The Operating Theatre

Operating theatres (also known as rooms and suites) are not the simplest environment in which to demonstrate and support your product. The primary focus of the operating team is to ensure safe completion of the patient’s surgery, so your product may not receive the attention that perhaps you feel it deserves. In order for you to safely support your product and educate the team on its use and function, it’s critical that you understand the risks of the area so that you can behave in an appropriate manner and at the correct time.   

There are other areas of the hospital where specialist interventions take place with the patient supported by anaesthesia. These consist of interventional radiology rooms, cardiac catheter laboratories as well as a few other areas such as interventional endoscopy. Many of the behaviours explained here are applicable in those areas to reduce risk of infection for the patient. 

Operating theatre departments are a high cost area of a hospital, where technology is constantly evolving and advancing often – which may mean that you spend many hours supporting your product and the team. Your role is welcomed and of great importance to the team in supporting the use of your product.     

Who’s Who in the Theatre?

Your key role once in the theatre is to work with the team. You may see the same people on a specialty team consistently, or they may change shift to shift according to the roster. Your role is to facilitate the effective use of your product so that it can benefit the patient. Education on your product will have been provided prior to it being used, but you are there to support its correct assembly, use and disassembly. Even if you have a healthcare background, it is no longer your role to take any other part in the surgical process. 

The environment may be referred to as perioperative, ie relating to the period of time surrounding the surgical procedure. Other terms include preoperative (before), intra (during) and post-operative (after).

You will need to know all the different characters in the team, their different skills and knowledge, what their roles are and something of their professional background. The team is made up of a variety of different professionals, and whilst everyone functions as a team, they also work autonomously being responsible for their own area of practice.

At any time that you are present in the theatre, you will need to remember that the primary focus of the team is on the patient, ensuring they get the correct surgery and to the best of everyone’s ability. Therefore you will need to be relatively self-sufficient, although asking for help should you need it is better than making fundamental errors.

 

Who’s Who in the Theatre?

All members of the surgical team need to be educated about the specifics of your equipment – it is the reason for your attendance for the surgery and in the department. It should always be intended that education has been given before the product is in use. Depending on the role of the user, the information given may vary a little, but all will need some level of knowledge.

Operating department manager
You will almost certainly need to make an appointment with the theatre manager prior to any access being granted, although some hospitals require initial appointment with the procurement department. However, as a courtesy it is as well to check with the manager’s secretary or theatre receptionist. It is the operating department manager’s role to be responsible for ensuring effective and efficient service to the patients and they also manage the environment, budget and staff 

Receptionist
Most operating departments have a receptionist and a signing-in book. It is important that there is a record of your attendance. The receptionist can give you help on local rules, access to fire and visitor policies and other essential information when you first visit and assist you in many different ways to orientate yourself properly in the department.

Patient
Consent to your attendance in the theatre should be given by the patient, usually via the operating surgeon preferably in writing but verbal consent is more commonly obtained. Not only is this ethically appropriate but also a matter of risk management. The patient is extremely vulnerable at this point in their journey and the staff are there to advocate for them, reducing opportunities for possible harm. If the patient for whatever reason refuses your attendance, that should be respected and you should leave.

Theatre porter
Porters may variably be known as orderlies, porters or ODOs (operating department orderlies). They are essential to the smooth running of an operating theatre suite. They help to move equipment, collect patients from the wards and deliver items such as blood samples and specimens to the correct area of the hospital. They facilitate efficiency and are an essential part of the team.   

Scrub practitioner
The scrub practitioner works directly with the surgeon to ensure that they have the appropriate equipment and supplies within the sterile field (the area that surrounds the incision site when sterile drapes are applied). This includes all gloved and gowned staff and the horizontal surfaces of instrument trolleys. They will anticipate the needs of the patient and will deliver care directly. Scrub practitioners and those circulating work together to undertake the surgical count, ensuring no items are left behind.

Circulating practitioner
Staff working as circulators may be registered or unregistered staff and may scrub as part of their day-to-day work. They co-ordinate the provision of equipment and instruments to the scrub practitioner and the sterile field, ensuring sterility. They provide hands-on direct care to the patient and record the care that is given - they are responsible for ensuring it is safe and free from potential harm. May also be referred to as 'runners'.

