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CHAPTER 20

Managing High-Risk Equipment

Chris Earl

Introduction

Management of high-risk equipment within the operating theatre department carries with it considerable responsibility and accountability. Medical devices may be used in the treatment of patients during surgery but, if used incorrectly, without sufficient training or being subject to regular maintenance, they can be the cause of unintended harm to patients.

Systems need to be in place in order that all practitioners are knowledgeable and responsible users. In the first instance a list or database of all equipment within the suite or department needs to be set up and maintained so that it is always current. Ideally, this database will hold details of purchase, regular maintenance visits and details of policies which relate to the equipments’ safe use on patients. This database may be held centrally by the biomedical engineering department or the operating theatre devices lead. In addition, a training database which lists every practitioner who has been ­educated to use specific medical devices listed on the asset register should be in place, detailing the date of education, who provided it and any updates available.

Responsible Authorities

The UK Competent Authority for Medical Devices is the Medicines and Healthcare products Regulatory Agency (MHRA). Their useful document on the responsibilities of management relating to medical devices (MHRA 2006) identifies that there should be a board member in every organisation who is responsible for ensuring safe device management, and that the organisation has policies which address:

• decontamination
  
• equipment life cycle
  
• procurement
  
• records
  
• adverse incident reporting
  
• actions required on the MHRA’s Medical Device Alerts and manufacturers’ corrective notices
  
• training
  
• technical specifications
  
• regulatory compliance and related issues
  
• rationalisation to single models, where possible
  
• risk management
  
• equipment inventory
  
• manufacturer’s instructions
  
• disposal.

Appropriate device management systems should ensure that whenever medical devices are used that they are:

• fit for purpose
  
• used in accordance with the manufacturer’s instructions
  
• maintained in a safe and reliable condition
  
• disposed of appropriately at the end of their useful life.

In addition, the medical device policy should set out clearly the mechanisms for:

• selection, acquisition, acceptance and disposal of all medical devices
  
• training of those who will use them
  
• decontamination, maintenance, repair, monitoring, traceability, record-keeping and replacement.

Each device should be given a unique identifier, a full history including the date of ­purchase and where and when it was put into use. There may also be specific legal requirements; whether these have been met or not (for example for laser use). Also whether the equipment has been properly installed and possibly commissioned for use (e.g. an autoclave); and the planned maintenance arrangements such as by an external contractor or internal department and the specific frequency of inspections required (e.g. an anaesthetic machine). Some devices have a recommended lifespan, which should also be included in the record. This enables appropriate planning for equipment replacement at suitable intervals.

Training

Training is an essential element of patient safety. Many medical devices in use in operating theatres are complex devices which operators must be confident to use and familiar with in order to reduce risks to patients.

Training must be given when a new device or piece of equipment is purchased and any practitioner who is going to set up or use the device must be able to manage it safely and with understanding.

New staff should be educated on local equipment as part of their induction process. Periodic refreshment may also be required as part of annual mandatory training.

Incident Reporting

All users have an additional responsibility to report to the MHRA if there are any adverse incidents involving medical devices. The process and online reporting mechanism are clearly laid out on the MHRA website (www.mhra.gov.uk). Incidents should be reported within 24 hours.

Accountability

As theatre practitioners, we are governed by our various Codes of Conduct and guidelines for good practice and these are quite unequivocal about our roles and responsibilities to patients for safe practice.

The Nursing and Midwifery Council (2008) states:

• a registrant must keep their skills and knowledge up to date
  
• you must have the knowledge and skills for safe and effective practice when working without direct supervision
  
• you must recognise and work within the limits of your competence
  
• you must keep your knowledge and skills up to date throughout your working life
  
• you must take part in appropriate learning and practice activities that maintain and develop your competence and performance.

The operating department practitioner’s Code states:

• a registrant must understand the obligation to maintain fitness to practise
  
• understand the need to practise safely and effectively within their scope of practice
  
• understand the need to maintain high standards of personal conduct
  
• understand the importance of maintaining their own health
  
• understand both the need to keep skills and knowledge up to date and the importance of career-long learning.

The Health Professions Council states in its standards of practice for operating department practitioners:

An operating department practitioner should understand the principles underpinning the safe and effective utilisation of equipment that is used for diagnostic, monitoring or therapeutic purposes in anaesthesia, surgery, post-anaesthesia care and resuscitation. (3a.1 Standards of proficiency, Health Professions Council 2008)

The Association for Perioperative Practice states: ‘Operating department practitioners and registered nurses are required to evidence their continuing professional development to maintain their professional registration.’

