illegal??

[sheepless]

the dme provider that initially set me up told me to submerge the hose and that it can be plugged back in wet. I've done both for the 2.5 years I've been using a cpap. I soak the mask and hose in dishwashing liquid for a while, rinse, shake off and air dry if there's time. but there rarely is time because I nap most days. so I simply put it all back together, connect to my machine and use mask fit to blow out the hose and mask.

edit: I should add that plugging the hose in while wet is probably asking for trouble given how easy it is to shake and wipe off residual h2o. I've never reconnected it dripping wet; I just never made much of an effort to dry the connector beyond shaking it off, air drying, and/or blotting it quickly with a towel or tissue.

[OMyMyOHellYes]

I have two questions. First off, why do I keep finding people saying it is illegal to buy or sell cpap machines outside of an hme or a doctor's prescription?
      
Second, how do you personally clean your heated tube? I know I should not submerge the end with the electrical connector, but should I just use hot water? hot water and a little dish soap?  What have you had the best luck doing?

Because the FDA is run by a bunch of bumblefarts. Or lobbying pressure from the DME/military industrial complex.

[Mosquitobait]

I have two questions. First off, why do I keep finding people saying it is illegal to buy or sell cpap machines outside of an hme or a doctor's prescription?
      
Second, how do you personally clean your heated tube? I know I should not submerge the end with the electrical connector, but should I just use hot water? hot water and a little dish soap?  What have you had the best luck doing?

Except in California, there are no restrictions on used machines anywhere in the US.  They are giving you false information because they don't know any better.  The FDA only regulates the manufacture of NEW machines - they have nothing to do with the secondary market.  Technically, anybody can sell new machines as well - just because it says on the machine 'prescription only' does not make it so. State laws DO regulate who may make adjustments to your machines - any patient or family member can make any adjustments they want - outside of that it requires a doctor, respiratory therapist or an authorized tech to do so legally or they can run into issues of practicing medicine without a license.   California lists CPAP as a 'dangerous medical device'. However, they only enforce their rules on companies who have set up shop and not individuals.

Second, you can submerge the entire heated tube in water.  Just do it in the am so that it has time to dry before using at night.  I use warm water and a little dish soap. You can also use children's hair shampoo.

Lots of medical people don't know what's allowed and not allowed. I've had diabetic educators freak out when I told them that I could get insulin at Walmart with no prescription. Most don't even believe me (this is at the endo. At my regular clinic, they were the ones who told me to just go to Walmart until I got in to the doc).

[3rdMarDiv]

I have two questions. First off, why do I keep finding people saying it is illegal to buy or sell cpap machines outside of an hme or a doctor's prescription?
      
Second, how do you personally clean your heated tube? I know I should not submerge the end with the electrical connector, but should I just use hot water? hot water and a little dish soap?  What have you had the best luck doing?

Except in California, there are no restrictions on used machines anywhere in the US.  They are giving you false information because they don't know any better.  The FDA only regulates the manufacture of NEW machines - they have nothing to do with the secondary market.  Technically, anybody can sell new machines as well - just because it says on the machine 'prescription only' does not make it so.  State laws DO regulate who may make adjustments to your machines - any patient or family member can make any adjustments they want - outside of that it requires a doctor, respiratory therapist or an authorized tech to do so legally or they can run into issues of practicing medicine without a license.   California lists CPAP as a 'dangerous medical device'. However, they only enforce their rules on companies who have set up shop and not individuals.

Second, you can submerge the entire heated tube in water.  Just do it in the am so that it has time to dry before using at night.  I use warm water and a little dish soap. You can also use children's hair shampoo.

Lots of medical people don't know what's allowed and not allowed.  I've had diabetic educators freak out when I told them that I could get insulin at Walmart with no prescription. Most don't even believe me (this is at the endo.  At my regular clinic, they were the ones who told me to just go to Walmart until I got in to the doc).

What you are saying about not being illegal to sell or give away a used CPAP machine makes more sense than anything else I've heard. 

---

I have two questions. First off, why do I keep finding people saying it is illegal to buy or sell cpap machines outside of an hme or a doctor's prescription?
      
Second, how do you personally clean your heated tube? I know I should not submerge the end with the electrical connector, but should I just use hot water? hot water and a little dish soap?  What have you had the best luck doing?

