Kevin Dent was instructed by the General Dental Council ('GDC') in the recent case of the GDC v Sheikh. Following the recent ruling, the GDC has issued guidance on the importance of dentists using and buying safe and legitimate equipment in order to protect patients.
Mr Sheikh is a dentist who was referred to the GDC following an investigation by the MHRA in respect of counterfeit and non-compliant dental equipment used by the defendant at his dental practice.
The registrant was found to have used counterfeit dental equipment in respect of a dental handpiece. He was also found to have purchased non-compliant dental equipment, namely handpieces, through eBay.
The MHRA inspected the registrant's practice in January and seized various items including non-compliant dental equipment.
Following this, in February , the registrant purchased further non-compliant handpieces from eBay despite warnings from MHRA not to do so. The registrant was found to have acted dishonestly when making these further purchases in February
The MHRA again inspected the surgery in July and R was found to have failed to co-operate with the MHRAs investigation on that date.
The registrant admitted that these purchases put patient and staff potentially at risk. There was no evidence that patients or staff had actually been harmed.
The registrant was suspended for 3 months without a review.
Jonathan Green, Director of Fitness to Practise at the General Dental Council, said:
“This case shows the importance of Dentists and DCPs adhering to the standards around compliant dental equipment. Non-compliant equipment endangers the health of both the patient and those using it and it is vital that all items meet safety requirements.
“As set out in our Standards for Dental Professionals, all members of the dental team must understand and follow the law and regulations in this important area, which go to the heart of patient protection. They must always put patients’ interests first.”
Kevin has built up a wealth of experience over 20 years in fraud and serious crime, and is often instructed as leading counsel. The core of Kevin’s practice is fraud, revenue evasion, money laundering, and healthcare frauds. Kevin is often instructed in multi-million pound fraud cases involving large volumes of complex material calling upon Kevin’s keen eye for detail.
Kevin is often instructed in matters relation to regulatory and professional discipline proceedings, particularly in relation to cases concerning medical professionals.
Warning as potentially-dangerous dental equipment is sold on eBay
Regulators issue alert as they work with internet shops to crack down on counterfeit medical devices
People should be cautious when buying any dental or medical equipment from the internet because unapproved medical devices can be dangerous or ineffective
The seizure of a number of potentially-dangerous dental instruments, including a portable X-ray unit that could emit harmful radiation, has led to a warning being issued by regulators.
The Medicines and Healthcare products Regulatory Agency (MHRA) today issued an alert to dental staff and individuals to be wary when buying dental equipment over the internet after enforcement officers raided a business address in the West Midlands.
At the property, they found fake dental instruments including scaler tips, light curer composite, gutta percha points, dental cleaning and scraping tools and detail high-speed handpieces that were not CE marked and did not carry the appropriate warnings or instructions for use as approved medical equipment does.
The MHRA carried out the raid after an anonymous complaint was received with regards to a non-CE marked portable dental X-ray unit that was purchased on eBay. Tests later revealed one of the machines available for sale had a lack of sufficient shielding in the X-ray tube, which could put patients and operators at risk of harmful radiation levels.
The MHRA is warning potential purchasers to be on the lookout for the following indications that equipment may be counterfeit or faulty.
- Instruments that have no recognised brand name and have missing information on the packaging
- No instruction leaflet included detailing how to use the device
- No lot or batch identification number listed
- No CE mark affixed
- No manufacturer or European representative details listed
- No four-digit unique identification number to show the device has been through the appropriate Notified Body assessment
John Wilkinson, the MHRA’s director of devices, said the regulator was now working with eBay to prevent any further unapproved devices being sold. He added: “People should be cautious when buying any dental or medical equipment from the internet because unapproved medical devices can be dangerous or ineffective.
The MHRA is committed to protecting the public and is working with internet sites to ensure that fake medical devices are not sold
“The MHRA is committed to protecting the public and is working with internet sites to ensure that fake medical devices are not sold. We urge the public to report faulty medical devices via our adverse incident hotline on or via our website at www.mhra.gov.uk.”
The warning over dental instruments follows a similar alert in June after MHRA teams raided addresses in Harrow and Oxford and uncovered more than fake thermometers, which were also being sold over the internet.
In that case they were tipped off after the parents of a young child with leukaemia used a thermometer they had bought online and realised it was giving a misleading reading. Their child had a high temperature and was rushed to hospital to receive urgent medical care, despite the device showing no abnormality.
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Fake dental products on eBay
The Medicines and Healthcare products Regulatory Agency (MHRA) has warned dentists and the public about buying dental equipment from the Internet after its enforcement investigators seized a number of potentially dangerous fake dental instruments.
