Healthcare establishments exist under frameworks for clinical governance and risk management systems which are in place to ensure a safe environment for patients, staff and visitors.
Risk management is an integral component of both a clinical governance framework and the quality assurance process for managing safe patient care. The purpose of risk management is to assist an organisation in the prevention, identification and, where possible, the control of adverse outcomes that may arise from its activities.
Risk management is particularly important for the perioperative environment because each patient is exposed to a number of risks, however minor or major the surgical or anaesthetic procedure. The number of visitors to an operating room at any one time is restricted for infection prevention reasons or because a patient has refused your presence.
However many times you have been into an operating room the risk to yourself and to the patient remains high unless you understand and work together with the team mitigate any potential risks.
Representatives visiting hospitals and in particular, high risk areas of hospitals such as ICUs (intensive care units) and operating rooms, are by many provider organisations required to have undergone relevant education and be able to demonstrate knowledge of safe behaviours. These programmes are set up in order to provide assurance to help the NHS and independent sector fulfils its duty of care to protect patients and ensure safe surgical and clinical outcomes.
The organisations that run these credentialing systems require that you register site visits with them and this enables access to the individual provider’s requirements including that you have read a variety of policies and procedures, before you receive permission to attend.
Each trust and independent hospital will have a policy in place which describes their framework for the management of visitors, external contractors, work experience personnel, students, staff and any others to the perioperative setting.
No matter what your familiarity with the environment and the surgical team is, your behaviour in an operating room should be focused on the purpose of your visit, in a professional and safe manner. An over-relaxed environment is not always a safe one.
A lot of what was previously identified as a “surgical” procedure which would have been performed in an operating theatre as an open surgical technique, is now, through technological innovation, able to be undertaken in interventional radiology departments and cardiac catheter laboratories using X-ray guided and computer guided methods.
The “surgery” may seem simple as MIS (minimally invasive) techniques are used but the interactivity with the patients’ internal anatomy is just as critical to a successful surgical outcome and no less major in its physical impact.
All of the principles that are used in open surgery still apply; products must still be sterile, sterile fields and surgical behaviours still apply and patients continue to be vulnerable, often conscious and sedated for their procedure, so requiring a calm environment, sterile equipment and good technique, aseptic practice and confidentiality.
Sometimes, untoward events occur and the procedure may need to be undertaken using open techniques, for instance, what was planned for a cardiac catheter laboratory procedure may result in open cardiac surgery with a theatre and a cardiac team on standby.
Your role remains the same, regardless or in which area you are present – you are there to support your product; keep out of the way of the procedure and the team and remain attentive.
As you will be aware the key reason for education on the risks inherent in an operating room environment is awareness on your part, to keep you safe and also to reduce risk to the patient. The patient under anaesthetic has no control over what occurs and cannot protect themselves.
The operating room team and all its’ members are there to advocate for the patient to reduce any possible harm which may happen in that environment. This includes unseen risks such as microbiological issues, unprofessional behaviour as well as patient safety issues. Within this wide team, you too should consider your role as an advocate for the patient and if you see anything happening which you think is wrong, speak up.
You are subject to hazards and risks when you are visiting the hospital.
The main issues are listed below:
The Health and Safety Executive (HSE) records and publishes data as well as enforcing improvement across all industries based on the most serious of issues.
Adverse events happen in many industries, including healthcare. There has been a recent emphasis on reducing the number of untoward events which happen to patients. The description and lists of “never events” which happen to patients are an important part of the emerging academic focus on patient safety and guidance for all healthcare providers. It is essential to all the team that a culture of safety exists within the team, so that patients and staff come to no harm.
Never events are defined as “serious incidents that are entirely preventable as guidance, or safety recommendations providing strong systemic protective barriers, are available at a national level, and should have been implemented by all healthcare providers”.
Policies and frameworks for care as well as standards of practice exist and are to the large part followed to reduce risk. International guidelines such as WHO Safe Surgery Saves Lives Checklists, national evidence based guidance for the reducing surgical site infections comes from organisations such as the National Institute for Health and Care Excellence (NICE) and local based policies for procedures for evacuation in the instance of a fire in the operating department, based on perioperative standards and recommended practices from professional bodies and associations such as AfPP, all contribute to safer teams and safer patients.
