Despite extensive evidence highlighting the risks associated with surgical smoke exposure, healthcare employers are still not listening to the concerns of healthcare workers and failing to provide adequate protection. Faced with a backlog of patients, are staff under pressure to ‘just get the job done’ – even when it means putting their own health at risk? Louise Frampton reports.
Healthcare providers across the UK are continuing to put the health of staff at risk by exposing them to surgical smoke without providing adequate protection. Staff continue to carry out procedures using laser and diathermy devices without proper smoke extraction – often wearing just thin surgical masks, in poorly ventilated treatment rooms.
Inhaling surgical smoke from the laser ablation of one gram of tissue has been described as the equivalent of smoking three cigarettes, while for electrocautery, the number is believed to be as high as six.1
In addition to the respiratory risks associated with inhaling smoke fumes, there is also a potential risk for infection.
Numerous studies have identified toxins, carcinogens, blood borne pathogens, prions, viable cells, viruses and bacteria in surgical smoke. An online literature search shows that the evidence-base is extensive, but even a small sample demonstrates there is significant cause for concern:
- Baggish et al highlighted the presence of human immunodeficiency virus DNA in laser smoke2
- Kwak et al detected the hepatitis B virus in surgical smoke emitted during laparoscopic surgery3
- A study by Yokoe et al demonstrated that surgical smoke may carry human coronavirus (although viral infectivity was considerably reduced)4
- A systematic review by Fox-Lewis et al identified 21 articles that demonstrated that surgical smoke can contain HPV DNA and that this can contaminate the upper airways of staff.5
Virologist, Dr. Sarah Pitt, from the University of Brighton, warns that there is also an increased risk of HPV-related cancers: “There are many different types of HPV, but the ones being excised using diathermy or laser devices are most likely to be those associated with a cancer risk,” she commented.
“When using lasers or during cauterisation, viral particles can become aerosolised and remain suspended in the smoke plume, which can then be inhaled. Some types of HPV can cause head and neck cancer. Inhaling smoke containing these particles is a real concern, especially if there is repeated exposure over a prolonged period.”
She added that there have been a number of important studies identifying the risk of infection via surgical smoke. Rioux et al, for example, reported on cases of HPV-positive tonsillar cancer in two laser surgeons following occupational exposures to laser plumes.6 Another study found that one in five surgeons, and three in five nurses, tested positive for HPV after performing operations for laryngeal and urethral papillomas. The HPV genotypes in the infected healthcare professional were identical to those identified in the patient.7
A study by Xiaoli Hu et al also found there is an increased prevalence of HPV infections in gynaecologists who are exposed to surgical smoke.8 As part of the study, a total of 700 nasal swab samples were collected in 67 hospitals. Standard polymerase chain reaction (PCR) was used to detect HPV DNA in the samples. Flow fluorescence hydridisation was used to determine the HPV type. This allowed analysis of related risk factors.
The HPV infection rate in the nasal epithelial cells of the participants who performed electrosurgery (8.96%) or loop electrosurgical excision procedure (LEEP) (10.11%) was significantly higher than in the remaining participants who did not perform electrosurgery (1.73%) or LEEP (2.91%), respectively.
The most prevalent HPV genotype in the electrosurgery group was HPV-16 (76.19%). This is particularly significant as 70% of cases of oropharynx cancer are caused by HPV-16.9 The HPV-positive rate was increased in the group that had a longer duration of electrosurgery.
The study also showed that the HPV detection rate was significantly lower in electrosurgery operators who used a surgical mask (7.64%) compared to those who did not use protective masks (24.32%). Furthermore, the N95 mask (0%) significantly reduced the risk for HPV infection compared to that with the general mask (13.98%).8
Given the growing body of evidence on the risks associated with surgical smoke, Trusts need to ensure staff are protected. It is not just gynaecologists that are at risk, however. Perioperative practitioners, surgeons, dermatologists, nurses, and colposcopists all face the same health risks from surgical smoke exposure. Furthermore, when procedures are carried out in outpatient departments, in treatment rooms where there is little or no ventilation, the risk may be even greater.