Anaesthetic practitioner
Anaesthetic practitioners check that all equipment required to enable a safe anaesthetic is given and maintained. They provide support and care to the patient undergoing anaesthesia, which incorporates pre-induction checks, support during induction and throughout the anaesthetic. They usually accompany the patient to recovery and provide a handover.

Consultant surgeon
Consultants are responsible for managing the care during surgery and are assisted by a team of doctors and other professionals who constitute the surgical team. Consultants may delegate surgery to another member of the team, but will retain overall responsibility for the standards of care delivered. Some consultants may work within a team of consultants and junior medical staff, sharing a specialty. They work collaboratively with the anaesthetist.

You may encounter some hospitals that employ staff who, although not doctors, are trained to undertake surgery and carry their own caseloads. They are largely known as surgical care practitioners.

Consultant anaesthetist
The consultant anaesthetist is responsible for providing safe anaesthetic care to the patients on an operating list. They are the head of the anaesthetic team responsible for the care of the patient under anaesthesia working collaboratively with surgeons. At many operations they are assisted by a trainee anaesthetist. Anaesthetists are responsible for the patient's care during recovery in the immediate post-anaesthetic period - often taking place in PACU (the post-anaesthesia care unit).

Anaesthetists also perform many other specialised roles in the hospital such as managing acute or chronic pain or managing intensive care.

Perioperative support worker
Support workers provide help to registered staff in all of the specialised areas of the operating department. They are important for the effective and efficient running of the operating room. Many have undertaken specialised vocational training and may become highly experienced in their team specialty over several years.

They may also be known as HCAs (healthcare assistants), HCSWs (healthcare support workers) or assistant practitioner. The latter undergo specific training and may, for a limited range of procedures, act as scrub practitioners.

Operating Theatre Environment

The operating room holds many potential dangers to all users including the patient, staff and you as a visitor. It is very focused and purposeful with the patient at the centre of care. You may not at first spot those hazards but there are electrical booms above head height and large pieces of surgical equipment, as well as possible electrical wiring on the ground.

If there are difficulties during a surgical procedure the atmosphere may seem to be tense and you will need to ensure that your behaviour is always appropriate to the situation. Understanding these points will assist you to undertake your business appropriately and safely.

There are many unwritten rules which will vary even within the same hospital’s different operating rooms and suites. Your skill at observing these differences will help to guide you.

Theatre Traffic
There are different areas within the operating suite and each requires different modes of dress. These will vary between department, dependent on the type of surgery done there as well as some possible custom and practice. 

Some of these different modes of dress are not related to the potential microbiological hazards, but the staff may be adamant that you follow them.

Unrestricted areas
You may wear normal clothing and shoes.

Eg, offices, corridors, coffee rooms and main reception.

Traffic unlimited.

Semi-restricted areas
Traffic limited to patients and correctly-attired people who have permission to be there.

There may be a red line on the floor which denotes the change of clothing and restrictions in access.

Restricted areas
Traffic is very limited and you are required to wear clothing specific to the operating theatre, specific footwear and sometimes a facemask. Your behaviour will be modified to suit the environment.

Personnel who are scrubbed and part of the team working within the sterile field have right of way at all times.

The area may just be the operating room or may also include, anaesthetic rooms, anterooms to the operating room and possibly recovery/PACU (post-anaesthetic care unit).

Access to Operating Rooms and Interventional Areas

Permission to attend high-risk environments has become far more difficult in the recent past. It may vary from one trust to another and many are now requiring a level of education to enable safe behaviours. Permission may be granted by the local manager (ie theatre manager or business manager) by the local procurement department or by a directorate lead such as from the department for anaesthesia.

The patient should know that you are going to be present and not have any objections – if they have, then you will have to leave. The surgeon will inform the patient and seek permission, so you need to ensure that they know when you expect to be in attendance. There are some trust consent forms which highlight visitors, although not all do. Ethically it is considered appropriate for the patient to know you will be there.

If there is no need for you to be changed and in theatre, then make appointments to see clinical staff when they are not concentrating on surgery. You will benefit from their undivided attention. Theatre coffee rooms may be an appropriate place for you to see staff, although in many units you will have to change into a scrub suit to get there.

