Buyers’ guide

Electrosurgery tip cleaners

CEP 08006

April 2008

Contents 2

CEP 08006: 2008

Introduction............................................................................................... 3

Technical considerations.......................................................................... 4

Operational considerations....................................................................... 5

Economic considerations ......................................................................... 7

Purchasing ............................................................................................... 8

Market review ........................................................................................... 9

Acknowledgements ................................................................................ 12

Appendix 1: Supplier and product details............................................... 14

Appendix 2: Evaluation protocol............................................................. 17

Author and report information................................................................. 18

Introduction 3

CEP 08006: 2008

Electrosurgery tip cleaners are single use devices designed to allow safe, effective cleaning of electrosurgical pencil tips. They generally comprise a foam pad with an abrasive surface and an adhesive backing.

During electrosurgery there can be a build up of eschar (charred tissue) on the electrosurgical tip. This causes adhesion of the tip to tissue, increased electrical resistance, reduced surgical effect and can serve as a fuel source leading to surgical fires [1,2,3].

Surgeons remove eschar by rubbing the electrosurgical tips on the tip cleaning pad. Tip cleaners are normally stuck to a surface within the sterile field, such as surgical drapes or an instrument tray.

Eschar build up can be minimised through use of appropriate generator settings and technique during electrosurgery [4,5] (see page 5). Non-stick coatings (such as silicone) on electrosurgical tips can also help to prevent eschar accumulating on the tip [3].

Consultation with stakeholders was carried out at the outset and used to identify the key factors to consider when making purchasing decisions. Two types of testing were performed:

• Objective testing was used to determine a) the adhesion of the pad to drapes b) presence of an X-ray opaque strip. Objective testing of samples (see Appendix 2) was performed by an independent testing organisation accredited by the United Kingdom Accreditation Service and the results form the basis of the ratings given in the Market review tables

• User evaluation examined a) ease of use, b) removal of eschar from tip, and c) damage to electrode tips. See Appendix 2 for further information. Results are discussed in the technical and operational considerations.

This buyers’ guide contains guidance on technical, operational and purchasing considerations for the use of electrosurgery tip cleaners. Stakeholders have identified these considerations as important in purchasing decisions. A comparison of a range of devices available on the UK market, including the test results, can be found in the Market review section.

Technical considerations 4

CEP 08006: 2008

Adhesiveness Tip cleaning pads are normally stuck to a surface such as a surgical drape, enabling the surgeon or scrub nurse to clean the electrosurgery tip using only one hand. The adhesiveness is important to ensure that the pad remains in place for the duration of the procedure.

For single use drapes, the pad does not need to be removed at the end of the procedure. Where reusable drapes are used, the pad must be removed at the end of surgery, prior to laundering. Pads tend to stick better to single use drapes than reusable ones, and can be easily peeled off. Where adhesion is very high some adhesive material may remain on the drape.

X-ray opacity X-ray opaque strips are incorporated into some tip cleaners to allow imaging verification in the event of a lost pad. Pads are not intended to be placed within the patient, but are often placed on drapes near the surgical site. The contrast between the pad material and x-ray opaque strip should be good enough to ensure easy detection on an x-ray image. An example image is shown in figure 1.

Special care should be taken when using a tip cleaner which resembles a cotton swab as this may absorb blood, could be mistaken for a swab and inadvertently left in the operative cavity. This would be a significant problem if the pad is not radio-opaque.

Figure 1

Operational considerations 5

CEP 08006: 2008

Eschar removal The primary purpose of a tip cleaner is to remove eschar. This is achieved by scraping the tip of the electrosurgical instrument being used across the abrasive surface of the pad. The abrasive action produces some tip damage.

Reduction in eschar build up Surgeons can reduce eschar build up by using cut or blend generator settings rather than coagulation while cutting and by reducing power settings during desiccation procedures.

Excessive smoke production or tissue charring that pulls away when the electrode is removed probably indicates that the power settings are too high. Decreasing the power settings, combined with slightly increasing the time, is likely to give a more even desiccation and avoid surface carbonisation (charring).

