for the clinical use of electrophysical agents 2006

Chapter 21 Guidance for the clinical use of electrophysical agents 2006

Reproduced with permission of the CSP, 14 Bedford Row, London WC1R 4ED

Sarah Bazin, Sheila Kitchen, David Maskill, Ann Reed, Alison Skinner, Deirdre Walsh, Tim Watson

CHAPTER CONTENTS

Section 1 363
Introduction
Section 2 364
Scope of practice, consent and monitoring
Section 3 365
Relationships with and advice to third parties
Section 4 367
Maintenance issues
Section 5 367
Competence to practise
Section 6 368
Contraindications, precautions, safety and application issues
Section 7 371
Agents
Section 8 383
Novel agents and equipment
Section 9 384
Bibliography
Section 10 385
Appendix 1: information sheet: electrophysical agents treatment record of unexpected effects

SECTION 1 INTRODUCTION

This guidance, developed by the Chartered Society of Physiotherapy, has been written to provide advice on the safe practice of electrophysical agents, where the use of such agents is indicated following assessment. Treatment parameters should be decided on the basis of the assessment, the known physiological effects of treatment, and any modifying factors, for example medication, past medical history. It would therefore be inappropriate for this document to include prescriptive protocols.

Chartered physiotherapists need to ensure that any interventions given will be clinically effective. Evidence of effectiveness can be drawn from research, expert opinion and patients’ and professionals’ experience. Recommendations in this document are based on a combination of the above, together with experience of the authors. A number of references are included in each section with additional suggested general literature in Section 9. Although these provide some key citations, they in no way provide a comprehensive review of the literature. The body of literature pertaining to electrophysical agents is both large and disparate. It is the responsibility of the user to keep up to date with this material.

1.1 DISCLAIMER

Although the information in this publication is relevant and accurate at the time of publication, readers and users of the material will need to take responsibility for identifying additional new information of relevance as it becomes available. It does not override the responsibility of the physiotherapist to make appropriate decisions for individual patients, in consultation with the patient and/or guardian or carer.

The authors and publisher disclaim responsibility for any adverse effects resulting directly or indirectly from the suggested procedures, from any undetected errors, or from the reader’s misunderstanding of the text.

This guidance was arrived at after careful consideration of the available evidence and should be used in conjunction with the Chartered Society of Physiotherapy’s (CSP) Core Standards of Physiotherapy Practice (CSP 2005), Rules of Professional Conduct (CSP 2002), Core Standards, CSP guideline paper PA47, Medical Devices Agency guidance, 1998 (see Section 4) and relevant legislation, including the Consumer Protection Act and Health and Safety at Work Act (1974). See also websites, e.g.:

• www.doh.gov.uk/hhsexec/manrec.htm (Managing records in NHS Trusts and Health Authorities), and
• www.open.gov.uk/doh/coinh.htm (Using electronic patient records in hospitals: legal requirements and good practice).

Although it is important for the profession to provide guidance, physiotherapists, when implementing the advice, will also need to take account of local regulations and policies.

