The Personal Protective Equipment (PPE) Legislation and Sports Mouthguards

THE PERSONAL PROTECTIVE EQUIPMENT (PPE) LEGISLATION AND SPORTS MOUTHGUARDS

By Peter J Natt I Dr Garth Rolls-Willson

There is a lot of confusion and misinformation within the Dental Laboratory Industry regarding the implications of the Personal Protective Equipment (PPE) Legislation in relation to the manufacture of Sports Mouthguards. Sports Mouthguards include all Mouthguards destined for sports use be they ‘Custom Made’, ‘Boil and Bite’ ‘Ready Made’ etc. This paper has been written so as to clarify matters.

The Personal Protective Equipment Legislation is a completely separate piece of legislation to the Medical Devices Directive and should not be confused with it.

Although the vast majority of Dental Laboratories are ensuring that they comply with the Medical Devices Directive the same is not true for the Personal Protective Equipment (PPE) Legislation which became law in 1995 which is now 25 years ago.

What are PPE’s PPE are products that the user can wear or hold, in order to be protected against hazards either at home, at work or whilst engaging in leisure activities.

The PPE Legislation The Personal Protective Equipment (PPE) Directive 89/686/EEC became European Law in June 1995.

It was superseded on the 21st April 2018, by Regulation (EU) 2016/425 on Personal Protective Equipment (PPE) which replaced the old Personal Protective Equipment (PPE) Directive 89/686/EEC.

Categories of the PPE Legislation The PPE Legislation allows for three categories being:

Category 1 Simple Category 2 Neither Simple nor Complex Category 3 Complex

Which category are sports mouthguards in? The exhaustive list of Category 1 PPE in the Regulation does not include Sports Mouthguards. They are therefore not covered by this categorisation.

Sports Mouthguards do not fulfil the criteria for Category 3 PPE either, so they can only be covered by the main Category 2 classification, which requires that testing and certification or a prototype of the Sports Mouthguard that they intend placing on the market is conducted by an Independent European Notified Body.

Any person or organisation that claims that Sports Mouthguards are Category 1 is incorrect and is providing others with false, misleading and inaccurate information. Independent European notifying bodies Independent European Notifying Bodies provide EEC Certification to show that the manufacturer’s products has complied to the Personal Protective Equipment (PPE) Legislation so that manufacturers may put their CE mark on its Sports Mouthguard.

Therefore an Independent European Notifying Body can help Sports Mouthguard manufacturers

find their way through conformity, declaration, certification and CE marking and support them with prototype testing.

A manufacturer of Sports mouthguards can select an Independent European Notified Body freely and is not restricted to Independent European Notified Bodies in their own country.

An Independent European Notifying Body will ensure its own test covers all the Essential Requirements of the Personal Protective Equipment (PPE) Legislation in the absence of a British Standards Test for the Testing of Sports Mouthguards.

The steps you need to take to comply with the Personal Protective Equipment (PPE) Legislation There are a number of steps that manufacturers of Sports Mouthguards must take to comply with the Personal Protective Equipment (PPE) legislation and these are:

1. A technical Data File must be created and must be available for inspection at the manufacturing site at all times.

2. A prototype of each of the Sports Mouthguards they intend placing on the market must be type tested and the technical data file validated by an Independent European Notifying Body. (This also includes the instructions, packaging and labelling that will be sent out with the mouthguard).

3. An information leaflet must be supplied with the Sports Mouthguard, which must include the details of the name and address

of the Independent European Notified Body, The Certificate Number, The Certificate of Conformity, The standards used in the requirements and test methods and the date that the product was certified.

4. The mouthguard and/or packaging must be labelled with the CE mark in its recognisable size and form.

Please be aware that it is the actual prototype of the Sports Mouthguard that is tested by the Independent Notifying Body.

CE Marking There appears to be a misconception and urban myth within the Dental Laboratory industry that one can simply use CE marked materials and then apply the CE mark to a Sports Mouthguards or its packaging and that this is all one has to do to comply with Personal Protective Equipment (PPE) Legislation.

This most certainly is not the case and by doing so is an illegal act and the manufacturer or supplier could be fined or imprisoned.