Except in California, there are no restrictions on used machines anywhere in the US.  They are giving you false information because they don't know any better.  The FDA only regulates the manufacture of NEW machines - they have nothing to do with the secondary market.  Technically, anybody can sell new machines as well - just because it says on the machine 'prescription only' does not make it so.  State laws DO regulate who may make adjustments to your machines - any patient or family member can make any adjustments they want - outside of that it requires a doctor, respiratory therapist or an authorized tech to do so legally or they can run into issues of practicing medicine without a license.   California lists CPAP as a 'dangerous medical device'. However, they only enforce their rules on companies who have set up shop and not individuals.

Second, you can submerge the entire heated tube in water.  Just do it in the am so that it has time to dry before using at night.  I use warm water and a little dish soap. You can also use children's hair shampoo.

Lots of medical people don't know what's allowed and not allowed.  I've had diabetic educators freak out when I told them that I could get insulin at Walmart with no prescription. Most don't even believe me (this is at the endo.  At my regular clinic, they were the ones who told me to just go to Walmart until I got in to the doc).

What you are saying about not being illegal to sell or give away a used CPAP machine makes more sense than anything else I've heard. 

---

I have two questions. First off, why do I keep finding people saying it is illegal to buy or sell cpap machines outside of an hme or a doctor's prescription?
      
Second, how do you personally clean your heated tube? I know I should not submerge the end with the electrical connector, but should I just use hot water? hot water and a little dish soap?  What have you had the best luck doing?

Except in California, there are no restrictions on used machines anywhere in the US.  They are giving you false information because they don't know any better.  The FDA only regulates the manufacture of NEW machines - they have nothing to do with the secondary market.  Technically, anybody can sell new machines as well - just because it says on the machine 'prescription only' does not make it so.  State laws DO regulate who may make adjustments to your machines - any patient or family member can make any adjustments they want - outside of that it requires a doctor, respiratory therapist or an authorized tech to do so legally or they can run into issues of practicing medicine without a license.   California lists CPAP as a 'dangerous medical device'. However, they only enforce their rules on companies who have set up shop and not individuals.

Second, you can submerge the entire heated tube in water.  Just do it in the am so that it has time to dry before using at night.  I use warm water and a little dish soap. You can also use children's hair shampoo.

Lots of medical people don't know what's allowed and not allowed.  I've had diabetic educators freak out when I told them that I could get insulin at Walmart with no prescription. Most don't even believe me (this is at the endo.  At my regular clinic, they were the ones who told me to just go to Walmart until I got in to the doc).

What you are saying about not being illegal to sell or give away a used CPAP machine makes more sense than anything else I've heard. 

---

I have two questions. First off, why do I keep finding people saying it is illegal to buy or sell cpap machines outside of an hme or a doctor's prescription?
      
Second, how do you personally clean your heated tube? I know I should not submerge the end with the electrical connector, but should I just use hot water? hot water and a little dish soap?  What have you had the best luck doing?

Except in California, there are no restrictions on used machines anywhere in the US.  They are giving you false information because they don't know any better.  The FDA only regulates the manufacture of NEW machines - they have nothing to do with the secondary market.  Technically, anybody can sell new machines as well - just because it says on the machine 'prescription only' does not make it so.  State laws DO regulate who may make adjustments to your machines - any patient or family member can make any adjustments they want - outside of that it requires a doctor, respiratory therapist or an authorized tech to do so legally or they can run into issues of practicing medicine without a license.   California lists CPAP as a 'dangerous medical device'. However, they only enforce their rules on companies who have set up shop and not individuals.

Second, you can submerge the entire heated tube in water.  Just do it in the am so that it has time to dry before using at night.  I use warm water and a little dish soap. You can also use children's hair shampoo.

Lots of medical people don't know what's allowed and not allowed.  I've had diabetic educators freak out when I told them that I could get insulin at Walmart with no prescription. Most don't even believe me (this is at the endo.  At my regular clinic, they were the ones who told me to just go to Walmart until I got in to the doc).

What you are saying about not being illegal to sell or give away a used CPAP machine makes more sense than anything else I've heard. 

