- 1 Is a Cure for Snoring Getting Closer?
- 2 OTC Anti-Snoring Devices are sold with exaggerated claims:
- 3 Claim 1 – OTC devices stop your snoring
- 4 Claim 2 – Does What the Expensive Ones Do
- 5 Claim 3 – OTC devices are ‘Cheap’
- 6 Claim 4 – Easy to Self-Fit
- 7 Claim 5 – Quick Fix – No Need to Wait
- 8 Claim 6 – Adjustable in Protrusion
- 9 Claim 7 – Fits Most People’s Teeth and Jaws
- 10 Claim 8 – NHS Recommended, FDA Cleared or Trusted by Doctors
- 11 Claim 9 – OTC Anti-Snoring Devices are: Low-Risk
- 12 OTC Devices delay Diagnosis and Treatment
- 13 Conclusion
- 14 The Real Problem
- 15 PostScript
- 16 Found this useful?
- 17 References
Is a Cure for Snoring Getting Closer?
I read with professional interest a recent (Mar 2018) Guardian post exploring whether a ‘Cure for Snoring‘ was getting closer.
The journalist began her piece by visiting a German museum of epic snoring cure fails, and touched on ‘jaw advancing devices’. Ignoring how the terminology made me cringe, the gist of the post was that ‘mouthpieces’ or mandibular repositioning devices (MRDs) have greatly improved in recent times.
The story continued with various commentators opinions (I’m not going there), but sadly it failed to explain the right way to get a mouthpiece, which ones to get, and why it matters.
In this definitive post, I explore the fiercely competitive, online market, for Over-the-Counter (OTC) Anti-Snoring Devices.
OTC Anti-Snoring Devices are sold with exaggerated claims:
Stops Your Snoring, Does What the Expensive Ones Do, Quick-Fix, No Need to Wait, Cheap, Easy to Self-Fit, Adjustable in Protrusion, FDA Cleared, NHS Recommended, Trusted by Doctors, Money-Back Guarantee…
OTC Anti-Snoring Devices sound so great. So, in this definitive post I’m going to show you everything you need to know about their claims. I should add that while Over-the-Counter (OTC) devices/mouthpieces are sold by manufacturers or by seemingly credible distributors; they all have two things in common…
I wonder if you can guess what they are?
Researched over 4 years, this comprehensive exposé, also looks at the regulatory framework governing the device manufacturers.
Let’s dive in and see what we have…
Claim 1 – OTC devices stop your snoring
That’s what you buy OTC devices for…
Sadly, OTC anti-snoring devices do not always stop snoring. But don’t take my word for it, the BBC, when covering a ‘Which?’ report1 (the UK’s consumer champion) noted, that claims made for their success were an ‘exaggeration’.
Indeed, the BBC report had a callout box stating, “Many snoring products simply don’t live up to their claims”.
in other words… “they don’t work”.
Hmm… It seems lots of OTC anti-snoring devices are sold, and the Which? report is a bit old (2001), so could the Beeb and Which? have looked at the wrong devices?
Many snoring products simply don’t live up to their claims
Claim 2 –
Does What the Expensive Ones Do
You might think:
“I will try this (OTC anti-snoring device) and if it works, then I’ll get a custom one”?
Which on the face of it, seems reasonable. Yet, clinical research2 has shown this way of thinking, doesn’t stand up. Essentially, because OTC anti-snoring devices bear little resemblance to custom-made ones.
But it’s harmless right?
If you fail with an OTC anti-snoring device, you may also think custom-made anti-snoring devices won’t work, which is known as a ‘false negative’.
This ‘false negative’ delays people getting valid help. Which for the snorer with undiagnosed sleep apnoea, who has tried and failed with an OTC device, is a potentially life-and-death issue.
They may kill themselves (and others) should they fall asleep in unsuitable circumstances
Undiagnosed sleep apnoea sufferers are up to 15 times more likely to have road traffic accidents3. They may injure or kill themselves (and others) should they fall asleep driving or performing a similar vigilance critical activity.
BUT I was just warming up! There’s more about OTC anti-snoring devices – much more...
