- Data Source：Food and Drug Administration, Ministry of Health and Welfare
- Created：2019-07-31
- Last Updated：2019-07-31
Mr. Liu was frequently aroused from sleep at midnight, and he suffered from habitual snoring, loud snore, awakening with dry mouth, daytime drowsiness, as well as other symptoms. Loud snoring also bothered his wife from sleeping well. In order to understand his physical status, Mr. Liu decided to go to hospital for diagnosis. A sleep study arranged by the doctor revealed that Mr. Liu had been suffering from Severe Obstructive Sleep Apnea Syndrome with Apnea Hypopnea Index (AHI) of 55 events per hour. After an evaluation of his clinical symptoms, together with the anatomy of the upper respiratory tract and comorbidity analysis, his doctor recommended him to use Continuous Positive Airway Pressure Device (CPAP Device) during sleep. By adhering to the CPAP therapy, Mr. Liu’s breathing became regular and he stopped snoring at night. With a better sleep quality, he felt wide awake every morning.
Sleep Apnea is a disorder in which an individual's breathing stops and starts repeatedly during sleep. Air cannot get into the lung and blood oxygen content is reduced. Patients might arouse from sleep and this may lead to severe impact on sleep quality. There are three main types of Sleep Apnea: Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA) and Mixed Apnea. Obstructive Sleep Apnea is the most common type. Causes of OSA might include excess weight, anatomical factor in upper respiratory tract (e.g., nasal septum deviation, turbinate hypertrophy, nasal polyp hyperplasia, elongated uvula, tonsils enlarged and tongue hypertrophy) which blocks the nasal passage. Clinical symptoms of OSA may include snoring, frequent urination at night, awakening with dry mouth, headache, daytime sleepiness and impaired concentration. Treatment choices of OSA are surgery, wearing mandibular advancement device, or using Continuous Positive Airway Pressure Device during sleep, etc. Doctors will prescribe appropriate therapy according to patients’ condition and sleeping habits.
Continuous Positive Airway Pressure Device therapy is very common for the treatment of OSA. The principle of the machine is to send a positive pressure flow using the internal motor to ensure that airway stays open during sleep. Some CPAP devices are designed to identify patients’ breathing condition using pressure or flow sensor to modify the applied pressure or flow. Others have designs that might include humidifier delivering warm and moist air to reduce irritation. Besides daily functional test, essential cleaning and maintenance of the CPAP device to see whether the applied pressure should be adjusted, TFDA recommends you to return to your doctor for regular check-up visits in order to ensure proper therapeutic effect. All the CPAP devices that have been issued medical device licenses are evaluated and approved by TFDA. The effectiveness and safety are ensured before legally marketed in Taiwan.
TFDA reminds you to consult your doctors before using the CPAP device, and follow the steps below. First, you should recognize whether the product is classified as a medical device. Second, you have to read the labels, instructions for use and packaging carefully, so as to confirm whether the manufacturer’s name, address, product name, registration number, batch number, manufacturing and expiry dates are clearly marked. Lastly, you should read the user manual thoroughly and strictly follow all the instructions to make sure that you have chosen the appropriate medical device and used it correctly. For more information related to medical devices, you can consult your doctor or visit the database at http://www.fda.gov.tw/MLMS/H0001.aspx. If you notice any device-related problems or adverse event after usage, please report at http://qms.fda.gov.tw, or call the adverse reaction reporting phone line at 02-2396-0100.