Surgical site considerations

Fundamental to the role of the perioperative practitioner is the principle that he or she shall “act to identify and minimise risk to patients and clients” (NMC).

Ensuring that practitioners deliver a high standard of patient care by providing a safe perioperative environment is one of the key components of this principle and infection control is a vital role for the whole perioperative team.

Patients enter the perioperative environment relying on the expertise of the surgical team to ensure that they come to no harm. Making a surgical incision compromises the body’s natural defence mechanism – the skin – and patients become vulnerable, entrusting practitioners to provide a safe environment where infection control and prevention of surgical site infection policies are based on best practice.

This article explores how legislation and benchmarks for best practice in the development of surgical drapes and gowns can influence patient care within the perioperative environment.

REVEALED
In 2000 the National Audit Office (NAO) revealed that approximately 9% of all UK hospital patients will develop a healthcare associated infection (HCAI) costing the National Health Service (NHS) around £1 billion per year. The NAO believed that 15% of these could be prevented by improving and implementing good practice. For the patient, acquiring a HCAI could mean 11 extra days in hospital, causing considerable discomfort and anxiety. In economic terms the cost implications resulting from delayed recovery cannot be estimated both for the patient and the healthcare organisation (NAO 2004). The Government acknowledged in 2003 when launching its document Winning Ways that, despite the publication of guidelines, the UK has one of the highest MRSA rates in Europe and surgical site infection (SSI) rates have remained static (DH 2005).

A further NAO report in 2004 detailing progress on reducing infection rates concluded that the cost to the NHS would be less if preventative measures were introduced rather than reactively treating of such infections. In 2005 the Government launched Saving lives: a delivery programme to reduce healthcare associated infection including MRSA aiming to halve Methicillinresistant Staphylococcus Aureus (MRSA) bacteraemias by March 2008 (DH 2005).

ACQUIRED
A surgical site infection occurs when an incision or cut is made by a surgeon to carry out a procedure and bacteria from the skin, other parts of the body or from the environment enter the incision and multiply. Therefore most SSIs are acquired at the time of the surgical procedure. In 2004, the NAO reported that the degree of improvement in SSI rates was small and that SSI accounts for 11% of all HCAI.

Aggregated SSI rates vary between 14% (limb amputations) and 1.1% (knee replacement) (HPA 2005a). Mandatory surveillance of SSI in orthopaedic surgery found that the rates were low, most SSIs affected the superficial layers of the wound and nearly one third were due to MRSA (HPA 2005b).

The risk of developing a SSI depends on a number of factors and varies according to the type of surgery, surgical procedure and technique, length of procedure, intraoperative interventions, and general health of the patient.

In 2005 the National Institute for Health and Clinical Excellence (NICE) commissioned a multi-disciplinary group to develop guidelines on SSI. The 2006 draft guidance covered all aspects of the surgical phase (pre-operative, intraoperative and post-operative) in making its recommendations for the prevention and management of SSI (NICE 2006). At the time of writing the author is unsure when the full NICE guidance will be produced following public consultation.

PURPOSE
The purpose of using drapes and gowns during a surgical procedure is to reduce the potential for surgical site infection by providing a barrier for the transference of microorganisms from the patient and staff into the open wound. With the emergence and increasing incidence of blood-borne infections such as Hepatitis B and Human Immunodeficiency Virus, drapes and gowns also protect the surgical team (Independent Multi-disciplinary Working Group 2003a).

Drapes and gowns are made from different materials with contrasting properties and specifications depending on whether they are single-use or reusable. Historically, the most common fabric was poly-cotton, an open structure material that provides little or no resistance to microbial penetration, particularly when wet. Such materials are no longer viable since drapes and gowns were classified as medical devices.

Manufacturers have developed single-use and reusable fabrics that offer greater protection for the patient and the surgical team and should be resistant to liquid and microbial penetration. Technological advances in textile materials have led to the development of everything from single layer micro-filament yarns to trilaminates with a microporous membrane in reusable fabrics, and from single layered non-woven fabrics with impermeable plastic products to multi-layered products, some with polypropylene reinforcement for single-use products (NATN 2005).

A medical device is a product used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability (MHRA 2005) and this includes surgical instruments and equipment.

Drapes and gowns are classified as medical devices and as such must comply with the Medical Device Directive (MDD). The MDD was introduced in 1998 and is mandatory in the UK and other European countries. The MDD describes the essential requirements for each product that must be met before it can be used on patients, and products are CE marked as official recognition of their compliance (Hurrell 2005).

European Standards have been developed to support the MDD and offer guidance to manufacturers and product users. The new European Standard EN 13795 (surgical drapes, gowns and clean air suits used as medical devices in healthcare facilities for patients, clinical staff and equipment) which has three parts, was approved in March 2006 and is due for publication in autumn 2006. This Standard was developed to standardise requirements for the manufacture and use of both reusable and single-use surgical drapes, gowns and clean air suits and details the technical requirements for materials to achieve to demonstrate compliance with the MDD requirements (Gilmour 2006). Materials must be resistant to wet and dry microbial penetration; tested for cleanliness; resistant to liquid penetration; tested for bursting and tensile strength wet and dry (Independent Multi-disciplinary Working Group 2003b).

However, there is no legal requirement for manufacturers to comply with European Standards and other technical solutions exist to ensure compliance with MDD requirements (NATN 2005). The EN Standard 13795 will become a recognised benchmark and purchasers, perioperative users and patients will be able to identify those manufacturers that have met the minimum requirements to ensure that they have greater safety and protection.