Claim 3 – OTC devices are ‘Cheap’
Over-the-Counter, anti-snoring devices range in cost from approx. £50 – £200 GBP. But remember you’re bypassing medical assessment and diagnosis, and then bypassing the dentist.
DIY appears to save money, but….
What are the risks of bypassing Dentists?
Moving past the medical risks of self-diagnosis for a moment…. which we’ll come to in Claim 5.
Dentists are experts in mouths, teeth and jaw-joints. Bypass them and self-fit your OTC anti-snoring device and you’re asking for trouble.
Always a pleasure, having failed at DIY, to then ask an expert to clear up after you…
When you bypass the dentist, you are:
- 1Self-diagnosing dentally, you’re determining that your oral hygiene, jaw joints, teeth and gums can cope with you wearing an anti-snoring device…
- 2Self-treating – you’re going to have to adjust the device (if it can be) to optimise your treatment and for it not to hurt you
- 3Self-monitoring – assuming you know what unwanted changes to look out for… it’s not easy to examine your own mouth and gums in the bathroom mirror…
From a dental perspective, if you use an OTC anti-snoring device your are ‘going it alone‘. The sleep-trained dentist would monitor your teeth for what is known as ‘uncontrolled orthodontic tooth movement’. Which means your teeth tilting in various undesired ways. This could result in a change to how the teeth in your upper and lower jaws bite together (creating what is known as a malocclusion).
That same sleep-trained dentist would also monitor your gums (periodontal condition) and jaw-joints. They wouldn’t prescribe a custom-made, anti-snoring device until they were sure it wasn’t going to harm you.
And, if they felt it necessary they would take X-rays to ensure your roots could withstand the lateral loads the device creates – and they carry professional indemnity insurance should anything go wrong…
While perspective is needed when considering tooth movement and breathing, a dentist and a custom-made, prescribed anti-snoring device can limit and control things.
Click to read: OTC devices cost you money and cause you pain
MONEY – perhaps much more than you would spend on a prescription alternative to correct jaw pain, dental and periodontal issues (assuming you don’t lose your teeth or any existing crown & bridge work aka ‘caps’).
PAIN – both short-term and perhaps permanent, chronic pain:
SHORT-TERM PAIN if you’re lucky, short-term pain from overloading individual teeth (typically the upper front incisors). This is short-term if you stop wearing the device, resume snoring, ‘put it down to experience’
PERMANENT (CHRONIC) JAW PAIN from an imposed incorrect ‘bite’ (when you close your teeth together). Jaw pain is known as temporo-mandibular joint dysfunction (TMD). It may be caused by devices that don’t close together evenly (known as a ‘premature posterior contact’) or devices that force your jaw to move beyond its limits.
Click to read: Risky Business
Having tried to wear the OTC device a few nights and found yourself dribbling profusely when it’s in your mouth, experiencing tooth ache and jaw-ache in the morning…. you might now think to return it for a refund.
Nope. You’re unlikely to be successful with any claim on the promoted ‘Money-back guarantee’, because the device is now ‘used’. Gotcha!
Permanent pain and occlusal change
So, OTC anti-snoring devices have other costs, even if financially they at first appear ‘cheap’. They may cause you permanent, chronic pain and occlusal change (which means how your teeth ‘bite’ together).
In 2014, an eminent British dental expert, Dr R.J. Wassell, published in the British Dental Journal4 about ‘Over-the-Counter’ devices (he focused on devices for people who grind their teeth – ‘bruxists’). This is relevant, because he notes OTC devices sold online (and he includes those for snoring and sleep apnoea) are purchased by individuals as a possible alternative to manage their condition, without the need for a dental or medical consultation.
He notes safety information on many internet sites was “notable for its paucity” or was totally lacking. He points out that manufacturers are not obliged to provide safety information online, but it must be provided with the product and observes that the MAUDE adverse events database5, maintained by the FDA, “showed a number of potentially serious adverse events associated with these splints including choking hazards, tissue damage and occlusal changes”.
Dr Wassell advised the GDC about the OTC device market in 2014. What are we to conclude from their apparent inaction, some 3 years on?
