Philips Respironics Recall: Philips Respironics announced a voluntary recall for continuous and non-continuous ventilators, and certain CPAP, Bi-Level PAP and ventilator devices due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. To get your machine repaired or replaced, register your device and start your claim at https://www.philipssrcupdate.expertinquiry.com/ For additional information or for patients that do not have access to the internet to register your device, contact Philips Respironics at 877-907-7508.

Columbus, OH

Diagnosis and Treatment Info

Sleep Apnea Diagnosis and Treatment Information

SDB (Sleep Disordered Breathing) – general term for a sleep disorder with apneas and hypopneas

  • Apnea: cessation of airflow for ten seconds or longer
  • Hypopnea: a 50% or greater decrease in air flow for ten seconds or longer
  • Both cause sleep arousals-moments when an individual wakes enough to resume breathing, but not enough to remember the interruption in sleep
  • Both may or may not decrease SpO2 levels
  • Both result from upper airway obstruction or a dysfunction of the body’s automatic drive to breathe

Definitions for diagnosis of Sleep Apnea:

  • AHI-Apnea Hypopnea Index, total number of apneas and hypopneas in 1 hour
  • RDI-Respiratory Disturbance Index, total number of arousals in 1 hour. This could be anything that may cause a disturbance (i.e. apnea, hypopnea, restless leg movements, etc.)
Types of Sleep Apnea:

1. Central Sleep Apnea

  • 5-10% of the sleep apnea population
  • Breathing stops, but airway is open
  • Body’s automatic breathing response fails
  • Treatment *Medication *BiPAP with back-up rate

2. Mixed Sleep Apnea

  • A mixture of both obstructive and central apneas and hypopneas

3. Obstructive Sleep Apnea

Most common

  • Approximately 8-10% of the adult population in the US suffers from Obstructive Sleep Apnea. Over 80% of cases are yet to be diagnosed.
  • Most sufferers are undiagnosed
  • OSA is as common as adult asthma

Primary causes

  • Lack of muscle tone during sleep
  • Excess tissue in the upper airway
  • Anatomical abnormalities in the upper airway and jaw
  • Breathing is prevented when obstruction occurs
  • Sleeper wakes up enough to gain control of the upper airway, breathe again, and fall back asleep. This may occur hundreds of times per night, but the sleeper does not remember

Symptoms

  • Snoring, interrupted by pauses in breathing
  • Gasping or choking during sleep
  • Restless sleep
  • Excessive daytime sleepiness
  • Large neck size
  • Morning headaches
  • Poor concentration
  • Irritability
  • Memory loss
  • High blood pressure
  • Depression
  • Obesity
  • Sexual dysfunction

Risk factors

  • Obesity
  • Snoring
  • Family history of OSA or snoring
  • Small upper airway (large tongue, large uvula, recessed chin, excess tissue in the throat and/or soft palate)

Complications

  • Each obstruction causes decreased oxygen and increased carbon dioxide
  • Increased heart rate
  • Increased blood pressure
  • Decreased quality of sleep, resulting in sleep deprivation

Untreated OSA risk factors

  • High blood pressure
  • Heart disease and heart attack
  • Stroke
  • Fatigue-related motor vehicle and work accidents
  • Decreased quality of life
  • Weight gain

Diagnosis

  • Epworth Sleepiness Scale
  • Polysomnography
    • EEG
    • Rapid Eye Movement
    • Respiratory effort-chest movement
    • Airflow
    • Heart rate and rhythm
    • Pulse oximetry
    • Video and sound recordings
    • One and two night studies
    • Split night studies