SECTION 2: SCOPE OF PRACTICE, CONSENT AND MONITORING

2.1 SCOPE OF PRACTICE

• Physiotherapists should confine themselves to the use of electrophysical agents which they are able to apply safely and competently. In order to achieve this, physiotherapists should ensure that they, as individuals, follow the guidance on competence to practise contained in Section 5 of this publication, and on Safety, in Section 6. Physiotherapists who are giving advice to others with regard to electrophysical agents must ensure that they are familiar with the guidance laid down in Section 3, Relationships with and Advice to Third Parties.
• Physiotherapists should be aware of the guidance and standards that relate to each specific physiotherapeutic agent. When using a procedure which is not specifically listed, they should follow the principles laid down for other agents, and also make reference to Section 8, Novel Agents and Equipment.
• The individual physiotherapist is ultimately responsible for the assessment and treatment they deliver. This responsibility is not absolved if a prescriptive treatment programme is followed, or if the task is delegated (Section 3.2). Attention is drawn to Rule 4 of the Rules of Professional Conduct (2002), which relates to the responsibility of the physiotherapist for their intervention, regardless of what may have been prescribed by, for example, a medical practitioner, manufacturer or another physiotherapist. The physiotherapist has to decide whether the treatment is appropriate, and if in doubt, it is their responsibility to seek further professional/expert opinion before undertaking the treatment.
• Before proceeding with the proposed treatment, physiotherapists must ensure that patients receive sufficient information, including the risks, benefits and alternatives, to allow them to make an informed decision.
• Physiotherapists must maintain an adequate record of the agents they use. This should include the assessment, the tests carried out and their results, the clinical reasoning and the patient interaction that led to the decision to apply these.
• Physiotherapists should be aware of, and comply with, the maintenance issues highlighted in Section 4 of this document. Although it is not the responsibility of physiotherapists to carry out the majority of the formal safety and calibration tests, it is their responsibility to ensure that these have been carried out for the equipment they are using. They also have a responsibility to ensure that a safety check programme is up to date. Physiotherapists should not use a machine which does not have an ‘in date’ safety check.
• Attention is also drawn to Rules 7 and 8 of the Rules of Professional Conduct, which relate to the advertising and sale of equipment and services. Care should be taken to ensure that patients are given adequate information with regard to machine purchase or hire.

The professional responsibilities of physiotherapists in relation to the application of electrophysical agents should conform to the principles set out in the Rules of Professional Conduct (CSP 2002).

2.2 VALID CONSENT

Patients must have the capacity to give valid consent to treatment. They should be able to comprehend and retain material information, especially consequences, and be able to use and weigh information in decision making. Information given by the physiotherapist should enable the patient to make a balanced judgement, understand material or significant risks, and questions should be answered truthfully. The DH Consent website www.dh.gov.uk/consent has the full text of all DH Consent publications.

2.3 MONITORING PERFORMANCE

Clinical audit

Routine clinical audit should include procedures that measure performance.

Unexpected effects reporting

In addition, it is the responsibility of the individual physiotherapist to report all unexpected effects of electrophysical treatments both in the appropriate way locally, and to the professional body. It is an important component of professional audits that all such unexpected effects are recorded and detailed accurately and fully. Included in this booklet is the current report form (Appendix 1) which should be completed and returned to the Clinical Effectiveness Unit of the CSP electronically via enquiries@csp.org.uk or to the postal address quoted in the event of a patient experiencing an unexpected response to treatment.

SECTION 3: RELATIONSHIPS WITH AND ADVICE TO THIRD PARTIES

There are a number of situations where a physiotherapist may give advice on the use of electrophysical devices. In all such situations, the physiotherapist should be aware of the full implications of giving such advice.

3.1 LOAN/HIRE OF ELECTROPHYSICAL DEVICES FOR USE BY A PATIENT (e.g. home use of a TENS unit)

Patients who are loaned or hired an electrophysical device by a physiotherapist, receive instruction on its safe and effective application.

Criteria

• Equipment is checked for electrical safety, output and cleanliness prior to the loan.
• The patient is fully instructed in the safe and effective use of the apparatus.
• There is a demonstration on the patient of the application of the device.
• The patient is supervised in practising the application of the device.
• Simple written instructions detailing use, adequate care, hazards of the apparatus, and contact details for assistance, are provided.
• A copy of the written instructions to patients is placed in the patient’s record.
• The loan of equipment is recorded in the patient’s record.
• A record is kept of all equipment loaned/hired.
• The patient’s use of the loan equipment is monitored normally on a monthly basis.
• Equipment returned by patients/third parties (e.g. another department or family member) is checked upon return, in accordance with a local protocol.