Claim 4 – Easy to Self-Fit
You should be screened for sleep apnoea before using any anti-snoring device (see Claim 5) and we looked at why going the DIY route (cutting out the dentist) is a bit dumb in Claim 3. However, for the sake of argument, let’s explore this ‘Easy to Self-Fit’ claim.
IF you read the instructions, you’ll learn you must heat up each part and – while its hot – ‘squidge’ (for want of a better word) the device onto your teeth.
Repeat this for the other jaw.
OK, not so bad you might think. But it gets worse…
For some devices, you must do both jaws AT THE SAME TIME and ensure both parts correctly line up. Or it won’t work and you can’t get your money back. Oh don’t forget to make sure it clicks comfortably into place or…
It won’t work.
If the pieces don’t line up – it won’t work – you will have to heat it up again, reform the material and try again. Assuming of course, that the material can withstand another heat cycle…
Try now to claim on the ‘Money-Back Guarantee’. Hah! Good luck with that!
But of course, this is exactly what the OTC device manufacturer wants. They’ve had your money after all – and there’s no comeback on them, if you give up. Regardless of whether it doesn’t work or causes you problems.
All the above assumes you fit the device – i.e. the shape of your mouth and the alignment of your jaws suit the device. Which is totally backwards, it would be like the shops only selling underpants in one or two sizes…
Anti-snoring devices, exist at the point where medicine and dentistry meet
Both are essential
Claim 5 – Quick Fix – No Need to Wait
Anti-snoring devices, exist at the point where medicine and dentistry meet.
Both are essential. I’ve highlighted the importance of the dental role. Here’s why assessment from a medical perspective is essential:
Medical assessment (screening for sleep apnoea at a minimum) for your breathing is a no-brainer. Subsequent dental assessment (should anti-snoring devices be the proposed option), is necessary because the anti-snoring device used to help you breathe, is in your mouth.
Cutting out either professional is, shall we say, ‘foolish’? Bypassing assessment and/or prescription (going the DIY route), is risky because the snorer may have undiagnosed, and therefore untreated, sleep apnoea/apnea.
If you go around professional assessment, ‘treat’ yourself with an OTC anti-snoring device and amazingly no longer snore (which is unlikely) you might assume you’re fine. Some professional argument exists here as to whether silencing snoring means its impossible to have obstuctive sleep apnoea (a silent apnoeaic). I don’t buy that.
Click to read: The correct way to approach a snoring or drowsiness problem:
- Professional screening for sleep apnoea using a recognised protocol
- Diagnosis if sleep apnoea is suspected
- Prescription of the appropriate therapy/treatment
If the proposed treatment is an anti-snoring device, you then have a dental examination prior to being prescribed an appropriate custom-made one.
Although not yet widely adopted, the UK refines this process further by permitting sleep-trained dentists to screen for sleep apnoea6, and in defined circumstances, provide a custom anti-snoring device, without a prior medical diagnosis. Sleep-trained dentist are ideally placed to help simple or ‘benign’ snorers.
This pragmatic solution short-circuits the costly, time-consuming and pointless referral to hospital, of anti-social snorers without sleepiness symptoms or other comorbidities (other related health problems).
The expensive-to-the-system (ask yourself who’s profiting?) alternative, which at the time of writing is current practice in the US and Europe is:
- For every snorer to be assessed by their GP (Primary Care Practitioner) and then if sleep apnoea/apnea is suspected, referred for further investigation to a sleep centre. This ‘paper assessment’ is time-consuming and requires knowledge that your GP/PCP may not possess.
- Only for the individual (who after consuming secondary care resources) doesn’t merit treatment with Positive Airway Pressure (PAP) therapy, to then be lost to the system, when they’re ‘advised’ to obtain an anti-snoring device (no formal referral being made due to a silo mentality – see my post about Guidelines for the medical profession).
And they’ve cost the system how many thousands of pounds/euros/dollars? Perhaps in some US States things aren’t so bleak, so perhaps I’m being cynical. But this IS the overall picture.
We’ve been over the medical and dental consequences of buying OTC anti-snoring device, but to summarise:
- Is BREATHING important to you? Assuming staying alive is important, why would you trust this device to keep your airway open, when you’re ASLEEP?
- How much would you pay for a pair of glasses (spectacles)?