Spray Coagulation (or fulguration) is the use of a high voltage spark to the tissue from an electrode that does not contact the tissue surface [4]. Using spray coagulation rather than contact coagulation (or desiccation) may reduce eschar build up on the electrode tip [6].

Use with coated tips The abrasive action of cleaning pads can damage the non-stick coating on coated electrosurgical tips, reducing the non-stick properties and resulting in eschar build up. Non-abrasive cleaners can be used, removing some eschar whilst protecting the coating. Generally products that did less damage to the silicone coating also removed less eschar. Results from a user evaluation are included in the market review.

Abrasive surface It has been reported that particles of the abrasive surface of tip cleaners may stick to electrosurgical tips and enter the site of surgery [7]. Most pads have black abrasive surfaces, making it impossible to differentiate visually between remaining particles of eschar and detached abrasive grit.

Operational considerations 6

CEP 08006: 2008

Ease of use Generally the abrasive surface is flat, and with firm foam backing. Where the surface is contoured the tip digs into it when a back and forth abrasive action is used.

Where there is no adhesive area then both hands are required for tip cleaning, with the thin foam pad held around the electrosurgical tip.

Instructions and training These are not normally provided or considered necessary.

Figure 2. Examples of tip cleaners showing contoured and flat abrasive surfaces.

Economic considerations 7

CEP 08006: 2008

Electrosurgical tip cleaners are single use products. They are usually supplied in individual sterile packaging, but some manufacturers can supply non-sterile tip cleaners for inclusion in theatre packs to be sterilised at a later date. They do not require any special storage in addition to standard surgical items.

Disposal would be in clinical waste bags and cost of disposal is according to weight.

A reduction in the use of tip cleaners may be achieved using improved electrosurgical technique [4,5] and the use of non-stick coated tips [3].

Non-stick electrosurgical tips will be damaged if abrasive tip cleaners are used. Selecting a tip cleaner which does not damage the coating (see Tables on pages 10 & 11) would be desirable if surgical use causes the non-stick surface to be covered with eschar.

Figure 3. Tip cleaner in sterile packaging.

Purchasing 8

CEP 08006: 2008

Purchasing considerations NHS Supply Chain (NHS SC) offers national contracts or framework agreements for some products, goods and services. NHS Supply Chain has recently published a national contract for Sharps Pads and Tip Cleaners which offers some of the products listed. Use of these agreements is not compulsory and NHS organisations may opt to follow local procedures.

Sustainable Procurement The UK Government launched its current strategy for sustainable development [8] in March 2005. The Strategy describes four priorities to progress sustainable development, in the UK and in the world as a whole:

• sustainable production and consumption – working towards achieving more with less

• natural resource protection and environmental enhancement – protecting the natural resources and habitats upon which we depend

• sustainable communities – creating places where people want to live and work, now

and in the future

• climate change and energy – confronting the greatest identified threat facing the global community.

The strategy also highlights the key role of public procurement in delivering sustainability. Reduction in use Fewer electrosurgery tip cleaners may be required if generator settings and technique are optimised during electrosurgery, to reduce eschar build up [4,5]. Non-stick coatings (such as silicone) on electrosurgical tips can also help to prevent eschar accumulating on the tip [3].

Disposal Contamination of tip cleaners with bodily fluids and tissue debris require their disposal with swabs and other biological waste. They do not contain metal parts and are low cost. Consequently these products do not warrant the expense of cleaning and decontamination prior to disposal to enable recovery of raw materials.

Market review 9

CEP 08006: 2008

Tip cleaners supplied by 11 companies (14 products) are summarised on pages 10-11. The market review tables contain a summary of user and objective evaluation results. Most results are given a star rating where indicates the best performance. How to use the market review tables

Notation used Location for

further information

Length (mm) External length of device in mm

Width (mm) External width of device in mm

Thickness (mm) External thickness of device in mm

Phys

ical

Weight Unpackaged weight of a single device in grams Page 7

Tip cleaning - Indicates removal of eschar Pages 5 & 17

Coated tip preserved - Indicates non-stick coating is undamaged Pages 5 & 17

Single use drape adhesiveness - Indicates adhesion to single use drape Pages 4 & 17