You may only place the CE mark on to the Sports Mouthguard and/or packaging if a prototype of the of the Sports Mouthguard has been tested and certified by an Independent European Notifying Body.

Type testing of the sports mouthguard by an independent notifying body The tests carried out on the prototype Sports Mouthguard may include an impact test, a minimum thickness test in a number of different places, a delamination test, a fluid absorption test, an innoxious test, ergonomic test and a retention test. In addition, the materials that the Sports Mouthguard are made from will also be tested to ensure that they and any colouring agents used to colour them are safe for use within the oral cavity.

The container which is supplied with the Sports Mouthguard will also be tested as will the user leaflet containing instructions and warnings. The name of the manufacturer must be placed on the packaging so that the manufacturer can be identified.

Once you have had your Sports Mouthguards etc. tested you must not change the materials or technique you use to make them as this can effect the performance characteristics of the mouthguard.

If you do make any changes then you must contact an Independent European Notifying Body and ask for a re-test.

Litigation We live in an age when consumers are only too aware that they can instigate legal action against suppliers and manufacturers of goods that they believe have not come up to expectations. Defending yourself against court action brought against you by an infuriated parent whose vast financial investment in their child’s orthodontic treatment has been lost by one blow to the mouth, while wearing a Sports Mouthguard which was manufactured by someone who was not complying with the Personal Protective Equipment (PPE) Legislation could cost the manufacturer or supplier thousands of pounds in legal fees to try to defend. This is not to mention the inconvenience, disruption and loss of reputation to their business.

Prescribers and suppliers of sports mouthguards Anyone sub-contracting/prescribing/supplying a Sports Mouthguard should take the precaution of checking that the Sports Mouthguards they are sub-contracting/prescribing/supplying has been manufactured by a manufacturer who can demonstrate that they are complying with the Personal Protective Equipment (PPE) Legislation by asking them to provide them with a copy of the test certificate and certification documentation provided by the Independent European Notifying Body rather than relying on the CE mark that has been placed on the packaging. (Unfortunately, a number of manufactures have simply been applying the CE mark to their products despite them not having their Sports Mouthguards tested by an Independent European Notifying Body).

The danger being that if a prescriber/ supplier was to be found to have supplied a non-compliant Sports Mouthguard then not only may they find themselves being prosecuted by the Trading Officers but if they are registered with the General

Dental Council then they are a ‘Notified Professional’ which means that they may also find themselves being investigated by the General Dental Council.

How to comply with the Personal Protective Equipment Legislation at this moment in time At the present moment in time and in the absence of a British Standard for the Testing of Sports Mouthguards Independent European Notifying Bodies can certify to their own test methods which satisfy the requirements of the Personal Protective Equipment (PPE) Legislation.

The manufacturer of the Sports Mouthguard will need to appoint a consultant to write their Technical Data File and once this has been completed get a prototype of each of the type of Sports Mouthguards they intend placing on the market tested by an Independent European Notifying Body.

The Technical File Consultant will be able recommend you to an Independent European Notifying Body who can carry out the Type Testing and provide the Certification of the prototype Sports Mouthguard.

Each Independent European Notifying Body will have their own test in the absence of a British Standard Test for the Testing of Sports Mouthguards.

The Independent European Notifying Body may send you a standard test model to make your prototype mouthguard on.

Manufacturer with multiple manufacturing sites Where a manufacturer of Sports Mouthguards has multiple manufacturing sites each site will have to comply with the Personal Protective Equipment (PPE) Legislation in its own right and supply a prototype for testing and certification for that site.

Procedure for when we leave the European Economic Community (EEC) - BREXIT The EU PPE Regulation was already enshrined in UK law with effect from 21st April 2018 – before the conclusion of the Brexit process. When the United Kingdom leaves the European Union, then there will still be a system for testing and certifying Sports Mouthguards across all 27 Member States plus the UK, which will involve products carrying the CE mark, the UKCA mark, or both.

The CE mark will remain valid for the United Kingdom for 2 years after we leave Europe.

Test Reports from ISO 17025 accredited Testing Laboratories should still be accepted by the Independent European Notifying Bodies in support of UK CA applications.