The clothing you are going to change into to go into theatre is specifically designed to reduce opportunities for infection transmission. The clothing is worn for a relatively short period of time and for is laundered at high temperatures. It should also help to reduce the risk of you taking highly infectious and possibly multi-drug resistant micro-organisms into your car, home and family.

What to Wear in the Theatre

  • Find the correct clothing for your size.
  • Reduce the valuables you bring into operating rooms. Hospital changing rooms are not a safe environment to leave items. You may be offered a locker for safe storage. Alternatively, leave them locked in your vehicle or better still, at home.
  • Remove all jewellery – it can be an infection hazard. Put it in your pocket or a safe place and remember to remove it when changing back into your outdoor clothes. If the soiled laundry is disposed of, you may never see it again.
  • You should aim to be “bare below the elbow”, which describes how you can help infection prevention in hospitals.
  • Find footwear to fit. Some sites have visitor footwear and they may be clean, but as long as you can honestly say that your own clogs are cleaned after each wearing with a detergent wipe and stored in a cloth bag, then no reasonable person should stop you from wearing your own. Sometimes, however, you will have to wear department footwear.
  • Once clothed, put on a hat and cover all the hair on your head. No hair should be exposed. Some departments will have different colours for different levels of staff. Find out first what colour you should be wearing. Cover any facial hair such as a beard with an appropriate mask.
  • On completion, wash your hands and forearms and put on a facemask before entering operating rooms if the surgery demands. Masks are usually available outside the operating room doors. The wearing of facemasks may be specific to the surgery or hospital recommendations but should be worn by you where any risk of facial splash might occur.

Entering the Operating Theatre

  • It is to be hoped that your contact person is available to show you the theatre and environment, however it is wise to remember that staff will now be focused on the patient and you need to keep out of the way. The best place to stand is with your back against the wall until everything is settled into place.
  • Focus on your role and ensure that you know who is who, so you can educate the staff who need to know at an appropriate moment.
  • If you have arrived early for the list you may be involved in the briefing. This “huddle” also identifies any possible issues for the operating list such as equipment problems. Team members are expected to introduce themselves and specify their role that day. You will be asked to do the same stating the purpose of the visit. It is a useful event for you to attend.
  • Leave your phone on vibrate or silent in your pocket and only move outside to take calls if they are urgent and cannot be avoided. Ringtones and conversations away from the operating table are often the cause of interruption for the surgeons’ concentration and should be undertaken at the correct time. Be sensitive to the atmosphere.

Your involvement

  • Should you feel unwell at any time during your theatre visit - and wearing a mask is often the cause of claustrophobia - tell someone and take yourself to the coffee room. If you can do this before you feel so faint that you cannot make it, that is helpful. It is not unusual - many people feel this way to start with.
  • If you have witnessed any kind of untoward incident during your visit, it is a good idea to write yourself a note of what you observed, date, time, place and people involved, etc, so should it go any further, you have a good record to jog your memory.
  • If your own company equipment in use is compromised in any way by the operating surgeon, it is also a good plan to write yourself a note to share with your line manager.
  • Should the surgeon ask you to help make a decision about how to use your company equipment, difficult as it is, you need to remind him you are only there to advise and the decision is theirs. Do not put yourself into the position of an adviser or of taking medical decisions under any circumstances. Make yourself a further note, should anything like this happen during your visit and inform your line manager.

Reducing Infection

Operating theatres are ventilated to reduce the opportunity for airborne organisms to infect the patient causing surgical site infections.

The environment of the theatre and supplementary rooms such as the anaesthetic room, is isolated from its neighbour, so that it is independently ventilated to meet temperature and humidity standards. The room is ventilated at 20 air changes an hour unless you are in a theatre which is used for orthopaedics or implant surgery, where the clean air or laminar flow ventilation operates at 300-500 air changes every hour. For effective ventilation, the doors to the theatre should remain closed.

The number of people in an operating room also has an impact on the potential for airborne organisms, although there is no absolute guidance on how many people constitutes too many.  

Operating theatre horizontal surfaces collect dust which may be hazardous to you, the staff or patients. They are cleaned regularly but you can help yourself to reduce risk by ensuring effective hand washing after you leave the environment.

