Evaluation report

Skin marker pens

CEP 08009

April 2008

Contents 2

CEP 08009: 2008

Executive summary .................................................................................. 3

Introduction............................................................................................... 5

Product description................................................................................... 6

Methods.................................................................................................... 7

Technical performance........................................................................... 13

Operational considerations..................................................................... 16

Economic considerations ....................................................................... 18

Purchasing ............................................................................................. 19

Acknowledgements ................................................................................ 20

References ............................................................................................. 21

Appendix 1: Supplier contact details ...................................................... 23

Appendix 2: Evaluation protocol............................................................. 25

Appendix 3: Risk of cross-infection ........................................................ 27

Appendix 4: Pharmacy prepared inks .................................................... 28

Author and report information................................................................. 29

Executive summary 3

CEP 08009: 2008

The product Skin marker pens are used to apply ink directly to the skin of a patient. They usually resemble a felt-tipped pen and the ink flows from the internal reservoir as the tip is brushed on the skin surface. Most are CE marked and supplied in sterile packaging with a ruler.

Field of use Marking the patient’s skin is important in a range of clinical settings and for different reasons but the principal functions can be to:

• ensure surgery is performed on the correct site • mark an important internal anatomical feature identified during diagnostic imaging • target non-invasive treatments • plan the surgical approach • ensure natural realignment of skin flaps during wound closure.

Methods An important reason for using a surgical marker is to ensure correct site surgery. National Patient Safety Agency (NPSA) guidelines, produced in association with several other healthcare bodies, recommends that an indelible pen should be used and that the mark should remain visible after normal perioperative skin preparation at the surgical site and the application of theatre drapes [1, 2].

Review of the literature and stakeholder consultation has been used to develop an evaluation protocol suitable for evaluating whether normal pre-operative skin preparations remove skin marks made by a range of pens sold for this purpose. Observers scored ink mark visibility of each pen and the sharpness of the line edge (a) shortly after the line was drawn on human skin, (b) after cleaning with several commonly used surgical preparation fluids and finally, (c) after the skin was covered with an iodophor-coated incise drape.

Eleven products were supplied for testing. Results of this evaluation study are combined with relevant features of each pen to produce a summary table of technical performance.

Technical performance Before surgical preparation the visibility of all pens were scored as either “acceptable” or “excellent” and we found that overlaying antimicrobial iodophor surgical incise drapes makes a minimal change to line visibility and sharpness.

No pens provided acceptable visibility after perioperative cleaning with 2 fluids. Povidone iodine solution causes minimal changes to the visibility of marks made by five pens (Aspen Richard Allen fine and regular tipped pens, Aspen Writesite pen, Codman Surgical bold tipped pen and the UN64 skin marker pen). Chlorhexidine gluconate (alcohol) severely reduces the line visibility of all pens, except for the Viomedex pens.

Executive summary 4

CEP 08009: 2008

Operational considerations Sterility of pens being used for marking the surgical site is an important factor as pens tested after clinical use have been identified as vectors for micro-harmful organisms. Multi-patient usage is not advocated and the use of sterile pens is recommended for marking close to the incision site and these are usually marked “single use”. In practice care is needed to avoid contaminating an operative site after using the pen on a potentially infected area on the same patient.

All pens in this report contain violet/black ink which may be less visible on darker skin tones. The line width obtained from the pens listed may not be sufficiently precise for use by plastic surgeons who generally require very fine lines for skin realignment to achieve a good cosmetic result.

Some patients seek to avoid obvious skin markings persisting for days after surgery. This could be achieved by selecting one of the five pens listed that are minimally faded by povidone, followed by postoperative cleaning of the area around the suture line with chlorhexidine gluconate.

Economic considerations The increased cost of using single use skin marker pens for all pre-operative marking should be balanced against the risk and costs associated with post-operative infections and wrong site surgery, which can include: increased patient stay; operating time; additional diagnostic imaging and medico-legal claims.

CEP verdict Some pens remain more visible than others after pre-operative skin cleaning but the results are dependant on the skin cleaning fluids used. The marks of five of the products tested remained clearly visible after the application of povidone preparations but were difficult to see after chlorhexidine gluconate based preparations were used for skin cleaning. By contrast, we found the Viomedex pens, using an aqueous solvent, remained visible after skin cleaning with chlorhexidine gluconate but fading occurred with povidone.

This study did not evaluate the performance of the sample pens with notably dark skin tones and none of the products tested were specifically designed for this clinical situation.

Key factors to consider when selecting a pen suitable for use close to the operative site are: • risk of infection (ie pen is sterile, especially when used after pre-operative cleaning) • absence of fading after cleaning with the specific skin preparation fluids used locally • tip shape, as this should be appropriate for surgeon’s purpose.

Introduction 5

CEP 08009: 2008

Marking the patient’s skin is important in a range of clinical settings and for different reasons but the principle functions can be to:

• ensure surgery is performed on the correct site eg by identifying the correct limb • mark an important internal anatomical feature identified during diagnostic imaging • target non-invasive treatments, eg radiotherapy beam target in cancer treatment • plan the surgical approach eg by marking incision lines • ensure natural realignment of skin flaps during wound closure to achieve a good

cosmetic result.

When responding to the problem of incorrect anatomical site surgery the National Patient Safety Agency (NPSA) emphasised the importance of surgical marking. NPSA guidelines produced in association with several other healthcare bodies recommends that an indelible pen should be used and that the mark should remain visible after normal perioperative skin preparation at the surgical site and the application of theatre drapes [1, 2].

