Special Report – Advances in Vaginal Examination Device Design Pelican

SPECIAL REPORT

Advances in Vaginal Examination Device Design

Future Developments in Feminine Healthcare Devices Consider the Patient A Considerate Procedure After a Vaginal Examination Difficult Circumstances for Examination

Published by Global Business Media

SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

SPECIAL REPORT

Advances in Vaginal Examination Device Design

Future Developments in Feminine Healthcare Devices

Contents

Consider the Patient A Considerate Procedure After a Vaginal Examination Difficult Circumstances for Examination

Foreword

2

John Hancock, Editor

Future Developments in Feminine Healthcare Devices 3 Pelican Feminine Health

Published by Global Business Media

Published by Global Business Media Global Business Media Limited 62 The Street Ashtead Surrey KT21 1AT United Kingdom Switchboard: +44 (0)1737 850 939 Fax: +44 (0)1737 851 952 Email: info@globalbusinessmedia.org Website: www.globalbusinessmedia.org

Quality Controls: Putting the Patient First by Design Materials and Design for Utility and Comfort Innovative Devices that Improve the Examination Experience Looking Ahead; Maintaining Quality Professional Inputs and Looking to the Future Pelican Feminine Healthcare: Products That Put the Patient First

Consider the Patient Camilla Slade, Staff Writer

Publisher Kevin Bell

Why Conduct Vaginal Examinations?

Conducting a Vaginal Examination A Comfortable Setting The Examination or Procedure

Business Development Director Marie-Anne Brooks

A Considerate Procedure

Editor John Hancock

Advertising Executives Michael McCarthy Abigail Coombes Production Manager Paul Davies

After a Vaginal Examination

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Material in advertisements and promotional features may be considered to represent the views of the advertisers and promoters. The views and opinions expressed in this publication do not necessarily express the views of the Publishers or the Editor. While every care has been taken in the preparation of this publication, neither the Publishers nor the Editor are responsible for such opinions and views or for any inaccuracies in the articles.

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Peter Dunwell, Medical Correspondent

Prepare the Room and the Patient A Comfortable Position for Examination A Considerate Procedure – Patient First Instruments and Devices Used Anaesthetic and Preferences

Senior Project Manager Steve Banks

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10

Camilla Slade, Staff Writer

What Comes After the Examination?

Further Tests Treatment and Advice Hysterectomy

Difficult Circumstances for Examination

11

John Hancock, Editor

Treating all Women the Same Rape and Sexual Assault Religious Considerations Female Circumcision Under Age

References 12

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SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

Foreword V

AGINAL EXAMINATION devices get used in

And the article considers what the future holds for

the most sensitive of circumstances for the

vaginal inspection devices.

most delicate of purposes and so their design,

We continue with an article considering the vagina,

composition and manufacture are very important

its function, how to care for it and what can go

elements in the comfort and effectiveness of

wrong. In particular, we review some of the more

any examination. In this paper we don’t attempt

common conditions that can affect it and how they

to duplicate information about speculums,

might be treated. Camilla Slade then considers the

colposcopes and all of the ancillary equipment that

circumstances, location and conditions in which

is used with them. Rather, we try to look into why

a vaginal examination will be conducted. So much

vaginal inspection devices might be used, where,

can be gained from making these as conducive and

when and what could be the outcome of their use:

relaxing as possible. Following that, Peter Dunwell

plus we try throughout to emphasise the key matter

looks at the procedure of examination itself, how it

mentioned in all literature around vaginal and pelvic

should be conducted, involving the patient and what

examinations and procedures – the dignity and

devices and instruments will assist.

comfort of the woman being examined. These are

Camilla again then briefly looks at what might follow

the factors that inform the design and manufacture

from a vaginal examination depending on what the

of vaginal inspection devices.

check reveals. She outlines what further tests there

This Special Report opens with an article that looks

might be and what treatments might follow. Finally, we

at developments in devices for carrying out vaginal

consider some of the more challenging conditions in

examinations. In particular, it reviews the ways in

which an examination might have to be conducted.

which new materials and technology have enabled

Given the constraints of space and the extent of the

the design and manufacture of devices that not only

field, we also recommend readers to read more

do a better job but also contribute to patient comfort

extensively the papers and guides to which we refer

and safety. There is also some coverage of the ways

in this paper.

in which manufacturing has progressed and how devices and instruments can be packaged to ensure full sterile safety in any examination or procedure.