3.2 DELEGATION OF TASKS TO PHYSIOTHERAPY ASSISTANTS

The responsibility for the patient’s care remains with the physiotherapist, who will undertake the initial assessment and make the decision that the application of an electrophysical agent is indicated, and prescribe the dose. The physiotherapist is responsible for the re-evaluation of the patient’s condition at each attendance, and has a responsibility for monitoring the assistant’s technique of application. Tasks should be delegated in accordance with the CSP’s Information Paper PA 6, ‘The delegation of tasks to physiotherapy assistants and other support workers’.

The physiotherapist must ensure, in every case, that the assistant has received adequate, documented training on the relevant and specific apparatus. This will include the operation of relevant devices, and information about potential dangers, risks and contraindications to treatment. Equally, the physiotherapy assistant should alert the physiotherapist if they feel their training is inadequate to allow the safe application of the agent.

Physiotherapy assistants who apply electrophysical agents to patients are responsible for satisfying themselves the task has been appropriately delegated and carried out.

Criteria

Physiotherapy assistants will:

• only use equipment for which they have received training
• apprise the delegating physiotherapist where they believe their training in the use of the specific equipment to be applied is inadequate
• ensure that all instructions are received in writing
• ensure that all instructions include body part, dose and application time
• inform the delegating physiotherapist of the progress of treatment
• notify the delegating physiotherapist immediately, whenever any unexpected reactions to treatment are observed, or where potential risks or contradictions become apparent.

3.3 ADVICE TO ANOTHER PHYSIOTHERAPIST

Regardless of any specific expertise or length of experience, physiotherapists considering giving advice to another physiotherapist are encouraged to be fully apprised of all relevant facts in the case in question, and preferably in writing. In such cases, it should be noted that the duty of care remains with the physiotherapist responsible for the treatment.

3.4 ADVICE FROM MANUFACTURERS/SUPPLIERS/DEVELOPERS

The claims, whether in terms of effects, efficacy or safety, of manufacturers, suppliers or developers should not be accepted by the physiotherapist in isolation. Evidence from reliable studies, or advice from suitably qualified clinicians, e.g. physiotherapists or physicians who are familiar or experienced in the use of the particular apparatus (in the case of a new machine) or agent (in the case of novel treatments), should be additionally sought.

3.5 ADVICE TO MANUFACTURERS/SUPPLIERS/DEVELOPERS

Individual physiotherapists should only undertake technical consultancy after fully considering the implications of the subsequent use of the advice provided. Provision of written or oral testimonials should normally be avoided.

3.6 ADVICE TO OTHER RECOGNISED HEALTH CARE PRACTITIONERS

Individual physiotherapists are encouraged not to provide informal advice on electrophysical agents to other recognized healthcare professionals e.g. physicians, nurses, chiropractors, osteopaths, podiatrists. Where the other party can demonstrate relevant knowledge and competence, advice may be given at the discretion of the physiotherapist in line with the recommendations noted above for advice given to other physiotherapists, i.e. in such cases, the duty of care remains with the other healthcare professionals, not the physiotherapist.

Under some circumstances, formalized training may be provided for such professionals by suitably qualified physiotherapists; in such cases, due consideration should be given to the implications for the profession(s) concerned and their recognized competencies.

3.7 ADVICE TO UNQUALIFIED PRACTITIONERS, EXCLUDING PHYSIOTHERAPY ASSISTANTS

It is considered inadvisable for physiotherapists to provide advice to practitioners whose qualifications are not recognized by statute, regardless of the ‘expertise’ or length of experience of the practitioner, as there is no continuing jurisdiction over their practice, unlike the position with physiotherapy assistants.

3.8 ADVICE TO INDIVIDUALS NOT UNDER THE DIRECT CARE OF A RECOGNIZED PRACTITIONER

In some cases, members of the general public may avail themselves of opportunities to obtain electrophysical apparatus directly from the manufacturer or supplier (e.g. by mail order) and subsequently seek advice on its use.