A primary objective of this evaluation report has therefore been to produce independent evidence demonstrating those skin marker pens capable of withstanding the normal skin preparation process at the surgical site and remain clearly visible to the surgeon.

Product description 6

CEP 08009: 2008

Skin marker pens are used to apply ink directly to the skin of a patient. All samples supplied for this evaluation study resembled a typical felt-tipped pen and were between 9.6 – 10.9mm in diameter, ranged from 135 – 172mm in length. Most were CE marked and supplied in sterile packaging (Figure 1).

As the tip is applied topically, when brushed on the skin surface, it draws ink from a reservoir in the pen body. Tip shapes vary (as shown in Figure 2) and may be described by manufacturers as fine (A), regular (B), bold (C) or versatile (D ie producing fine lines when held vertically and broader lines when the pen is held at an angle). One pen assessed in this evaluation contained two tips, one on each end, allowing the user to select a fine or bold tip.

Many pens have centimetre and millimetre scale markings printed on the side of the pen (Figure 3) to facilitate measurement when marking the skin. Some products may also include a separate plastic ruler (Figure 4) in the packaging for the same purpose.

Figure 1 Example of pen in sterile packaging

Figure 2 Comparison of tip sizes

Figure 3: Ruler markings on side of a pen

Figure 4 Separate plastic ruler supplied

Methods 7

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Literature review and consultation To enable the development of an evaluation protocol for the objective assessment of skin marker pens this section establishes (a) the normal perioperative processes that pen marks on the patient’s skin need to withstand and (b) reviews the methodologies described in published evaluation studies.

Skin preparation before surgery It is reported that there is wide variation in practice, even amongst surgeons in the same hospital and, despite scientific evidence supporting change, traditional practices still dominate [3]. This diversity of protocols was confirmed in a recent postal audit [4] and consultation with perioperative staff in a tertiary referral hospital. Generally the key stages comprise:

• marking the patient prior to surgery, after they have cleansed with soap (anti-bacterial is recommended [4]) and before sedation

• painting the surgical site with a skin preparation applied using a swab or sponge • air drying • application of an iodophor-coated surgical incise drape (in a minority of cases [3]).

Factors affecting the choice of skin preparation A range of different skin preparations are available for use preoperatively and they all have different properties.

Isopropyl alcohol is anti-bacterial but of limited use against fungi. Alcohol may be used alone by some surgeons but more commonly it is a component of a number of proprietary skin cleaning products, as it enhances the activity of other antiseptic solutions [4]. Surgeons using alcohol-based skin preparations must ensure there is no pooling of flammable vapour, as fire is a risk during electrosurgery [5].

Iodine-based skin paints are popular as it is easy to verify the area covered by the antiseptic solution. Iodine is known to kill bacteria, fungi, viruses and spores but skin sensitisation is a problem for 15% of patients [4]. Povidone-iodine, a mixture of iodine and polyvinyl-pyrrolidine available in aqueous or alcohol based solutions, was developed to reduce the problems of skin sensitivity.

Chlorhexidine is a broad spectrum antibacterial agent, similar to the iodophors, with a prolonged action and there is a lower risk of patient sensitivity [6], although anaphylactic reactions in patients undergoing surgery has been reported [7]. It is a primary component in many proprietary skin preparations, either as an aqueous or alcohol based solution, and has become equally popular for pre-operative skin cleansing.

There is conflicting evidence about the most effective agent. Iodine based preparations are more effective against fungal spores but chlorhexidine may retain its effectiveness for longer [8]. In practice both appear equally popular. The ratio of surgeons who used iodine compared to chlorhexidine was found to be 54%:46% in a survey conducted in the early 1990’s [3]. In a

Methods 8

CEP 08009: 2008

more recent survey the usage was 46%:60% [4], as some 6% of surgeons reported using both iodine and chlorhexidine products [4].

Friction is considered important for removing micro-organisms from the skin as it can reduce surface tension and so plays a vital role in improving the efficacy of germicidal solutions [4]. Use of a swab or sponge to apply the skin preparation fluid is therefore popular practice and was used by all surgeons in the 2005 survey [4].

Using plastic adhesive drapes (incise drapes) to protect the surgical wound from organisms that may be present on the surrounding skin during surgery is advocated as a way of preventing surgical site infection. A recent systematic review [9] concluded that clear adhesive drapes resulted in a higher proportion of infections whilst iodine-impregnated drapes had no effect on surgical site infection rate. For practical reasons, such as holding dressing towels in awkward areas (eg the hip and knee), the use of iodine-impregnated drapes may continue for certain surgical procedures [3]. Our evaluation methodology has therefore incorporated an assessment of pen marker visibility after the application of iodophor-coated incise drapes because the coloured plastic film may obscure pen markings.

Review of published evaluation methodologies Five studies reporting evaluation of skin marker pens were identified in the literature [10 -14,] and their methodologies are summarised in Table 1 on page 9. These protocols have been used to form the basis of the test protocol developed for this evaluation study.

A single subject was used in four of these studies [10-13] and the fifth referred to “patients” and was poorly described [14]. Details of the pre-operative skin preparation fluids used and their application were provided for three studies[12, 13, 14] and two documented that marker visibility differed depending on the cleaning agent used [12, 14]. To improve on these earlier protocols this evaluation study used eleven subjects, so the effect of skin variables (eg oilyness, skin tone or hairiness) could be included, and we specifically investigated the influence of a range of skin preparation fluids on marker fading.