Protecting staff
David Gazzard, head of clinical negligence at BLB Solicitors, states that employers have “a non-delegable duty of care for the health and safety of their employees”. This duty extends to an employee’s exposure to substances hazardous to health. In short, healthcare employers that fail to protect their staff could find themselves open to litigation.
In particular, the Control of Substances Hazardous to Health Regulations (COSHH) places a duty on employers to carry out an assessment of the risks from hazardous substances and to always try to “prevent exposure at source”.10
Guidance from the British Occupational Hygiene Society (BOHS) acknowledges the harmful effects of the contents of surgical smoke and recommends that local exhaust ventilation (LEV) be used to evacuate and filter the smoke. It states: “‘Theatres usually have high rates of general ventilation. This does not, however, prevent the emission of smoke into the room or the exposure of staff. LEV is required to achieve this. The known irritancy, the other hazardous properties of the component contaminants, and the persistent concerns of chronic effects combine to lead to the conclusion that effective LEV should be considered a required control measure.” (BOHS 2006).11
The Health and Safety Executive also states that if “exposure to diathermy emissions can’t be prevented, then it should be adequately controlled. This is usually achieved by effective local exhaust ventilation (LEV).” Typically, this takes the form of extraction incorporated into the electrosurgery system to remove emissions at source, known as ‘on-tip’ extraction.12
Both PPE and surgical smoke extraction are considered important, but masks are considered ‘secondary protection’. The Association of periOperative Registered Nurses (AORN) states: “Personnel should wear respiratory protection (ie, fit-tested surgical N95 filtering face piece respirator or high-filtration surgical mask) during procedures that generate surgical smoke as secondary protection against residual plume that has escaped capture by local exhaust ventilation (LEV).”13
It is widely accepted by industry that the N95 is comparable to an FFP2. However, during the pandemic, the HSE stated that ‘when in an airborne state, micro-organisms can be classed as particles, so can usually be removed by filter-type Respiratory Protective Equipment (RPE). You should always use equipment fitted with the highest efficiency filter possible (protection factor of at least 20) to control exposure down to the lowest levels.’ Therefore, HSE recommends the use of an FFP3 for use against viruses.” (Rapid Evidence Review, document HSG53)14
Virologist, Dr. Pitt also pointed out: “It is also important to wear gloves and PPE with elasticated wrists, so nothing can get in. Legs should also be covered so no skin is exposed.”
A recent paper by Samuel et al concluded that, due to the viral particle diameter of 55 nm, mask-wearing during laser procedures [alone] is “ineffective for preventing contamination.”
The authors point out that even N95 masks filter particles larger than 300 nm. They emphasise that a smoke/plume evacuator is the most effective way to reduce viral contamination and recommend using a smoke evacuator within two inches of the site of HPV lesions being treated with laser therapy.15
They also suggest that surgeons may wish to consider receiving the monovalent human papillomavirus vaccine (Gardasil), which is now FDA-approved for the prevention of head and neck cancers related to high-risk HPV subtypes.
Calls for change
Despite the growing body of literature highlighting the risks, many healthcare providers are failing to provide suitable extraction devices and it appears that health and safety practices differ widely between – and even within – healthcare Trusts.
Numerous professional organisations are now calling for better protection for those working with lasers and diathermy devices, highlighting the potential risk of respiratory illnesses, viral infections, and cancer.
Among these concerned bodies include the Association for Perioperative Practice (AfPP), which recently launched an anonymous survey in a bid to better understand staff concerns around exposure and the policies in place to minimise risks within UK theatres.
Lindsay Keely, patient safety and quality lead at AfPP, commented: “All healthcare professionals working in the perioperative environment are exposed to surgical plume. As an association, we feel this is one of the most overlooked hazards in the operating theatre. Inhalation of surgical plume caused by energy-based device emissions can adversely affect the respiratory systems of theatre staff, patients and visitors.
“We have been campaigning to raise awareness of the risks associated with surgical smoke plume for years. We’ve created and distributed safety information resources, spoken at conferences, started petitions and recently collaborated with the US-based International Council on Surgical Plume (ICSP) to form the Surgical Plume Alliance…We still regularly hear anecdotal evidence that hospitals aren’t using surgical smoke plume evacuation units or appropriate PPE.”
