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Ahead of the game

18 October 2023

While the public recognises Personal Protective Equipment (PPE) as being face masks, gloves, safety boots and eye safety wear, bizarrely head-worn sports protection is in some instances not regarded as PPE by players, coaches, parents, governing bodies, schools and clubs. Judith McMinn explores why head-worn protection in sport has until now been largely ignored as PPE, and how new, innovative, head-worn PPE can reduce brain injury, against sport’s growing global crisis over concussion and early-onset dementia.

THE LAW is clear: all head protection claiming to protect the wearer is PPE and is included within the scope of the Personal Protective Equipment Regulation (EU) 2016/425 (including as amended to apply in Great Britain following the UK’s exit from the European Union). It must carry the CE and or UKCA mark to be legally placed on the market in the UK, and the CE mark for Europe. This is regardless of any other ‘approvals’ offered by sporting bodies or standards used for testing.

Head protection falls into either Category II PPE (independent testing and certification) or Category III PPE (independent testing and certification, plus ongoing surveillance of production quality). It is illegal to place any protective headwear on the UK and European product market for sale without certification. 

Head-worn protection could only be category I PPE if it is claimed to be protection from superficial mechanical injury (e.g., light scuffs and abrasions), but as soon as you include impact or the possibility of concussion, the risk of injury is subcutaneous and not superficial.

Yet the understanding of PPE law and its application in sport is anything but clear, and this places the health of players at risk, both today and in the future. 

In 2019, World Rugby, the global governing body for Rugby Union introduced a trial to enable the assessment of protective headgear devices which, according to the products’ manufacturers, have been designed to achieve specific, quantifiable, medical purposes. This allowed a new form of non-CE/UKCA certified head-worn protection (scrumcap/headguard) for use in gameplay, and encouraged players, parents and coaches to purchase this product through media coverage and by demanding that a World Rugby Trial Approved Logo was positioned on the device. 

Not only was World Rugby’s definition of a medical device at odds with both British and European law, it also completely missed the law around PPE.  Anything that claims to protect the wearer from impact hazards will always be PPE regardless of whether it is also a medical device. Both regulations must apply equally and simultaneously. Manufacturers of protection cannot make claims that it protects the wearer, and then put in disclaimers that it is just a medical device to circumvent the PPE Regulation.

In field hockey, the governing body for the sport, FIH, are carrying out research into hockey injuries, their prevention, investigating further standards for safety equipment (EN 13546 specifies hand, arm, chest, abdomen, leg, foot and genital protectors for field hockey goalkeepers and shin protectors for field players) and the negative effect of protection on injury rates. It is questionable if this work has PPE legislation in mind, given their position is that PPE is only permitted for medical reasons.

In professional clubs, community clubs and schools there is a failure to ensure products used for protection comply with the PPE Regulation, or that products sold by retailers, club and school shops are legal to be sold. This lack of understanding exposes organisations to be criminally liable for injuries received because of selling/mandating uncertified protective equipment, and with insurers in a position to potentially refuse responsibility for any related claim. 

Allowing the continued use of illegal PPE, regardless of best intentions and tacit endorsement from a governing body, that is promoted by a professional or amateur organisation for the protection of its members will not demonstrate a sufficient level of duty of care, and almost certainly leave these organisations open the risk of both civil and criminal action.

Mounting crisis

New head-worn PPE can help reduce the mounting crisis in sport around brain injury if the head-worn protection is focused on protecting the brain. Typically, head-worn protection in sporting and non-sporting applications has focused on protecting the skull, and not the brain.

In the UK, almost 400 former professional rugby and football players, some of whom have been diagnosed with Chronic Traumatic Encephalopathy (CTE), a progressive neurodegenerative disease that leads to early-onset dementia, are taking the sport’s governing bodies to court over the lack of care and failure to protect them from the risk of brain trauma whilst playing.

To understand how to protect the brain, the mechanics of brain injury and the physicality of the brain need to be understood. 

