SoClean 2

Date Issued: February 27, 2020

The U.S. Food and Drug Administration (FDA) wants to make consumers and health care providers aware that, to date, the FDA has not authorized for market any products using ozone gas or ultraviolet (UV) light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories (for example: hoses, masks, tubing and headgear).

CPAP machines are devices prescribed to patients with obstructive sleep apnea to keep their airways open during sleep. Most often, CPAP manufacturers recommend regular cleaning of CPAP device accessories with mild soap and water.

...

Ozone (O3), sometimes called “activated oxygen”, is a gas that can be used to kill harmful bacteria. However, for ozone to be effective in destroying harmful bacteria, it must be present at a concentration above levels considered safe for humans.

Although products that claim to use ozone gas to clean CPAP machine equipment are designed to keep the ozone generated inside the machine and its accessories, leaks can occur at tubing connections, filters or through fabric containers used to house CPAP accessories. When leaks occur, ozone gas in the nearby space may temporarily rise to unsafe levels, especially if the space is not well ventilated. Ozone gas concentrations within the CPAP machine and tubing can also remain above safe levels even after the recommended waiting periods for ozone gas products that claim to clean. If the CPAP accessories are used without first allowing fresh air to circulate through the entire CPAP machine to remove any remaining ozone gas, this could lead to nasal, lung or any other type of irritation to the user’s breathing passages. Exposure to high levels of ozone gas also may worsen chronic respiratory diseases, such as asthma, or increase vulnerability to respiratory infection.

The FDA has received reports from patients experiencing cough, difficulty breathing, nasal irritation, headaches, asthma attacks and other breathing complaints when ozone gas-based products were used to clean, sanitize or disinfect CPAP devices and accessories.

Using UV Light Products that claim to Clean CPAP Machine Equipment and Accessories

UV light may be used to disinfect surfaces in a setting where UV light does not escape to the surroundings. If products generating UV light do not shield the user from exposure, they pose a potential health hazard depending on the wavelength, intensity, and exposure time.

Although FDA has not received any problem reports associated with using UV light products that claim to clean CPAP devices and accessories, unintentional or excessive exposure to UV light during cleaning may put a user at risk of eye injury, skin burns or even an increased risk of skin cancer. Additionally, when UV light is used with the purpose of disinfecting CPAP machine equipment and accessories, UV light may be unable to penetrate all areas of the CPAP accessories such as the hoses, masks and connectors. This may result in inadequately disinfected CPAP devices and accessories that may not be safe for reuse.

Full notice: https://www.fda.gov/medical-devices/saf ... chines-and

Risks:
The residual smell of ozone may be unpleasant and risky. Ozone exposure is potentially dangerous among those with respiratory conditions. The U.S. Food and Drug Administration describes it as a “toxic gas with no known useful medical application.” The Environmental Protection Agency says that relatively low amounts of ozone can cause shortness of breath and worsen chronic respiratory disease.

In fact, ironically, exposure to it may compromise the body’s ability to fight respiratory infections.

...

Ultimately, the available CPAP cleaners and sanitizers seem unlikely to provide additional cleaning capacity beyond standard methods of cleaning with soap and water. There is no evidence that these devices reduce the risk of infection.

These companies also have no financial interest in investigating this possibility. The devices sell well without any such study. This may reveal much about the motivation behind the recent push in direct-to-consumer marketing of the product, beyond the science supporting its use.

A Word From Verywell
Further research may be helpful to determine if these devices have any role in routine CPAP therapy. The risk of infection is so small, and the evidence for benefit so weak, that these devices are not currently recommended. Save your money and buy a lifetime supply of liquid dish soap instead!

https://www.verywellhealth.com/do-you-n ... in-4171650

I will give you some facts, and I base the facts on the fact that I am the one who works in the industry of low temperature sterilzation

1. So Clean claims they use the same technology as is used in hospitals. LIE - the hospital ozone sterilizers cost upwards of 100,000.00 and require an O2 farm (a room with 15 to 20 tall O2 cylinders) to provide pure oxygen to extract the ozone. Besides the fact that SoClean lied about this, why on earth do you think a 300.00 device can even come close to what a 100,000.00 device can do. If SoClean was validated to sterilize or even high level disinfect, hospitals would have hundreds of them rather than the 100K devices. The SoClean just does not have the power to do what you think it does.

2. It does not clean. Period. You think it does, place a small dab of peanut butter in your hose and see if it is still there when the cycle is complete. You think this is not a good test, it is the basis of the VA soil test, the test that all medical cleaners must pass or they cannot claim to clean.