- Quite a lot, I imagine because you consider it essential to see. Why then do you think your teeth, gums and jaw-joint are any less important?
- Do you like to eat without chronic long-term pain in your jaw joint(s)? and to retain your smile?
Claim 6 – Adjustable in Protrusion
(How much they push your chin forwards)
Some, but not all, OTC anti-snoring devices are adjustable in protrusion. In either relatively large steps or for more money, with a screw-thread at the front of the mouth, like a ‘volume control knob’!
The increment technology (approx. 2mm steps) is inherently flawed, because assuming everything else is good…, the difference between an effective position and a painful, impossible to tolerate one, may be much less e.g. 0.5mm.
Outcome: It won’t work
As for the ‘volume control knob’ type, you fit the device in one position and as you adjust it (most likely forwards, because you’re still snoring and think more advancement is required), the ‘biting’ relationship changes. Which changes the alignment of the upper and lower parts of the device, most likely making it hard or even impossible to close your mouth and put your teeth together evenly.
Now, you’re in trouble, whichever way you go:
- If you persist with the device (because you feel emotionally blackmailed by your partner) and ignore the pain, you risk creating permanent dental and jaw-joint issues. See Claim 3 above.
- If you stop wearing the device, you’re in ‘hot water’ with your partner, because you’ve ‘quit’ trying to stop snoring…
Oh, and forget the ‘Money-Back Guarantee’ – you’ve used the device. Did you read the small-print? No, thought not.
Claim 7 –
Fits Most People’s Teeth and Jaws
I covered ‘Easy – Self-Fit’ (Claim 4) above, and arguably, yes, the overall shape of OTC anti-snoring devices approximates people’s teeth and jaws BUT, and here’s the thing:
- 1OTC devices are inherently bulky (to make them ‘one-size-fits-all’ so they cannot be discrete and comfortable). Which means you may attractively dribble while it’s in your mouth. If it isn’t comfy you won’t wear it, and of course if you don’t wear it – it won’t work.
- 2You might struggle connecting the two parts, once in place in your mouth (upper and lower jaw). If you struggle with it – you’re unlikely to wear it – if you don’t wear it – it won’t work.
- 3It might not stay in place on your teeth. Your dentist will call this ‘poor retention’. If it doesn’t fit properly then (you guessed it) – it won’t work.
Above, are three more reasons why it’s pointless, struggling in the bathroom mirror with boiling water, squidging bits of hot plastic into your mouth. Incidentally, custom-made, prescription devices would be remade or professionally adjusted if they exhibited these problems.
You guessed it… but…
It won’t work
Claim 8 –
FDA Cleared or Trusted by Doctors
Where Everything Gets Lost with which Regulator is Responsible
Claiming to be ‘NHS Recommended’, is not something apparently regulated by the NHS. Consequently, it’s hard to find anything to substantiate, prove or disprove this claim – which is why they make it. Clever marketing. I can only guess that one rather uninformed NHS professional, in a moment of desperation perhaps, thought the OTC device was useful… and the manufacturer seized that opportunity.
In 2013, I contacted the United Kingdom’s Medicines and Healthcare Products Regulatory Authority (MHRA) about OTC devices. Time went by and not much appeared to happen. Months later, I chased them up. They suggested I contact the Advertising Standards Authority. Which I did. I also tried Trading Standards.
In desperation, I contacted the Care Quality Commission (CQC) who referred me back to the MHRA. The MHRA did eventually investigate, but couldn’t decide. So, “asked an Expert”, two in fact. Who couldn’t agree. Honestly, you couldn’t make this up.
I also contacted the Charities Commission because one business, seemed ‘confused’ about its commercial status, variously claiming to be a ‘not-for-profit’ organisation or a Charity.
The result of all the above?
The status quo: Encouraging snorers to DIY their diagnosis, ‘treatment’ and follow-up. Which is wrong on so many levels. Regrettably, unlike snorers, the above regulatory organisations are (so far) silent…
As for claiming ‘FDA Cleared’ [FDA means Food and Drug Administration and they control the US market for medical devices]…. my advice is to read what it is cleared for. OTC devices have been FDA cleared for snoring – not for sleep apnoea/apnea. This means the manufacturers can market them.