The number of observers grading pen visibility were usually one in the earlier studies [10, 12, 13], two were used in one study [11] and four observers were used another [14]. We adopted the best of these protocols and ensured that all observers were ‘blind’ to the identity of the pen when they scored visibility of the marking, a separate score was obtained at each stage in the skin preparation process [11]. For this evaluation protocol we further improved the rigour and independence of observer scoring by (a) using multiple observers to score the same pen marks, (b) displaying the pen marks individually (ie one pen marking at a time and under controlled viewing conditions) to prevent the visibility of adjacent lines to influence the observer’s score and (c) displaying pen marks in random order.

Methods 9

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Table 1 Summary of published research comparing visibility of skin marker pens

Reference Method Notes Lafferty K, Glass RG. 1986 [10]

• Eight marking pens collected from junior hospital staff • A patient for varicose vein surgery • Patient bathed in the evening and morning before surgery • Operator draws a line and code number in random order, 4

each on both legs • Spirit based antiseptic solution • Visual grading by the operator

Study included pens sold for use on dry wipe boards and other general applications

Single subject Observer was not ‘blind’

to the identity of the pens or the location of the markings

Magee TR et al. 1990 [11]

• Eleven commonly available marking pens • A patient for vein bypass surgery • Operator marked leg to indicate course of long saphenous

vein through ultrasound coupling gel • Visibility ranked 1(best) to 11 (worst) by single observer,

blinded to pen identity • Visibility scoring repeated after gel removed and again after

skin cleaning with a spirit based antiseptic solution • Study repeated by a second observer using the same subject • All scores added for each pen and used to rank them as best,

mediocre & unsatisfactory

Study included pens sold for use on dry wipe boards and other general applications

Single subject Observer was ‘blind’ to

the identity of the pens or the location of the markings

Two observers

Tatla T, et al. 2001. [12]

• Six pens commonly used for skin markings in plastic surgery • Volunteer forearms • Operator draws a line and code number with each pen on

both arms • Operator cleaned each arm with single application of

antiseptic paint for 60 seconds. Alcohol based povidone-iodine on left arm and chlorhexidine gluconate on right arm

• Operator assessed all markings for visual durability from 0 (disappeared) to 5 (no fading)

Study included pens sold for use on dry wipe boards and other general applications

Single subject Observer was not ‘blind’

to the identity of the pens or the location of the markings

Able to compare effect of different antiseptic paints on pen marking durability

Tatla T, Lafferty K. 2002 [13]

• Eight pens used for skin markings • A patient due for surgery • Operator draws a line and code number using each pen, 4

each on both legs • Two applications of antiseptic paint, firstly alcohol based

povidone-iodine then chlorhexidine gluconate (0.5% in 70% methylated spirits) and an application time of 2 minutes each

• Operator assessed makings for visual clarity and durability

Study included pens sold for use on dry wipe boards and other general applications

Single subject Observer was not ‘blind’

to the identity of the pens or the location of the markings

Single observer Ayhan et al, 2005 [14]

• 6 types of skin markers inc. a skin marking ink (Appendix 4) • Number of patients not provided • Operator draws a line and code number with each pen on

both arms • Operator cleaned each arm with six separate 10 second rubs

of antiseptic paint. Povidone-iodine on one arm and Betadine (chlorhexidine gluconate) on the other arm

• Four observers independently assessed all markings after each rub but detailed scores not provided

Study included red, blue and black pens, some sold for general use, two pens sold for surgical use, two inks applied with toothpick

Method poorly described Four observers Able to compare effect of

different antiseptic paints on pen marking durability

Methods 10

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Evaluation methodology

This evaluation study was designed to compare the performance of skin marker pens, in terms of ink visibility and line sharpness, when used on human skin which is subsequently exposed to the typical pre-operative surgical preparation process. As human volunteer subjects were required for this evaluation study we sought and obtained local ethical committee approval (REC reference number 06/WSE02/105).

Eleven pens were supplied for evaluation, one sample having two different pen tips on opposite ends. Information from the suppliers revealed that some pens were sourced from the same manufacturer, so only ten pen tips required testing.

Pilot Study The primary objective of the pilot study was to determine which of six commonly used surgical preparation fluids (see Table 2) were most effective at removing or fading skin marks made by all the pens supplied for evaluation.

Table 2 Surgical preparation fluids selected for pilot study

Cleaning solution Proprietary name

Saline (0.9% sodium chloride, sterile)

Surgical Spirit

Povidone-iodine (aqueous solution) Betadine® Medlock Antiseptic solution, povidone-iodine 10%

Povidone-iodine (in alcohol) Betadine® Medlock Alcoholic solution, povidone-iodine 10%

Chlorhexidine gluconate (aqueous solution) Unisept® Medlock Solution 0.05%

Chlorhexidine gluconate (in alcohol) Hydrex® Adams Health Solution chlorhexidine gluconate 0.5% in IMS 70% pink

Four normal volunteers were used for the pilot study. Ten pen markings were drawn in the same random sequence on both inner forearms of each volunteer. Each arm was swabbed for 60 seconds with one of the cleaning fluids selected from the above list. The fluids were selected in pairs and used on opposing arms, eg saline on the left arm and surgical spirit on the right arm. Each arm was photographed before and after cleaning and two observers separately visually assessed the degree of fading and sharpness of the edge of the pen line.