John Hancock Editor

John Hancock has been Editing Primary Care Reports since launch. A journalist for 25 years, John has written and edited articles, papers and books on a range of medical and management topics. Subjects have included management of long-term conditions, elective and non-elective surgery, Schizophrenia, health risks of travel, local health management and NHS management and reforms – including current changes.

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SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

Future Developments in Feminine Healthcare Devices Pelican Feminine Health

New devices are developed, designed and manufactured with patients and clinicians in mind

T

HERE ARE a number of reasons why a woman would need to undergo a vaginal examination or procedure in the context of a routine health check or as part of a more specific and concern-related process. Probably the most widely known of the former (routine health check) occasions in the UK would be the regular cervical screening offered to women between the ages of 25-64 (25-60 in Scotland) by the National Health Service (NHS). Concernrelated, examinations and procedures would follow from a routine check, if the findings suggest further intervention to be necessary, or would be in response to symptoms raised by a woman to her clinician. Whichever it is, the hygiene, comfort and effectiveness of the procedure are very important and the quality of equipment is integral to that. Most vaginal examination devices are a version or derivative of a speculum and often used with an accompanying dilator.

Quality Controls: Putting the Patient First by Design In that context, there is an increasing move towards single use devices and towards devices that maximise patient comfort in what is inevitably a very sensitive and invasive procedure.

Features such as sterility, absence of sharp edges and fail safe points are not just desirable but, by today’s standards, essential.

Pelican Feminine Healthcare (‘Pelican FH’) brand products are manufactured in the firm’s own high quality, state-of-the-art facility in the UK, giving total product quality control in the manufacturing process, including very strict testing of items taken from the production line every hour or so. Having been packaged and sealed into a pouch as part of the sterile process, devices will not then be unpacked until the point of use.

Ensuring that all single use devices are manufactured to CE sterile standards in a clean room (before packing into a medical pouch and being sent to a separate plant for ethylene oxide sterilisation) supports the highest standards among clinicians administering tests using vaginal examination devices. Notwithstanding all of that, no manufacturer can afford to rest on their laurels but must constantly strive to improve the design and build of devices, and incorporate new capabilities made possible by material and manufacturing developments. Manufacturers must also listen to and take account of users’ comments as to how devices might be modified and/or enhanced to improve the process and outcomes of vaginal examinations and related procedures.

As a further quality control, each completed pouch from Pelican FH, containing a product or pack, carries a lot number showing week and year of manufacture, machine used, shift and operator with a unique reference number for complete traceability that the clinician can record on the patient’s notes at the time the device is used. Pelican FH records all lot numbers for each delivery so that, if ever there was a need to, the firm would know exactly where each pouch and contents had gone.

Materials and Design for Utility and Comfort Just as important are the materials used and, wherever practical, Pelican FH uses plastic rather than metal because it is more flexible (therefore inherently safer), warmer (more comfortable) and better suited to single use applications.

Also, plastic devices can more easily incorporate transparency which supports the examination process itself: and plastic lends itself readily to the type of designed-in safe breaking points to cope with however the patient might react to the procedure.

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SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

Manufacturers must also listen to and take account of users’ comments as to how devices might be modified and/or enhanced to improve the process and outcomes of vaginal examinations and related procedures

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Innovative Devices that Improve the Examination Experience A typical case in point has been the introduction of a light source to Pelican FH’s PELIspec device, introduced in response to customer feedback.