Policies exist which relate to visitors and external contractors who visit operating rooms are in place in most hospitals. You should ensure for your own safety that you have read them and adhere to their principles.
Some manufactured products are quite heavy and if you are required to carry them from a car park to the clinical area it may be useful to have a trolley bag if possible. If the product is too large for this solution, then it is worthwhile establishing a relationship with the stores department and delivering the product at goods inwards, park the car and go back to take your product to the clinical area. They may even lend you a trolley to use.
Fundamentally, don’t lift patients. It’s not your role. Even if you come from a healthcare background as many do and have been formally trained, it is not your job now. You have no vicarious liability from the hospital or your employer. If the staff know that you have been trained to lift and turn, it is not what you do now and whilst it’s recognised; they may not appreciate your refusal, you must refuse. In fact, when the patient needs to be turned or lifted, it’s a good time for you to be talking to the surgeon or removing yourself from the area. It’s really difficult but essential.
Should the theatre be mostly empty and the patient is falling off the table and you are asked to help, then your natural instincts will come to the fore and it is most unlikely if the patient suffered harm, that you could be deemed culpable.
Many operating rooms and other surgical areas now require access permissions or credentials which show awareness of the environment and its risks. Many hospitals also need to know that visitors to its high risk areas for sales and education purposes are undertaken only with appointments, relevant training demonstrated and visits logged either with procurement or another hospital authority. In addition, some hospitals require proof of a negative MRSA swab – prior to any visit, though this trend seems now to have diminished and it is a local decision.
Permissions to attend an area during surgery to support the team and surgeon with new equipment has of necessity, to be more formal than in the past. The UK passed a law on bribery prevention, that is recognised as international best practice. It has already had considerable impact in healthcare practice.
The Bribery Act 2010 created new offences which were:
This act requires every commercial organisation to have policies which set out how they will implement bribery prevention procedures which are proportionate to the risks they face. Public sector organisations can have strange attitudes to commercial companies, some believe them to have unlimited funds for the support of personal education or other apparently professional endeavours and others are suspicious of any activity which may be seen (although entirely innocent) to be facilitating positive views towards one product range or another. Representatives need to be aware and wary of this diversity of views especially when approaching the completion of a tender for new business.
The reduction of infections in hospitals is a key target for all healthcare staff. Prevention is practiced throughout surgical care and whilst not all perioperative care is evidence based, the remainder being set for common sense or discipline reasons, you will find some differences in practice between your hospitals.
In England, the Health and Social Care Act 2008 set for the first time, in law, a code of practice on the prevention and control of infections and related guidance. This specifies principles which the hospital CEO is responsible for, including your safety and providing a clean environment in which to treat patients.
The requirement to wear scrub suits or specific clothing in a high risk interventional area – operating rooms, catheter labs and interventional radiology areas, is universal and concerns the reduction of opportunities for cross infection. What is not universal are the rules which pertain to where one has to wear changes of clothing and shoes. Each hospital and sometimes operating room suites have their own rules and they may vary within a hospital.
As a reminder – together with removal of all outdoor clothing (barring underwear), jewellery should be removed prior to any entrance to an interventional area. Jewellery, particularly necklaces, and to a lesser extent rings and watches carry significant microbiological bioburden and may be the source of potential infection. Your clogs may be carried and worn by you and as long as they are cleaned between hospital visits and kept in a cloth bag (not plastic as this provides a good environment for bugs to multiply). Many companies will reimburse you the cost of clogs to wear in theatre.
“Bare below the elbow” is a useful epithet to help one remember what needs to be removed. Scrub suits are usually organised into sizes in the changing room.
You may pick up significant biological material on your hands, when touching surfaces, furniture and items in the environment which in the absence of thorough hand hygiene will be taken back to your car and home life. You may also be exposed to blood and body fluids which carry their own risks to you. There are many opportunities to wash your hands – take them!