But, I must repeat, in the US (just like the rest of the world), there is:
NO WAY to differentiate between snoring and sleep apnoea/apnea symptoms without an overnight sleep study.
Seriously though, after reading this, do you think DIY is sensible? There’s more about the US system in Claim 9 below.
Click to read: Do You Recall This Materials Scandal?
Relying on a manufacturer’s assertion the product or materials used are safe (which is what you do with an EU Class 1 device, US Class 2 device) leaves you potentially at risk, should the manufacturer not be entirely honest. I’m not saying they’re all dishonest but…
Do you remember this?
French firm, Poly Implant Prothese (PIP) manufactured breast implants using industrial grade silicone not medical device grade7,8. And this was for an implanted medical device (EU Class 3) that should have been tightly regulated. Not something seen as ‘low-risk’ e.g. an OTC anti-snoring device….
Having a professional at least look at the product before you rely upon it to help you breathe while you’re defenceless (asleep) might be considered a good idea!
Surely consulting an expert is no-brainer…?
Claim 9 –
OTC Anti-Snoring Devices are: Low-Risk
A bunch of boring but essential rules exist for US and European medical devices. In medical device language, they control how devices are ‘placed on the market’.
In the process of researching this, I found some US pre-market notifications (FDA 510k’s) for OTC devices and observed that the FDA review boards for some were ‘dental’ (were any medical professionals involved?).
In Europe, the medical device ‘Class’ is defined by the manufacturer, when they register with the ‘Competent Authority’. If they choose, they may opt for ‘Low-Risk’ (Class I) without any checks on this decision – no external assessment. They may then put the CE mark on their packaging.
In this way, they’re:
- 1Avoiding the cost (and the commercial risk of failure) of a ‘Notified Body’ assessment
- 2Gaining access to the whole EU market without external verification of that decision
This trivialises undiagnosed sleep apnoea/apnea
Sadly, EU regulators appear impotent, despite my notification (and notifications by others and also some reputable professional organisations). They fail to protect the Public (yes, I did say that). They continue to allow unscrupulous businesses to sell gadgets directly to the Public, because the manufacturers have declared the product a ‘low-risk’ Class 1 device.
In May 2017, I happened to visit a leading brand, High Street pharmacy. Amongst the snore-relief products (which irritates me enough) I found an OTC anti-snoring device that claimed to treat SLEEP APNOEA/APNEA…
In the US, the FDA does assess whether medical devices are safe and categorised correctly, before they’re sold. The FDA took legal action against one manufacturer9 – yet the device is still available. The FDA did make the manufacturer stop claiming their product treats sleep apnoea/apnea. Consequently, the manufacturer calls it a ‘Snore Relief Device’…
A quote below from an OTC anti-snoring device website Disclaimer (brand name removed), where they proclaim the device is for sale in Europe without a doctor’s prescription and the materials are safe [accessed 22 Oct 2016]:
Click to read: OTC device Disclaimer
“The XXXXX mouthpiece is designed to cure snoring but the United States, FDA will not allow us to make the claim that our mouthpiece is a cure for sleep apnea, which is a medical condition. Should you suffer from this complaint then you should consult your doctor. While we do not claim to cure sleep apnea, many people have found relief from it as an additional benefit of eliminating snoring with the XXXXX mouthpiece.
Though the FDA won’t allow us to sell the XXXXXX anti-snoring mouthpiece without a doctor or dentist prescription, it is approved for sale in Europe under the European Union Seal of Approval without a doctor’s prescription.
We have deliberately decided to not pursue FDA approval for our product because of the associated costs that we would have to pass on to you, our customer. It has always been our intent to provide a low-cost snoring relief solution. Rest assured, 100% of our product is sourced and made in the USA with non-toxic, latex and BPA-free materials.
It just so happens that the XXXXXX mouthpiece also works very well as a “sports” mouthpiece. That is why we have decided to only sell the very same “anti-snoring” mouthpiece in the United States as a XXXXXX brand “sports mouthpiece”.
Stating: “Should you suffer from this complaint [sleep apnoea/apnea] then you should consult your doctor”, is scandalous. It is impossible to differentiate between snoring and sleep apnoea (unless you’re a sleep-trained expert!) If it was easy, we wouldn’t need Doctors or sleep units….
