Surgical Drapes and Gowns in Tod

Document Sample
Surgical Drapes and Gowns in Tod Powered By Docstoc
					Surgical Drapes and Gowns in
Today’s NHS:

Moving Forward From
Traditional Textiles




Report from an Independent
Multi-Disciplinary Working Group:
May 2001
CONTRIBUTORS


Lynn Graff                    - Manager Critical Care Services, The Royal Wolverhampton
                                Hospitals NHS Trust


Neil Wigglesworth             - Senior Nurse, Infection Control, The Leeds Teaching
                                Hospitals NHS Trust


David Rose                    - Head of Procurement Services, Gwent Healthcare
                                NHS Trust


Vicki Parkin                  - Clinical Nurse Specialist - Infection Control, York NHS Trust


Sue Millward                  - Independent Infection Control Nurse Adviser


Rosemary Carey                - Clinical Manager, Theatres and Day Surgery,
                                Ashford and St Peters Hospitals NHS Trust


Diane Gilmour                 - Advanced Theatre Practitioner, Surrey and Sussex NHS Trust


Maria Fleming                 - Clinical Nurse Specialist, Infection Control,
                                Epsom & St Helier NHS Trust (St Helier Hospital)




INTRODUCTION

This publication has been developed because quality assurance and clinical governance provided the
impetus to examine the evidence for and against different types of operating theatre drapes and
gowns. Peri-operative healthcare in the UK is, for many reasons, moving away from the use of re-
useable cotton and poly-cotton patient drapes and operating gowns. This document takes as its
starting point the view that these traditional materials have no place in the modern operating theatre
and then provides an overview of the benefits and drawbacks of the two alternatives to traditional
textiles: single-use drapes and gowns and synthetic reusables.


It has been compiled by eight independent contributors who combine extensive experience in
infection control, operating theatre management and procurement. The views expressed in this
document are intended to assist other healthcare professionals and provide them with the
information they need to make informed choices about the selection of an appropriate drape and
gown system, as well as a structure for moving forward and changing existing systems.
HISTORICAL PERSPECTIVE AND THE NEED FOR CHANGE

Hospital-acquired infection (HAI) is a major concern for all health care providers. Recent estimates from
the Public Accounts Committee, covering England have suggested that there are over 100,000 cases of
HAI a year in England at a cost of £1 billion and causing 5,000 deaths1.


HAIs can be caused by a variety of transmission routes, which include infection acquired during surgery.
In fact, it has been reported that 11% of HAIs are as a result of surgical wound infection1.


The sole purpose of patient draping and staff gowning has traditionally been to reduce wound infection
by providing a barrier to the transfer of micro-organisms from patients’ own skin flora and the skin of
operating staff, into the surgical wound. In recent years, with the growth in concern about infections
that can be carried in blood and other body fluids, there has been growing awareness of the added
importance of drapes and gowns in the protection of the operating team2.


There are currently several types of fabric used for surgical drapes and gowns. It is established that
impermeability should be a key function of any fabric, especially in a patient drape3. This is due to the
lower levels of wound contamination demonstrated by impermeable drapes clinically and in the
laboratory (the likelihood of micro organisms being present in the wound at the time of surgery is
accepted as one of the key risk factors for surgical site infection4).


The most common fabric in use in the NHS today is still poly-cotton, which has been in use for many
years. However, since poly-cotton fabrics provide little or no resistance to microbial penetration,
especially when wet,5 there has been a significant move away from this type of fabric.


The independent hospital sector uses predominantly single-use drapes and gowns, with very little
cotton product. Furthermore, compared with the rest of western Europe, the high use of traditional
textiles in the NHS is notable.6


It is now widely accepted that these traditional, open-structure materials are not viable in the UK in the
future. This has, in fact, been inevitable since drapes and gowns were classified as medical devices (and
therefore not normal laundry items) under the EU directive 93/42/EEC7.


More recently the European Committee for Standardisation (CEN) has contracted with the European
Commission to establish a mandatory European Standard of basic requirements for single-use and
reusable materials to protect both the patient and surgical team. This new standard will require both
single-use and reusable drapes and gowns to be resistant to liquid penetration, resistant to microbial
penetration and with a minimal release of particles (i.e. lint). Further use of cotton and polyester-cotton
blended drapes and surgical gowns is not recommended5.