Reducing the occurrence of surgical site infection is the aim of a great deal of surgical and team practice in the operating theatre. the remainder may relate to “rules” which are often unwritten so that everyone uses behaviour which is appropriate to the environment for the patient. However the prevention of infection, which can cause pain, suffering and greatly lengthened hospital stays is one of the key clinical priorities and why theatre teams (and other hospital staff) behave the way they do.

Reducing Infection

In the UK, infection prevention and control (IPC) measures are subject to law. Individuals are responsible at board level for ensuring that hospitals have policies, procedures and appropriate regulations in place at each hospital and that staff receive continuing education focused on IPC. 

One of the most effective measures is hand hygiene and many hospitals have a zero tolerance to poor compliance rates.

Not only do high rates of hospital associated infection have potentially poor outcomes for the individual patient but they also do a great deal of reputational damage to the hospital. In addition, the era when antibiotics are available to treat all infections is rapidly coming to an end.

It is a sad fact that antibiotics have been used and abused so that the organisms which cause many of the common infections have developed resistance to drugs used to treat them. We are running out of effective treatments and there are now many activities being promoted by governments and the World Health Organization to try to slow the effect of antimicrobial resistance and to preserve those antibiotics that are described as “last resort”.

Many of the possible bacteria you may collect on your hands in hospital, may be multi-drug resistant bacteria. The best action you can take to prevent these possible infections affecting you and others, is to wash and dry your hands thoroughly at every possible opportunity.

What is the Sterile Field?

The sterile field comprises of the surfaces that have been draped with sterile drapes. These will be the instrument trolleys being used by the scrub practitioners and the patient, in a way that isolates the wound site, surrounding it. The people who have prepared the sterile field will be those who have scrubbed and donned a gown and gloves. There is usually an operating surgeon, an assistant and a scrub practitioner. The team may be joined by students who scrub to get closer to see the anatomy better.

In order for an item to become sterile it has to be stripped of any living micro-organisms that have the potential to cause disease or infection. All items which are part of the sterile field have been through processes which ensure that they are sterile. This reduces the opportunity for causing surgical site infection.

The patient is often the most likely source of bacteria or other micro-organisms which may cause a surgical site infection. Around 5% of all surgical patients succumb to post-operative infection.

Preparation of the skin around the wound site, using antiseptics, bathing the patient preoperatively and many other actions, are all evidence-based methods of reducing opportunistic pathogens from causing harm to patients.

Remember that team members who are scrubbed, gowned and gloved, have right of way at all times in theatre. Another good reason to stay back at the wall, until trolleys, people and equipment have all been moved into place.

All items need to be cleaned and sterilised before they are presented to the sterile field as part of surgery. Many single use items such as prosthetics, are subject to radiation to sterilise them, as part of the manufacturing process.

Some items may be difficult to open from their packaging. Perioperative staff expect that you have been taught how to open your own company items. You should be honest, and not assist in this way, as you may potentially compromise the whole sterile field.

When there is complicated equipment on the sterile field which you may need to be describing how to put it together and how to take apart, the process can be greatly assisted by use of a laser pointer.  

Standard Precautions

Standard precautions (formerly known as universal precautions) are a set of infection control practices used to prevent transmission of diseases that can be acquired by contact with blood, body fluids, non-intact skin (including rashes), and mucous membranes.

One key element of standard precautions is risk assessment. This will provide you with an indicator of high, medium and low risk activities. Generally, surgery would be defined as high risk but there are further levels of potential risk, ie splash from blood in an open case or lower risk procedures where access is minimally invasive. The best advice is to protect yourself fully to reduce risk.

In an operating room, you do not know the infection status of the patients, they may have underlying hepatitis or HIV or another potentially infectious disease, so standard precautions to protect yourself should be in place. WHO categorise them as a minimum set of prevention measures. Hand hygiene is a key preventative measure, which is augmented by use of PPE (personal protective equipment).

Standard Precautions

PPE includes facemasks, eye protection, gloves and gowns.

Facemasks
Facemasks are not always worn in the operating theatre – it will depend on the surgery being performed. If you are asked or need to be close to the surgical field, there is always a risk of blood splash. There is a small risk of blood borne disease transmission (eg, hepatitis or HIV) if blood splash comes into contact with mucous membranes, such as eyes or inside of the mouth.