Arguing the toss, by saying manufacturers comply with the rules, just means the rules are wrong, inadequate or in reality unpoliced. Regardless of which side of ‘the pond’ you are, unscrupulous manufacturers are swerving the existing rules and lack of action by the regulators to sell (in my view) incorrectly categorised products that should be prescription items, directly to the naïve Public. Buyer beware!
To add insult to injury…. In the UK, anti-snoring devices (both OTC and custom-made) are classified by HMRC as ‘luxury items’10. Which means they’re standard rated (currently 20% VAT).
What an indictment!
It just goes to show, how poorly sleep related breathing disorders, of which snoring is one, are understood.
OTC Devices delay Diagnosis and Treatment
Encouraging self-diagnosis and self-treatment to profit from sales of an OTC anti-snoring device, is irresponsible, harmful to the individual’s health, costly and perhaps dangerous to society.
The step-by-step illustration below is meant to illustrate what typically happens. While fictitious and dramatised, it is based on typical disease progression.11
- 1“Johnny Snorer” self-diagnoses his snoring and buys an OTC Anti-Snoring Device online. Miraculously his snoring is silenced, but his undiagnosed sleep apnoea remains untreated:
he remains drowsy during the day, yet doesn’t snore at night.
- 2“Johnny” has a near-miss on the motorway because he ‘nodded off’ for a moment. This time, he’s fortunate not to have an accident. He brushes it off and later forgets all about it.
- 3“Johnny” is prescribed high blood pressure medication. He falls asleep on the settee immediately after dinner – every night. He never sees the end of the movie. His wife leaves the bedroom after he goes to sleep because his snoring is so bad.
- 4He wakes up with a headache every morning, feels hungry all the time, and struggles with his weight. His wife cannot broach the subject of his snoring, because it just ends up in blazing row.
- 5“Johnny” has lost interest in sex. His relationship is in crisis, he’s irritable and not much fun to be around. His weight gain is seemingly out of control.
- 6“Johnny” is diagnosed with type II diabetes. His GP sends him for dietary advice.
- 7His family thinks he “Drives like he’s Drunk” and are very worried about him.
- 8His work performance is woeful, and when he has an accident at work through inattention, his employer issues a formal warning and refers him to Occupational Health. His GP refers him for a sleep study.
- 9His obstructive sleep apnoea syndrome is diagnosed, some years after he began using an OTC Anti-Snoring Device.
- 10 He begins PAP therapy and rediscovers his love of life. His erectile dysfunction resolves itself and he begins to take exercise. He feels “ten years younger”. He fights to hold on to his job, his home and his family.
- 11 Sadly, irreversible damage has been done, to his heart, blood vessels and metabolism. He’s lucky not to have had a stroke.
Time and Money
I’ve indicted our regulators, examined flawed thinking, explored nine misleading claims and illustrated the bad practices commonly employed by OTC anti-snoring device manufacturers and their distributors.
Everyone likes to save money, but OTC anti-snoring devices are a false-economy, and in my view are incorrectly categorised medical devices, that delay sleep apnoea diagnosis and effective treatment.
The personal and socio-economic cost of quite possibly years of mismanaged undiagnosed sleep apnoea, through the inappropriate sale and use of OTC anti-snoring devices, far exceeds the cost of consulting trained professionals.
Effective, life-transformational, sleep apnoea therapy is NHS funded (it’s ‘free’ in the UK) because it makes economic sense for the NHS to pay for it12. Businesses that sell OTC devices have flourished in a vacuum because, until now, there has been no viable alternative. Snorers searched online and were easy ‘prey’.
The Real Problem
Is how these things are supplied
So what do you do if you snore?
Your GP is there to help, but you must realise that the NHS will NOT fix your snoring.
GPs must determine if your snoring is a symptom of sleep apnoea that needs a hospital referral for further investigation by sleep study. Their problem is that they’re ‘time-poor’.
The solution is to get someone else to screen you!
In the UK, a sleep-trained dentist can screen you for obstructive sleep apnoea and in defined circumstances provide a custom-made, anti-snoring device without a prior medical assessment.
