CPAP Machine

Continuous Positive
Airway Pressure

Prepared by:
Khaled Abu Sharar
What is a CPAP
machine

The CPAP machine is a medical device that is intended

to provide noninvasive ventilation to people with
breathing difficulties, especially in sleep. The United
States Food and Drug Administration (FDA) categorizes
CPAP machines as Class II medical devices intended for
home use.
They have provided guidance on the classification of
CPAP machines, highlighting their intended use in a
home environment for the treatment of sleep apnea.
Specifically, the "Class II Special Controls Guidance
Document: Positive Airway Pressure Systems for Use in
the Home Environment" outlines the regulatory
considerations, performance criteria, and labeling
requirements for these devices.
Eng. Khaled Abu Sharar
 Clinical need
Continuous Positive Airway Pressure (CPAP) is a medical therapy
primarily used to treat sleep apnea. Sleep apnea is a sleep
disorder characterized by repeated interruptions in breathing
during sleep. Worldwide, over 100 million people suffer from
obstructive sleep apnea. While sleep apnea is common, most
cases go undiagnosed.
There are two main types of sleep apnea:
• Obstructive Sleep Apnea (OSA): This is the more common form of
sleep apnea. It occurs when the muscles at the back of the throat
relax excessively, leading to a partial or complete blockage of the
airway. CPAP is particularly effective in treating OSA by delivering a
continuous stream of air through a mask, which helps keep the
airway open and prevents interruptions in breathing.

• Central Sleep Apnea (CSA): This less common form of sleep apnea
is associated with a failure of the brain to send appropriate signals
to the muscles that control breathing. CPAP is generally less
effective for CSA, and other types of positive airway pressure
devices may be considered.
Eng. Khaled Abu Sharar
Eng. Khaled Abu Sharar
 Functional
Block
Diagram

Eng. Khaled Abu Sharar

FDA Recalls

Eng. Khaled Abu Sharar

The Foam Recall

• Philips breathing devices were recalled in 2021 because

of disintegration and toxicity risk from PE-PUR foam in
the devices’ airways.
• In 2021, Philips recalled certain CPAP and BiPAP
ventilator devices out of concern that sound abatement
foam within the devices could disintegrate and cause
health problems. Over time, the foam can break down
into particles and release gases that may increase the
risk of cancer or breathing problems.
• Certain conditions may have caused the foam in the
recalled devices to break down. Devices older than three
years or those kept in humid or very hot environments
were more likely to have foam disintegration issues.
• By the end of 2022, the FDA had received 346 death
claims linked to the recalled Philips ventilation machines.
Eng. Khaled Abu Sharar
Thermal recalls
• The FDA recently received medical device reports (MDRs) for the Philips Respironics’ DreamStation 2 CPAP
machine associated with issues such as fire, smoke, burns, and other signs of overheating while using the
machine.
• Reports gathered and analyzed by the FDA indicate the thermal issues may be related to an electrical and/or
a mechanical malfunction that may cause the machines to overheat in certain situations.
However, the FDA does not believe the safety issue is related to the foam used in the machine.
• The FDA recommends that anyone using the machines follow the instructions in the user manual and check
the machine for unusual smells or changes in appearance before and after each use.
• “The FDA is committed to assuring this new safety issue is resolved expeditiously. We will continue to
monitor the company’s handling of this, among other safety issues, to ensure they take appropriate steps to
mitigate the risk to patients,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological
Health. “We share the public’s concerns regarding the new and continued safety issues of CPAP machines
and certain recalled medical devices manufactured by Philips. Addressing these safety concerns remains a
top priority for the FDA.”
• The FDA is in discussions with the company about mitigation strategies for this safety issue and will update
the public accordingly.

Eng. Khaled Abu Sharar

 • 1-62 ISO 5356-1 Third edition 2004-05-15Anaesthetic and respiratory equipment - Conical
connectors: Part 1: Cones and sockets
• 1-106 ISO 17510 First Edition 2015-08-01Medical devices -- Sleep apnoea breathing therapy -- Masks
and application accessories
• 1-115 ISO 80601-2-70 First Edition 2015-01-15Medical electrical equipment - Part 2-70: Particular
requirements for the basic safety and essential performance of sleep apnea breathing therapy
equipment
• 1-134 ISO 18562-1 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 1: Evaluation and testing within a risk management process
• 1-135 ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 2: Tests for emissions of particulate matter1-136 ISO 18562-3 First
Iso standards edition 2017-03Biocompatibility evaluation of breathing gas pathways in healthcare applications -
Part 3: Tests for emissions of volatile organic compounds
• 1-137 ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in
healthcare applications - Part 4: Tests for leachables in condensate1-138 ISO 80601-2-74 First edition
2017-05Medical electrical equipment - Part 2-74: Particular requirements for basic safety and
essential performance of respiratory humidifying equipment
• 1-151 ISO 80601-2-70 Second edition 2020-11Medical electrical equipment - Part 2-70: Particular
requirements for the basic safety and essential performance of sleep apnea breathing therapy
equipment
• 13-74 IEEE Std 11073-10424-2014Health informatics - Personal health device communication, Part
10424: Device Specialization - Sleep Apnea Breathing Therapy Equipment (SABTE)
• 13-94 ISO IEEE 11073-10424 First edition 2016-06-15Health informatics - Personal health device
communication - Part 10424: Device specialization - Sleep Apnea Breathing Therapy Equipment
(SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]

Eng. Khaled Abu Sharar

References
1. https://fox59.com/news/national-world/your-cpap-machine-might-
have-a-safety-issue-fda-
cautions/#:~:text=CPAP%20(Continuous%20Positive%20Airway%20
Pressure,overheating%20while%20using%20the%20machine.
2. https://www.analog.com/en/technical-articles/how-continuous-
positive-airway-pressure-cpap-respiratory-ventilation-systems-
function.html
3. https://www.fda.gov/medical-devices/safety-
communications/carefully-monitor-philips-dreamstation-2-cpap-
machines-signs-overheating-fda-safety-communication

Eng. Khaled Abu Sharar