Dawn Stott, CEO at AfPP, added: “Preliminary results from a sample of our survey responses so far demonstrate the scale of the issue surrounding surgical smoke plume. 94% are concerned about risks to their health, 39% have not received any training on the hazards associated with exposure and only 17% can confirm that there is a local policy for surgical plume management within their organisation.”
Professor Nick Levell, of the British Association of Dermatologists, has also criticised the lack of protection for staff: “In our hospitals, all kinds of precautions are taken to reduce the risks of cross infection. However, despite being aware of the potential risks for 30 years, surgeons are still breathing in smoke generated by human tissue, along with any viral particles present in the skin,” he commented.
The British Association of Dermatologists is calling for:
- Smoke extractors to be available in all settings where dermatology surgery takes place so that surgeons can use these devices when they consider it appropriate.
- Further occupational health research into the risks of virus in surgical smoke.
- There should be education for doctors and nurses undertaking surgical procedures so that they are aware of the types of lesions (e.g. genital and oral lesions, warts in transplant patients, Merkel cell carcinoma) and procedures (e.g. bipolar cautery rather than unipolar; lower power setting) most likely to generate surgical smoke containing potentially harmful virus particles.
“Recent data reviews by the Centers of Disease Control and Prevention (CDC) and Health and Safety Executive (HSE) have found that the number of healthcare professionals known to have developed an HPV-associated disease is small, however, there are concerns that this is severely under-reported issue, due to the fact that HPV can lie dormant in the body for decades. We are aware of reports of head and neck infections, including cancers, in specialists from ENT surgery, gynaecology, and dermatologists specialising in genital disease,” Prof Levell continued.
“More research must be done looking into this issue as an ever-increasing number of dermatologists find themselves in the operating theatre day-in-day-out. We are also urging hospitals to ensure that appropriate PPE and smoke extractors are available for use in all surgeries where surgical smoke may be generated.”
Staff are urged to approach their health and safety advisor and occupational health representative to raise their concerns, so that a risk assessment can be undertaken and/ or reviewed. However, anecdotal evidence suggests that when staff do raise their concerns, action isn’t always taken until outside agencies become involved.
A nurse colposcopist from a gynaecology out-patients department at a major UK hospital, spoke to CSJ about the difficulties staff face when they approach occupational health departments for help.
“At one point, I went to occupational health because I was concerned that I had developed a cough after I had performed numerous treatments in a row. The smoke extractor that we were using was over twenty years old and was no longer fit for purpose.
“When I was performing diathermy, there was still a smoke plume – I was concerned that I was inhaling HPV-related surgical smoke and knew there were reported instances where gynaecologists have contracted oesophageal and oral cancer through exposure to HPV,” Jane York* commented.
“For the past year, during the pandemic, I have been wearing an FFP3 mask which offers some protection; but pre-pandemic, we were just wearing surgical masks and, eight years ago, I wore no protection at all,” she continued.
However, even when the Trust was presented with the literature highlighting the risks of surgical smoke, the hospital’s occupational health department failed to take preventive action, instead opting to ‘monitor’ her. Jane said that it was not clear what was being ‘monitored’ or even how, and she was worried about the long-term consequences for her health
“My gynaecology colleagues who worked in operating theatres had ventilation and air changes, but they were still reporting visible smoke plumes. All I had, in my outpatients’ clinic, was a fan that was 15 years old,” Jane explained.
A new machine, with built in smoke extraction, was eventually acquired but this, in her view, was initiated by the need for increased capacity, as opposed to concerns around staff health. Practitioners were still expected to use an ageing device without smoke extraction, alongside the new one, so they continued to be exposed to surgical smoke.
Eventually, following an inspection by Public Health England, the ageing diathermy machine was “condemned”. The hospital was given seven days to replace the old device and a second diathermy machine (with built in smoke extraction) was subsequently procured
“There has been a lot of discussion about ‘enabling staff to raise concerns’ and speaking up. In reality, it isn’t that easy – my colleagues were aware of the health risks associated with inhaling surgical smoke, but we carried on regardless. In the NHS, we ‘just get on with it’ and make do with the equipment we’ve got. You can voice your opinions, but it doesn’t always get acted upon,” she commented.