Physiotherapists approached in such cases should encourage the individual to seek assessment from a chartered physiotherapist or other suitably qualified practitioner, who can then advise on the suitability and appropriateness of the apparatus or agent purchased. Physiotherapists are encouraged not to provide informal advice to such patients, regardless of individual circumstances e.g. patient with chronic pain, unless a full assessment has been performed and the physiotherapist is familiar with the apparatus in question and its suitability.

SECTION 4: MAINTENANCE ISSUES

The standards for the maintenance of electrophysical equipment should be read in conjunction with Section 7, as they may be modified for specific electrophysical agents.

4.1 ELECTROPHYSICAL EQUIPMENT RECEIVES ROUTINE AND APPROPRIATE MAINTENANCE, WHICH INCLUDES QUALITY ASSURANCE OF FUNCTION AND SAFETY FEATURES

Criteria

• There is a local policy for the maintenance of all electrotherapeutic equipment
• There is a contract for the maintenance and repair and quality assurance of equipment with:
• manufacturer/supplier and/or
• hospital Medical Engineers Department and/or
• hospital Medical Physics Department and/or
• a reputable third-party maintenance organization.
• The contract specifies maintenance and quality assurance to be carried out at least once per year.
• There is a written record of all maintenance, repairs and quality assurance results, which should be accurate, detailed and readily assessable. Consideration should be given to permanent preservation of records (publication HSC1999/053 refers and can be found via www.dh.gov.uk).
• Prior to use a visual check of all electrotherapy equipment includes:
• electrodes
• leads
• cables
• plugs
• power outlets
• switches
• controls
• dials
• screens
• indicator lights
• mechanical stability.
• Faults, or suspected faults, are reported immediately.
• Machines or parts with faults or suspected faults are removed from use immediately until repaired.
• Where a piece of electrophysical apparatus is loaned by a supplier, an indemnity form is signed by both supplier and a representative of the health authority or practice, prior to the start of the loan period.
• All new equipment is tested in accordance with the manufacturer’s guidance to ensure that it is functioning as intended and is safe for the patient and operator.

The Medical Devices Agency, an Executive Agency of the Department of Health, has produced guidance on ‘Acceptance Testing’ and ‘The Management of Medical Equipment and Devices’ (www.medical-devices.gov.uk).

All new equipment sold in the European Community should be CE marked, in accordance with the Medical Devices Directive. European Standards describe the specification to which equipment should be manufactured, and are documented in the British Standards BS EN46000 series. Manufacturing and maintenance organizations should be aware of these, and the user is unlikely to need to refer to them. If the equipment gives rise to any major concerns, the user may wish to consult the documents, which are available from the British Standards Institute, or from major city or university reference libraries.

SECTION 5: COMPETENCE TO PRACTISE

Professional competence is essential to safe and effective practice. Before using the electrophysical agent, practitioners must ensure that they are knowledgeable about its physical, physiological and clinical effects and efficacy, based on the best available evidence. Contraindications, precautions and methods of safe application must also be known.

Rule 1 of the Rules of Professional Conduct of the CSP states ‘Chartered physiotherapists shall only practise to the extent that they have established and maintained their ability to work safely and competently…’ (CSP 2002). Physiotherapists should therefore confine themselves to the use of agents in which they have undertaken relevant pre- and/or post-qualifying programmes. Learning from manufacturer’s literature alone is not adequate. Physiotherapists have a responsibility for updating themselves, as new knowledge becomes available.

Continuing professional development is described by the CSP as ‘the lifelong learning that professionals need to undertake throughout their career in order to maintain, enhance and broaden professional competence’. As in other areas of the profession, competence to practise is maintained through the incorporation of information obtained from a variety of sources, including:

• participating in courses, workshops
• reviewing research, equipment evaluations and safety literature on a regular basis
• discussing the use and effects of relevant agents with other knowledgeable professionals.