Preliminary results revealed the aqueous and alcohol based povidone-iodine solutions were almost identical in their removal of the skin markings. Chlorhexidine gluconate in alcohol was more effective than the equivalent aqueous solution. Saline had very little pen removal effect and surgical spirit was only found to be an effective cleaner with prolonged application. We confirmed an earlier study which reported different results for chlorhexidine gluconate and povidone-iodine [13]. Consequently both aqueous povidone-iodine solution and chlorhexidine gluconate in alcohol were selected for the main study as these represented the worst case scenario and the response of all the pen marks may not be identical.

Methods 11

CEP 08009: 2008

Main Study

Eleven healthy normal volunteer subjects between the ages of 25 and 54 were recruited. The main evaluation study followed a standardised procedure which was finalised during the pilot study and is described more fully in Appendix 2.

During all subject testing the pen order was randomised and recorded. After washing with soap and drying the skin both inner forearms were marked on with a single line from the ten pen tips, approximately 55mm long and with a spacing of approximately 15mm. The pen marks were allowed 3 minutes to dry before a digital photograph of each forearm was taken under controlled conditions (see Figure 5 (a)).

Each forearm was then cleaned using either aqueous povidone-iodine or chlorhexidine gluconate in alcohol by application with a folded gauze and standardised number of strokes. The solutions were allowed to dry and a second photograph taken (see Figure 5 (b) and (c)).

An antimicrobial iodophor surgical incise drape was then placed on the test site and a third photograph was taken (not shown).

Three observers independently scored each pen mark for ink visibility and sharpness of the edge of the pen line using the scoring criteria summarised in Table 3. The photographs of individual pen marks were displayed in a random order on a viewing screen under controlled conditions. The observers were required to score markings as acceptable or excellent only if the line was very clearly seen along the whole length, to reflect the potential serious consequences of incorrect mark identification.

A more detailed description of the evaluation methodology can be found in Appendix 2.

Table 3 Observer scoring system for pen marks.

Visibility Sharpness of the line edge

Excellent E Sharp S

Acceptable A Blurred B

Re-mark of line is necessary R Unacceptable U

Invisible I

Methods 12

CEP 08009: 2008

a) after drying in air b) povidone iodine c) chorhexadine gluconate

Figure 5 Photographs of ten lines drawn with different marker pens on the inner forearms of a single subject. From left to right the images show the pens markings (a) right arm after the lines have dried in air (b) after the application of aqueous povidone-iodine on the left arm and (c) after chlorhexidine gluconate in alcohol was applied to the right arm.

Summary of evaluation test results

• Before surgical preparation the visibility of all pens were scored as either “acceptable” or “excellent”. Two pens were more frequently scored as “sharp” lines than the others

• No pens provided acceptable visibility after perioperative cleaning with both fluids

• Povidone iodine solution causes minimal changes to the visibility of five pens

• Chlorhexidine gluconate (alcohol) severely reduces the line visibility, except for two pens

• Overlaying antimicrobial iodophor surgical incise drapes makes a minimal change to line visibility and sharpness.

Product specific results are listed in the Technical performance section. Visibility and sharpness scores are given a star rating, delete “such that indicates the best performance”. For more information see page 13.

Technical performance 13

CEP 08009: 2008

How to use the technical performance tables

Notation used

Location of further

information

Tip description Tip description as quoted by the manufacturer Page 6

Ink solvent Ink solvent from papers (#Appendix 3 [17]) or provided by manufacturer Pages 16, 27

Sterile packaging - Pen (and rule if included) is supplied sterile in sealed packaging Page 6

Single Use Label - Pen is marked for single use Pages 6, 27

Pen rule xcm – A measuring scale, x cm in length, is marked on the pen body Page 6

Separate rule ycm – A separate rule, y cm in length, is packaged with the pen Page 6

Adhesive labels - Adhesive labels are packaged with the pen

Feat

ures

CE Marked - The pen is CE marked Page 6

Percentage where mark visibility was scored as Excellent or Acceptable:

Before skin prep 0 – 20% 21 – 40% 41 – 60% 61 – 80% 81 – 100%

1 most marks were invisible or needed remarking

Pages 11, 12, 25 & 26

After PI (aqueous) Ratings as above, after povidone iodine (aqueous) preparation Pages 11, 12, 25 & 26

Visi

bilit

y

After CH (alcohol) Ratings as above, after chlorhexidine gluconate (alcohol) preparation Pages 11, 12, 25 & 26

Percentage of pen markings where the line edge was scored as Sharp:

Before skin prep 0 – 20% 21 – 40% 41 – 60% 61 – 80% 81 – 100%

2 most line edges were blurred or unacceptable

Pages 11, 12, 25 & 26

After PI (aqueous) Ratings as above, after povidone iodine (aqueous) preparation Pages 11, 12, 25 & 26

Shar

pnes

s

After CH (alcohol) Ratings as above, after chlorhexidine gluconate (alcohol) preparation Pages 11, 12, 25 & 26

Technical performance 14

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Aspen Richard Allen

Aspen Richard Allen

Aspen Writesite

Codman Microsurgical

Codman Surgical Novatech Dermotrace*

Tip description Fine Regular Regular Fine Bold Fine Bold

Ink solvent Isopropyl (0-12%) Isopropyl (0-12%) Isopropyl (0-12%) ? ? Aqueous Aqueous

Sterile packaging

Single Use Label

Pen rule 5cm 5cm 5cm

Separate rule 15cm 15cm 15cm 15cm 11cm 11cm

Adhesive labels

Feat

ures

CE Marked

Before skin prep

After PI (aqueous)