The light source attachment was designed in house to match the PELIspec and add to the quality of examinations. This is still a single use product but with a replaceable lead cover so that the lead itself can be safely re-used – a safe cost saving measure. Light is an important contributor to better investigative work and procedures.

Also in response to customer (healthcare professionals) feedback, Pelican FH have introduced a complete IED kit, PELIpack, which does incorporates some metal parts but is still single use. As part of that, an improved design coil remover has a reduced size of tip which ensures a faster safer procedure.

Pelican FH reviews all products every few months to see whether new technology, improved materials, better design possibilities or client feedback can be applied as the basis for product improvement. Improvements like the FETOfit strap to better hold transducers to a woman’s abdomen during any scan procedure (usually as part of a pre-natal check).

In this way, the UK manufactured PELIspec and associated instrument are a sufficiently well respected and trusted system among health care professionals to make them the UK speculum market leader. Pelican FH are acknowledged experts in devices for obstetrics and gynaecological examination – an area in which they already specialise.

population. New products will need to account for screening and treatment of patients at an ever-increasing age and where more support around the investigation site will be required. Longer term innovation will require techniques that limit or negate the invasiveness of procedures expanding on the great advances made in foetal monitoring, cervical screening and contraception.”

Professional Inputs and Looking to the Future Just as any progressive business must continually look to new opportunities and client feedback to inform developments, they must also participate in the wider healthcare and research communities. In this respect, Pelican FH maintains a number of relationships with healthcare institutions and with healthcare professionals. Products are often tested by and commented upon by Midwives, General Practitioners and Nurses and the company works with clinicians across the board and Consultants when specifying, formulating and designing new devices. Feedback from healthcare professionals supports improvements in device design and size specifications to meet the changing needs of an evolving population. Looking to the longer term, Pelican also has beneficial working relationships with Welsh universities where areas such as advanced materials development and the possibilities created by new processes can be evaluated and, where appropriate, incorporated into future product developments.

Looking Ahead; Maintaining Quality

Pelican Feminine Healthcare: Products That Put the Patient First

Continuing this theme and looking to the future, Richard Carter, CEO at Pelican Feminine Healthcare explains that the firm “will continue its patient focused research and development around the high quality range of speculum and moulded plastic instruments. These are produced at its state-of-the-art manufacturing facility in Cardiff. Pelican will introduce up to four new products this year [2014] spearheaded by the PELIspec Light Source which provides maximum visibility during gynaecological procedures. Over the next five years the main drivers for development will mirror the ageing and more obese demographic trends in the

State-of-the-art manufacturing, research and development with input from professionals in the field and a commitment to the feminine healthcare market have all contributed to the high quality and patient-centred products that make up Pelican FH’s contributions to better gynaecological and obstetric care devices for more comfortable and effective vaginal examinations.

In particular, devices in the PELIspec Vaginal Speculum range are engineered with safety and comfort foremost among their specifications.

Failsafe points have been included in the devices to ensure flexibility or even safe breakage

SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

outside of the vagina in the event of vaginismus or other stresses that might occur during an examination. Any vaginal speculum will be intrusive by nature of its purpose; PELIspec devices are designed with this and the patient in mind. The range includes devices for a variety of vaginal examination purposes.

At the heart of the system is the PELIspec Vaginal Speculum, a sterile, disposable vaginal speculum, manufactured from clear plastic and available in five sizes, with or without a locking mechanism. The speculum is designed for use in gynaecological procedures, cervical screening, IUD fittings and vaginal examinations. And, because not all examinations use the same procedures or are for the same purposes, the PELIspec range includes optional additional features.

The PELIspec with Light Source supports maximum visibility during gynaecological procedures. While the battery pack and lead are re-usable to maintain cost control, the lead cover is disposable single use to ensure complete sterility at point of use. Where loop diathermy is used as part of colposcopy biopsy procedures it produces smoke and so a special PELIspec device is available made from white plastic for best light reflection and maximum visibility and with a smoke extractor.