3. Amazon reviews - nothing but feel good stories. I have not read one Amazon review that can factually claim that the SoClean kills germs. If you know of one, please post the link because I would like to read it. What is the basis of a 5 star review when all they can go on is they like it? Meaningless.

4. I did own a SoClean on the 30 day trial, when I realized what it was vs. the claims they make I returned it under the 30 day return policy. Why not just get one of the room ozone fans and hang your mask in front of it, they would both do the same thing which is nothing.

I am just repeating the same thing I have typed here about a hundred times; for now on I will just say it is awesome, give the scammers your money, you will love it.

viewtopic/t157842/viewtopic.php?f=1&t=1 ... 9#p1210375

January 8, 2020
To Our Valued Patient,
ResMed announced an update to its limited warranty that may affect whether you choose to use an ozone
device with your ResMed machine and mask. Please review the detail of this update below.*

ResMed user guides advise patients to periodically clean ResMed machines, components and masks with
mild detergent and warm water only. Some patients choose to use other means to clean and/or disinfect
their machines. With the increased use of ozone devices, ResMed has observed that prolonged and
repeated use of an ozone device may eventually cause internal damage to a ResMed machine, leading to
an increase in motor noise.
Warranty update: Effective for sales of ResMed machines on or after February 1, 2020, ResMed’s limited
warranty will exclude damage to ResMed machines caused by use of ozone devices. The limited warranty
on ResMed masks, with the exception of ResMed AirTouch™ products, will not be affected.
ResMed is not taking a position on whether you should use an ozone device. That decision is up to you, as
the patient, to balance the convenience of using an ozone device versus the likelihood of potential damage
to your ResMed machine. ResMed is reinforcing the cleaning instructions in its machine user guide:
periodic cleaning with mild detergent and warm water is all that is required with a ResMed machine,
component or mask. This letter requires no action on your part.
If you have any further questions, please feel free to contact the manufacturer of the ozone device you are
currently using or, for medical advice, your physician.
Sincerely,
Your home care provider

https://www.resmed.com/us/dam/documents ... letter.pdf

jimbud wrote: ↑

Mon Jul 26, 2021 2:47 pm

Old "Earn" knows all the negatives, he just posts to stir crrrap up.

ChicagoGranny wrote: ↑

Mon Jul 26, 2021 2:40 pm

Ozone and ultraviolet cleaners are included in the notice.

Date Issued: February 27, 2020

The U.S. Food and Drug Administration (FDA) wants to make consumers and health care providers aware that, to date, the FDA has not authorized for market any products using ozone gas or ultraviolet (UV) light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories (for example: hoses, masks, tubing and headgear).

CPAP machines are devices prescribed to patients with obstructive sleep apnea to keep their airways open during sleep. Most often, CPAP manufacturers recommend regular cleaning of CPAP device accessories with mild soap and water.

...

Ozone (O3), sometimes called “activated oxygen”, is a gas that can be used to kill harmful bacteria. However, for ozone to be effective in destroying harmful bacteria, it must be present at a concentration above levels considered safe for humans.

Although products that claim to use ozone gas to clean CPAP machine equipment are designed to keep the ozone generated inside the machine and its accessories, leaks can occur at tubing connections, filters or through fabric containers used to house CPAP accessories. When leaks occur, ozone gas in the nearby space may temporarily rise to unsafe levels, especially if the space is not well ventilated. Ozone gas concentrations within the CPAP machine and tubing can also remain above safe levels even after the recommended waiting periods for ozone gas products that claim to clean. If the CPAP accessories are used without first allowing fresh air to circulate through the entire CPAP machine to remove any remaining ozone gas, this could lead to nasal, lung or any other type of irritation to the user’s breathing passages. Exposure to high levels of ozone gas also may worsen chronic respiratory diseases, such as asthma, or increase vulnerability to respiratory infection.

The FDA has received reports from patients experiencing cough, difficulty breathing, nasal irritation, headaches, asthma attacks and other breathing complaints when ozone gas-based products were used to clean, sanitize or disinfect CPAP devices and accessories.

Using UV Light Products that claim to Clean CPAP Machine Equipment and Accessories

UV light may be used to disinfect surfaces in a setting where UV light does not escape to the surroundings. If products generating UV light do not shield the user from exposure, they pose a potential health hazard depending on the wavelength, intensity, and exposure time.