Reusable drape adhesiveness - Indicates adhesion to reusable drape Pages 4 & 17 Ev

alua

tion

X-ray opaque strip - indicates clearly visible on x-ray image Pages 4

Product code Product or ordering code

Number in pack Number of devices in a pack as provided by supplier

Ord

erin

g

List price / unit ex VAT Manufacturer’s list price per device, excluding VAT

Product specific information All but two tip cleaners readily removed all eschar from the tip and damaged coated tips. Medasil Cautery Tip Cleaner removed some pieces of tissue but not all eschar. It reduced damage to coated tips, however some damage still occurred. It has a contoured surface requiring a slightly different tip cleaning technique. Covidien Microwipe Tip Cleaner removed some tissue only. It has no abrasive surface and did not damage coated tips. It also has no adhesive properties and worked best when held around the electrosurgical tip. Small fragments of the tip cleaner material were observed on the diathermy tip on two occasions during user evaluations when using the Medasil Cautery Tip Cleaner. It should be noted that this pad is green and therefore the material is very evident. Other pads may also deposit material but since the surfaces are black it would not be visible (see page 5).

Manufacturer comments: Aspen Surgical, manufacturers of AMS Cautery tip cleaner TC100 state “Our testing has shown that the adhesion level in our Cautery Tip Cleaner meets or exceeds the aggressive requirements of today’s operating room setting.

Market review 10

CEP 08006: 2008

AMS

Aspen cautery tip cleaner

ASM Cautery tip

cleaner

Covidien Cautery tip

Polisher

Covidien Tipolisher

Covidien Microtip

Wipe

Intelligent Tip cleaner

J&J Surgiste tip

Cleaner

Dark grey

Dark grey

Dark grey

Dark grey

White

Dark grey

Dark grey

Length (mm) 46 51 51 51 89 50 48

Width (mm) 43 50 50 50 89 50 48

Thickness (mm) 6.0 6.0 6.7 6.3 3.0 4.7 6.0

Phys

ical

Weight 1.7g 2.3g 3.7g 3.7g <1.0g 2.0g 2.0g

Tip cleaning Coated tip preserved

Single use drape adhesiveness n/a Not tested

Reusable drape adhesiveness n/a Not tested Ev

alua

tion

X-ray opaque strip

Product code TC100 30500 31142790 31142717 31142535 None 4315

Number in pack 100 200 100 240 100 200 36

Ord

erin

g

List price/unit ex VAT (£) 0.28 0.65 0.93 0.67 1.15 0.40 0.94

Market review 11

CEP 08006: 2008

Leonard Lang Skintact ESU tip Cleaner

Medasil Cautery tip

cleaning pad

P3 Medical Cautery tip

cleaning pad

Pennine Surgical tip

Cleaner

Squadron Surgical tip

cleaner

Universal Electrosurgical

tip cleaner

Unomedical tip cleaner

Dark grey

Green

Dark grey

Dark grey

Dark grey

Dark grey

Dark grey

Length (mm) 46 51 51 48 47 51 45

Width (mm) 44 51 51 48 45 51 45

Thickness (mm) 6.0 8.7 5.7 6.0 6.0 5.7 5.3

Phys

ical

Weight 1.7g 2.0g 2.0g 1.7g 1.7g 2.0g 1.3g

Tip cleaning Coated tip preserved

Single use drape adhesiveness

Reusable drape adhesiveness Ev

alua

tion

X-ray opaque strip

Product code TC1001 CT1 CTC050 TC1000/100 TC1000/100 UN58200 PM0837

Number in pack 50 50 50 100 100 50 50

Ord

erin

g

List price/unit ex VAT (£) 0.30 0.48 0.80 0.43 0.55 0.70 0.40

Acknowledgements 12

CEP 08006: 2008

We would like to thank all the manufacturers and suppliers for providing samples for evaluation free of charge. We also thank the stakeholders who helped us to prepare this Buyers’ guide, in particular: Jane Ashworth, Team Administrator, NHS Supply Chain, Chester