Visi

bilit

y

After CH (alcohol) 1 1 1 1 1 1 1

Before skin prep 2

After PI (aqueous) 2

Shar

pnes

s

After CH (alcohol) 2 2

Technical performance 15

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UN64 Skin marker pen

Viomedex VX100

Viomedex VX110

Viomedex VX200

Viomedex VX210

Tip description Versatile Bold Bold Fine Fine

Ink solvent ? Aqueous # Aqueous # Aqueous # Aqueous #

Sterile packaging

Single Use Label

Pen rule 4cm 7cm 7cm 7cm 7cm

Separate rule 15cm 12cm 12cm

Adhesive labels

Feat

ures

CE Marked

Before skin prep

After PI (aqueous) 1 1

Visi

bilit

y

After CH (alcohol)

Before skin prep 2 2 2

After PI (aqueous)

Shar

pnes

s

After CH (alcohol)

Operational considerations 16

CEP 08009: 2008

Clinical impact Sterility Many pens tested in this report were supplied sterile and are marked “for single use” with the sterility shelf life and the use by date also marked on the packaging.

Cross-contamination and sterility of the skin markers pens is an important factor to consider, especially for procedures such as joint replacement and the insertion of prosthetic grafts, where infection at the operative site can be catastrophic [15]. Pens have been identified as vectors of harmful organisms [16] and some studies report that is common practice for marker pens to be used indiscriminately on patients, regardless of their known infection status [15].

A brief overview of published studies assessing the viability of micro-organisms on pen tips (Appendix 4) indicates that some pens contain ink and/or solvents that appear to have anti-bacterial and anti-fungal properties. Details of the ink solvent are included in the market survey tables, as this may indicate their potential for resisting contamination to the pen tip. One of the products cited in a paper [17] refers to pens listed in this report and other data are provided by the manufacturer.

Line width Plastic surgeons require skin markers to have a very fine tip [18] so that ink lines drawn across the incision line can be accurately matched when the skin is realigned. Some surgeons report the line produced with currently available pens is not sufficiently precise for operations where delicate marking is required, such as cleft lip repair or scar revision [19]. Shaping the fibre tip using a blade is advocated to convert it into a thinner applicator which is more effective and more convenient to use than the other alternatives (see below) [19].

When marking the identity of the limb or organ to avoid wrong site surgery the type of tip is less important, as long as the ink mark remains clearly visible.

Skin tone and condition All pens in this study use violet/black ink, which may be less visible on darker skin tones. For dark-skinned people, light coloured ink materials (white, green, yellow, red) are more visible [20] but light coloured skin marker pens are not yet commercially available in the UK. Pharmacy prepared ink materials in a range of colours (see Appendix 4) have been reported as visually effective on darker skin and non-reactive with other chemicals used on the skin, eg aqueous povidone-iodine, but it has been shown these are easily removed with alcohol [20].

Cosmetic considerations There is a very rare risk of inadvertent tattooing from gentian violet ink in the marking pen being incorporated into skin tissue during the incision. If patients are anxious about the visibility of skin marks post-operatively the market table enables choice of a pen which remains visible after pre-operative cleaning with povidone and can be mostly removed by chlorhexidine gluconate.

Operational considerations 17

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Alternative technologies

General purpose pens Published papers report the use of general purpose felt tipped pens, permanent markers and whiteboard markers [15, 21, 22] by surgeons for pre-operative marking of the skin (Appendix 3). Their use can not be recommended as none of these products are sold for this purpose.

Liquid inks prepared in the pharmacy A range of colourings are commonly used in the pharmaceutical industry and several of these have been reported as being useful for skin marking (see Appendix 4).

Henna Henna powder, mixed into a paste, is advocated for situations where long term, but not permanent, marking is required, eg for repetitive non-invasive therapeutic procedures [23]. This can be particularly useful for radiotherapy where skin marks are required to enable repeated location of laser positioning beams and they need to remain clearly visible for 6-8 weeks. If normal skin marker pens are used the patient must refrain from washing or frequent reapplication of the pen mark at the target is common which causes positional inaccuracies. Henna marks can remain visible for 12-48 days, even allowing the patient to wash and shower freely, so reducing remarking and thereby increasing the accuracy of external radiotherapy [23].

Tattoo For situations where accurate and robust long term marking is required (e.g. skin marking for long term radiotherapy localisation or to provide medical alerts, eg diabetic disease) medical tattoos may be used. Permanent marks are created by introducing pigment into the deeper layers of the skin through ruptures in the skin surface made by a fine needle, but there can be a risk of infection.

User experience Skin condition Skin condition was observed to influence the durability of pen markings in this study. Age-induced looseness of the skin was marked in one subject and the skin surface appeared to fold around the pen tip during marking, causing the line to be blurred for all pen tips. Although surface oils and creams were removed by washing with soap before pen marking the initial visibility still varied between subjects, especially for aqueous based inks.

Patient comfort and allergic sensitivity During this evaluation study no subjects reported allergic reaction to any of the pens studied or the cleaning agents used during the study. Four subjects spontaneously commented on their discomfort while the operator was drawing with two products: Microsurgical, which has a fine tip, and UN64, which is described as having a versatile tip.

Economic considerations 18

CEP 08009: 2008

To achieve best value when purchasing skin marker pens the benefits of using a particular product needs to be balanced against wider economic considerations. A product will provide an overall economic benefit if the risk of wrong site surgery is decreased by the pen markings being visible after patient washing and perioperative skin preparation. Costs to consider include: Cost of increased length of stay Failure to use a skin marker pen which remains visible after perioperative cleaning could, in the extreme, result in wrong site surgery. This may be fatal and/or require extended hospitalisation for a second operation to achieve the intended therapeutic result.