PELIspec devices are supported by a range of single use instruments to ensure a safe, comfortable and sterile vaginal examination. The range includes a Sims Speculum for inspection of the vaginal walls and a full range of instruments for use in any type of vaginal examination or procedure. These include lubricant, dilators, scissors, vulsellum and tenaculum, sponge holder, coil remover, thread retriever… everything that a clinician needs in order to carry out a safe and effective examination or procedure.

For each type of examination or procedure, Pelican Feminine Health supplies complete packs that contain the appropriate PELIspec model plus all other instruments needed.

A vaginal examination or procedure is always going to be intrusive into bodily areas that are sensitive in every way and vulnerable to injury and infection. For these reasons, it is important that vaginal examination devices should be designed and made to ensure sterility, safety, effectiveness and comfort for women during these examinations and procedures.

Company History Pelican Healthcare was formed in 1994 and, from the outset, manufactured disposable products for both the Stoma Care and Feminine Healthcare markets. In 2007 Pelican was acquired by TG Eakin Limited and is now part of the Eakin Group of companies. Since the acquisition, the company has embarked on an ambitious development plan intended to transform its premises in Cardiff to a state-ofthe-art manufacturing and distribution centre.

In 2011 the Eakin Group acquired Clinical Innovations Europe Limited, who specialise in Obstetric and Gynaecological instruments which made it possible to separate the Feminine Healthcare Division into a company in its own right – Pelican Feminine Healthcare Limited – which aims to be the market leading feminine healthcare brand, providing world class disposable medical products and excellence of service. In pursuit of this end, Pelican Feminine Healthcare has attained full accreditation for the ISO 13485:2003 quality standard, and all products are CE marked in accordance with the European Directive 93/42/EEC. All sterile processes are assessed for sterility by an MHRA accredited regulatory body.

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SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

Consider the Patient Camilla Slade, Staff Writer

Steps that can be taken to conduct vaginal and pelvic examinations in ways that respect dignity and ensure comfort

The UK National Health Service (NHS) routinely invites women from 25 to 64 years old for regular cervical screening to identify changes in the cervix that might point to a condition or future risk

Why Conduct Vaginal Examinations?

Although vaginal examinations will often be linked to a specific concern, condition or treatment, the UK National Health Service (NHS) routinely invites women from 25 to 64 years old for regular cervical screening to identify changes in the cervix that might point to a condition or future risk. The Royal College of Nursing (RCN) publishes a useful guide as to why vaginal, genital or pelvic examinations are performed5…

•A ssessment or diagnosis– for example, of adnexae, vagina, external genitalia, genital infections, colposcopy, cervical biopsy, pregnancy and labour, uterine and vaginal prolapse, incontinence, vaginal swabs, Bartholins cyst and abscess, transvaginal ultrasound, vaginal bleeding, amenorrhoea, searching for illegal substances, vaginal trauma, hysteroscopy, investigation of alleged sexual abuse or rape.

•S creening – for example, cervical cytology, transvaginal ultrasound, vaginal and cervical swabs.

•T reatment – for example, removal of polyps, cervical curettage, fitting of ring pessaries, insertion of prostaglandin pessaries, postsurgical/radiotherapy follow-up, removal of a foreign body, vaginal dilatation, fitting of contraceptive devices, removal of placenta, evacuation of retained products, transvaginal chorionic villus sampling, endometrial ablation, and assisted reproduction techniques such as insemination or embryo transfer.

Conducting a Vaginal Examination Whatever the reason for the examination, even if it is routine, conducting a vaginal examination should be approached with sensitivity at all levels.

In the first place, the organ itself is sensitive and so should not be handled any more firmly or stressfully than necessary. There are a number of devices designed to expedite and render as comfortable as practicable this unavoidably

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intrusive procedure and manufacturers regularly review products to see where advances in technology, manufacture or materials might improve the patient experience. Also, safety measures such as the ability for a speculum (device) to break outside of the vagina should the woman suffer a spasm is very important. And a clinician should always be alert to the possibility that the cause of a woman’s symptoms might be pregnancy.