In order for you to be protected from hepatitis B (blood borne virus), it is likely that the company occupational health check will have ensured that you have an adequate personal level of immunity prior to any attendance in the high-risk environment.

How to wear your facemask
Before you step closer to the sterile field, you should collect a facemask. Wear these properly, covering both your mouth and nose and do not touch the mask surfaces once applied as this causes moisture to seep through.

Change your facemask regularly
Facemasks should be changed at the end of each operation with a fresh facemask being worn for each procedure. Dispose of the facemask (holding the ties, not the facemask) into a clinical waste bag and wash your hands.

Eye protection
Eye protection should also be worn close to the sterile field and should be available in operating rooms.

Gloves
As you are a visitor to this environment, you have no role other than that as a medical rep. You should not be handling anything that needs glove wearing. However, should you be taking a piece of your company's equipment away then it should be handled with gloves. Nitrile (non-latex) examination gloves will offer you sufficient protection for this activity.  

If you have not worn them before, gloves can be awkward to put on. Ask a member of staff to show you. Should you damage the gloves then discard and replace them.

When patients are known to present a high risk of infection, ie they already have MRSA (methicillin-resistant Staphylococcus aureus) in their wound, it is highly unlikely that extra people will be invited to be present for their surgery as further preventative measures will be in place.

However, if it is essential that you are present, ask local staff for guidance as to how you can best protect yourself and for any advice on specific behaviours during the surgery.

Scrubbing Up

Medical device company reps working in the UK have no vicarious liability while on a hospital visit. Companies do not usually offer any indemnity for reps to “scrub up” and be part of the surgical team at the operating table within the sterile field.

There is no reason for you to scrub up at any time or in any place. Decisions regarding the surgery and the surgical process have to be made by a licensed medical practitioner and not by any adviser – however well intentioned. No action on your part should stray into assisting with surgical next steps.

Waste Disposal

Hospitals produce vast quantities of waste which may be a hazard to anyone handling it. It is therefore carefully segregated at source, identified to the source and handled with great care.  It may be infectious, contaminated with blood or other dangerous tissues or be contaminated with drugs or chemicals.

Sharps which have been used also present high-risk waste which needs to be carefully managed. EU regulations cover healthcare waste, which is often transported away from the hospital for appropriate disposal. Sharps should be disposed of in special protective waste bins that are clearly marked.

In the operating suite, in general, yellow or orange bags contain clinical waste and black bags uncontaminated domestic waste. Anything which may be contaminated by body fluids from the patient and is disposed of in a high temperature incineration facility away from the hospital site.

Laundry can also be contaminated and if you have been splashed during surgery, you will need to dispose of your clothes into a bin/bag in the changing room which will be sent to the washing machine without being handled by workers.    

Decontamination and Sterilisation

Instruments, swabs and any product must be scrupulously free of any microorganisms, viruses or fungal spores when they go to the patient, from the sterile field during surgery. In order to ensure that this is the case, all items which go onto the sterile field must be sterile.

Cleaning is usually undertaken by machine at high temperatures for reusable items, prior to the sterilisation process. Once items are checked for cleanliness they are packed and autoclaved. The most common form of sterilisation is achieved by autoclaving, using steam. This is a process which subjects the pack to pressure at high temperatures (134 degrees centigrade) for a number of minutes (usually three or more). This achieves sterilisation which is the process that eliminates, removes or kills all forms of microbiological life.   

The specialists who undertake this action may be sited away from the hospital site in the sterile service unit. 

Other methods of sterilisation or high-level disinfection may be via an irradiation process which is undertaken by industrial processes or locally, cold chemicals may provide the means to kill or reduce harmful organisms.

Strict regulations affect decontamination and sterilisation in the EU. As part of ensuring that each instrument or device is appropriately cleaned and sterilised, manufacturers' instructions must be provided by the company.

These instructions should ensure that information is provided for cleaning methods and dis-assembly (if required for cleaning) as well as re-assembly for safe use.

Medical device companies that frequently lend instruments to hospitals may have a loans department that manages the entire despatch process.