Although FDA has not received any problem reports associated with using UV light products that claim to clean CPAP devices and accessories, unintentional or excessive exposure to UV light during cleaning may put a user at risk of eye injury, skin burns or even an increased risk of skin cancer. Additionally, when UV light is used with the purpose of disinfecting CPAP machine equipment and accessories, UV light may be unable to penetrate all areas of the CPAP accessories such as the hoses, masks and connectors. This may result in inadequately disinfected CPAP devices and accessories that may not be safe for reuse.

Full notice: https://www.fda.gov/medical-devices/saf ... chines-and

Risks:
The residual smell of ozone may be unpleasant and risky. Ozone exposure is potentially dangerous among those with respiratory conditions. The U.S. Food and Drug Administration describes it as a “toxic gas with no known useful medical application.” The Environmental Protection Agency says that relatively low amounts of ozone can cause shortness of breath and worsen chronic respiratory disease.

In fact, ironically, exposure to it may compromise the body’s ability to fight respiratory infections.

...

Ultimately, the available CPAP cleaners and sanitizers seem unlikely to provide additional cleaning capacity beyond standard methods of cleaning with soap and water. There is no evidence that these devices reduce the risk of infection.

These companies also have no financial interest in investigating this possibility. The devices sell well without any such study. This may reveal much about the motivation behind the recent push in direct-to-consumer marketing of the product, beyond the science supporting its use.

A Word From Verywell
Further research may be helpful to determine if these devices have any role in routine CPAP therapy. The risk of infection is so small, and the evidence for benefit so weak, that these devices are not currently recommended. Save your money and buy a lifetime supply of liquid dish soap instead!

https://www.verywellhealth.com/do-you-n ... in-4171650

From a microbiologist with 25 years experience with sterilization and disinfection of equipment and facilities used in the production of sterile pharmaceuticals:

I will give you some facts, and I base the facts on the fact that I am the one who works in the industry of low temperature sterilzation

1. So Clean claims they use the same technology as is used in hospitals. LIE - the hospital ozone sterilizers cost upwards of 100,000.00 and require an O2 farm (a room with 15 to 20 tall O2 cylinders) to provide pure oxygen to extract the ozone. Besides the fact that SoClean lied about this, why on earth do you think a 300.00 device can even come close to what a 100,000.00 device can do. If SoClean was validated to sterilize or even high level disinfect, hospitals would have hundreds of them rather than the 100K devices. The SoClean just does not have the power to do what you think it does.

2. It does not clean. Period. You think it does, place a small dab of peanut butter in your hose and see if it is still there when the cycle is complete. You think this is not a good test, it is the basis of the VA soil test, the test that all medical cleaners must pass or they cannot claim to clean.

3. Amazon reviews - nothing but feel good stories. I have not read one Amazon review that can factually claim that the SoClean kills germs. If you know of one, please post the link because I would like to read it. What is the basis of a 5 star review when all they can go on is they like it? Meaningless.

4. I did own a SoClean on the 30 day trial, when I realized what it was vs. the claims they make I returned it under the 30 day return policy. Why not just get one of the room ozone fans and hang your mask in front of it, they would both do the same thing which is nothing.

I am just repeating the same thing I have typed here about a hundred times; for now on I will just say it is awesome, give the scammers your money, you will love it.

viewtopic/t157842/viewtopic.php?f=1&t=1 ... 9#p1210375

Edit: SoClean is being sued for False Advertising and other violations of law - https://www.courtlistener.com/docket/14 ... clean-inc/

Edit: ResMed changed their warranty terms to include a statement that use of an ozone-cleaning machine may void their CPAP machine warranty.

January 8, 2020
To Our Valued Patient,
ResMed announced an update to its limited warranty that may affect whether you choose to use an ozone
device with your ResMed machine and mask. Please review the detail of this update below.*

ResMed user guides advise patients to periodically clean ResMed machines, components and masks with
mild detergent and warm water only. Some patients choose to use other means to clean and/or disinfect
their machines. With the increased use of ozone devices, ResMed has observed that prolonged and
repeated use of an ozone device may eventually cause internal damage to a ResMed machine, leading to
an increase in motor noise.
Warranty update: Effective for sales of ResMed machines on or after February 1, 2020, ResMed’s limited
warranty will exclude damage to ResMed machines caused by use of ozone devices. The limited warranty
on ResMed masks, with the exception of ResMed AirTouch™ products, will not be affected.
ResMed is not taking a position on whether you should use an ozone device. That decision is up to you, as
the patient, to balance the convenience of using an ozone device versus the likelihood of potential damage
to your ResMed machine. ResMed is reinforcing the cleaning instructions in its machine user guide:
periodic cleaning with mild detergent and warm water is all that is required with a ResMed machine,
component or mask. This letter requires no action on your part.
If you have any further questions, please feel free to contact the manufacturer of the ozone device you are
currently using or, for medical advice, your physician.
Sincerely,
Your home care provider

https://www.resmed.com/us/dam/documents ... letter.pdf

SummerTime wrote: ↑

Mon Jul 26, 2021 4:37 pm

Wish this could be a sticky

Pugsy wrote: ↑

Mon Jul 26, 2021 4:47 pm

Besides...people don't bother reading stickies anyway.