Since the British Standards Institute (BSI) intends to remain a member of the European Committee for Standardization (CEN) and to continue to contribute to the development of European Standards, European Standards (EN) are expected to continue to be published as British Standards; although whether this will be as BS EN XXXX or just BS XXXX has not as yet be clarified.

For Sport Mouthguards already Certified by an Independent European Notifying Body then they will be able to continue to be sold within the United Kingdom or abroad. However, when sold within the United Kingdom then the product will be CA marked rather than CE marked.

If a Sports Mouthguard has not been Certified and is to be placed on the market and is just to be sold within the United Kingdom then it will require to be Tested and Certified by an Independent European Notifying Body and then once certified the manufacturer must affix a CA mark followed by a specific number to the packaging and instructions.

If the Sports Mouthguard has not yet been Certified and is to be placed on the European market then it will require to be Tested and Certified by an Independent European Notifying Body and then when certified the manufacturer must affix a CE mark followed by a specific number to the packaging and instructions.

Enforcement of the Personal Protective Equipment (PPE) Legislation and Trading Standards In the UK the Personal Protective Equipment (Enforcement) Regulation 2018 (SI 2018/390) provide an enforcement and penalty regime for Regulation (EU) 2016/425

The Personal Protective Equipment (PPE) legislation is enforced by Trading Standards Officers and anyone found manufacturing PPE which are not compliant with the legislation can face a fine or imprisonment as well as having any stock confiscated.

Considering the very long time that the Personal Protective Equipment (PPE) Legislation has been in force anyone that manufactures a Sports Mouthguard should be complying and ignorance of the law is no defence especially as the Personal Protective Equipment (PPE) Legislation has been in existence since June 1995.

Therefore, it is very important that every dental laboratory that is not complying with Personal Protective Equipment (PPE) Legislation should take immediate action to comply. Organisations that will be able to assist you in testing your mouthguards and writing your technical data manual: You will need to instruct an Independent Notifying Body to test your Sports Mouthguard or range of Sports Mouthguard and also have a Technical Data File written for you. Below are the names and web site details of two organisations that routinely do this for Sports Mouthguards.

Independent European Notifying Body: SATRA, Wyndham Way, Teford Way, Kettering Northamptonshire NN16 8SD T: 01536 410000 E: info@satra.com W: www.satra.co.uk (Satra routinely test Sports Mouthguards to their own standard in the absence of a British Standard)

Technical Data File Consultant: PVA-PPE Group E: info@pva-ppe.org.uk W: www.PVA-PPE (UK) Ltd (PVA-PPE (UK) Ltd routinely write Technical Data Files for the manufacturers of Sports Mouthguards)

Development of a British Standard for the testing of Sports Mouthguards It is the long term intention to develop a British Standard for the testing of Sports Mouthguards so that Independent European Notifying Bodies can all test to the same British Standard, however until this has been developed Independent European Notifying Bodies can develop their own tests as long as they fulfil the requirements of the Personal Protective Equipment Legislation. A British Standard for Sports Mouthguards would also ensure a level playing field and a competitive element between the different Independent European Notifying Bodies.

ABOUT THE AUTHORS

Peter Natt developed a range of 4 Pressurelaminated Sports Mouthguards in 1976.

He has written a number of articles on Sports Mouthguards including ‘Close Fitting Contact Sports Mouthguards’ about how to construct pressure laminated mouthguards which was published in the Dental Practice magazine in June 1979 and also ‘The Flexible Custom Made Close Fitting Contact Sports Mouthguard’ which was published in The Dental Laboratory Magazine in September 1982.

He has given hands on courses on constructing ‘Custom Made Multi-layered Pressure Laminated Sports Mouthguards and complying with the Personal Protective Equipment (PPE) Legislation.’ He has lectured widely on the subject of Tooth Protection and Sports Mouthguards to both

members of the dental profession and the governing bodies of various different contact sports. He has been an active member of the British Standards Institute Protective Sports Equipment committee since 1990 and has been awarded a British Standards Institute Certificate for Distinguished Service to the British Standards Institute.