For some operations pen mark fading may require pre-operative imaging or diagnostic investigation to be repeated to ensure the tissue to be excised is correctly localised. This would increase direct patient care costs as well as extend the hospitalisation period.

Medico-legal costs Medico legal claims by the patient or their relatives could be substantial if inappropriate pens were used for skin marking and these resulted in wrong site surgery.

Operating time cost If an inappropriate choice of pen causes fading during bathing or pre-operative skin cleaning so the mark becomes invisible then additional theatre time will be needed to thoroughly check the patient’s records and remark the skin. Purchase cost Prices quoted by suppliers/manufacturers as their list price are usually negotiable depending on volume and frequency of orders. Disposal cost Many products listed in this report are marked as intended for single use. To avoid the risk of cross-contamination all pens require incineration and this cost is normally based on weight, each pen weighing between 6 to 9 grams.

Purchasing 19

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Determining the clinical requirements The major factors to consider when choosing to use a skin marker pen are summarised in the decision tree below.

Figure 6 Decision tree indicating whether use of a skin marker pen is appropriate

Key factors to consider when using the market survey tables to choose a pen suitable for use close to the operative site are:

• risk of infection (ie pen is sterile, especially when used after pre-operative cleaning) • absence of fading after cleaning with the specific skin preparation fluids used locally • tip shape, as this should be appropriate for surgeon’s purpose.

Consult Comparative

Market SurveyTable

Patient requiring a skin mark

Cleaning inc. Chlorohexadine

Gluconate

Duration of marking

Consider henna

Consider changing skin cleaning

protocol

Consider a custompharmacy preparation

Considertattoo

Cleaning inc. Povoiodine

Skin marking areais operative site

Patient’s skin tone

permanent

> 2 weeks

1 day

dark

light

YES

YES

NO

YES

NO

Cleaning inc. Povoiodine

YES

NO

Acknowledgements 20

CEP 08009: 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: Richard Dale, Medical Director, Commercial Directorate, Department of Health

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

Rob Heggie, Principal Clinical Engineer, University Hospital of Wales

Sue Jenkins, Senior Technician, Pharmacy, University Hospital of Wales

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

Jacqueline Scroggs, Clinical Lead, West Midlands Healthcare Purchasing Consortium

References 21

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1. National Patient Safety Agency. Patient safety alert 06: Correct site surgery, 2005 http://www.npsa.nhs.uk/site/media/documents/883_CSS%20PSA%20FINAL.pdf

2. Association for Perioperative Practice. Standards and Recommendations for Safe Perioperative Practice, 2007. http://www.afpp.org.uk/publications.cfm?start=51

3. Graham GP, et al. Preparation of skin for surgery. J R Coll Surg Edin 1991; 36: August

4. McGrath DR, McCrory D. An audit if pre-operative skin preparative methods. Ann R Coll Surg Engl 2005; 87: 366-368

5. Briscoe CE, et al. Inflammable antiseptics and theatre fires. Br J Surg 1976; 63: 981-3

6. Mackenzie I. Perioperative skin preparation and surgical outcome. J Hosp Infect 1988; 11: 27-32

7. Garvey LH, et al. Anaphylactic reactions in anaesthetised patients – four cases of chlorhexidine allergy. Acta Anaesthsiol Scand 2001; 45: 1290-4

8. Kaul AF, Jewett JF. Agents and techniques for disinfection of the skin. Surg Gynaecol Obstet 1981; 152: 677-85

9. Webster J, Alghaamdi AA. Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane database of Systematic Reviews 2007, Issue 4, Art. No.: CD006353. DOI: 10.1002/14651858.CD006353.pub2

10. Lafferty K, Glass RG. Making your mark in surgery Br J Surg 1986; 73: 609

11. Magee TR, et al. Vein marking through ultrasound coupling gel. Br J Vasc Surg 1990; 4: 491-2

12. Tatla T, et al. Preoperative surgical skin marking in plastic surgery. Br J Plast Surg 2001; 54: 556-7

13. Tatla T, Lafferty K. Making your mark again in surgery. Ann R Coll Surg Engl 2002; 84: 129-130

14. Ayhan M, et al. Skin marking in plastic surgery. Plast Reconstr Surg 2005;115:450-1

15. Kane TPC, et al. Can the tips of marker pens act as a source of cross-infection? Ann R Coll SAurg Engl 2003; 85: 73

References 22

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16. French G, et al. Contamination of doctors’ and nurses’ pens with nosocomial pathogens. Lancet 1998; 351:213

17. Wilson J, Tate D. Can pre-operative skin marking transfer methicillin-resistant Staphylococcus aureus between patients? J Bone Joint Surg 2006; 88: 541-2

18. Sarifakioglu N, et al. Skin marking in plastic surgery: a helpful suggestion. Plast Reconstr Surg 2003; 111: 946-7

19. Tuncer S, et al. Increasing the accuracy of sterile marker pens. Plast Reconstr Surg. 2004; 114:1979-80

20. Sarifakioglu N, et al. Skin marking in plastic surgery: colour alternatives for marking. Plast Reconstr Surg 2003; 112: 1500-1

21. Cronen G, et al. Sterility of Surgical Site Marking. J. Bone Joint Surg. Am. 2005; 87: 2193-2195

22. Tadpathi S, et al. Using marker pens on patients: a potential source of cross infection with MRSA. Ann R Coll Surg Engl. 2007; 89: 661-4