[Diotima245]

https://www.justice.gov/usao-ndga/pr/cou...al-devices


Couple charged with illegally selling prescription medical devices
Tuesday, January 30, 2018

ATLANTA - Kimverlee Aderhold and Eric E. Ramey, Jr., have been arraigned on federal charges of unlawfully selling stolen medical devices that require a prescription without an actual prescription. Aderhold and Ramey were indicted by a federal grand jury on January 23, 2018.

“The medical products the defendants allegedly stole can only be obtained with a prescription from a medical provider,” said U.S. Attorney Byung J. “BJay” Pak. “They sold them to unsuspecting consumers without determining whether the products were safe for the consumers to use and without instructing the consumers on how to use the products safely. In doing so, the consumers’ health and safety were placed in jeopardy.”

“When prescription devices are stolen and diverted from the legal supply chain, there is no longer any assurance that the products are safe and effective for their intended uses,” said Peter Kuehl, Acting Special Agent in Charge, FDA's Office of Criminal Investigations' Miami Field Office. “This announcement should serve as a reminder of the FDA's continued focus on individuals that put profits ahead of the health and safety of U.S. consumers.”

According to U.S. Attorney Pak, the charges, and other information presented in court: Aderhold was employed as the Retail Manager in Georgia for Advanced Home Care, a durable medical device company that has retail locations in Marietta and Norcross. Advanced Home Care is a retail distributor of CPap and BiPap machines and portable oxygen concentrators. The use of these medical products is not safe except when used under the supervision of a medical practitioner licensed by law to oversee their use. Federal law requires that CPap and BiPap machines and portable oxygen concentrators be purchased only with a prescription issued by a licensed medical practitioner.



Aderhold allegedly stole CPap and BiPap machines and portable oxygen concentrators from the inventory of the Advanced Home Care stores she managed. She and Ramey would advertise the stolen products for sale, primarily on Craigslist. Once a buyer responded to their advertisement, Ramey or Aderhold allegedly would meet with the buyer and sell the stolen medical equipment for cash only. The defendants did not ask the buyers to produce prescriptions for the devices. Ramey and Aderhold did not provide instructions to the buyers regarding the safe use of the stolen medical devices.



Kimverlee Aderhold, 27, and Eric E. Ramey, Jr., 31, both of Grayson, Georgia, were arraigned before U.S. Magistrate Judge Catherine M. Salinas, and are charged with conspiring to steal medical products that can be obtained only with a prescription and possession of the same stolen medical products. They are also charged with multiple counts of theft of such medical products and possession of stolen medical products. Members of the public are reminded that the indictment only contains charges. The defendants are presumed innocent of the charges and it will be the government’s burden to prove the defendants’ guilt beyond a reasonable doubt at trial.

[Big Guy]

I see plenty of new and used SA machines on CL all the time. As well as all the equipment that is associated with them.

[3rdMarDiv]

I see plenty of new and used SA machines on CL all the time. As well as all the equipment that is associated with them.

Right...Somebody is confusing criminal intent, fraud, misrepresentation, etc., with person to person sales. If someone wants to upgrade and sells their used machine, a family member dies and their machine is sold on CL, etc., transactions are totally different. 

[Sleeprider]

Diotima245, thanks for your post regarding the indictment of the couple charged with "unlawfully selling stolen medical devices that require a prescription without an actual prescription"  I am including more specific cites of the indictment below, and it should be noted that although this indictment was handed down January 30, 2018, there has been no word of a trial or settlement in the case. 

I think the legal case tying FDCA regulations with the couple's behavior are convoluted and included mainly to establish Federal jurisdiction in a case where the main problem is theft, deception and embezzlement.  The construction of this case is interesting and apparently remains to be prosecuted or even scheduled for trial.  My opinion, which is worth what you paid for it, is that this matter was probably dropped by the US DOJ and the defendants may have been prosecuted for the easily proven theft charges; however I have found no record or news article of such prosecution.  My point is that the case to extend FDA regulations regarding distribution of prescription devices to individuals is secondary to the criminal activities of these defendants. I don't see any federal prosecution of the rampant marketing of devices by individuals and businesses outside of the accepted physician / DME marketing channels.

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION

V,

KIMVERLEE ADERHOLD ERIC E. RAMEY, JR.