We train dentists online to screen for OSA, and we are creating a signposting tool.
Grab our GP Guidelines for snoring and sleep apnoea, and take them with you.
The Two Commonalities?
Do you remember me hinting about two commonalities? Did you guess what they were?
Both OTC anti-snoring device manufacturers and their distributors want:
- 1You to DIY.
- 2To profit from your naivety.
They use crafty marketing to hide the risks of doing so, behind a low headline price. Waiting for a professional assessment might be frustrating, but ask yourself:
How long you have already ignored the problem?
When you know, whether you can or cannot breathe AND sleep at the same time, you think about treatment choices.
Not the other way around!
Found this post informative? Please share it with your snoring friends and their wives/partners. Thanks 🙂
I am reliably informed, (name withheld) that should a medical professional, suggest to a snoring patient that they use an Over-the-Counter anti-snoring device (self-fit), their professional indemnity insurer would consider them having acted outside their area of professional expertise.
They would then be personally liable for the dental consequences.
Clearly, the correct thing to do, is to refer to appropriate expertise: a sleep-trained dentist. I blogged about the need for Guidelines for the Medical Profession when it comes to oral appliance therapy, in 2012!
More about Snorer.me Signposting
Snorer.me signposting utilises the British Society of Dental Sleep Medicine (BSDSM) pre-treatment screening protocol, as published in the British Dental Journal (2009) by Prof. Stradling and Dr Dookun BDS.
This forms part of the ARTP (Association for Respiratory Technology and Physiology (UK)) Standards of Care for MRDs (mandibular repositioning Devices) 13.
The relevant extract from the Standards of Care Document:
Both Dental Protection (UK) Ltd and the Dental Defence Union would indemnify individual members to treat simple, uncomplicated snoring with an MRD following a pre-treatment screening protocol, without the involvement of a medical practitioner, subject to proof of appropriate, formal training. Such cover would be considered on an individual member basis, and application should be made to the relevant underwriting department.
Found this useful?
Let others know what you think.
- Snoring cures success ‘exaggerated’ http://news.bbc.co.uk/2/hi/health/1701735.stm [accessed 16th Oct 2016]
- Vanderveken OM, Devolder A, Marklund M, et al, 2008. Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea. Am J Respir Crit Care Med; 178: 197–202. Available here: http://www.atsjournals.org/doi/abs/10.1164/rccm.200701-114OC#.V9ukcFT_rio[accessed 12 April 2017]
- Horstmann, S. et al, 2000, Sleep related accidents in sleep apnea patients. Sleep 1;23(3):383-9.https://www.ncbi.nlm.nih.gov/pubmed/10811382
- Wassell, R. J. et al 2014. Over-the-counter (OTC) bruxism splints available on the Internet. British Dental Journal 216. E24. Available here: http://www.nature.com/bdj/journal/v216/n11/full/sj.bdj.2014.452.html [accessed 9th April 2017]
- FDA maintained MAUDE database of adverse events: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Search.cfm
- Stradling, J. and Dookun, R. 2009, Snoring and the role of the GDP: British Society of Dental Sleep Medicine (BSDSM) pre-treatment screening protocol, British Dental Journal, 206, 307 – 312. Available here: http://www.nature.com/bdj/journal/v206/n6/abs/sj.bdj.2009.214.html [accessed 12 April 2017]
- Breast implant register for UK in the wake of the PIP scandal. https://www.theguardian.com/world/2013/dec/29/breast-implant-register-established-pip-scandal [accessed 17th October 2016]
- Wikipedia link https://en.wikipedia.org/wiki/Poly_Implant_Proth%C3%A8se#Scandal [accessed 9th April 2017]
- The legal fight between the FDA and an OTC anti-snoring device manufacturer: https://www.meddeviceonline.com/doc/legal-brief-anti-snoring-mouthpiece-manufactu-0001 [accessed 8th August 2017]
- HMRC VAT Notice 701/57: health professionals and pharmaceutical products https://www.gov.uk/government/publications/vat-notice-70157-health-professionals-and-pharmaceutical-products/vat-notice-70157-health-professionals-and-pharmaceutical-products [accessed 27 Oct 2016]
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