At a business address in the West Midlands, an MHRA raid seized fake dental instruments consisting of scaler tips, light cured composite, gutta percha points, dental cleaning tools and high speed handpieces not CE marked and not carrying warnings or usage instructions.
The MHRA launched the raid after an anonymous complaint was received with regards to a non-CE marked portable dental X-ray unit bought on eBay. Tests revealed that one of the machines available for sale lacked sufficient shielding in the X-ray tube.
The MHRA advises that fake medical equipment can be spotted by looking out for the following: the dental instruments have no recognised brand name and the packaging has missing information; an 'instructions for use' leaflet is not enclosed with the product; no lot or batch identification number is listed; no CE mark is affixed; no manufacturer or European representative details are listed; the product has no four digit unique identification number.
The MHRA is working with eBay to prevent any further unapproved devices being sold.
You can report faulty medical devices by phoning or via the website at www.mhra.gov.uk.
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Fake dental products on eBay. Br Dent J, (). https://doi.org//sj.bdj
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Huge fake dental equipment haul
By Branwen Jeffreys
Health correspondent, BBC News
More than 12, pieces of illegal dental equipment have been seized in the UK in the past six months.
The products, ranging from drills to X-rays, were counterfeit copies of major brands or sub-standard with fake documentation.
Some products appeared to have official safety CE marks, but importers said it meant "Chinese export".
The regulator said that dentists could be prosecuted if they knowingly bought equipment that put patients at risk.
The items were discovered during an investigation by the Medicines and Healthcare Regulatory Agency (MHRA), which is responsible for making sure that dental equipment in the UK meets safety standards.
Among the items seized on arrival in the UK were poorly made dentist power drills and handheld X-ray machines with dangerous wiring.
Danny Lee-Frost, from the MHRA enforcement team, said there was a real risk to patients from equipment that does not meet strict European safety standards.
He said: "We don't need to stretch your imagination too far to think if you've got a high-speed drill, operating at 30, revs per minute in close proximity to your teeth, and the end falls off, it's going to do some pretty serious damage inside your mouth. "
Dental equipment is easy to find for sale at a low price online, including on major e-commerce sites such as eBay and Amazon. Both worked with the MHRA in the investigation.
The MHRA said it was working with retailers to make them aware that some of the equipment was being sold with fake certificates or counterfeit branding.
Some of the drills are marked with the letters CE implying they meet the European safety standards.
When challenged, some importers have said this simply stands for "Chinese export".
Sonia Tracey, from the dental manufacturer W&H UK, said dentists should realise that some of the drills being sold online were implausibly cheap.
"A dental turbine, which most people would know as a drill, was being sold online for £
"There is no way you can buy a good quality product at £70 - you would be looking at a £ to £ difference."
She points out that dental equipment has to be repeatedly sterilised to keep patients safe, and if it is not robust enough, it will fall apart.
Jade Blinco was injured by poorly maintained dental equipment, not imported tools, but it is a reminder of the importance of safety standards.
The year-old, who wanted to be a model, was left with a scar after a drill broke in her mouth.
She said: "My face feels funny in winter and summer, hot and cold food, it tingles.
"I constantly worry about it - I feel it pulling and tugging even when I'm talking."
The British Dental Trade Association has launched a campaign to encourage dentists to report suspect equipment.
Danny Lee-Frost, from the MHRA, said dentists who knowingly bought equipment that doesn't meet regulations "could be struck off, they could be sued, all for saving a few pounds on stuff they use every day".
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Learn from the mistakes of others. You can never live long enough to make them all yourself.
In business and in life, paying for the experience of others is often money well spent. If you are reading this blog because you want to sell your CEREC, youre in luck. I am sharing my experience for free! In this blog, I provide a summary of options for selling your CEREC system.
Option 1: Sell it Yourself (a.k.a. the hard way)
There are no shortage of options when it comes to selling things on the Internet, but when it comes to selling CERECs, eBay has no equal. I have tried everything from Facebook, Adwords, DentalTown, DotMed, Craigslist and various other used dental equipment sites. None of them offer the worldwide platform, payment systems, listing capabilities or general all-in-one sales solution that eBay provides. Now, this is not to say that selling your CEREC on eBay is easy. In fact, it is very difficult, but thats not the result of a deficiency with eBay, but rather with the seller. Let me explain.