Standard precautions are in place for risk reduction. These are a minimum set of precautions which protect the patient and also the staff and you from the potential of infection transmission either way; from you to the patient or from the patient to you. In addition to strict hand hygiene, personal protective equipment (PPE) is a fundamental element of standard precautions.
This comprises of:
Facemasks are variably worn and local rules will stipulate when you must wear a mask. Some operating rooms have largely stopped wearing them other than when any prosthesis is being inserted, ie vascular, ophthalmic or orthopaedic and cardiac. However, a facemask also protects the wearer from splashes of blood and body fluids which occur in many situations when you are close to the sterile field even as an observer. In some surgeries such as neurosurgery and orthopaedics, exposure to tissue and blood are likely due to the access of the operating site. It is advised that you consider carefully your own protection by wearing a face mask.
Gloves should not need to be worn by you unless you are receiving an explant from the patient. So, if it is indicated that you wear them, ensure you choose the correct size, that they are robust and suit the job in hand. Aprons only need to be worn when there is a high risk of wet surgery. You should not be close enough to get wet, so it is unlikely that you need to wear one.
Eye protection is often available and you should undertake the same assessment of risk as you do for mask wearing in order to identify whether you should look for eye protection or not. There may be face masks with a shield, visors or goggles available. Mucous membranes and eyes are at high risk of splash and very susceptible when you are close to a wound site. Caution is often the best policy.
The often-cited occupational transmission risks of hepatitis in a variety of types and human immunodeficiency virus (HIV) are:
Patient to healthcare worker
Hepatitis B (HBV)
Up to 30%
Hepatitis C (HCV)
If you have an upper respiratory tract infection (any cold, cough or other bugs) please get someone else to attend on your behalf or remake your appointment for another occasion. The patient is fighting any number of other risks and does not need any more.
Dress properly if you are going into theatre and ensure that you wash your hands frequently. Scrub suits are meant to be worn against the skin, ie not with a t-shirt underneath, which will be contaminated with bacteria. Clogs should be cleaned since you last wore them, so that they do not increase transmission between hospitals – a clean with a spirit wipe will suffice. Cover your hair completely with the hat and wear a mask for your own protection.
Attention to appropriate disposal of clothing in the laundry bag will assist to reduce opportunistic infections arising. There is no need to enter an operating room, or other interventional area if you can provide the information and support required in an office or the coffee room. You are far more likely to get the undivided attention of the surgeon or surgical team member when they are not involved in surgery.
Ventilation of the operating room at 20 changes per hour or 300-500 for laminar flow or ultra clean ventilation is to reduce the chance of airborne bacteria or viruses landing in the wound requires that the doors to the operating room are closed and stay closed as much as possible.
Therefore, once you go into theatres, it is best to stay there for the duration of the need to be there, unless you are feeling ill. Movement around the sterile field should be as little as possible.
Antibiotics, initially Penicillin, were first discovered by Alexander Fleming in 1929, but it was not until the early 1940s that its true potential was acknowledged and large-scale fermentation processes were developed for the production of antibiotics. Since then, more and more advanced antibiotics have been developed to fight specific diseases however, in order to know which infection is present, a specimen of, blood, sputum, pus etc, needs to be analysed in the laboratory.
There are some broad-spectrum antibiotics which manage many basic infections and have been frequently prescribed even though the evidence of an infection has not been properly identified. Viruses often mimic a true infection and do not respond to antibiotics but the complexity of primary healthcare time: patient ratios has meant that over-prescription of antibiotics has happened and their usefulness has diminished.
Bacteria can rapidly mutate and this has rendered some antibiotics no longer effective. This leaves us humans vulnerable for the future. Prior to the introduction of antibiotics, an infected finger left untreated might have led to eventual death. That is now a possible future. Major surgery, now undertaken with antibiotic cover may not be possible in the not too distant future if behaviours are not changed both by the patient and the prescribing clinicians.