This begs the question, how to do all this? This chapter aims to lay the foundation of understanding on which to build and maintain competence in your role as far as some high-risk equipment safety is concerned. It will do this by describing how diathermy (or electrosurgery) was developed, how it works, some of its dangers and some current/future developments of the technology. In addition, it will seek to do the same for safe management of tourniquets.

As practitioners it is our responsibility to maintain and evidence this basic knowledge and keep abreast of developments. One effective way of doing this is to access the MHRA website education package on diathermy and use the material to assess your knowledge and demonstrate it by completing the online assessment. This can be found at www.mhra.gov.uk. However, this is only a generic based programme and is not company specific. That assessment should be done by the manufacturer of the systems that you use in your own workplace.

Diathermy or Electrosurgery

The diathermy machine is a piece of equipment that is familiar to all who work in an operating theatre, but how many of us know how it actually works, what unintended damage it can do and how as theatre practitioners we can and should avoid the ­possibility of this happening?

History

In the early eighteenth century, Luigi Galvani discovered that when two different metals came into contact with muscle, the muscle would contract. Allessandro Volta later ­concluded that electricity could be generated independently of animals and that this property was true of all metals. This form of energy was named ‘Galvanic current’ in Galvani’s honour and it has been suggested is what gave rise to the Frankenstein stories written by Mary Shelley.

As early as 1839, Gustave Crussell began experimenting with electro-cautery following work done by Charles Pravaz which showed how quickly blood could coagulate when electricity was applied to it. Others went on to develop various instruments so that practical applications within surgery could be developed with this discovery, until it was an accepted practice in the removal of skin blemishes such as warts and moles by the 1870s.

However, it was not until George Wyeth developed his endothermic knife that the true value of using this electrosurgical technique instead of the standard scalpel was realised when he demonstrated that he could overcome the problem of cancerous cells spreading during tumour surgery by using it. By 1921, this work had proved so successful that Tesla was awarded the Nobel Prize in Medicine for his use of diathermy in the treatment of diseases and tumours.

Diathermy was originally used as a treatment for arthritis, bursitis and other ­disorders of the tendons and muscles. A short definition of diathermy could be: ‘the therapeutic use of heat to body tissues’. Electrodes are used to send an electric current which has the effect of increasing the local blood circulation, therefore accelerating the process of repair to the body. However, because of the high-frequency current used in diathermy, care must be taken to avoid burning the skin.

Understanding diathermy

Several properties of electricity must be understood in order to understand electrosurgery and this will help the theatre practitioner ensure its safe use on patients.

• Current flow occurs when electrons flow from one atom to an adjacent atom. Voltage is the force that enables the electrons to do this.
  
• If electrons encounter resistance, heat will be produced and this is known as impedance.
  
• A complete circuit must be present in order for electrons to flow.
  
• To complete the circuit the electrons must return to ground. Any grounded object can complete the circuit

In the operating room these properties equate to:

• The electrosurgical generator is the source of the electron flow and voltage.
  
• The patient’s tissue provides the impedance, producing heat as the electrons overcome the impedance.
  
• The circuit is composed of the generator, active electrode, patient and patient return electrode.
  
• Pathways to ground are numerous but may include the operating table, stirrups, staff members and equipment.

Electric current and frequency

Standard household electric current alternates at a frequency of 60 cycles per second or Hertz (Hz). Diathermy could function at this frequency, but because the current would be transmitted through body tissue at 60 cycles, excessive neuromuscular stimulation and perhaps electrocution would result. Stimulation of muscles at this frequency is similar to the rate of a heart beating and could therefore potentially cause it to stop.

However this nerve and muscle stimulation ceases at 100 000 cycles/second (100 kHz), and so electrosurgery can be performed safely at frequencies above this. As this is also the frequency at which many radio stations operate, interference can be heard on ­activating the active electrode while a radio is on in the operating theatre. An electrosurgical generator increases 60 Hz household current to over 200 kHz so enabling ­electrosurgical energy to pass through the patient with minimal neuromuscular stimulation and no risk of electrocution.

Types of electrosurgery

Bipolar

In bipolar electrosurgery, the functions of both the active electrode and return electrode are performed at the site of surgery. The two tips of the diathermy forceps perform the active and return electrode functions. Only the tissue grasped between them is included in the electrical circuit. Because the return function is performed by one tip of the ­forceps, no patient return electrode is needed.

Monopolar

There are four components of a monopolar electrosurgical circuit:

• the generator
  
• the active electrode
  
• the patient
  
• the return electrode.

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