“Having extraction at source gives me much more reassurance. All of the smoke is sucked away, and we change the filters regularly. But I still worry about the exposure I experienced in the past. A colleague of mine, who worked in colposcopy for 15-20 years, retired and then developed cancer of the tongue. It is difficult to say whether it was directly caused by HPV-related surgical smoke, but she had no protection, during that time, and it makes you wonder.”
Jane revealed that she and other colleagues had experienced symptoms of HPV transmission: “Prior to the pandemic, I was performing 6-8 diathermy procedures a day. A colleague and I contracted warts and it crossed my mind that this may have been due to the lack of protection from the surgical smoke. The warts were all around the top of my glove line, and around my ankles, where my scrubs ended. A colleague even had warts on his eyelid.” She believes there should be better protection and legislation.
Ralph Day, clinical director of Robinson Healthcare (a Vernagroup company), works closely with colposcopists – he hears firsthand the struggle that staff are currently facing: “The bottom line is that there is awareness of the issue among practitioners but there has been slow adoption of smoke evacuation technologies and slow acknowledgement by employers that the risk is real. The situation is improving but it is far from where it needs to be,” he commented.
“As a result of the pandemic, PPE has become more bespoke and there is increased access to Respiratory Protective Equipment fit testing. Many practitioners in outpatient settings are embracing fit-tested RPE as it has become more available. Looking at the appropriate ventilation systems within treatment rooms is another key issue. On many occasions it will be found lacking as there hasn’t been an appropriate safety review. While some units have bespoke smoke evacuation devices available, access varies widely,” he continued.
An extensive R&D programme has resulted in the development of a new single use vaginal speculum with an integral surgical smoke extraction insert, which helps to facilitate electrosurgically-generated smoke evacuation at source when connected to an appropriate smoke evacuation device. (Erbe Medical UK helped support the development by providing access to an IES3 smoke evacuation system throughout the R&D programme.) Robinson Healthcare will also be supporting users by campaigning to ensure that the use of single-use vaginal specula with integral surgical smoke evacuation inserts becomes mandatory
“The message should be very clear on the responsibilities for employers on the protection of staff and patients. For many years there has been no consistent messaging across the NHS or the private sector. We need national guidelines from the Government.
“Due to COVID, cancers are now being diagnosed at a later stage and there is a significant backlog of patients waiting for cervical biopsies. There will be large numbers of patients going through treatment units and staff will feel under pressure to get their patients through, but it must not be at the expense of their health and safety. Manufacturers also need to play their part in influencing the decision making and in providing education, to help to protect clinicians,” he concluded.
Suppliers of smoke evacuation technologies report that while uptake has increased, there is still a long way to go. Some of the barriers to adoption have been due to historical experiences with older iterations of smoke evacuation technology – but the latest generation of smoke evacuation systems have overcome these issues.
“Despite the guidance and recommendation provided by HSE, MHRA, a Joint Commission and the British Hygiene Society, smoke evacuation within the confines of operating theatres and associated departments remains poor. The uptake has increased recently, due in some part to COVID-19, but there is still a low uptake of smoke extraction products within the healthcare market.
“Smoke evacuation systems have been described as cumbersome, bulky, noisy, and can potentially act as a distraction during surgery.16 When Starkstrom previously conducted field trials, the feedback from customers would back up this view. Earlier, poorly constructed smoke pencils and hoses added additional weight which led to wrist fatigue and complaints regarding the vacuum noise produced by smoke evacuation generators. However, we have noticed that attitudes are slowly changing. The introduction of new, lighter, quieter, and more ergonomic equipment and the emergence of champions in selective specialities, where large volumes of surgical smoke are produced, is leading to increased uptake of effective smoke evacuation equipment,” commented Guy Pomroy from Starkstrom.
He pointed out that many Nordic countries have already introduced legislation to combat the long-term effects of exposure to surgical smoke. “The only way to ensure compulsory surgical smoke evacuation would be to mandate throughout all NHS and Private Hospitals. This would then ensure perioperative staff are protected from prolonged surgical smoke exposure.