If you are not a regular eBay user, you will be challenged with zero to little positive feedback and/or a low rating. You havent necessarily done anything wrong, but in the eyes of shoppers you are a high risk seller. That feedback rating is like your credit score; and nobody wants to give money to people with low credit scores. Even if you are a regular eBay user and may have great feedback ratings, chances are it is as a consumer, not a seller. Most buyers dont care if you paid for that vintage action figure in a timely manner. They want to know what you have sold lately. How many items have you sold? What are the value of those items? Basically, buyers want to know if they can trust you with a big ticket purchase. In most cases, a CEREC machine will be far and away the most expensive thing you have for sale, if not the only thing. With the number of eBay scams involving CERECs going around these days, low feedback and a meager sales history is enough to put you at a serious disadvantage right out of the gate. Poor or scant seller feedback affect buyer confidence, which goes hand in hand with price. This is because peace of mind is a commodity in and of itself. As a result, most individual CEREC sales on eBay are undervalued.
Perform a search for the same type of CEREC you have to sell on eBay and filter the results to show Sold Listings only. You will find that most of the listings populated by the search were sold by dental equipment companies. If you are able to locate an item from an individual seller, I am confident you will find the sales price to be noticeably lower than its peers. With so many options available from established businesses with a solid track record of sales, many buyers dont seem to be interested in taking their chances with an individual seller.
But for the sake of argument, lets say that you create a visually appealing, thorough and compelling listing. You develop a solid rapport with a buyer through the messaging system and made them an attractive offer, which was accepted. Woohoo! You did it!
Well, hold on there just a minute partner- now youve found out that eBay charged you a $ final value fee, PayPal took an uncapped % off the top, and % of the funds have been placed on hold for 21 days, pending your ability to provide proof of delivery. Now what? The CEREC system is too large and heavy for USPS, UPS or FedEx. So how do you pack it? Who do you ship it with? Whats the freight class? What on earth is an NMFC code? How much does this weigh? Do you need a liftgate? Whats considered Limited Access? How do you fill out a Shippers Letter of Instruction? How much does it cost? This is the part where experience, earned or bought, pays dividends.
Aside from the riddle that is CEREC shipping, there are common frustrations that both professional and amateur eBay sellers must deal with from time to time, including disputes with a buyer. Amateur CEREC sellers are more prone to disputes because they have a tendency to be light on the details in the item or condition description fields. Buyers typically shy away from listings that are lean on the details anyway, but if someone does purchase the system and you were a little careless with describing your item, then you have almost guaranteed yourself a problem down the road. Buyers have up to 30 days after delivery to open a case or request a refund under eBays Buyer Protection Policy, in spite of your claims of no returns or sold as-is. After a case has been opened, PayPal will freeze your funds (again) and give you and the buyer 3 business days to come to a solution. If you cant, eBay will step in and force a solution upon you, which is usually not seller friendly. In situations like these, the effort you put into the listing on the front-end could be your saving grace.
To sum up the do-it-yourself option: this offers perhaps the largest potential return, but comes at the considerable expense of time, effort and risk.
2. Wholesale it to a Used Dental Equipment Company (a.k.a. the easy way)
This strategy is perhaps the fastest way to get rid of your CEREC, but it comes at a price. The dental equipment business is a high overhead business. Maintaining an inventory requires a sizable investment, so businesses have to be selective. This is especially true when dealing with CEREC. Most used dental equipment companies wont touch the technology. A select few will, but only if the price is really attractive. Essentially, if theres no chance theyll hit a home run, they wont bother swinging. Most times, a cash offer will be % or less of the resale value of the equipment. For most sellers whove paid $k+ for their CEREC, selling at wholesale prices isnt going be an appealing option. However, if you are in a situation where you have relatively little invested into the product or money is tight, sometimes speed is more valuable than return.
There are three companies known to purchase used CERECs with cash: CAD/CAM HERO (Texas), Atlas Resell (Idaho) and 4 Star Dental Equipment (Florida). Id suggest contacting all three to compare offers, terms, the process, etc.
In summary, wholesaling to a used dental equipment company is recommended for anyone with minimal investment into the machine or those that require fast cash as a matter of preference or need.
3. Consignment (a.k.a. working smarter not harder)
The simple definition of consignment is the agreement to pay the supplier of goods after the goods are sold. It is a very appealing option for those with high value systems or for anyone who would prefer to let someone else do the heavy lifting in exchange for a slice of the pie. The following companies will sell your CEREC on consignment:
Atlas Resell Management (atlasresell.com)
O3 Asset Management Group (o3amg.com)
Global Imaging Resources (globalimagingresources.com)
And of course, theres CAD/CAM HERO. We are extremely confident that we offer the most seller-friendly consignment program available (thats why we just supplied you with links to our competitors).
Some highlights include:
- A no cost, in-person inspection.
- A no strings attached handshake agreement until your CEREC is sold.
- A return visit by a CAD/CAM HERO representative to pack and ship the system.