Loans management by companies with highly specialised sets of instruments are subject to localised policy and company procedures. Reps involved in the process of lending instrument sets to hospitals should learn the processes involved and if possible assist the customers (users and sterile service departments) to understand the kit which is lent. Checks to ensure everything is present after delivery are an essential part of customer service and may help you when you support the surgery. 

Loan kits often have to be ordered to arrive at least 48 hours in advance of use, in order for all the content checking and decontamination processes to be completed.

Decontamination and Sterilisation

Before the items are sent for sterilisation they need to be checked by theatre staff and this can be assisted by you, as you should know the equipment well.

What needs to be checked?

  • Are the manufacturer’s cleaning instructions included?
  • Is a complete list of all contents present, including individual tray/set contents and all the implants (if relevant)?
  • Is the decontamination certificate present?

Products should be checked to ensure that all sizes and types are present. If they are pre-sterilised, as many implants are, each should be checked to ensure they are:

  • sterile — ie, the indicator by which the product has been sterilised, has changed colour (gamma indicators change from brown to red after sterilisation)
  • they are in date and CE marked
  • there is no interruption to packaging — ie, they are all still sterile

Clean Hands

It is vitally important that your hand hygiene is of the highest calibre at all times, as hand cleanliness has been proven to reduce most of the transient micro-organisms and thus reduce the risk of them been passed to the patient.

There should be alcohol gels available at many points in the hospital that you visit and should be used to remove organisms. Gels should only be used on clean hands and must only be used up to five times without a proper hand wash. This will prevent the gel building up on your skin.

Your nails should be kept clean and short.

There are six steps to that should be used to wash hands effectively with soap and water:

  1. Wet your hands first with lukewarm water as soap is concentrated and should not be applied to dry skin as it can damage the tissues. The water helps soap to create lather and spread over the whole hand.
  2. Use about 5ml of liquid soap in one hand and rub the hands together to get a good lather.
  3. Make sure that both hands are thoroughly covered and rubbed, especially between the web spaces between the fingers, and the creases of the wrist as these are the areas which are frequently missed.
  4. Rinse under running lukewarm water while rubbing hands together to remove all the soap as it dries the skin if left and can lead to damaged skin, especially in cold weather.
  5. Gently and thoroughly dry the hands, web spaces and creases.
  6. Use a water-based, not oil-based hand cream if there is one available. This will keep your hands in better health.

Clinical Trials

Before new products are introduced, clinical trials usually take place and you may need to take part, so you will need to understand the process.

Loans and trials
Most hospitals manage the purchase of products for clinical use via the procurement or purchasing department. It is worth asking how this is managed at your hospitals as this may differ, but individuals are almost never permitted to make purchases based on their own wishes. You will be signposted to the individual who will be your link to the process and they should help you to enable any trials or new product introductions go according to plan. If you get things wrong at this stage it could jeopardise future plans and also damage relationships with you as an individual and also your company. 

Staff training
Many modern products require the staff to be trained in their use and with good planning and a suitable timescale, all training must have been done prior to blanket introduction of the product. Provide visual guides and written instructions as well as personal support where required throughout the trial process. You must assure that staff are safe and confident in the use of the product before leaving them unsupervised. Contact details to ask you for assistance must be provided in case of need for support.

Trial product supplies
When planning the trial it is vital that enough product is provided for the length of the project. You must also make sure that there is clear understanding as to who is paying for the products as some trusts might believe that the cost is the company’s and not theirs.

It will be important to have a large enough trial sample to make the trial acceptable, therefore the number of people involved, there availability during the trial period and the length of the trial must be determined early on. In addition, it may be that approval needs to be sought from the hospital ethics committee

Master indemnity will need to be placed with the procurement department. 

Evaluation of the product
Evaluation forms should come from the hospital and must have been developed between the company and the clinical and procurement staff to remove any risk of bias in the questions. At the end of the trial, you may be asked to help with the collation and reporting of the trial responses. 

During the trial, you will need to ensure that a sufficient supply of evaluation forms are available in all trial areas. 

Trials involving electronic equipment
All powered products must undergo an electrical safety check with EBME or the medical engineers prior to introduction, so you will need to liaise with the department to ensure that they have the time allocated before the trial is due to start. Electrical safety stickers will be printed and attached to your equipment when they are deemed to be safe for use.