Dr Garth Rolls -Willson, MA (Cantab), MRCS (England), LRCP (London) Injury and Mental Harm Prevention Consultant and a System Analyst Consultant.

He has been an active member of the British Standards Institute Sports Equipment committee and its Medical Adviser since 1991 and was the chair of the Sports Mouthguard Sub Committee from 2016. He has also been awarded a BSI Certificate for Distinguished Service to BSI.

The authors very much welcome any questions relating to this article.

AIM : To explain the Personal Protective Equipment Legislation. CPD OUTCOME : To be aware of the Personal Protective Equipment Legislation and its implication on the construction of Sports Mouthguards. To understand how to comply with the Personal Protective Equipment Legislation. DEVELOPMENT OUTCOMES : C & D

QUESTION 1

What does PPE stand for? A Personal Priority Equipment B Personal Protective Equipment C Personal Privacy Protection D Personal Prime Protection

QUESTION 2

When was the Personal Protective Equipment Legislation first introduced? A 1995 B 1996 C 1997 D 2018

QUESTION 3

What category of the Personal Protective Equipment Legislation do mouthguards come under? A Complex (3) B Neither Simple nor Complex (2) C Simple (1) D None of them

QUESTION 4

To Comply with the Personal Protective Equipment legislation the following must be undertaken: A A technical Data File must be created and kept at the place of manufacture B A prototype of the Sports Mouthguard to be placed on the market must be tested by an Independent European Notifying Body C An information leaflet must be supplied with the Sports

Mouthguard and the packaging ce marked in it’s recognisable form D All the above

QUESTION 5

The type of different tests carried out on a Sports Mouthguard by an Independent Notifying Body may be? A A minimum thickness test, a delamination test, a fluid absorption test, an innoxious test, a retention test, a material test and a colouring agent test B A minimum thickness test, a delamination test, a fluid absorption test and a colouring agent test C An impact test, a minimum thickness test, a delamination test, a fluid test and a colouring agent test. D An impact test, a minimum thickness test, a delamination test, a fluid absorption test, an innoxious test and a retention test, a material test, an ergonomic test and a colouring agent test.

QUESTION 6

Anyone prescribing or supplying a Sports Mouthguard should: A Check it is CE marked in its recognisable form B Check the Technical Data File C Check the manufacturer is complying with the Medical Devices

Directive D Ask the manufacturer to provide a copy of the test certificate and certification documentation provided by the Independent

European Notifying Body

QUESTION 7

The Personal Protective Equipment Legislation is: A Part of the Medical devices Directive B A completely separate piece of legislation to the Personal

Protective Equipment Legislation C Being withdrawn when we leave the EEC D Is being made part of the Medical Devices Directive when we leave the EEC

QUESTION 8

An Independent European Notifying Bodies will: A Check the Technical Data File B Test a prototype of the Sports Mouthguard being placed on the market C Carry out all of A, B and D. D Check the instructions

QUESTION 9

When instructing an Independent European Notifying Body to Certify a Sports Mouthguard: A It must be within the United Kingdom B It must be in Germany C It must be in France D It can be anywhere

QUESTION 10

The Personal Protective Equipment Legislation is enforced by: A The General Dental Council B The British Dental Association C The Trading Standards Officers D All the above

1: A 2: A 3:B 4:D 5:D 6:D 7:B 8:C 9:D 10:C ANSWERS

5 THINGS I CANNOT WORK WITHOUT! With Daniel Shaw I Maxillofacial Laboratory Manager at Chesterfield Royal Hospital

Thank you for the invite from Matt Everatt, the editor asking me to share my top five tips for happy work. There’s a saying - a bad workman blames his tools. Now be honest, you know your favourite items to work with and you would likely spend the rest of the afternoon hunting around the lab looking for that tool, whilst blaming your colleagues for again, borrowing your stuff and not putting it back!

So, to start off at number 1, I would struggle to pack prosthetic work as neatly as I do if I didn’t use this small spatula. It was a tool I found kicking around in the lab that allows a perfect placement of silicone into the mould, without adding unwanted air.