“Smoke evacuation systems keep the surgical field clear, prevent aerosolised chemicals from corroding equipment and reduce odour but, most importantly, they minimise the exposure of healthcare professionals to potential contaminants,” Pomroy continued.
James Williams at Eakin Surgical also reports that the uptake of smoke evacuation systems is improving, but there is also a need for further education: “Since the start of the COVID-19 pandemic we have observed an increased adoption of smoke evacuation devices because of the risks associated with viral transmission in smoke particles. However, there is also a misconception of what constitutes adequate smoke management, with a false reliance on room ventilation, which only disperses harmful smoke particles. Evidence continues to support the need for filtered, point of creation smoke evacuation, but more needs to be done by decision-makers and occupational health to introduce mandatory measures that will ensure a safe work environment for surgeons and perioperative staff,” he commented.
Mandatory smoke evacuation?
The case for compulsory surgical smoke evacuation systems in the operating theatre was recently explored in a paper by Daniel Rodger in the journal Clinical Ethics. 16 To get a snapshot of the implementation of the Health and Safety Executive guidance on surgical smoke, 10 large NHS Trusts in England were contacted on 28/09/21 by freedom of information request by email or online form. As of 2013 there were 3025 operating theatres at NHS Trusts in England and the six NHS Trusts who responded represented approximately 7% of the total number of operating theatres in England.
The NHS Trusts were asked two questions:
- Has a risk-assessment of surgical smoke exposure been conducted in the last 10-years?
- If a risk-assessment was conducted in the last 10-years what were the recommendations?
None of the six NHS Trusts had conducted a risk-assessment in the previous 10-years and therefore had no recommendations to make. This would indicate that several large NHS Trusts in England are not following the Health and Safety Executive guidance on diathermy and surgical smoke. Worryingly, one of the largest NHS Trusts contacted expressly stated that there was no requirement to conduct a risk assessment for surgical smoke under COSHH (2002) or any Health and Safety legislation. He concluded: “There is no sufficiently strong justification for maintaining the status quo and surgical smoke evacuation systems should be made compulsory. Merely recommending their use has proved insufficient since the available evidence indicates that it is rarely followed in practice.”
Changing attitudes?
Despite an uphill battle over the acceptance of surgical smoke evacuation devices, there is cause for some optimism, however. Fears around COVID appear to have driven a change in attitudes and there are signs of improvement. Researchers at University Hospitals Plymouth conducted a telephone survey to ascertain the availability and use of surgical smoke extraction systems in the operating theatres of orthopaedic trauma units before and during the COVID-19 pandemic. A list of 157 British orthopaedic trauma units was obtained from the National Hip Fracture Database and the authors contacted members of the orthopaedic theatre team at each unit.17
The researchers asked: “was a purpose designed surgical diathermy smoke extractor system available for use in your trauma theatre prior to March 2020” and “since the COVID-19 pandemic has a purpose designed surgical diathermy smoke extractor system been introduced.” (Questions were asked to avoid confusion between the use of a purpose-designed surgical smoke extractor system and the use of standard suction tubing.)17 All 157 British orthopaedic trauma units responded. Prior to the first COVID-19 lockdown in March 2020, 38% of orthopaedic trauma units had a surgical smoke extractor system available for use, which increased to 56% by the third lockdown in January 2021.17
While this a significant step forward, there is still a long way to go – just under half of units did not have access and this needs to change. The UK is lagging behind other nations – in the US, states are signing legislation that will see the adoption of smoke evacuation systems becoming mandatory in hospitals and freestanding ambulatory surgical facilities from 2023,18 while in parts of Europe it is already mandatory.
Conclusion
Ultimately, there needs to be clear Government advice on the safe use of diathermy and laser devices, audit of healthcare providers to ensure the correct protection is provided; and enforcement to ensure there is full compliance. Furthermore, the use of smoke evacuation needs to be seen as more than a ‘recommendation’; there should be no ambiguity or misunderstanding around the legal requirement to “always try to prevent exposure at source”.10
The MHRA’s electro surgery ‘top tips’ says that practitioners should “think” about using a smoke evacuator to reduce the effects of the plume.19 But now is the time for action – the messaging must be clear. It is time we followed the lead of other countries that have made smoke evacuation explicitly a legal requirement
In the UK, a significant hurdle, is the fact that this will require investment, but the cost of lost productivity due to ill health and litigation must also be taken into account. We have heard how staff are currently living in fear that they will develop HPV-related cancer. Ultimately, the human cost of inaction could be the greatest cost of all.