- Up front payment (some deals may involve alternative arrangements, but you will know beforehand and have the option to decline).
- Industry low consignment fees of %.
For the do-it-yourselfers out there, eBay is your best bet. Although eBay and PayPal fees will take a good chunk of change out of the deal ($1, on a $30, deal) and they will probably hold onto the money for a few weeks, it will still offer the highest potential return in exchange for considerable effort. Wholesaling your CEREC for cash is going to be the fastest and most convenient way to liquidate the asset, but youll also be giving up on 50% or more of the value. Consignment will be the preferred strategy for those with high-value equipment or who dont have the time or will to do it all by themselves. No matter which way you go, CAD/CAM HERO is available to provide you with honest feedback and guidance to assist you with making the right decision for you.
Thank you for reading.
For prompt, professional and effective help with selling your CEREC system, call the CAD/CAM HERO at () DTL-HERO.
What you need to know about buying dental products through a secondary marketplace
Our caution to clinicians is to remember, when you buy something through a secondary marketplace, there’s nothing a manufacturer can do when something goes wrong. Things may be great for 90 days or so, but on that day when something breaks or there is a failure, our hands and the dealers’ hands are tied because we and/or our authorized dealers weren’t involved in the transaction. The correct course of action goes back through the company that actually filled the order for the doctor.
Henry: What can you and Midmark do about secondary marketplace sales?
Aycock: We have spent many hours researching and working with counsel to find solutions. There is a limit. From the standpoint of someone reselling one of our products, they can’t use any of our photos or copyrighted materials such as descriptive wording we have in flyers, collateral, or ads. They also can’t make a misleading statement about our product. If they want to use their own photos and their wording, there’s not much we can do. The FDA does have a standard if in a transaction for a controlled device like a handpiece, laser, sterilizer, or implant in that the buyer and seller both must comply with FDA standards. For instance, a dental dealer and a dentist are both running businesses that have been given the green light by the FDA for these transactions. However, those checks aren’t in place at eBay or other online marketplaces. I’ve had conversations with eBay, and they have been very active and responsive to our concerns. As an online marketplace, they push the transaction responsibility to the seller and the buyer. They are not auditing any activities to confirm they are compliant with the correct standards or approved to sell the products advertised. Any violations of any kind need to be brought to the attention of eBay or the online marketplace.
The biggest problem, in my view, is all of the non-FDA approved products coming in from overseas. The FDA simply doesn’t have the resources to follow up on something that is questionable on every secondary or online marketplace out there. There’s certainly an interest to keep things like this from happening, but the resources simply aren’t being used to find these products that might be dangerous to patients and staff members in the office. Working directly with eBay, we have had more than devices removed from their site because they were not FDA-approved. It is shocking to think how many of these products have slipped through the cracks.
Henry: What if a dentist sees an offer out there at a price that seems almost too good to be true?
Aycock: Chances are, it is. Have a conversation with your sales rep who comes into your office and ask him or her why the price online is so much lower than what he or she is offering. There is likely a good explanation. The products may not be the same. The service levels will likely never be the same. My experience has shown that the dealers support, expertise, and the transaction terms always exceed those of the online seller. The services provided through your local rep include warranty, setup, installation, and more. When ordering from a secondary marketplace online, you don’t have any of that.
Also, I would definitely warn against “bait and switch” tactics. That could be a Midmark sterilizer in the photo seen online, but when you receive the product, it’s a completely different product, or a no-name brand, or even a knock-off from overseas.
It is very important to fully understand the full extent of the freight, delivery, and installation of the product being ordered. I’ve heard of one truck driver who simply pushed the equipment out of the back of the truck when the dental office didn’t have the resources to help unload it. If that happens to you, and you bought from an online company or an unauthorized distributor, there isn’t anything a manufacturer can do to help the office. There’s no paper trail, and the transaction isn’t between the office and the manufacturer. It is between the office and this nameless, faceless online company.
Henry: Any final thoughts or words of advice?
Aycock: Don’t forget that when it comes to complying with the FDA, your dental board, CDC, OSHA or any regulatory body, the ultimate responsibility lies with the clinic that makes the final purchase. If you’re a dentist, you have to know you are purchasing an FDA-approved product, that everyone on the staff complies with the proper use, and the piece of equipment performs properly. If you can’t say that and something happens in your practice, the regulatory body and media will say you were the dentist who wasn’t using an FDA-approved device to treat patients. At that point, your ability to practice and your reputation will be questioned.
We all want to ensure the safety of patients and team members. Often, the family of the dentist and team members will be patients of the practice. Do you really want to treat them with something that isn’t FDA-approved or doesn’t comply with all of the rules that are used to regulate your office?
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