At number 2, this plaster knife is short and sharp. It is perfect for adding aesthetic detail to the plateau on Orthodontic study models, rather than waiting for the hard stone to set and then using a burr/hand piece to neaten the area. It was purchased from Technovent (Bridport, Wales www.technovent.com).

At number 3, I have found the best way to finish pressure/vacuum formed retainers or any other suck down such as fracture splints using polycarbonate plastics, is good old Wet’n’Dry. This particular batch I bought in bulk from screw-fix (cheaper than dental companies). The finer the better as it prevents the small lesions of “fluffling” the plastic when it gets hot following burr work.

The fourth item I don’t like working without are these Polishing mops from WHW Plastics (www.whwplastics.com). They provide a lovely finish whilst using them for your pumice work and final polishing also. As they are mops they don’t scratch the plastic surface unlike bristle style, which also allows you to put extra pressure on whilst polishing without creating a nasty groove.

Finally, forgive me for this sounding a little corny but Teamwork and Communication are aspects of work that I simply cannot work without. We do an important area of manufacture that we all like to get right, first time. Unless your patients or clinicians do not effectively inform you of their requirements we can be left guessing and having to improvise. Working within the dental team is a great environment for striving to do our best for our patients and our input (as Technicians, Prosthetists etc.) is vital as part of the team.

5 SIMPLE TIPS FOR A HEALTHIER RETURN TO WORK

By Katie Bell Physiotherapy & Wellness

As an owner of a large Physiotherapy & Wellness company I am delighted to have been asked to contribute and share my advice and ideas. For me, there has been quite a shift in people’s health & wellbeing over the last few months and not all for the positive.

A period of working from home on poor desk positions, a huge change to people’s routine, new hobbies, less sport played, more screen time, and a period of isolation for many.

I am predicting zoom fatigue to be a new medical term that hits the papers and as Physio’s we are seeing more people with back pain than ever before due to all these factors above, I have just listed.

So, what can you do as dental technician returning to work and trying to re-establish this new normal?

GET PLENTY OF REST Sleep is essential to keeping us happy and healthy. Studies show that over time, lack of quality sleep impairs the immune system which makes us more susceptible to colds and viruses that frequently float around during those cooler months. Try and return to a routine, for many who have been away from work for a period of time, sleep has been hugely affected due to later bedtimes and rise times and the mental stress and worry during this unprecedented time.

KEEP IT SIMPLE Don’t go overboard setting crazy goals for yourself. It’s important to consider our obligations and what our current schedule looks like when we’re in the goal setting process. In the long run it is more beneficial to set goals that are reachable, and then add on from there. We are all returning to work, and for some of us we may have got into good habits and become more active during lockdown. How can you keep this going? What is sustainable and achievable long term?

CHECK YOUR VITAMIN D LEVELS We get most of our vitamin D from the sun. Naturally our intake decreases in cooler months from spending more time indoors. Vitamin D increases fertility keeps our bones strong and supports the immune system. We see many people in clinic who have muscular aches and pains and often it is low vitamin D levels which is the cause. Schedule a visit with your doctor to check your vitamin D levels so you can know how much you need to supplement with. This is a very routine test with a quick turnaround time for results. Do not assume because we have a warm spring you have absorbed enough Vitamin D!

LEARN TO SAY NO! Over committing is something we all do! No is an immensely powerful word, much more powerful than YES! During lockdown we have all had a moment to readdress the balance and focus on what is important.

Look at where and what you are spending your time on or at, and what you would like to change in your week. Do you feel you never take time for yourself; do you always say yes and then have a feeling of regret? Saying no is not selfish, but often necessary to not use all your energy reserves up for other people, family, friends, events etc. What can you say NO to and be happy with your decision?

MOVE How often do you move in the day? How much of your day is spent in the lab or sat at a desk? How much time do you spend moving your body and not just going for a walk? Flexibility is the key to reducing injury risk, reducing aches and pains, and staying physically fit.

We are running a full online Pilates schedule which includes Live and Pre-recorded classes and we have some complimentary sessions running in August & September. If you are interested in joining in for a FREE class, just email hello@katiebellphysio.com and we will send you the list of options.

Choose one thing you are going to action this week and share it with someone!