*The name has been changed to protect the identity of the nurse colposcopist.
References
1 Tomita Y, Mihashi S, Nagata K, Ueda S, Fujiki M, Hirano M, & Hirohata T. Mutagenicity of smoke condensates induced by CO2-laser irradiation and electrocauterization. Mutation Research, 1981.
2 Baggish MS, Poiesz BJ, Joret D, Williamson P, Refai A.Presence of human immunodeficiency virus DNA in lasersmoke. Lasers Surg Med, 1991;11: 197–203.
3 Kwak HD, Kim SH, Seo YS, Song KJ. Detecting hepatitis B virus in surgical smoke emitted during laparoscopic surgery. Occup Environ Med, 2016;73: 857–863.
4 Yokoe T et al, Detection of human coronavirus RNA in surgical smoke generated by surgical devices, The Journal of Hospital Infection, November 2021, DOI:https://doi.org/10.1016/j.jhin.2021.08.022
5 Fox-Lewis A, Allum C, Vokes D, Roberts S. Human papillomavirus and surgical smoke: a systematic review. Occup Environ Med. 2020 Dec;77(12):809- 817. doi: 10.1136/oemed-2019-106333. Epub 2020 May 8. PMID: 32385189.
6 Rioux et al. HPV positive tonsillar cancer in two laser surgeons: case reports, Journal of Otolaryngology - Head and Neck Surgery 2013, 42:54, http://www.journalotohns.com/content/42/1/54
7 Ilmarinen T, Auvinen E, Hiltunen-Back E, Ranki A,Aaltonen LM, Pitkaranta A. Transmission of humanpapillomavirus DNA from patient to surgical masks, gloves and oral mucosa of medical personnel during treatment of laryngeal papillomas and genital warts. Eur Arch Otorhinolaryngol 2012;269: 2367–2371.
8 Xiaoli H, et al, Prevalence of HPV infections in surgical smoke exposed gynecologists, International Archives of Occupational and Environmental Health (2021) 94:107–115 https://doi.org/10.1007/ s00420-020-01568-9
9 Accessed at: https://www.mountsinai.org/locations/ head-neck-institute/cancer/oral/hpv-faqs
10 HSE, COSHH guidance, Accessed at: https://www.hse.gov.uk/coshh/basics/whatdo.htm
11 BOHS 2006, COSHH Guidance, Surgical Smoke Derby, British Occupational Hygiene Society.
12 HSE, Diathermy Emissions Guidance. Accessed at: https://www.hse.gov.uk/healthservices/diathermy-emissions.htm
13 Association of perioperative registered nurses. Recommended Practices for Laser Safety in Perioperative Practice Settings. Denver, CO: AORN; 2013:147-148.
14 HSE Rapid Evidence Review. Accessed at: https:// www.hse.gov.uk/coronavirus/assets/docs/facemask-equivalence-aprons-gown-eye-protection.pdf
15 Samuel A. Stetkevich BS, Craig G. Burkhart MD, MPH, Dangers of HPV Laser Plume and Best Safety Practices, International Journal of Dermatology, October 28, 2021
16 Rodger D. The case for compulsory surgical smoke evacuation systems in the operating theatre. Clinical Ethics. November 2021. doi:10.1177/14777509211063589
17 Hill D, et al, Changing attitudes towards the management of surgical smoke, (published on the BOA website), September 2021, Accessed at: https:// www.boa.ac.uk/resources/changing-attitudes-towards-the-management-of-surgical-smoke.html
18 AORN, Oregon Becomes Fourth State to Go Surgical Smoke-Free. Accessed at: https://www.aorn. org/about-aorn/aorn-newsroom/health-policynews/2021-health-policy-news/oregon-smoke-free
19 Electrosurgery Top Tips. Accessed at: https://assets. publishing.service.gov.uk/government/uploads/ system/uploads/attachment_data/file/477600/ Electrosurgery_top_tips_Nov_15__2_.pdf
