Device Requirements

RequirementSpecificationsJustification
1. The device must be able to measure the pressure applied by the mask onto the nose bridge, cheeks, and chin.1.1. Measure pressure on nose bridge, cheeks, and chin at 10-100 mmHg.8,9 
1.2. Pressure measurements above 95% accuracy.
This range describes pressures applied to nose bridge, cheeks, and chin, which  are most susceptible to pressure ulcers.5 Above 95% accuracy provides a proper confidence interval for medical devices.10
2. The device must actively adjust in response to detected pressure that exceeds safe time frames.2.1. Adjustments must be initiated when pressure exceeds 30 mm Hg for longer than an hour.11,12,13
2.2. Adjustment will be terminated when pressure is reduced to 25 mmHg.
Blood vessels become occluded when applied pressure exceeds capillary pressure for prolonged periods of time.11 This causes ischemia which leads to the formation of ulcers.
3. The device must allow for normal airflow functionality of the noninvasive ventilation mask.3.1. The pressure between the device and skin interface must be 1.5 mmHg greater than the patient’s peak inspiratory airway pressure.A pressure range that is 1.5-2.5 mmHg greater than peak inspiratory airway pressure is enough to prevent extensive air leaks that could interfere with desired airflow.14 BiPAP circuits typically deliver an inspiratory airway pressure of 5-20 mmHg.15
4. The wearable components of the device must be lightweight. 4.1. The weight of the wearable components of the device must not exceed 1 ounce in addition to the existing mask.Heavy masks may negatively impact patient compliance when used in a home setting.16 The weight of the mask must not cause additional and excessive pressure on a patient’s face, as current masks are 3-4.5 ounces.
5. The device must be powered for a clinically relevant period of time.5.1. The device must be powered for 8 hours of passive pressure sensing and active adjustments.Most long term therapies last anywhere between 6-8 hours, across treatments in the hospital or for at home use.5 Thus, the active and passive components must be powered for 8 hours.
6. The noise generated by the device must not impact a patient’s quality of sleep.6.1. Noise generated by device should be less than 40 dB.17Exceeding this decibel threshold can result in sleep disturbances. Quiet noises would positively impact patient compliance, avoid potential damage to patient’s hearing, and prevent sleep disruption.
7. The device must be able to be disinfected between patient uses.7.1. The device must follow the disinfection guidelines of ISO 17664-1.Noninvasive ventilation devices are disinfected during repeated use by the same patient.18 Thus, following the current cleaning procedures, the device can be properly disinfected.
8. The device must adhere to electrical safety standards.8.1. The device must follow the guidelines of IEC 60601-1-12.Electrical components of the device integrated into the mask must be safe for use on the patients face while promoting safety during exposure to high voltage sources.
References
[1] Mansukhani, M. P., Kolla, B. P., Olson, E. J., Ramar, K., & Morgenthaler, T. I. (2014). Bilevel positive airway pressure for obstructive sleep apnea. Expert review of medical devices, 11(3), 283–294. https://doi.org/10.1586/17434440.2014.900435 
[2] Hore C. T. (2002). Non-invasive positive pressure ventilation in patients with acute respiratory failure. Emergency medicine (Fremantle, W.A.), 14(3), 281–295. https://doi.org/10.1046/j.1442-2026.2002.00346.x 
[3] Belchior, I., Gonçalves, M. R., & Winck, J. C. (2012). Continuous noninvasive ventilation delivered by a novel total face mask: a case series report. Respiratory care, 57(3), 449–453. https://doi.org/10.4187/respcare.01275 
[4] Gong Y, Sankari A. Noninvasive Ventilation. [Updated 2022 Dec 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK578188/ 
[5] Ahmad, Z., Venus, M., Kisku, W., & Rayatt, S. S. (2013). A case series of skin necrosis following use of non invasive ventilation pressure masks. International wound journal, 10(1), 87–90. https://doi.org/10.1111/j.1742-481X.2012.00948.x 
[6] Worsley, P. R., Prudden, G., Gower, G., & Bader, D. L. (2016). Investigating the effects of strap tension during non-invasive ventilation mask application: a combined biomechanical and biomarker approach. Medical devices (Auckland, N.Z.), 9, 409–417. https://doi.org/10.2147/MDER.S121712 
[7] McCoskey L. (2008). Nursing Care Guidelines for prevention of nasal breakdown in neonates receiving nasal CPAP. Advances in neonatal care : official journal of the National Association of Neonatal Nurses, 8(2), 116–124. https://doi.org/10.1097/01.ANC.0000317260.99072.ae
[8] Brill, A. K., Pickersgill, R., Moghal, M., Morrell, M. J., & Simonds, A. K. (2018). Mask pressure effects on the nasal bridge during short-term noninvasive ventilation. ERJ open research, 4(2), 00168-2017. https://doi.org/10.1183/23120541.00168-2017 
[9] Munckton, K., Ho, K. M., Dobb, G. J., Das-Gupta, M., & Webb, S. A. (2007). The pressure effects of facemasks during noninvasive ventilation: a volunteer study. Anaesthesia, 62(11), 1126–1131. https://doi.org/10.1111/j.1365-2044.2007.05190.x 
[10] White, G. H., Farrance, I., & AACB Uncertainty of Measurement Working Group (2004). Uncertainty of measurement in quantitative medical testing: a laboratory implementation guide. The Clinical biochemist. Reviews, 25(4), S1–S24. 
[11] Agrawal K, Chauhan N. Pressure ulcers: Back to the basics. Indian J Plast Surg. 2012 May;45(2):244-54. doi: 10.4103/0970-0358.101287. 
[12] Bhattacharya S, Mishra RK. Pressure ulcers: Current understanding and newer modalities of treatment. Indian J Plast Surg. 2015 Jan-Apr;48(1):4-16. doi: 10.4103/0970-0358.155260. 
[13] Rathore, F. A., Ahmad, F., & Zahoor, M. U. (2016). Case Report of a Pressure Ulcer Occurring Over the Nasal Bridge Due to a Non-Invasive Ventilation Facial Mask. Cureus, 8(10), e813. https://doi.org/10.7759/cureus.813 
[14] Brill, A. K. (2014). How to avoid interface problems in acute noninvasive ventilation. Breathe, 10(3), 230-242. 
[15] Potchileev I, Doroshenko M, Mohammed AN. Positive Pressure Ventilation. [Updated 2023 Jan 30]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560916/ 
[16] Wu, Y. Y., Acharya, D., Xu, C., Cheng, B., Rana, S., & Shimada, K. (2018). Custom-Fit Three-Dimensional-Printed BiPAP Mask to Improve Compliance in Patients Requiring Long-Term Noninvasive Ventilatory Support. Journal of medical devices, 12(3), 0310031–310038. https://doi.org/10.1115/1.4040187 
[17] Passchier-Vermeer, W., & Passchier, W. F. (2000). Noise Exposure and Public Health. Environmental Health Perspectives, 108, 123–131. https://doi.org/10.2307/3454637 
[18] Care, cleaning and disinfection of BiPAP/CPAP devices. World Health Organization. 2022.