A Comfortable Setting

The sensitive approach should start with the examination facility. Although this can be a variety of locations ranging from hospitals to GP surgeries or sexual health clinics to police stations or prisons, the location should not, in any way, affect the sensitivity with which examinations are conducted. The first rule is that, wherever it takes place and under whatever circumstances, where practical, the woman’s consent should be obtained and her dignity maintained. There are

SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

other steps that can be taken to make the process less uncomfortable. A pleasant waiting area with appropriate material (leaflets and posters) will help to alleviate any stress and easy access to toilet facilities will support dignity: also waiting time should be kept to a minimum. A place to change should be comfortable and private or, if possible, the woman can be offered the opportunity to wear her own clothes.

Where she has to undress, there must be a convenient and safe place to leave clothes and other personal items and a clean gown should be provided as well as a facility for hygienic disposal of sanitary or incontinence aids: clean products need to be available for after the examination. The room must be secure against entry from outside during the examination and should already contain all of the equipment that will be needed plus any examination couch should face away from the door. In this way, any stress or distress caused by the examination can be reduced.

The Examination or Procedure Before an examination, a gynaecological history should be taken from patient records and through discussion with the patient.

Anybody conducting a vaginal examination should be properly qualified and competent not just in medicine but in this particular procedure. Usually that will mean a doctor, midwife or nurse and any diagnosis will certainly require the opinion of a specialist in the area. Again, consent should always be confirmed, not just for the sensitivity mentioned above but also because an examination without explicit consent could leave the examining clinician open to a charge of assault. The presence of a chaperone is always to be recommended but especially where a woman might have reasons to be uncomfortable with or object to the examination or procedure. In

the event that the woman shows any signs of arousal during the process, the clinician should halt as soon as it is safe to do so. It is good practice to offer the woman the chance to decline to be examined. Where it is difficult to get consent, guidelines for each situation will need to be followed for steps that should precede any examination.

As well as consent, there are a number of things to consider before any examination. The RCN guide (see above for reference) suggests…

“Review the following considerations before commencing the procedure.

•W hat is the reason for performing the procedure?

•H ow will the information obtained be used to benefit the woman?

•A re you competent to perform the planned procedure?

•H as valid consent been obtained and documented?

•H ow will the information be recorded, stored or referred, if necessary?

“Effective communication is a critical skill required throughout this procedure. Explain to the woman what is happening, before and during the examination.”

As well as all of the above, it is also good practice to ensure that the woman understands the reason and purpose for the examination, how it will be conducted and what the examining clinician will be looking for. And patient confidentiality is essential with regard to any examination or procedure. For readers who would like to consider this in greater depth, refer to Sultan Qaboos University Medical Journal published in August 2013, ‘Improving Vaginal Examinations Performed by Midwifes’6.

The article usefully reviews and distils a number of items from available literature.

This is a sensitive area of clinical practice but a thorough approach will ensure that it is not intrusive or demeaning.

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SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

A Considerate Procedure Peter Dunwell, Medical Correspondent

It’s never going to be easy but good practitioners and good practice will ensure that a woman being examined is neither distressed nor suffers needless pain or discomfort

Ask the woman whether she has previously had a similar examination and, if so, did any concerns arise from that experience

In the preceding article, Camilla Slade considered conditions that can impact on the quality of a vaginal or pelvic examination for the patient. In this article we’ll look more closely at what happens during the examination and what devices might assist in either the efficacy or the comfort for what will always be an intrusive procedure.

