Product safety is the leading concern for ventilation equipment manufacturers to address and will be one of the primary barriers to the respiratory ventilators and resuscitators market, which is expected to grow slowly to $1.2 billion by 2023, according to research and consulting firm GlobalData.
The company’s report states that safety is paramount, as in many cases the patient depends entirely on the ventilator or resuscitator for breathing. However, FDA figures showed that more than 1,700 adverse events and 15 recalls associated with ventilator and resuscitator use were reported from 2015 to 2016, with almost all flagship ventilators from leading companies featuring on the list. About a third of the adverse events indicated an alarm-related issue.
Tina Deng, GlobalData’s Analyst covering Medical Devices, explains: “Ventilation equipment is subject to a variety of problems, from software to hardware, associated with breathing circuits, control systems, monitors, alarms, and other components. Among all these malfunctions, alarm management is one of the most common safety concerns. Some alarm systems can be suppressed unintentionally, whereas others allow clinicians to disable all alarms including critical ones. Both cases are hazardous and can result in very serious harm.
“Key opinion leaders (KOLs) interviewed by GlobalData noted the importance of reliability, patient safety and comfort when making purchases of ventilation equipment, which indicates the areas of focus for players wishing to enter this device space.”
KOLs also noted that ventilator-associated pneumonia (VAP), the most common complication found with respiratory ventilators and resuscitators, is a major concern. To reduce VAP, infection control procedures in maintaining ventilators should be enhanced, while ventilators should monitor a patient’s changing situation and not prolong mechanical ventilation unnecessarily.
Deng continues: “Generally, prolonged periods of mechanical ventilation greatly increase a patient’s risk of acquiring VAP. Following a proper infection control process to maintain the ventilator, breathing circuit, and all associated equipment, can minimize patient risk. Non-nasal intubation and proper nutrition also reduce the rate of VAP.
“Enhanced safety features of the devices have achieved better safety, but there is room for improvement. Common problems, such as leakage and patient-ventilator asynchrony, can usually be avoided by using a well-designed ventilator and maintaining it correctly. Advanced ventilators are able to compensate for leakage by quantifying the leak, and improve patient-ventilator matches by measurements of the electrical activity of the diaphragm.”
Source: Global Data