Whatever the sport and level of play, an impact on the head from a ball, head, elbow, shoulder, knee and the ground all create rotational forces to the brain. These forces rotate the brain inside the skull, shearing brain cells, tearing blood vessels, and disrupting the protective blood-brain barrier. This results in an abnormal, uncontrolled inflammation that damages the brain. Repeated inflammations increase the risk of longer-term neurodegenerative consequences.

In sport, the brain is vulnerable to rotational forces from both single (high-force impacts) concussions and multiple sub-concussions. Sub-concussions are smaller force impacts that damage brain cell function, but do not produce evident signs or symptoms, so they go unnoticed by players and those around them. Sub-concussions are over 500 times more common than concussions. 

The risk and severity of CTE is caused primarily by the cumulative damage of multiple sub-concussive impacts, and not by concussions. The lack of awareness of sub-concussions and the understanding that CTE is the result of repeated sub-concussions is not widely known. There is a conflation between concussion and early-onset dementia in the media, in medics outside those that are brain experts, in players, in decision makers, in those with a legal duty of care (sporting clubs, sports trainers, schools, sports teachers) and the public. A further example of this is that almost every sporting body, club and school has concussion protocols or guidelines, but no CTE risk minimisation policy.

Recent research, in June 2023, quantified that every additional estimated 1,000 head impacts is associated with 21% increased odds of being diagnosed with CTE. Importantly, every additional estimated 1,000,000 rad/ s2 cumulative rotational acceleration to the head (from rotational forces) is associated with 22% increased odds of being diagnosed with CTE. 

So only head-worn brain protection that reduces rotational forces to the brain in concussive and, importantly, sub-concussive impacts can reduce the risk and exposure to players on present brain injury, and later longer-term neurodegenerative consequences. It is noted that concussion can never be prevented but reduced. CTE is preventable. 

An emerging innovator

Rezon is a British company revolutionising PPE in sport through brain protection. Backed by world-leading expertise and technology, Rezon has created Halos, a ground-breaking headband offering wearers unparalleled brain protection. It’s the only UKCA/CE-marked PPE Category II protective headwear of its type in sport globally, minimising the life-changing risks of concussions and sub-concussions leading to early-onset dementia. 

Rezon has developed Rotection technology, a soft-form protective layering construct made up of nine independent layers that reduce rotational forces to the brain. When the layers move over each other they reduce the transmission, or passing through, of rotational forces.

Rotection technology reduces injury caused by rotational forces from the first impact point. Subsequent rotational forces become smaller, and the rotation of the brain is less, with reduced tearing of brain cells, blood vessels, and reduced brain inflammation. This is significant given the high number of sub-concussions sustained in sports (a player will likely receive hundreds/thousands over each season and many thousands in a playing career from childhood onwards). 

Independent testing shows Halos reduces concussion risk by 74%, and reduces rotational forces by up to 61%, in concussive and sub-concussive impacts.

Halos is rated five stars by US testing body, Virginia Tech and is registered as a medical device with the MHRA in the UK.

Rezon Halos was the winner of the BSIF Product Innovation Award – PPE Category, announced on 26 April 2023 as part of the Safety & Health Excellence Awards.

Whatever the marketing hype on being faster, fitter and stronger to achieving sporting success, only the brain determines performance in sport. Innovative head-worn PPE that protects the brain really challenges the notion that sporting performance is only below the neck.

If there is an apparent misunderstanding on the status of head-worn protection in sport, the start of a new sporting season is the time for the legal position on PPE to be made clear and be understood by governing bodies, players, coaches, parents, schools, clubs, retailers, and manufacturers.

The distinction between a single concussive impact, and the cumulative exposure of sub-concussive impacts over a playing career, to longer-term neurodegenerative consequences needs greater awareness and understanding across all of sport’s stakeholders.

Head-worn PPE that focuses on reducing rotational forces to the brain in sub-concussive impacts really will yield a new era – a future where every athlete can have the option to protect their brain, and where the societal risk of players in their 20s, 30s, 40s and 50s having to face the potential outcome of neurodegenerative diseases like CTE can be reduced.

Judith McMinn is founder and CEO of Rezon. For more information, visit www.rezonwear.com