Jan Collins, Theatre Manager, Princess of Wales Hospital, Bridgend

Peggy Edwards, Patient Safety Manager (Wales), National Patient Safety Agency

Paul Fram, Technical Officer, SMTL, Princess of Wales Hospital, Bridgend Gavin Hughes, Technical Manager, SMTL, Princess of Wales Hospital, Bridgend

Lorraine Kruger, Clinical Leader, Main Theatres, University Hospital of Wales, Cardiff

Susan Pirie, Professional Officer, Association for Perioperative Practice, Harrogate

Peter Phillips, Acting Director, SMTL, Princess of Wales Hospital, Bridgend

Alun Tomkinson, Consultant, University Hospital of Wales, Cardiff

Neil Warren, Manager, Welsh Institute for Minimal Access Therapy (WIMAT), Cardiff Medicentre, Cardiff

Peter Willson, Consultant General Surgeon, Kingston Hospital NHS Trust, Surrey

References 13

CEP 08006: 2008

1. AORN. Recommended practice for electrosurgery. AORN Journal 2005; 81: 616-642

2. Massarweh N et al. Electrosurgery: History, Principles, and Current and Future Uses. J Am Coll Surgeons 2006; 202: 520-530

3. ECRI. Ignition of Debris on Active Electrosurgical Electrodes. Health Devices 1998; 27: 367-70

4. MDA. Low/medium power electrosurgery review 2002. MDA 02037 http://www.wales.nhs.uk/sites3/docmetadata.cfm?orgid=443&id=54116

5. MHRA. High power electrosurgery review 2004. MHRA 04080 http://www.wales.nhs.uk/sites3/docmetadata.cfm?orgid=443&id=54115

6. Willson P. Personal communication. Consultant General Surgeon, Kinsgton Hospital NHS Trust

7. Haigh P et al. Origin of Metallic Particles Resembling Microcalcifications on Mammograms after Use of Abrasive Cautery Tip Cleaning Pads during Breast Surgery: Experimental Demonstration. Radiology 2000; 216: 539-544

8. UK Government. Securing the Future: delivering UK sustainable development strategy. TSO 2005. http://www.sustainable-development.gov.uk/publications/uk-strategy/index.htm

Appendix 1: Supplier & product details 14

CEP 08006: 2008

Supplier Product Order code

Advanced Medical Systems Ltd PO Box 4 Banbury OX17 1TQ Oxfordshire Tel: 01295 738244 www.advmedical.com

Aspen Cautery Tip Cleaner

TC100

ASM Ltd Brunel Science Park Gardiner Building Kingston Lane Uxbridge, Middlesex UB3 2TG Tel: 01895 239121 www.asm-group.com

Cautery Tip Cleaner

30500

Covidien (formerly Tyco Healthcare UK) 154 Fareham Road Fareham Hampshire PO13 0AS Tel: 01329 224000 www.covidien.com

Cautery Tipolisher Cautery Tipolisher Microtip wipe

31142790 31142717 31142535

Intelligent Medical Supplies Ltd The Poplars Landican Lane Upton, Wirral CH49 5LJ Tel: 0151 648 0955

Tip Cleaner

Unknown

Johnson & Johnson Medical Ltd The Braccans London Road Bracknell Berkshire RG12 2AT Tel: 01344 864000 www.jnjgateway.com

Surgisite Tip Cleaner

4315

Appendix 1: Supplier & product details 15

CEP 08006: 2008

Supplier Product Order code

Leonhard Lang UK Ltd Unit 6, Frogmarsh Mill South Woodchester Gloucestershire GL5 5ES Tel: 01453 874130 www.leonhardlang.co.uk

Skintact ESU Tip Cleaner

TC1001

Medasil (Surgical) Ltd Medasil House Hunslet Road Leeds LS10 1AU Tel: 0113 243 3491 www.medasil.com

Cautery Tip Cleaning Pad

CT1

P3 Medical Ltd (formerly Amba) 1 Newbridge Close Bristol BS4 4AX Tel: 0117 972 8888 www.ambamedical.co.uk