Additionally, patients are placing increasing demands upon health care professionals, much of which is
driven by the media, particularly as there is currently a major government focus on cleaning up
hospitals.


A French study undertaken in 19968 showed that:




                                                                                             1
92% of people would prefer to have single-use products used on them or their relatives
6 out of 10 were in fear of contracting disease by the use of reusable products
62% were prepared to pay for single-use products


With the NHS putting by more money each year for litigation settlements it is vital that patient worries
are now addressed9.
    Interestingly, it appears that it is not just the general public who are keen to see single-use products being
    used. The Pharma Strategy Group10 conducted a survey of 145 surgeons and 75 nurses, which revealed:

    72% of surgeons would want single-use products used on their family if they had an operation
    68% of nurses felt the same way


    Whether a single-use or synthetic textile drape and gown system is selected as the way forward, there
    may be resistance to change from surgeons and theatre staff, due to the threat of losing some of the
    positive qualities of cotton products – drapeability, comfort, and fluid absorbency. Also the move from
    cotton may be adding a new cost to the operating theatre budget, because the costs of cotton were
    scattered around the hospital (and often hidden) in laundry, sterile services, hotel services etc.


    All of these factors need to be addressed sensitively and appropriately in each trust.



    OVERVIEW OF DRAPE AND GOWN
    MATERIALS AVAILABLE ON THE MARKET

    TEXTILES

    Cotton / Cotton-polyester
    These are the traditional materials for drapes and gowns. They are comfortable to wear when dry,
    drapeable, and strong. However, their open structure means they have practically no barrier effect in the
    absence of special measures (e.g. repeated impregnation with hydrophobic agents to maintain a uniform
    barrier)3.


    Tightly woven textiles of a blend of polyester and long-staple cotton made with liquid repellent
    fluorocarbon treatment are also available. The repellent finish reduces after each wash and must thus be
    re-applied regularly to maintain a barrier effect.


    Micro-filament yarns
    These are densely woven materials made from very fine endless polyester filaments. For fluid control
    the fabrics are treated with a liquid repellent finish. Again, reliable barrier action is assured only with a
    hydrophobic treatment in each reprocessing cycle.


    Laminates
    A tri-laminate is produced through combining a micro-porous membrane, bonded between an upper
    and lower layer of endless-fibre polyester.



    SINGLE-USE
    A wide range of materials are used by manufacturers, with the common theme being that they are "non-
    woven" in structure. These range from single-layer hydrophobic materials through to fully impermeable
    plastic products. Many products are multi-layered and combine a number of functions in a single
    product. For example, a patient drape may have an impermeable plastic layer combined with an
    absorbent cellulose top layer, or a hydrophobic layer combined with an impermeable absorbent patch




2
    close to the wound.


    Most single-use products are sterilised by the manufacturer and delivered pre-sterile to the user.
    However, some materials are suitable for hospital steam autoclaves, and thus non-sterile product ranges
    are available.
BENEFITS AND CONSTRAINTS OF SINGLE-USE
AND REUSABLE MATERIALS – HELPING HEALTH CARE
PROFESSIONALS DECIDE

A recent draft document entitled "Behaviours and Rituals in the Operating Theatre" produced by the
Hospital Infection Society Working Party (Draft January 01) recommends that theatre drapes and gowns
should be made of waterproof, disposable material11. However, there are always many aspects to be
considered and some of the key considerations are detailed below.


SYNTHETIC REUSABLE DRAPES AND GOWNS

THE BENEFITS

Environment
The ability to reprocess gowns and drapes means that the amount of clinical waste is minimised,
obviating the need to dispose of potentially hazardous, contaminated materials.


Cost
By limiting clinical waste there is a potential for substantial cost savings both in terms of incineration
and the need to maintain a stock of single-use materials.


User/Wearer Preference
There may be clinician preference for reusable materials (e.g. comfort, colour, closer feel to cotton etc).
The issue of comfort may be particularly noticeable in the case of gowns, with surgeons complaining that
they do not wish to wear what they sometimes perceive as a "papery" single-use gown.