QUESTIONS
Continuing to be raised will be questions about single-use versus reusable materials and the Hospital Infection Society Working Party (2002) and NICE guidance (2006) recommend that surgical drapes and gowns should be made of disposable material.

Perioperative practitioners as users and healthcare organisations as purchasers of these products now have guidance to assist in the decision-making process. The EN 13795 provides the quality assurance and raises the standard of performance of surgical drapes and gowns for both single-use and reusable products, but are reusable products still a viable option?

Literature debates the efficacy of reusable fabrics for drapes and gowns questioning the life cycle of the product and challenging the process of guaranteeing performance (Gilmour 2006). If a manufacturer of reusable drapes and gowns complies with EN 13795 it is guaranteeing that the fabric used achieves minimum standards whether used once or 50 times (depending on the manufacturer’s fabric details). This enables purchasers and users to ensure that they receive a quality product, knowing that the manufacturer is responsible for monitoring the drape or gowns use, testing its effectiveness against recognised standards and producing a product fit for purpose each time.

Extensive literature and research evidence is available to enable practitioners to consider and evaluate the risk of infection when choosing the materials for drapes and gowns. The NICE draft guidance said that there was insufficient evidence to clearly determine differences in SSI rates between re-usable and single-use drapes and gowns. Yet a cost analysis found substantial savings when using both single-use gowns and drapes. However, it should be noted that many of the studies used are over six years old and improvements in materials, both single-use and re-usable, have been made in that time (NICE 2006).

Manufacturers will assist purchasers and users in deciding what type of gowns and drapes to use and purchase. Key considerations should not only include a cost analysis but also evaluation of the fabric by perioperative staff themselves. Does the fabric provide a barrier; is it easy to use and handle; does it prevent glare Multifrom reflected light; and is it resistant to tearing? (NATN 2005).

Purchasers and users should consider all the benefits and constraints of both re-usable and single-use drapes and gowns to enable them to make a decision and assist them in preparing a business case for procurement. The benefits and constraints focus on environment, cost and user/wearer preference (Independent Multi-disciplinary Working Group 2001).

Table 1 details some of the questions to be answered as part of the procurement process.

Practitioners should now question the efficacy of the drapes and gowns currently in use and challenge purchasers and management to consider alternatives. Evidence is available to support a review and revision of policies and procedures. Increasingly in this technologically advanced era, with Internet access to healthcare providers, patients can ascertain local infection control policies and therefore for a Trust or private sector provider to purchase or use drapes and gowns that are not compliant with EN13795 or MDD regulations has serious implications. As identified in the opening paragraph of this article, practitioners must ensure that their patients come to no harm (NATN 2005).

Discussions and debates will continue among manufacturers, purchasers and users about single-use versus re-usable drapes and gowns, and although the draft NICE guidance recommends single-use, purchasers and users have additional quality assurance methods through the introduction of EN 13795. This provides benchmarks for influencing and delivering the highest standard of patient care within the perioperative environment.

Due to the huge response to the NICE Guideline Consultation, the organisation has now decided to re-shape the guidance to meet the needs of the clinical community. A new group will review and build on the work to date which may significantly delay the final publication date.

REFERENCES
1 Department of Health (2005) Saving Lives: a delivery programme to reduce healthcare associated infection including MRSA. High Impact Intervention No3: Preventing Surgical Site Infection. London. Department of Health.

2 Gilmour D. (2006) Improving Perioperative Patient Care – EN 13795. Theatre Matters Spring 2006 16-19.

3 Health Protection Agency (2005a) Surgical Site Infection. HPA website www.hpa.org.uk accessed 2 July 2006.

4 Health Protection Agency (2005b) Mandatory surveillance of surgical site infection in orthopaedic surgery. London. Health Protection Agency.

5 Hurrell D. (2005) Decontamination of reusable medical devices in: Woodhead K & Wicker P Eds (2005) A Textbook of Perioperative Care. Edinburgh. Elsevier Churchill Livingstone.

6 Independent Multi-disciplinary Working Group (2001) Surgical Drapes and Gowns in Today’s NHS: Moving Forward from Traditional Textiles. A report from an Independent Multi-Disciplinary Working Group. Rickmansworth. HSD Communications.

7 Independent Multi-disciplinary Working Group (2003a) Considering the Consequences: An evaluation of Infection Risk When Choosing Surgical Gowns and Drapes in Today’s NHS. A report from an Independent Multi  disciplinary Working Group. Rickmansworth. HSD Communications.

8 Independent Multi-disciplinary Working Group (2003b) Under Scrutiny – Are you at Risk? Making Sense of New EU Regulations in Medical Devices Case Study EN 13795. A report form an Independent Multi-disciplinary Working Group. Rickmansworth. HSD Communications.

9 Medicines and Healthcare Products Regulatory Agency (2005) What we regulate: Devices. MHRA website www.mhra.gov.uk accessed 2 July 2006.

10 National Audit Office (2004) Improving patient care by reducing the risk of hospital acquired infection: A progress report. Report by the Comptroller and Auditor General HC 876 Session 2003-2004. London. National Audit Office.

11 National Institute for Health and Clinical Excellence (2006) Clinical Practice guideline for Surgical Site Infection: prevention and treatment of surgical site infection. DRAFT for Consultation. London. NICE.

12 NATN (2005) NATN Standards and Recommendations for Safe Perioperative Practice. Harrogate. NATN.

13 Nursing and Midwifery Council (2002) Code of Professional Conduct. London. NMC.

Diane Gilmour
Diane Gilmour is clinical team leader, Day Surgery Unit, Crawley Hospital, Surrey & Sussex Healthcare NHS Trust, and is deputy chairman of the Association for Perioperative Practice (AfPP).