Prepare the Room and the Patient At the start of a vaginal or pelvic examination, the clinician should ask the woman whether she has previously had a similar examination and, if so, did any concerns arise from that experience. It’s important from the point of view of the woman’s assurance and that of the examining clinician that the examiner cleans their hands and puts on gloves – check that the woman does not suffer from a latex allergy before selecting the gloves. Make sure that all of the equipment that might be required is to hand and that a good light source is ready and switched on – any light source used should give a cold light without the exterior of the instrument becoming hot as this could cause discomfort to the woman. Ensure that the woman understands what will be used for what, any sounds she might hear and what they represent: the better a woman understands the process, the less likely she is to tense at any point which would cause discomfort or pain and add to her concerns.

A guide to examination good practice can be found at OSCE Skills7.

A Comfortable Position for Examination The patient will need to be exposed from the waist down and requested to lie on her back with ankles together and knees as far apart as possible. Where practical and as long as

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it doesn’t interfere with the examination, a cover should be draped over the area and the woman should be informed as the examination is about to commence.

The Royal College of Nursing (RCN) guide ‘Genital examination in women’8 suggests “Assist the woman into the correct position for the examination, ensuring her comfort and taking into account any problems such as joint and back problems – it may be appropriate to offer a choice of position. Examinations may be undertaken in the prone or left lateral position, depending upon the procedure. Ensure that you inform the woman of the position she will be in and request that she remains in that position for the anticipated length of the examination or procedure.”

A Considerate Procedure – Patient First The initial inspection is of the outer genitalia to assess whether they are normal, bear any signs of infection or display any signs of violence or mutilation – especially important with examinations following rape or sexual assault but also to guide the examiner as to what or what not to do to avoid patient discomfort or pain. The next stage should be a vaginal examination and good practice is to use a water based lubricant on the finger or any device used to perform the examination.

Bimanual genital examinations and examination of the cervix should be carried out by appropriately trained nurses and midwives for assessment and diagnostic purposes. The RCN guide cited above includes extensive notes on each stage. Notwithstanding all of that, the first thing in guidance ‘Performing a vaginal examination’9 issued by King Edward Memorial Hospital is, “A vaginal examination shall only be carried out if it will benefit the woman’s management and care.”

SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

Instruments and Devices Used In most examinations and procedures it will be necessary to use instruments and devices to assist in, improve the results from and comfort during any examination or procedure.

The instrument most used in these procedures is a speculum. ‘A speculum… is a medical tool for investigating body orifices, with a form dependent on the orifice for which it is designed…

Like an endoscope, a speculum allows entry into a body cavity; endoscopes, however, tend to have optics while a speculum is intended for direct vision.’10 These days, single-use, disposable devices are favoured for most circumstances. They are hygienic and, usually being made from plastic, they will be more comfortable (softer, flexible and warmer) for the woman being examined. A light will also be useful to help an examining clinician to thoroughly inspect the areas being examined or to help a clinician carrying out a procedure.

Before inserting the speculum, the examining

clinician should offer to demonstrate to the patient how it works and how it might feel – sometimes it will be appropriate to offer the woman the chance to insert the speculum herself. One very important consideration will be the size of the speculum used; the wrong size can cause pain and might affect the ability to properly conduct the examination or procedure.

Another instrument used for specific purposes is a colposcope, ‘a microscope fitted with a light and used for examining the uterine cervix, particularly for warning signs of cancer. Using the device, abnormal tissue or blood vessel development in the vagina and around the cervix can be identified and tissue samples taken for biopsy, if necessary.’11

Anaesthetic and Preferences There will be occasions when it will be preferable to conduct an examination or procedure under anaesthetic but a woman might feel more vulnerable with that prospect so it is important to confirm her feelings beforehand. For instance, she might not wish to be examined by students while under anaesthetic. But, whatever her feelings, they must be respected. Usually, while a woman is under anaesthetic, a nurse or midwife can be nominated to act as her advocate.

Although any examination or procedure involving the vagina is going to be an intrusive examination or procedure, with preparation, care and a considerate approach, it need not be unduly unpleasant.