23. Wurstbauer K, et al. Skin marking in external radiotherapy by temporary tattooing with henna: improvement of accuracy and increased patient comfort. Int J Radiat Oncol Biol Phys 2001; 50: 179-81

24. Thomas RJ, et al. The transmission of MRSA via orthopaedic marking pens – fact or fiction. Ann R Coll Surg Engl 2004; 86: 51-2

25. Ballal MS, et al. The risk of cross-infection when marking surgical patients prior to surgery - review of two types of marking pens. Ann R Coll Surg Engl. 2007; 89: 226-8

26. O’Boyle C. Wooden Skewrs are cheap, effective , versatile, and safe instruments for the preoperative marking of skin incision lines. Plast Reconstr Surg 2000; 106: 232-3

27. Granick M, Heckler FR. Caution in the use of marking solutions. Plast Reconstr Surg 1990; 85: 154

28. Safranek TJ et al. Mycobacterium chelonae wound infections after plastic surgery employing contaminated gentian violet skin-marking solution. N Engl J Med 1987; 317:197-201

Appendix 1: Supplier contact details 23

CEP 08009: 2008

Supplier Product Order code

Advanced Medical Systems Ltd PO Box 4 Banbury OX17 1TQ Oxfordshire Tel: 01295 738244 Fax: 01295 730792 Email: sales@advmedical.com www.advmedical.com

Aspen Writesite Aspen Richard Allan

Johnson & Johnson Medical Ltd The Braccans London Road Bracknell Berkshire RG12 2AT Tel: 01344 864000 Fax: 01344 864001 www.jnjgateway.com

Codman Microsurgical Codman Surgical

Leonhard Lang UK Ltd Unit 6 Frogmarsh Mill South Woodchester Gloucestershire GL5 5ES Tel: 01453 874130 Fax: 01453 874131 Email : sales@leonhardlang.co.uk www.leonhardlang.co.uk

Aspen Richard Allan Fine Regular

SM00372

SM0572

Appendix 1: Supplier contact details 24

CEP 08009: 2008

Supplier Product Order code

Meddis Ltd (Subsidiary of Pro-Care Ltd) Blackwood Hall Business Park North Duffield Selby North Yorkshire YO8 5DD Tel: 01757 288694 Fax: 01757 288689 Email: info@pro-care.co.uk www.pro-care-group.co.uk

Novatech Dermotrace

18996

Universal Hospital Supplies George House Unit 6 Delta Park Industrial Estate Millmarsh Lane Enfield London EN3 7QY Tel: 0845 082 0182 Fax: 0845 0820180 Email: sales@uhs.co.uk www.uhs.co.uk

UN64

Vio Healthcare Ltd Unit 13 Swan Barn Business Centre Old Swan Lane Hailsham East Sussex BN27 2BY Tel: 01323 446130 Fax: 01323 847417 Email: sales@viohealthcare.com www.viomedex.com

Viomedex VX100 Viomedex VX110 Viomedex VX200 Viomedex VX210

Appendix 2: Evaluation protocol 25

CEP 08009: 2008

This study assessed the performance of commercially available skin marker pens through testing on human subjects. We sought and obtained local ethical committee approval (REC reference number 06/WSE02/105) for the pilot study and main study. Informed consent was obtained from all volunteers in accordance with the protocol submitted to and agreed the ethical committee.

The pilot study used the same protocol as the main study (see below) and was used to determine:

• The minimum drying time for the applied pen inks

• A standard photography set-up in terms of camera, subject and lighting positions and camera and lighting settings

• Standard application technique for liquid skin preparation (application device and number of wipes)

• The minimum drying time for the liquid skin preparation

• Standard observer viewing conditions for assessing the photographs, in terms of lighting, screen background colour and brightness and observer position

• Sample images to illustrate the scoring system for use in observer training so the variability in observer scores could be minimised

• Cleaning techniques for the most effective removal of skin marks and skin preparations after the experimental study was complete

• Any potential to reduce the complexity of the main study, eg establishing that two skin preparations have similar effects on the pen markings, this allowing removal of one of them from the main study.

During the main experiment participants were required to attend for up to 60 minutes, but usually the session was approximately 35 minutes. The evaluation protocol was as follows:

1. Each participant changed into a cotton top and trousers (surgical ‘blues’) and a plastic apron to prevent any damage to their own clothing, eg from iodine splashes, etc.

2. Each participant had both forearms washed with liquid soap (Leverline Liquid Soap (Soft), Johnson Diversey Ltd) to remove creams and standardise the skin surface

3. Each pen tip (code A -J) was used to make a mark approximately 40mm long (perpendicular to the long axis of the arm) on both inner forearms of each subject (with a spacing between lines of 15mm). The pen order was randomised and recorded for each subject, with both left and right arms being the same order

4. The pen marks were allowed 3 minutes to dry before a digital photograph of each forearm, was taken under controlled conditions using studio lighting and a fixed camera position relative to the arm and pen markings (see Figure 5a on 12)

5. Each forearm was then cleaned using either aqueous povidone-iodine (left arm) or chlorhexidine gluconate in alcohol (right arm). The antiseptic cleaning solution was applied with a folded gauze held in Rampley’s forceps using standardised number of strokes. The solutions were allowed to dry and a second photograph taken (see Figures 5b and 5c, respectively)

