“Medovate brings a unique combination of clinical innovation and expertise through its association with the United Kingdom’s National Health Service and we are proud to partner with them to advance regional anesthesia,” says Eric Sumner, executive vice president Ultrasound Sales at Konica Minolta. “Our companies have a shared vision to promote safer solutions that deliver clinical efficiency, simplify use and advance better outcomes for patients.”

Featured image: Medovate SAFIRA (Courtesy: Medovate)

Mindray’s new anesthesia systems empower anesthesiologists to ensure comprehensive patient safety throughout the perioperative period, from induction to recovery. Using High Flow Nasal Cannula oxygen (HFNC), Mindray’s new systems extend safe apnoeic time from 8 minutes to up to 30 minutes to help clinicians intubate more easily.

The A9 and A8 machines also integrate Automatic Controlled Anesthesia (ACA), a pioneering assistive technology that automatically adjusts fresh gas and vaporizer output to quickly achieve preset target end-tidal agent and inspiratory oxygen concentration, ensuring accurate and stable levels of anesthesia. The technology also helps cut down on workload for clinicians; while reducing cost by minimizing the consumption of gas and agents used throughout the case.

Committed to improving safety, Mindray’s new systems feature ICU-quality ventilation technologies to protect a patient’s respiratory system throughout the perioperative period. Both systems have integrated a Volume Exchanger, an innovative system that delivers precise and reliable ventilation to patients with rapid wash-in and wash-out time. Additionally, Mindray has incorporated powerful protective ventilation toolkits to reduce the incidence of post-operative complications, such as transpulmonary pressure monitoring.

Furthermore, to create a greener operating room, the A9 employs anesthetic gas reduction strategies during surgery. Clinical decision-support tools, such as the Optimizer, AA measurement, and AA prediction, help advise clinicians of the most efficient gas flow to reduce waste. It also features an e-AGSS system that monitors the waste gas scavenging flow rate and indicates anomalies – plus switches off in standby to reduce energy consumption.

Designed with deep insights into the clinical workflow of the operating room, the intuitive user interfaces eases the workload of busy and stressed anesthesiologists. An 18.5-inch capacitive touchscreen with 360-degree rotation provides intuitive interface and up to 10 customizable profiles for different clinical scenarios or use requirements. Automated pre-use system check helps ensure proper functioning with a graphic display of errors, and it can be scheduled any time as needed.

In addition, the machines can be physically connected to many other Mindray devices as a highly integrated anesthesia workstation. It can also seamlessly connect to multiple hospital information systems using Mindray’s flexible integration solution, so caregivers can check on a patient’s status anywhere, anytime.

For more information, visit Mindray.

Featured image: Mindray brings new A9 and A8 anesthesia systems to the high-end anesthesia machine market. (courtesy of Mindray)