No. 1:2018cr00018

Criminal Indictment

THE GRAND JURY CHARGES THAT:

Count One

INTRODUCTION

1. The FDA is the federal agency responsible for protecting the health and safety of the American public by ensuring, among other things, that medical devices are safe and effective for their intended uses and bear labeling that contains true and accurate information. FDA's responsibilities include regulating the manufacture and distribution of medical devices shipped or received in interstate commerce, as well as the labeling of such medical devices. FDA carries out its responsibilities by enforcing the FDCA and other pertinent laws and regulations.
   
   
   
2. The FDCA defines a medical device as, among other things, "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes." 21 U.S.C. §§321(h)(2), 321(h)(3).
   
   
3. A prescription device is a device which, because of its potential for harmful effects, methods of use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to direct the use of such device. 21 C.F.R. § 801.109.
   
   
4. Under the FDCA, devices are deemed to be "misbranded" unless their labeling bears adequate directions for use. 21 U.S.C. § 352(f)(1). Under regulations promulgated by the FDA, "adequate directions for use" is defined as directions under which a layman can safely use a drug or device for its intended uses. 21 C.F.R. § 801.5
   
   
   
5. Prescription devices by their very nature are safe for use only under the supervision of a licensed practitioner. See 21 C.F.R. § 801.109. Adequate directions for use, therefore, cannot be written for prescription devices, and prescription devices are per se misbranded under 21 U.S.C. § 352(f)(1). To allow for the lawful movement of prescription devices in interstate commerce, FDA regulations exempt prescription devices from the adequate directions for use requirement, but only if certain conditions are met. See 21 C.F.R. §§ 201.100 (drugs) and 801.109 (devices).
   
   
   
6. Two such conditions require that the device is: (a) in the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; and (b) is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice. See 21 C.F.R. § 801.109(a)(l)(i) and (2).
   
   
   
7. Under the FDCA, the doing of any act to a device, after the device or its components have moved in interstate commerce and while such device is held for sale, which results in the device being misbranded, is prohibited. 21 U.S.C, § 331(k).
   

DEVICES AT ISSUE

• 8. Continuous positive airway pressure (CPap) and Bi-level positive airway pressure (BiPap) machines are devices that deliver air through a tube into a mask that fits over the nose. While CPap machines generally deliver a single air pressure, BiPap machines deliver two-levels of air pressure - an inhale pressure and an exhale pressure. CPap and BiPap machines are both used to treat sleep apnea. BiPap machines are often also used to treat conditions other than sleep apnea, such as certain pulmonary conditions like chronic pulmonary obstructive disorder (COPD) or cardiac conditions like congestive heart failure. CPap and BiPap machines are both prescription devices under the FDCA.
  
  
• 9. Portable oxygen concentrators (POC) are portable medical respiratory therapy devices that deliver concentrated oxygen to a respiratory patient. POC takes ambient air and filters out everything except for the oxygen. POCs are prescription devices under the FDCA.
  

The Conspiracy and Its Objects

• 10. Beginning on or before September 15, 2016, and continuing until on or about September 5, 2017, in the Northern District of Georgia and elsewhere, defendants, KIMVERLEE ADERHOLD and ERIC E. RAMEY, JR., did knowingly and willfully combine, conspire, confederate, agree, and have a tacit understanding with each other to commit the following offenses:
  

• a. In and using means and facilities of interstate commerce, to steal, and by fraud and deception obtain, and knowingly and unlawfully take, carry away, and conceal pre-retail medical products, that is CPap, BiPap, and POC devices, in violation of Title 18, United States Code, Section 670(a)(1); and
  
  
• b. In and using means and facilities of interstate commerce, knowingly to possess, transport, and traffic in pre-retail medical products, that is CPap, BiPap, and POC devices, that were involved in a violation of Title 18, United States Code, Section 670(a)(1), in violation of Title 18, United States Code, Section 670(a)(3).
  

[SarcasticDave94]

When I do clean parts, I submerge the heated hose fully, and using hot water and Dawn (or equivalent) dish soap.

[Mosquitobait]

This is all about Pre-retail medical equipment being sold out the back door. No different from a pharmacist who sells some of his drugs cut rate and off-book. Again, FDA has nothing to do with USED machines. Once someone buys the machine from a provider, it's used.