Product trials for clinical use: unsterile products
Any products that need to be sterile prior to use and for use in surgery need to have a decontamination certificate before taking to the theatres for checking. After the contents have been checked against the content list, they will need to be sterilised on or off-site. This should be determined well in advance as off-site sterilisation can take two or more days to be back on site.

Product trials for clinical use: sterile products
You will need to ensure that the trial products are in uncompromised dry packaging, in-date and accompanied by manufacturer’s instructions. If the trial runs to many uses, then storage space will need to be identified and the trial products changed out with the product that has been used but some must be kept available under control of a suitable member of staff to prevent trial slippage

Loan and Trial Equipment

As previously stated, not all hospitals use the same processes for managing trial and loans, so you will need to determine these for each of your sites before you start to lend items for use. Education in advance of trail is key to success.

In all cases, the products must be fit for use and accompanied by a decontamination certificate from your company not from whosoever sterilised it last.

You will need to make sure that you have spares of any single use or disposable products or parts of products that are being trialled just in case of destabilisation or droppage. Some sites are no longer able to re-sterilise items on site and an incident could lead to surgery being cancelled.

All compliance documentation should accompany the product and you should be well-versed in these to inform staff should they enquire.

Tracking and Tracing

The traceabilty of surgical instruments through the decontamination and sterilisation process and back to stock is critical to support patient safety. It should provide an accurate audit trail for risk management, managing valuable hospital assets and monitoring performance and productivity throughout the chain.

It is a key patient safety activity to ensure robust records of all prosthetic implants placed into patients, in case they malfunction in any way. Most prosthetics or implants have labels for insertion into clinical records which can include data on:

  • manufacturer
  • product source
  • type of implant
  • code number
  • batch lot
  • size

Adverse Incidents

An adverse incident is one that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons.

The MHRA (Medicines and Healthcare products Regulatory Authority) operates the yellow card reporting system. Should a product fail for any reason or appear to have been tampered with, the first line of action is for staff to report this to the MHRA within 24 hours of the event. The device should be removed and kept on site until a response is received from the MHRA.

You must not remove the product from the site but may be made aware of the event by staff. You should note the product details and batch number. It is likely that the MHRA will contact your company and ask for the product to be inspected and the outcome reported back to them.

Sometimes, you will know about an issue with one of your products before the staff do at the hospitals. They frequently rely on you to contact them and let them know if stock should be taken off their shelves and when new stock will be available.

The MHRA manages issues with medical devices, so that the market and their customers are aware of issues and problems with devices which may follow an adverse incident. 

Their system of reporting incidents by users, is completed by notification to all users of any changes that have been made to the design of the device or it’s preparation for use. These notifications are called FSNs (field safety notices) which the MHRA defines as below.

A field safety notice is an important communication about the safety of a medical device that is sent to customers by a device manufacturer, or their representative. FSNs tell users what they need to do to reduce the specified risks of using the medical device. The actions are referred to as FSCAs (field safety corrective actions).

Products can be removed or replaced in the market under a FSCA. All field safety notices are sent to the MHRA and the customer by the responsible manufacturer. It is the company's legal duty to report any corrective actions taken on devices.

The MHRA site lists all alerts and recalls for drugs and medical devices.

 

Patient Confidentiality

There are a number of legal requirements to ensure privacy of information for patients, particularly:

  • Data Protection Act 1998
  • Article 8 of the Human Rights Act 1998 which refers to an individual’s right to respect for their private and family life, for their home and for their correspondence
  • The Computer Misuse Act 1990
  • NHS Code of Practice on Confidentiality 2003

All of the above emphasise the need for healthcare to be secure in its management of data and care records, as well as accountable for breaches of information security.

Information on operating lists, operating room boards and patient records should not be subject to discussion outside of the hospital.

Mention of a patient's name may be heard by their relatives in hospital public places. Ensure you exercise care to uphold confidentiality.

In 1999, Dame Fiona Caldicott chaired a national committee which developed and subsequently introduced and mandated Caldicott guardians in all hospitals in the UK with the purpose of safeguarding any use of confidential NHS information.