It has been proven that hand washing is fundamental to the reduction of the spread of infection and sadly this message has to be constantly reiterated in healthcare. Patients are being told that they should watch the staff and remind them to wash their hands between tasks and patients. Staff are busy and often go from one critical event to another, it is easy to forget. Mostly, they will not mind being reminded!
After you change from outdoor to theatre clothes (scrubs/blues/pyjamas) you should wash your hands or use hand gel. There should be gel available in the most vital areas so should be easily located.
Gel should not be used on soiled hands, so always wash your hands thoroughly before initial use of gel. Gel should only be used up to five times before another proper hand wash.
So where are the dirtiest places that you touch?
This list could go on, but the message is, wash your hands but also use a hand cream, they are available in most loos and will keep your skin in good condition. Poor skin condition can lead to cracks and splits which can harbour bacteria and exacerbate eczemas and other skin conditions.
In your work, you will be party to information about patients which is personal to them and must be treated with confidentiality. You are privileged to be present at their surgery and must respect that you are a visitor and their situation is not for any inappropriate discussion outside of the department.
Should you need to keep a record of the patients details for company product information, this must be unidentifiable and where possible encrypted.
Should you know the patient personally, you must remove yourself from the theatre unless it is absolutely vital for the successful outcome of the surgery. This situation should never be necessary.
One of the more recent discussions and concerns raised is that the patient might be unaware that you will be present during their surgery. If you imagine that it is possible that something goes to court and the lawyers discover that you were present without consent, what might the outcome be?
Medical representatives and medical students etc. are in some hospitals included as possible attendees on consent forms so there would be a competent defence. It is worth checking at your hospitals to see if this practice is followed.
If patient consent forms don't include “other visitors” for the patient to consent then it would be useful to ask the clinicians if the patient could be told that you will be there and give them the reason why.
Some patients are conscious for their surgery and as part of the introductions in the “check-in” phase of the Safe Surgery Saves Lives process, you should be introduced. Now is not the time to be asking the patient if you can be in the room for their surgery. They are in a compromised and vulnerable situation and this could, (remember the lawyers), be seen as coercive. If the patient declines, then you need to leave.
Budgets are an increasingly important element of any role by the operating room management team due to pressure on one of the highest spending units in any hospital. They are variably held by the medical director for theatres and anaesthetics, the business manager or the operating theatre manager. There is usually a separate budget for capital items and these are managed on a specific need basis and subject to a business case and significant tenders.
Revenue items are frequently subject to hospital contracts and theatres have a voice but no control over items being purchased. Since the Carter review in 2015, which found huge unwarranted variation across trusts and suggested that £5 billion could be saved in England by smarter purchasing; there has been a renewed approach to reviewing, merging and renegotiating contracts across Trusts, areas and hospital departments, to release funds. For example the average price paid for a hip prosthesis varies from £788 to £1,590 and trusts buying the most are not paying the lowest price. In procurement Lord Carter found in a sample of 22 trusts use 30,000 suppliers, 20,000 different product brands over 400,00 manufacturer product codes and more than 7,000 people are able to place orders.
The text for the following is taken directly from the guidance but in principle any possible benefits to either the company or the healthcare team or individual might be considered to be illegal. This is difficult reading but the facts follow, be careful.
Any payment or other benefit that the company confers on healthcare providers carries some risk of being deemed to involve an impermissible quid pro quo (that is, providing a benefit to the healthcare provider in exchange for the purchase of the company's products rather than those offered by competitors).
The company compliance programme should include a variety of safeguards against this risk. If the company pays a healthcare provider to conduct a study, for example, care should be taken to ensure that the study serves a legitimate scientific purpose. Similarly, advisory boards and consultancies should provide verifiable value that can be shown through documentary evidence. Further, the amount paid for any engagement must not exceed the fair market value for such an engagement in the particular country.
In addition, care should be taken to ensure that such engagements are not controlled or significantly influenced by those having responsibility for the sale of the company's products. Scrupulous compliance with local rules governing engagements with healthcare providers is also essential. Clear records should be made and retained describing why a particular engagement occurred. Relying on the recollection and co-operation of company personnel who may or may not be employed by the company five or ten years in the future is no substitute for written documentation and other issues prepared before the particular engagement is approved.