Treatment

  • Laser surgery
  • Oral appliances
  • Medication
  • Tracheostomy
  • CPAP/Bilevel therapy
Positive Airway Pressure (PAP)
  • Is a method of respiratory ventilation used primarily in the treatment of sleep apnea, for which it was first developed.
  • A PAP machine is used mainly by patients at home for the treatment of sleep apnea. In sleep apnea, the patient’s airway becomes restricted as the patient’s muscles relax naturally during sleep, which causes arousal from sleep. The PAP machine stops this phenomenon by delivering a stream of compressed air via a face mask and hose, splinting the airway (keeping it open under air pressure) so that unobstructed breathing becomes possible, reducing and/or preventing apneas and hypopneas.
  • The Most Common Conditions for which PAP ventilation is used in hospitals are congestive cardiac failure and acute exacerbation of obstructive airways disease, most notably exacerbations of COPD (chronic obstructive pulmonary disease) and asthma. It is not used in cases where the airway may be compromised, or consciousness is impaired.
  • Definitions:
    • AHI-Apnea Hypopnea Index, total number of apneas and hypopneas in 1 hour
    • RDI-Respiratory Disturbance Index, total number of arousals in 1 hour. This could be anything that may cause a disturbance (i.e. apnea, hypopnea, restless leg movements, etc.)
Types of Paps
  • CPAP (Continuous Positive Airway Pressure) provides one constant pressure to the patient
  • APAP or AutoPAP (Automatic Positive Airway Pressure) automatically titrates, or tunes, the amount of pressure delivered to the patient to the minimum required to maintain an unobstructed airway on a breath-by-breath basis by measuring the resistance in the patient’s breathing, thereby giving the patient the precise pressure required at a given moment and avoiding the compromise of fixed pressure.
  • VPAP or BiPAP® (Variable/Bilevel Positive Airway Pressure) provides two levels of pressure, one for inhalation (IPAP) and a lower pressure during exhalation (EPAP)
  • Bi-PAP ST (Spontaneous Time) is a machine that forces a number of set breaths per minute and is used to treat patients with central apneas.
  • Medicare Requirements:
    • Must have a facility based polysomnography to determine OSA diagnosis
    • Apnea-Hypopnea Index ≥ 15
    • AHI ≥ 5 and ≤ 14 with associated symptoms of excessive daytime sleepiness, mood disorders, hypertension, heart disease, or history of stroke
    • These test results are based on a minimum of 2 hours of sleep
    • Rent to cap

Cpap:

  • Provides a flow of air through a mask to splint the airway open at night
  • Most common treatment for Obstructive Sleep Apnea
  • Results:
    • Regular breathing pattern
    • Snoring stops
    • Restful sleep is restored
    • Quality of life is improved
    • Decrease health risks (high blood pressure, heart attack, stroke, heart disease, etc.)
  • Features
  • Humidifier adds moisture to the air
    • Heated a heated water chamber that can increase patient comfort by eliminating the dryness of the compressed air. The temperature can usually be adjusted or turned off to act as a passive humidifier if desired.
    • Passive Air is blown through an unheated water chamber and it is dependant on ambient air temperature. Not as effective a the heated type above but can increase patient comfort by eliminating the dryness of the compressed air.
  • Ramp is used to temporarily lower the pressure to allow the user to more easily fall asleep. The pressure gradually rises to the prescribed level over a period of time that can be adjusted by the patient and/or the DME provider.
  • Exhalation pressure relief gives a short drop in pressure during exhalation to reduce the effort required. This feature is known by the trade name C-Flex® in some PAPs made by Respironics and EPR in Resmed machines.
C-Flex or EPR (Expiratory Pressure Relief)
  • Tracks breath-by-breath
  • It lowers the amount of pressure delivered exhalation
  • Three C-Flex settings
  • Improved compliance
Auto-Titrating
  • Automatically adjusts CPAP pressure
  • When apnea, hypopnea, and/or snoring are detected the system immediately begins to ramp up the pressure to eliminate the event
  • 4-20 cm H20 (water)
  • Prescription must include low setting and high setting
  • Smart card capability

Data logging (Smart Card) records basic compliance info or detailed event logging, allowing the sleep physician (or patient) to download and analyze data recorded by the machine to verify treatment effectiveness.

  • Tracks compliance
  • FOSQ test (Assesses daily activity)
  • Allows the elimination of the one month RCP follow-up visit
  • Pressure changes can be done through the card
Bilevel Positive Airway Pressure (BiPAP)
  • First alternative to CPAP non-compliance
  • Independently adjusted pressures
    • IPAP (Inspiratory Positive Airway Pressure)
      • Takes the work of breathing away
    • EPAP (Expiratory Positive Airway Pressure)
      • Pressure needed to splint the airway open
Indications for use
  • Intolerant of CPAP
  • CPAP not effective
  • Sleep apnea with ventilatory disorder
  • Ventilatory disorder (respiratory failure, COPD, neuromuscular, etc.)
Models
  • BiPAP S (All spontaneous breathing
  • BiPAP S/T (Timed back-up capability)