There is therefore a responsible individual at each of your sites who could intervene should you or your company keep any identifiable patient information without competent authority.

Six Caldicott principles
The principles applying to the handling of patient-identifiable information, are: 

  • justify the purpose of every proposed use or transfer
  • don't use it unless it’s absolutely necessary, and
  • use the minimum necessary
  • access to it should be on a strict need-to-know basis
  • everyone with access to it should be aware of their responsibilities, and
  • understand and comply with the law

Whilst most of us have cameras on our phones, you must not take or agree to take any photographs in theatres or other clinical areas, even on someone else’s phone or camera. In most hospitals, there are professional medical photographers who have the skills to take clinical photographs.

The clinician must have asked for patient consent to take clinical photographs and there are rules and ethical guidelines for the clinician from the General Medical Council on the use of images.

Health and Safety Matters

Each hospital must follow the Health and Safety at Work 1974 guidelines for the safety of patients, staff, visitors, contractors and others. It is of course not a one-way process and you must take responsibility for not causing or risking harm when on site. Hospitals are full of risks.

Specifically — but not exclusively — the following are of most concern:

Slips, trips and falls
The areas that you will work in may contain wet floors and trailing leads which can create the risk of slipping or tripping. Many theatres are too small for the increasing technologies and this causes a lack of space for movement. If you should be unfortunate and have an accident, you must tell the senior member of staff and your line manager about what happened. You will need to complete an incident form at the hospital.

Should your injury cause you to be off work, for more than seven days, the incident will need to be reported to RIDDOR (Reporting of Injuries, Diseases and Dangerous Occurrences Regulations) via the Health and Safety Executive (HSE). This is your employer’s responsibility but they will also need to keep records — not reported to RIDDOR — of any absence for more than three days.

Fire
Best practice would suggest that in each of your areas, you will have been told what to do in the event of a fire. If you are not told, then make it your responsibility to find out. Many theatres are at basement level and if lifts are not to be used, as mandated, you will need to know how to get out. There have been serious fires in theatres.

Control of Substances Hazardous to Health (COSHH part of the Health and Safety at Work Act)
There is range of fluids/potential toxins used in hospitals that have been shown to cause harm from exposure. You should not be exposed to any of these but if they are used in your presence then you must be provided with the appropriate personal protective equipment (PPE) relevant to the product. Wherever possible, it is much better to remove yourself from the area if you are not needed at the time of use or there is insufficient PPE.

Risks from x-ray
X-ray is frequently used during surgery, especially in orthopaedics and spinal surgery. It can harm the foetus so if you might be pregnant it is better than you are not present during procedures using x-ray. You must be provided with a lead apron and hopefully a thyroid collar which prevents the thyroid gland from absorbing rays. The radiographer should warn the room verbally that they are about to use X-ray. This is your opportunity to leave if not adequately protected.

Some radiographers wear dosemeters which measure the background becquerels in the room. Modern x-ray focuses the beam much more accurately than in the past and there is less scatter of radiation. Modern theatres have a light outside the door linked to the x-ray machine which warns that x-rays are being taken.

Laser
Laser (light amplification stimulated emission of radiation) is used therapeutically in many theatres. Its purpose is to damage unhealthy tissues but it can also burn and seriously harm the eyes. There are several types of laser differently powered and goggles must be worn in the presence of their use. You should be offered goggles appropriate to the laser before entering the theatre. They should not be removed until instructed to do so.

Exiting the Operating Suite

It is good to reflect that you have experienced a privilege accorded to few. If the patient whose surgery you have witnessed is awake, say thank you and also thank the team. Your politeness will be remembered.

Back in the changing room, remove scrubs and clogs and dispose of them in the areas indicated. Remember to take your visitor badge, company ID, etc, off the scrubs before disposing of them. If you have your own footwear, clean and bag it in your own cloth bag, then wash and dry your hands before putting on your own clothes.

Leave the department by the proper route. You may be asked to sign out. 

Please remember
Just remember that no matter how well you know your hospitals and the surgical teams, you are a company employee who must behave responsibly, minimising risk and behaving professionally at all times, ensuring patient confidentiality dignity and safety.

Exam

This ends the course. You can now continue to the exam. 

 

Take Exam

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