Compliance with industry codes
The Eucomed Code of Ethical Business Practice (Europe), the Prescription Medicines Code (UK) and the PhRMA Code on Interactions with Healthcare Professionals (US) are just three examples of the codes that healthcare companies have developed and implemented around the world to govern interactions between healthcare companies and healthcare providers. Healthcare companies are advised to take these industry codes into account when developing their compliance programmes.
Compliance with applicable industry codes does not necessarily protect a company against a bribery charge. However, it generally reduces the risk of an allegation being made. By contrast, failure to comply with an industry code can substantially increase risks that accompany activities such as the following:
Should you witness an incident occurring you have a responsibility to speak up. If an event occurs and you have been a witness, then you should be prepared to contribute to an incident report and make a personal note with times, dates and facts of the event and make these available for the team and your own line manager.
In reality, you should not need any contact with sharps during your work in the clinical areas, however others do and sometimes they may carelessly omit to complete safe disposal. Sharps bins should be available in all areas required. They are made to a European Standard and are, in the majority, yellow in colour and made of a semi-rigid plastic.
Be careful and aware that on occasions, sharps can be left on surfaces in the clinical area, for future use for instance on the anaesthetic machine.
Should you receive a sharps insult, there is a local protocol to follow, so you should report the injury to a member of staff who will advise you.
You should have been offered Hepatitis B vaccine cover from your company in advance of being in clinical areas.
Blood borne pathogens continue to provide healthcare workers and other team members with significantly high risk of exposure. Health Protection England collates all the data and provides a regular report, which in 2014 highlighted that since 2004 exposures to a known or thought to be infected patient, Hepatitis C occurred in 58% and HIV in 32% of reported exposures. The exposures were most common during the procedure and occurred to doctors 40% and to nurses and healthcare assistants 41% and to other team members 19% of the time. Injury is most commonly from a hollowbore needle 43% and also myocutaneous exposure occurs 29% of the time.
It should be remembered that there is thought to be a high degree of under reporting. The Health and Safety executive recommend that NHS employers ought to provide healthcare workers with safety engineered device in line with the EU Sharps Directive 2010 and the Health and Safety Executive (Sharps Injuries in Healthcare) 2013 regarding safer working conditions.
When the WHO Safe Surgery Saves Lives Campaign was first being implemented in England and Wales in 2009, the Patient Safety First movement suggested that an additional briefing and debriefing would add significantly to the safety activity and culture in each operating room.
Briefing – also known as a “huddle”. This is an opportunity for all team members, permanent and adjunct to make a plan for the list, to anticipate and plan for any problems that can be foreseen. Any team member can lead the briefing, ensuring that everyone has introduced himself or herself and clarified their role and responsibilities for the list. An overview is taken of the schedule, highlighting any changes, equipment considerations, special requirements or safety concerns. All theatre team members should be present for the briefing and debriefing.
The debriefing occurs at the end of the list, before any team members have left the theatre or department. The purpose is to reflect on the list and share perspective on tasks that went well and those that did not go well. This may include discussion of teamwork, the theatre atmosphere, errors or near misses, and a retrospective look at the briefing and use of the surgical safety checklist throughout the day. It is important to register successes, learning points, areas that require change or escalation and for this to be conducted in a non-threatening, open environment.
Anyone involved in the list in whatever capacity can contribute to the briefing and debriefing and other than ensuring that all team members know why you are involved today, it gives you a voice – to be included in the focus on patient safety and care.
Surgery will continue to change and develop and if this is your area of focus and sales then you need to keep up with the broad areas of advancements being made in minimally invasive surgery and robotics, for example. Surgery that was previously undertaken via large incisions is now being performed using minimally invasive techniques and this practice continues to advance which has a direct outcome for patient outcomes and recovery.
Healthcare practice and the Departments of Health in the devolved nations are becoming increasingly diverse. If you are working across borders or in one of the devolved nations wholly, you should ensure that you are fully aware of the policies and frameworks which govern the healthcare providers which you visit.
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