Cautery Tip Cleaning Pad

CTC050

Pennine Healthcare Ltd City Gate London Road Derby DE24 8WY Tel: 01332 794880 www.penninehealthcare.com

Surgical Tip Cleaner

TC1000/100

Squadron Medical Unit A, Ireland Industrial Estate Griffen Close Staveley Chesterfield Derbyshire S43 3LJ Tel: 01246 470999

Surgical Tip Cleaner

TC1000/100

Appendix 1: Supplier & product details 16

CEP 08006: 2008

Supplier Product Order code

Universal Hospital Supplies George House Unit 6, Delta Park Industrial Estate Millmarsh Lane Enfield London EN3 7QY Tel: 0845 082 0182 www.uhs.co.uk

Electrosurgical Tip Cleaner

UN58200

Unomedical Ltd Thornehill Road North Moons Moat Redditch B98 9NL Tel: 01527 587700 www.unomedical.co.uk

Tip Cleaner

PM0837

Appendix 2: Evaluation protocol 17

CEP 08006: 2008

Technical Evaluation The technical evaluation was performed at the Surgical Materials Testing Laboratory (SMTL). Where sterile and non-sterile samples were supplied the sterile samples were used, when possible, however no differentiation was made in the results. A tip cleaner was placed on one end of a strip of drape and weighted down for 1 minute with a 1Kg mass. The weight was then removed and the drape peeled back by a couple of millimetres from the adhesive edge. The tip cleaner was then placed in the tensiometer jaws and the drape material peeled back at a speed of 50mm/min. The limit of the load cell was 100N, in some cases this limit was exceeded. The same method was used for both disposable and reusable drapes. The results were presented as an average from three samples of each tip cleaner and given star ratings according to the following table.

Star rating

Adhesiveness (N/mm) 0-0.49 0.5-0.99 1.0-1.49 1.5+ User Evaluation Tip cleaners were evaluated by building up eschar on an electrosurgical tip until the tip was observed to be sticking, using a sample of meat. The tip was repeatedly wiped on the tip cleaner, and observations made as to the ease of cleaning, the removal of eschar from the tip, debris surrounding the pad and ease of cutting after tip cleaning. Each pad was tested three times and the mean score used to determine the star rating. No tip cleaner had instructions stating that they were to be used with either non-coated or coated tips, therefore all products were tested in the same manner. The results for tip cleaning are based on how clean the electrosurgical tip was (by visual inspection) after cleaning. The evaluator scored the following statement:

Statement: Electrode tip remains black after cleaning

Strongly agree Agree Neither Disagree

Score allocated by evaluator 1 2 3 4 Damage to non-stick coatings on electrosurgical tips was assessed by rubbing a new coated tip on the pad. Data from this test was observational rather than numerical.

Star rating

Tip Cleaning Mean Score 1 2 3 4

Coated Tip Protected

Extensive damage after

single use

Slight damage after single use

Slight damage after repeated

use

No damage observed

Author and report information 18

CEP 08006: 2008

Electrosurgical Tip Cleaners Megan Dale, Jonathan Lane, Dr Diane C Crawford Clinical Engineering Device Assessment and Reporting (CEDAR) Cardiff Medicentre Cardiff CF14 4UJ Tel: 029 2068 2120 Fax: 029 2075 0239 Email: diane.crawford@cardiffandvale.wales.nhs.uk For more information on CEDAR and our earlier reports visit www.cedar.wales.nhs.uk About CEP The Centre for Evidence-based Purchasing (CEP) is part of the Policy and Innovation Directorate of the NHS Purchasing and Supply Agency. We underpin purchasing decisions by providing objective evidence to support the uptake of useful, safe and innovative products and related procedures in health and social care.

We are here to help you make informed purchasing decisions by gathering evidence globally to support the use of innovative technologies, assess value and cost effectiveness of products, and develop nationally agreed protocols.

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Centre for Evidence-based Purchasing Room 152C Skipton House 80 London Road SE1 6HL Tel: 020 7972 6080 Fax: 020 7975 5795 Email: cep@pasa.nhs.uk www.pasa.nhs.uk/cep © Crown Copyright 2008