SECTION 6: CONTRAINDICATIONS, PRECAUTIONS, SAFETY AND APPLICATION ISSUES

The following guidelines apply to all the equipment referred to in Section 7. Additional safety measures are also specified in Section 7 for specific agents, and these should also be adhered to.

In order to ensure safety during the application of electrophysical agents, the physiotherapist must consider the patient, the electrotherapy apparatus, the surrounding environment and other people.

6.1 CONTRAINDICATIONS FOR ALL AGENTS

During the selection and application of any electrophysical agents (EPAs), the following measures should be taken to ensure safety and good practice.

  Reference
• Those who are unable to comprehend instructions, or who are unable to co-operate CSP Core Standards (2005)
• The application of electrophysical agents over the abdomen, lower back or pelvis is normally contraindicated during the first 35 weeks of pregnancy. Refer to specific information for each agent Expert opinion
• In the area of a tumour where there is active or suspected malignancy, except for palliative care 001*/002*/003* 004*/005*/006* 007*/008*/009*
• Areas of recent bleeding tissue or haemorrhage Expert opinion
• Active tuberculosis in treatment area Expert opinion

*001 Auda SP, Hall G, Elias J et al (1979) Selective tumor heating and growth retardation by shortwave radiofrequency. Surg Forum 30: 154-156.

6.2 PRECAUTIONS FOR ALL AGENTS

Treatment should not normally be carried out:

  Reference
• Over the anterior aspect of the neck Expert opinion
• Where there is significant impairment in the circulation/sensory loss of the area to be treated Expert opinion
• Where there is devitalized tissue, e.g. after recent radiotherapy Expert opinion
• Where there are local acute skin conditions, e.g. eczema, dermatitis Expert opinion

6.3 HEALTH AND SAFETY CONSIDERATIONS

  Reference
• Treatment is carried out in compliance with local regulations Norm
• The surrounding environment is safe for treatment Expert opinion
• There is a warning sign relating to patients with internal stimulators where high-frequency equipment is used Expert opinion

6.4 QUICK REFERENCE GRID

image

6.5 APPLICATION FOR ALL AGENTS

  Reference
Measures should be taken to ensure that the electrophysical equipment is applied in a manner that is conducive to safe usage Expert opinion
The user manual for each piece of equipment is read and understood before its use Expert opinion
Equipment and accessories are checked as appropriate prior to application Core standard 18
Relevant technical safety checks are carried out for the specific apparatus Core standard 18
Equipment is kept clean Expert opinion
Where appropriate, the intensity indicator is set at zero prior to switching on or off Expert opinion
The equipment is switched on/off in the correct sequence Expert opinion
Where appropriate, intensity dials are turned up or down gradually Expert opinion
The patient should be positioned comfortably with adequate support to remain in the given position for the duration of the treatment Expert opinion
Preparation of patient  
• an explanation of the planned treatment is given to enable valid consent 010*/011*
• the sensation of the planned treatment to be experienced is explained 010*/011*
• the patient is warned of any effects that should be reported 010*/011*
Examination and testing  
• this refers to specific examination of the part of the body to be treated for possible hazards, contraindications and precautions, plus any appropriate tests. A check should be made to ascertain whether the patient might suffer an allergic reaction to any substance being applied to the skin 010*/011*
Drug information  
• information must be obtained from the patient concerning medication that may interfere with or mask the effects of the electrophysical agent. Expert opinion
Assembly of apparatus  
• visual checks are made of electrodes, leads, cables, plugs, power outlets, switches, controls, dials and indicator lights 010*/011*
Preparation and testing of apparatus  
• the operator(s) should minimize their own exposure to the agent 010*/011*
Preparation of the part to be treated  
• this involves any preparatory procedure, e.g. washing the area 010*/011*
Setting up  
• the apparatus should be set up to ensure optimum therapeutic effect and safety 010*/011*
• where possible the same piece of equipment is used at each visit. Expert opinion
• the functional output of the equipment is tested on the day of use Expert opinion
• local policies relating to infection control are adhered to, and specialist advice is sought where appropriate Expert opinion
Application  
• the patient should be monitored appropriately to ensure that treatment is progressing satisfactorily and without unexpected effect 010*/011*
Treatment  
• if pain, discomfort or unexpected sensations are experienced by the patient treatment intensity should be modified Expert opinion
• at the termination of treatment the part treated should be examined, and the general condition of the patient evaluated 010*/011*
For those devices that allow a hands-free application:  
• a member of staff remains within calling distance during treatment Expert opinion
• the patient is provided with a means of calling for assistance Expert opinion
Recording  
• an accurate record of assessment findings, machine settings, all treatment parameters and effects must be made. This is required to enable accurate treatment replication and as a legal requirement. 010*/011* Core standard 14 Core standard 18