SummerTime wrote: ↑

Mon Jul 26, 2021 4:37 pm

Thank you
for taking the time to do this CG.

Pugsy wrote: ↑

Mon Jul 26, 2021 4:47 pm

SummerTime wrote: ↑

Mon Jul 26, 2021 4:37 pm

Wish this could be a sticky

I am really torn about making anything related to the ozone devices any sort of sticky because to me that gives them free ad space...even if it is negative.
For some....any press is good press.

So unless I change my mind or Carolyn decides she wants to make a sticky....not going to happen.
I won't even mention the name... I just say ozone device. I won't even say "cleaning" device because it doesn't clean anything.

Besides...people don't bother reading stickies anyway.

ChicagoGranny wrote: ↑

Mon Jul 26, 2021 5:00 pm

Not much trouble. Just copy one of my old posts.

SummerTime wrote: ↑

Mon Jul 26, 2021 4:37 pm

ChicagoGranny wrote: ↑

Mon Jul 26, 2021 2:40 pm

Ozone and ultraviolet cleaners are included in the notice.

Date Issued: February 27, 2020

The U.S. Food and Drug Administration (FDA) wants to make consumers and health care providers aware that, to date, the FDA has not authorized for market any products using ozone gas or ultraviolet (UV) light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories (for example: hoses, masks, tubing and headgear).

CPAP machines are devices prescribed to patients with obstructive sleep apnea to keep their airways open during sleep. Most often, CPAP manufacturers recommend regular cleaning of CPAP device accessories with mild soap and water.

...

Ozone (O3), sometimes called “activated oxygen”, is a gas that can be used to kill harmful bacteria. However, for ozone to be effective in destroying harmful bacteria, it must be present at a concentration above levels considered safe for humans.

Although products that claim to use ozone gas to clean CPAP machine equipment are designed to keep the ozone generated inside the machine and its accessories, leaks can occur at tubing connections, filters or through fabric containers used to house CPAP accessories. When leaks occur, ozone gas in the nearby space may temporarily rise to unsafe levels, especially if the space is not well ventilated. Ozone gas concentrations within the CPAP machine and tubing can also remain above safe levels even after the recommended waiting periods for ozone gas products that claim to clean. If the CPAP accessories are used without first allowing fresh air to circulate through the entire CPAP machine to remove any remaining ozone gas, this could lead to nasal, lung or any other type of irritation to the user’s breathing passages. Exposure to high levels of ozone gas also may worsen chronic respiratory diseases, such as asthma, or increase vulnerability to respiratory infection.

The FDA has received reports from patients experiencing cough, difficulty breathing, nasal irritation, headaches, asthma attacks and other breathing complaints when ozone gas-based products were used to clean, sanitize or disinfect CPAP devices and accessories.

Using UV Light Products that claim to Clean CPAP Machine Equipment and Accessories

UV light may be used to disinfect surfaces in a setting where UV light does not escape to the surroundings. If products generating UV light do not shield the user from exposure, they pose a potential health hazard depending on the wavelength, intensity, and exposure time.

Although FDA has not received any problem reports associated with using UV light products that claim to clean CPAP devices and accessories, unintentional or excessive exposure to UV light during cleaning may put a user at risk of eye injury, skin burns or even an increased risk of skin cancer. Additionally, when UV light is used with the purpose of disinfecting CPAP machine equipment and accessories, UV light may be unable to penetrate all areas of the CPAP accessories such as the hoses, masks and connectors. This may result in inadequately disinfected CPAP devices and accessories that may not be safe for reuse.

Full notice: https://www.fda.gov/medical-devices/saf ... chines-and

Risks:
The residual smell of ozone may be unpleasant and risky. Ozone exposure is potentially dangerous among those with respiratory conditions. The U.S. Food and Drug Administration describes it as a “toxic gas with no known useful medical application.” The Environmental Protection Agency says that relatively low amounts of ozone can cause shortness of breath and worsen chronic respiratory disease.