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SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

After a Vaginal Examination Camilla Slade, Staff Writer

The examination is often just the first step so it is important that women understand what could come next and why

If there are further matters to be addressed, the clinician will recall the woman for a further examination and tests or to discuss a course of treatment and advice on how the problem can be avoided

What Comes After the Examination?

While most vaginal and pelvic examinations are routine or part of a preventative medicine programme, some are to follow up on a particular set of symptoms or concerns that a woman or her clinician might have identified. Whichever is the case, the period following an examination can often be more stressful owing to uncertainty about the results. In this light it is important that a woman knows what will happen in her body and in the process following an examination.

After an examination, there might be minor bleeding or a bloody discharge. When the results are available, either the service running the examination programme will write to the woman confirming that they have been found to be clear of any problems or, if there are further matters to be addressed, the clinician will recall the woman for a further examination and tests or to discuss a course of treatment and advice on how the problem can be avoided.

Further Tests There will usually be follow-up tests after any treatment or colposcopy but it will depend on what, if anything, has been found. If, for instance, cancer is suspected and further material is required for testing, it may be necessary to carry out a cone biopsy. NHS Choices describes this as12, “a minor operation… carried out in hospital, usually under a local anaesthetic. During a cone biopsy, a small, cone-shaped section of [the] cervix will be removed so that it can be examined under a microscope for cancerous cells.

[The patient] may experience vaginal bleeding for up to four weeks after the procedure [and] may also have period-like pains.”

If cervical cancer is confirmed, then it will be necessary to undertake more intrusive examinations including a full pelvic examination (usually under general anaesthetic) to assess the extent of any spread.

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Treatment and Advice More often, one of the common vaginal infections will be diagnosed for which a range of treatments are available. BUPA has set out a clear directory of treatments for ‘Common vaginal infections’13. Many of the diagnosable conditions (including chlamydia, gonorrhoea, genital herpes, genital warts, syphilis and HIV) are sexually transmitted. For this reason, any medication or treatments offered should be accompanied 0with preventative and lifestyle advice such as using a condom during sex. Because this is an intensely personal area, it might sometimes be correct to refer a patient to a specialist sexual health counsellor.

A woman suffering from sexually transmitted conditions should be aware of the longterm impact of her condition which might include difficulty or inability to conceive or carry a pregnancy.

Hysterectomy One surgical outcome from a vaginal examination can be a vaginal hysterectomy. This is an operation to remove a woman’s womb through her vagina.

It is usually undertaken in order to treat a pelvic prolapse although there can be other reasons such as irregular or heavy menstrual bleeding that hasn’t responded to other treatments; cancer of the womb where complete removal is often best; or adenomyosis, a benign but painful condition. Because it involves the complete removal of the womb, following a hysterectomy, a woman will no longer be able to get pregnant.

Also, if the ovaries are removed at the same time, the woman will immediately go into the menopause. Recovery time will vary from case to case but might be as much as a couple of months.

Most of the above conditions will necessitate further follow-up examinations but some women, following a hysterectomy, will no longer need cervical screening.

SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

Difficult Circumstances for Examination John Hancock, Editor

Criminally inflicted injury and religious considerations create exceptional circumstances but should not affect the quality of care offered

Treating all Women the Same Vaginal examinations are usually either part of a routine preventative healthcare programme or in response to a woman’s or her clinician’s concerns that something might not be right.

However, there are occasions when the examination follows on from the allegation of a rape or sexual assault or where culture or religion can make examination contentious, or even where a woman is suspected of transporting illicit substances within her vagina. Also, there will be women who are not deemed competent to decide and yet who must still be treated with full respect. The General Medical Council’s (GMC) Code of Practice for clinical students14 explains that clinicians must “Be prepared to physically examine all patients regardless of their lifestyle, culture, beliefs, race, colour, gender, sexuality, disability, age, or social or economic status.”

Rape and Sexual Assault A rape investigation is particularly sensitive.