Improved Microbial Barrier Versus Traditional Textiles
A range of synthetic textile materials are available, ranging from single layer micro filament yarns to tri-
laminates that incorporate a micro-porous membrane. All of these materials provide a significantly
better barrier to the transfer of micro organisms than cotton, and thus can be viewed as more effective
measures at reducing wound infection risk.


THE CONSTRAINTS

Quality
After constant use, there are doubts about the quality of reusable materials and the capacity of hospitals
to monitor their use. A study undertaken in Germany in 1998 looked at the quality of materials used in
surgical drapes and gowns3 using products processed both internally and by external contractors. The
majority of the products tested performed poorly in light table, liquid penetration and microbial
penetration tests. It concluded that it is difficult to maintain a good barrier for the life of a reusable
product due to the high number of processing cycles required to make the products affordable. The
study, therefore, raised doubts about the suitability of synthetic textiles as a replacement for traditional
cotton.


In 2000 an update to this study was conducted in England, Wales and France12 with similar results found.




                                                                                             3
The authors conclude that to reach the goals set out in legislation for reusable fabrics, standardised,
validated processing procedures must be established. Products made from microfibres must be
repeatedly impregnated in order to maintain a uniform barrier performance. Also key is the reliable
recording of the frequency of processing for each individual surgical item.
    Environment
    Available research on the environmental impact of reusable versus single-use drapes and gowns does
    not provide a clear conclusion. Because reusable materials undergo much more processing than single-
    use (cleaning, sterilisation, ironing, repairs, provision of repellent finish, packaging, daily delivery etc)
    it cannot be assumed that they are more environmentally friendly when considering the total product
    life cycle.


    In a report by Bell in 1998 it was noted that when considering the effect on the environment it should be
    remembered that the cleaning and sterilising of reusable products and equipment have significant
    environmental implications and as such should not automatically be assumed ‘environmentally more
    friendly’13.


    Considering In-House versus Contracted-Out Laundry and Sterile Services Processing for
    Drapes and Gowns


    When the recycling of reusable materials is contracted-out there must be a contractual obligation for the
    provision of appropriate monitoring, quality assurance mechanisms and audit trails. The recent studies
    on product quality (3,12) highlight the importance on contractors to provide evidence of this obligation
    being implemented for the life of a contract.


    Additional issues that should be considered include:-
    Accountability, enforced through contract monitoring
    HSDU regulations / CE mark
    Accessibility / convenience
    Replacement / repair criteria
    Personnel: training and motivation
    Infrastructure
    Expansion capacity
    Capital, personnel costs and overheads



    SINGLE-USE DRAPES AND GOWNS

    THE BENEFITS

    Quality Control
    Because the products are used only once, any concern about damage to the barrier caused by
    reprocessing does not exist, and product quality is highly consistent. Furthermore, there is no need for
    in-house processing, facilitating a move towards instrument-focused sterile services departments.


    Minimising Infection Risks for Patients and Operating Staff
    Because the products are new every time and more likely to be of a consistent quality, the probability of
    an effective microbial barrier being in place for an operation is greater than with reusables (3,12).


    A recent study comparing the barrier quality of textile and single-use products found that 56% of the
    textile products tested on the light table showed serious faults impairing functionality, compared with




4
    0% of the single-use products12.


    Furthermore, the most comprehensive study undertaken to measure the effect of drape and gown
    materials on surgical wound infection, undertaken by Moylan in 1987 and including over 2000 surgical
procedures, found that single-use products reduced infection by 2.5 times, compared with traditional
textiles14. Single-use could thus be seen as a more effective measure than traditional textiles for
minimising the risk of contamination of the wound and / or surgical team.


Ease of Implementation
Single-use is often associated with improved reliability of supply. Benefits are also seen in terms of
quality assurance, traceability and guaranteed sterility.


Ease of Use
Single-use manufacturers provide a wide range of products specific to the requirements of particular
procedures. Thus, gowns can be standard for dry procedures through to 100% impermeable for very wet
or infected cases. Drapes are also procedure specific and thus allow for more efficient draping (quicker,
less wastage). With regard to wastage, over-draping14 with existing reusable products is a common
theme and represents an avoidable additional cost(14,15).