In fact, ironically, exposure to it may compromise the body’s ability to fight respiratory infections.

...

Ultimately, the available CPAP cleaners and sanitizers seem unlikely to provide additional cleaning capacity beyond standard methods of cleaning with soap and water. There is no evidence that these devices reduce the risk of infection.

These companies also have no financial interest in investigating this possibility. The devices sell well without any such study. This may reveal much about the motivation behind the recent push in direct-to-consumer marketing of the product, beyond the science supporting its use.

A Word From Verywell
Further research may be helpful to determine if these devices have any role in routine CPAP therapy. The risk of infection is so small, and the evidence for benefit so weak, that these devices are not currently recommended. Save your money and buy a lifetime supply of liquid dish soap instead!

https://www.verywellhealth.com/do-you-n ... in-4171650

From a microbiologist with 25 years experience with sterilization and disinfection of equipment and facilities used in the production of sterile pharmaceuticals:

I will give you some facts, and I base the facts on the fact that I am the one who works in the industry of low temperature sterilzation

1. So Clean claims they use the same technology as is used in hospitals. LIE - the hospital ozone sterilizers cost upwards of 100,000.00 and require an O2 farm (a room with 15 to 20 tall O2 cylinders) to provide pure oxygen to extract the ozone. Besides the fact that SoClean lied about this, why on earth do you think a 300.00 device can even come close to what a 100,000.00 device can do. If SoClean was validated to sterilize or even high level disinfect, hospitals would have hundreds of them rather than the 100K devices. The SoClean just does not have the power to do what you think it does.

2. It does not clean. Period. You think it does, place a small dab of peanut butter in your hose and see if it is still there when the cycle is complete. You think this is not a good test, it is the basis of the VA soil test, the test that all medical cleaners must pass or they cannot claim to clean.

3. Amazon reviews - nothing but feel good stories. I have not read one Amazon review that can factually claim that the SoClean kills germs. If you know of one, please post the link because I would like to read it. What is the basis of a 5 star review when all they can go on is they like it? Meaningless.

4. I did own a SoClean on the 30 day trial, when I realized what it was vs. the claims they make I returned it under the 30 day return policy. Why not just get one of the room ozone fans and hang your mask in front of it, they would both do the same thing which is nothing.

I am just repeating the same thing I have typed here about a hundred times; for now on I will just say it is awesome, give the scammers your money, you will love it.

viewtopic/t157842/viewtopic.php?f=1&t=1 ... 9#p1210375

Edit: SoClean is being sued for False Advertising and other violations of law - https://www.courtlistener.com/docket/14 ... clean-inc/

Edit: ResMed changed their warranty terms to include a statement that use of an ozone-cleaning machine may void their CPAP machine warranty.

January 8, 2020
To Our Valued Patient,
ResMed announced an update to its limited warranty that may affect whether you choose to use an ozone
device with your ResMed machine and mask. Please review the detail of this update below.*

ResMed user guides advise patients to periodically clean ResMed machines, components and masks with
mild detergent and warm water only. Some patients choose to use other means to clean and/or disinfect
their machines. With the increased use of ozone devices, ResMed has observed that prolonged and
repeated use of an ozone device may eventually cause internal damage to a ResMed machine, leading to
an increase in motor noise.
Warranty update: Effective for sales of ResMed machines on or after February 1, 2020, ResMed’s limited
warranty will exclude damage to ResMed machines caused by use of ozone devices. The limited warranty
on ResMed masks, with the exception of ResMed AirTouch™ products, will not be affected.
ResMed is not taking a position on whether you should use an ozone device. That decision is up to you, as
the patient, to balance the convenience of using an ozone device versus the likelihood of potential damage
to your ResMed machine. ResMed is reinforcing the cleaning instructions in its machine user guide:
periodic cleaning with mild detergent and warm water is all that is required with a ResMed machine,
component or mask. This letter requires no action on your part.
If you have any further questions, please feel free to contact the manufacturer of the ozone device you are
currently using or, for medical advice, your physician.
Sincerely,
Your home care provider

https://www.resmed.com/us/dam/documents ... letter.pdf

Wish this could be a sticky It would make answering the same questions over and over and over and over so much easier. Thank you
for taking the time to do this CG.

ErnieH wrote: ↑

Mon Jul 26, 2021 7:30 pm

What a fing waste of my time.

ErnieH wrote: ↑

Mon Jul 26, 2021 7:30 pm

What a . . . waste of my time.