The sooner evidence is gathered, the better and the woman who has been raped carries the most useful DNA evidence. She might be understandably ambivalent about a vaginal examination and, given the violence that often accompanies rape, there might be real physical difficulties to overcome. Plus if a woman is trying to make a false allegation, she might be even more reluctant to be examined. However, a proper examination can yield a number of useful clues for the police. From any semen or blood left by the perpetrator, they might be able to match with a record on their database; but often the rapist or assailant is known to the victim.

In that case, a vaginal examination can still yield evidence about injuries inflicted during the rape or assault. Often, a colposcopy is used to perform a magnified visual inspection of the genitalia (internal and external) and record any injuries. And, of course, a post rape or post assault examination is also to

provide healthcare and determine courses of treatment.

Religious Considerations But the difficulty with an examination might not be as a result of trauma. “The ethnic, religious and cultural background of some women’, says The Royal College of Radiologists15, “can make intimate examinations particularly difficult, for example, Muslim and Hindu women have a strong cultural aversion against being touched by men other than their husbands. Muslim women should be allowed the opportunity to limit the degree of nudity by, for example, uncovering only that part of the anatomy that requires investigation… Wherever possible, particularly in these circumstances, a female… healthcare practitioner should perform the examination.”

The GMC code of Practice for clinical students referenced above also says clinicians, must not, “allow their views about patients’ lifestyle, culture, beliefs, race, colour, gender, sexuality, disability, age, or social or economic status, to prejudice their behaviour towards them.”

Female Circumcision Other difficult situations include female genital mutilation (FGM), sometimes known as female circumcision. This is illegal in the UK so, where a woman (more often a girl) acquires an infection as a result of FGM her family might not wish for her to have a vaginal examination, even if conducted by a female clinician of their religion.

Under Age The other area where care must be exercised is in examining young teenagers and children where it is often recommended that the examination be conducted under anaesthetic.

There is no room here to cover more than the obvious cases but the general rule is always to treat a woman undergoing vaginal examination with respect and where possible (unless there is a specific legal ruling to the contrary) respect her wishes.

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SPECIAL REPORT: ADVANCES IN VAGINAL EXAMINATION DEVICE DESIGN

References: 1

NHS Choices http://www.nhs.uk/Livewell/vagina-health/Pages/normal-vagina.aspx

2

Mayo Clinic, Women’s Health http://www.mayoclinic.org/healthy-living/womens-health/in-depth/art-20046562

3

WebMD http://www.webmd.com/women/picture-of-the-vagina

4

NHS Choices http://www.nhs.uk/Livewell/vagina-health/Pages/keep-vagina-clean.aspx

5

RCN, Genital Examination in women http://www.rcn.org.uk/__data/assets/pdf_file/0004/512734/004_368.pdf

6

Improving Vaginal Examinations Performed by Midwifes http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3749030/

7

OSCE Skills http://www.osceskills.com/e-learning/subjects/bimanual-vaginal-examination/

8

RCN, Genital Examination in women http://www.rcn.org.uk/__data/assets/pdf_file/0004/512734/004_368.pdf

9

‘Performing a vaginal examination’ http://www.kemh.health.wa.gov.au/development/manuals/O&G_guidelines/sectionb/1/b1.6.4.pdf

10

Wikipedia http://en.wikipedia.org/wiki/Speculum_(medical)

11

News Medical www.news-medical.net/Colposcopes

12

NHS Choices http://www.nhs.uk/Conditions/Cancer-of-the-cervix/Pages/Diagnosis.aspx

13

BUPA http://www.bupa.co.uk/individuals/health-information/directory/v/vaginal-infections

14

University of Bristol http://www.bristol.ac.uk/medical-school/staffstudents/rulesandpolicies/gmccodeofpractice.doc

15

The Royal College of Radiologists http://www.rcr.ac.uk/publications.aspx?PageID=310&PublicationID=73

12 | WWW.PRIMARYCAREREPORTS.CO.UK

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