*010 Kitchen S (ed) (2002) Electrotherapy: Evidence-based Practice. London, Churchill Livingstone.

*011 Low J, Reed A (2000) Electrotherapy Explained – Principles and Practice, 3rd edn. Oxford, Butterworth-Heinemann: 27-28.

Supplementary reading: all agents – application

Chartered Society of Physiotherapy (CSP) Safety of Electrotherapy Equipment working group. Guidelines for the safe use of ultrasound therapy equipment. Physiotherapy. 1990;76(11):683-684.

Chartered Society of Physiotherapy (CSP) Safety of Electrotherapy Equipment working group. Guidelines for the safe use of microwave therapy equipment. Physiotherapy. 1991;77(9):653-654.

SECTION 7 AGENTS

The information in the following sections should be read in conjunction with the generic information in Section 6.

7.1 BIOFEEDBACK

7.1.1 Introduction

A technique which enables the individual to readily determine the activity levels of a particular physiological process, and with appropriate training, learn to manipulate the same process by an internalized mechanism.

[For the purpose of this documentation, Biofeedback will specifically relate to the use of EMG Biofeedback, although it is acknowledged that there are many different forms of this therapy.]

The EMG Biofeedback unit allows the detection of the gross electrical signals arising from active muscle, passes them through several electronic processes and presents them to the patient in a simplified format (lights, sound).

7.1.2 Contraindications

None known.

7.1.3 Precautions

  Reference
• Ensure that the skeletal and soft tissues are capable of withstanding the enhanced forces that may be generated by the facilitated muscle. Expert opinion

7.1.4 Hazards

Patients with epilepsy may experience an adverse response to the visual display (flashing lights/computer screen). Such patients should be treated with caution and careful monitoring, following consultation between the therapist and the appropriate medical practitioner.

7.1.5 Application and mandatory warnings

Patients should not feel any skin irritation, discomfort or pain. Any such sensations should be reported to the therapist immediately.

7.1.6 Treatment record

See ‘Application for all agents’ – Recording.

7.2 COLD THERAPY

7.2.1 Introduction

Read in conjunction with the generic information in Section 6.

Cold therapy is the application of cooling agents to the tissues to produce a reduction in body tissue temperature. The temperature changes affect a wide variety of structures including skin, muscle, nerves and blood vessels.

Little evidence is available to support the following contraindications, which are based on current clinical norms.

7.2.2 Contraindications

  Reference
• Acute febrile illness Expert opinion
• Vasospasm (e.g. Raynaud’s disease/development of white/blue fingers with cold) Expert opinion
• Cryoglobulinaemia Expert opinion
• Cold urticaria/allergy Expert opinion

7.2.3 Precautions

  Reference
• Appropriate precautions should be taken in the presence of open wounds, infected tissue and skin lesions Expert opinion
• Very large areas (e.g. bilateral lower limbs) should never be subjected to very low temperatures Expert opinion

7.2.4 Hazards

• Cold burns.

7.2.5 Application and mandatory warnings

• The treatment can result in a cold burn.

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Aug 31, 2016 | Posted by in NEUROLOGY | Comments Off on for the clinical use of electrophysical agents 2006

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