Appendix 2: Evaluation protocol 26

CEP 08009: 2008

6. A self adhesive antimicrobial iodophor surgical incise drape (Ioban™ 2 Antimicrobial 3M containing iodophor acrylate 0.12%) was then applied to both test sites on each arm and each test site was photographed for the third time (not shown)

7. Each photograph was given a unique identifying code which recorded the subject number, skin status and pen randomisation allocation code

8. All photographic images were separated into segments containing only a single pen mark (see Figure 8). During observer scoring sessions the photograph of each line were displayed individually in a random order on a viewing screen under controlled conditions

9. Three observers ‘blind’ to the identity of the pen, skin status or subject independently scored each pen mark for ink visibility and line sharpness using the scoring criteria summarised in Table 3. The photograph number and observer identifying initials were recorded on an assessment sheet along with the scores

10. The scores from all observers were counted for each pen mark at every stage of the marking and cleaning process. The counted scores were then converted to star ratings as described in Technical Performance (page 13).

Figure 7 Standardised (a) illumination and (b) photographic arrangement for all images

Figure 8 Povidone solution was applied with a folded gauze held in Rampley’s forceps

Appendix 3: Risk of cross infection 27

CEP 08009: 2008

Review of the viability of micro-organisms on marking tips The bacterial content of ‘used’ pens collected from surgical wards has been studied by several researchers. No microbial activity was found on sixteen ‘used’ pens collected from orthopaedic wards [14]. Organisms were isolated from eight pens in another hospital but no evidence of methicillin resistant Staphylococcus aureus (MRSA) was found [24]. In a study of 26 marker pens (Penflex, Pentel, Guilbert, Niceday and Edding) no growth was found on culture plates after 24 hours incubation but two pens cultured positive to Micrococci species (skin commensals) after 72 hours [22]. Clearly pens can harbour bacteria commonly present on human skin but some authors have suggested that some pens demonstrate antibacterial activity which they attribute to alcohol in the ink solvent used by many manufacturers.

Transmission of MRSA has been studied in the laboratory using two different new pens (Viomedex and Penflex) which were contaminated with a higher rate of MRSA inoculation than normally found in a clinical setting by drawing the pen tip across a contaminated culture plate. Each pen was then used to draw a line on a blood agar plate at 0, 5,15 and 60 minutes, 24 and 48 hours and 1,2 and 3 weeks after inoculation. The MRSA did not survive for more than 15 minutes on the Penflex marker pen whereas Viomedex pens grew MRSA for over 1 week after contamination. The different response was credited to their solvents because the Penflex uses isopropyl alcohol and ethyl alcohol whilst the Viomedex uses water and no antiseptic is added to inhibit bacterial growth [17]. [Manufacturer comment: Viomedex states that their pens are for single use only and contain non-toxic ink.]

Antifungal properties of ink colourings Gentian violet (hexamethyl pararosaniline chloride) is a water soluble dye derived from coal tar. As a weak solution in water it is painted on skin, gums, serious heat burns, etc. to treat fungal infections and is also used in histological procedures, as it stains gram positive bacteria blue-violet. Gentian violet’s worst side effect is staining skin and cloth, so for this reason it is commonly a key component in the ink of skin marker pens.

Summary Currently the evidence is not sufficient to advise reuse of skin marking pens unless the practice is explicitly endorsed by the supplier. Care should also be taken to avoid cross-site contamination in the same patient, eg from an ulcerating wound to the surgical site.

Appendix 4: Pharmacy prepared inks 28

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Pharmacy prepared inks reported as useful for skin marking

Reference Preparation Applicator

O’Boyle, 2000 [26]

Bonney’s blue Non-sterile Plastico wooden skewers, using a broken end

Sarifakioglu et al, 2003 [18]

Red ink - Basic fuschin (1.34g), 4g phenol (antiseptic), 5.6ml acetone, 7.56g resorcinol (antiseptic), 11ml alcohol, 100ml distilled water

Sterile or non-sterile plastic stick or needle

Sarifakioglu et al, 2003 [20]

A range of different coloured inks can be prepared with 1.34g of the selected colouring (see list below) mixed with 4g phenol (antiseptic), 5.6ml acetone, 7.56g resorcinol (antiseptic), 11ml alcohol, 100ml distilled water Red ink – Carmoisine (Colour index number: 14720/ E122) Red ink – Carmine (75470/ E1210) Black ink – Black PN (28440/ E151) Orange ink – Canthaxanthine (40850/ E161) Claret red ink – Amaranth (16185/ E123) Green ink – Green S (44090/ E142) Blue ink – Indigo carmine (73015/ E132) Yellow ink – Tartrazine (19140/ E102) Yellow ink – Curcumine (75300/ E100)

Sterile or non-sterile plastic stick or needle

Ayhan et al, 2005 [14]

Red ink - Basic fuschin (1.3g) 5.6ml acetone, 11ml alcohol, 100ml water

Toothpick

Care should be taken to ensure aseptic conditions are maintained during ink preparation and storage. Skin marking solution has been identified as a source of wound infections in 5 patients after plastic surgical procedures, where the organism had contaminated the water used to make up the gentian violet marking solution, [27] and eight infections following cosmetic face lifts and augmentation mammoplastics [28].

Clinical use of these and other alternative technologies (see page 17) close to the operative site is not advised unless a full risk assessment has been conducted (including: indelibility after local pre-operative procedures; assessment of sterility; risk of cross-infection; risk of an allergic reaction).

Author and report information 29

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Skin marker pens Paul O’Connell, Jonathan Lane, Dr Sue Peirce, 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