THE CONSTRAINTS

Environment
There is a perceived adverse impact on the environment in terms of increased clinical waste caused by
the need to incinerate single-use materials. The additional clinical waste costs need to be taken into
consideration when setting budgets (although the actual costs are normally less than anticipated).
Regarding the environmental impact of incineration, most single-use drapes and gowns are reduced to
carbon dioxide and ash16.


As stated earlier, the overall environmental burden of single-use materials when compared with
reusable, is unclear.


Re-Allocation of Costs
Converting to a single-use system often entails an immediate budget increase for the operating theatre
directorate. Much of this increase is a result of the transparent cost structure for single-use products, i.e.
an invoice is presented for each product used. With reprocessed drapes and gowns, costs are often
spread around the hospital in different cost centres, with some costs hidden altogether (e.g. autoclave
costs). The change to single-use can therefore require significant work by the theatre budget holder, to
secure funding from other directorates and build a sound business case.


The Need for a New Draping Technique
Single-use draping technique is different from that of textile products, and this can present a barrier to
change. This constraint must be tackled by placing responsibility on the manufacturer to provide
appropriate training resources during implementation (in terms of specialist staff, training manuals etc)


Disruption of Change
Any change from a reusable strategy, particularly from an in-house processing system, will have
personnel implications, including task re-allocation or even redundancy of laundry and sterile service
staff (in practice the former is much more likely than the latter).




                                                                                               5
    IMPLEMENTING THE CHANGE FROM POLY-COTTON DRAPES
    AND GOWNS

    The fact that cotton drapes and gowns are normally processed and costed in various departments of a
    trust, can complicate the change process. This is often sited as a barrier to moving forward, and other
    "quick win" activities gain priority. However, the decision making and implementation process is
    relatively straightforward. The recommendations outlined in the remainder of this report are based on
    the experiences of several of the authors who have successfully managed the transition from traditional
    textiles. (see appendix one)


    There are three key factors that determine a successful transition from cotton to single-use or synthetic
    reusable:

    1.   Having a clear "owner", who is strongly motivated to implement the change and has the authority
         or ability to involve others in the process. This person is often the Theatre Manager or Business
         Manager for theatres.
    2.   Identifying and gaining the support of the relevant stakeholders in the Trust. These might include:
         Infection Control, Surgeons, Theatre Staff, Sterile Services, Laundry, Finance, Procurement.
         Regarding finance, any budgetary implications of the planned change should be highlighted very
         early, in the business case, so that the Board ratifies the move before too much time and effort is
         spent (designing specifications, evaluating suppliers, tendering etc). (see appendix two)
    3.   When a tender for the drape and gown service is issued, it should state either "single-use" or
         "reusable", ie. the decision about the type of system should have been made by this stage. If this is
         not done, the tender specification will, because of the basic differences in the management of the two
         systems, be too non-specific to attract the best possible offers from either type of supplier.



    WHEN YOU HAVE MADE YOUR DECISION OF EITHER SINGLE-USE OR
    SYNTHETIC REUSABLE, THE FOLLOWING PROCESS IS RECOMMENDED:

    ACTION PLAN

    Phase One:
    1. Outline costs and potential savings to gain approval in principle from Trust board. A template is
       attached to assist in the cost comparison of the different types of system.
    2. Identify stakeholders and gain support. This could be in the form of a meeting where the case for
       change is presented along with the initial budget implications.
    3. Prepare a detailed business case, to include financial considerations (including incineration, staff,
       training, capital charges, insurance)
    4. Set realistic time lines, incorporating the OJEC tender process if applicable.


    Phase Two:
    1. Work with supplies/procurement department to draft contract specification. The specification
       should be structured so that suppliers bidding for the contract have to demonstrate that they can:
         Provide products (range and material specification) that match the trust’s clinical requirements.




6
         Effectively run the implementation of their system, providing adequate training resources, specialist sales staff
         and project management skills
         Manage the contract for it’s entire lifetime, so that costs stay within budget and clinical standards are
         maintained. (This can be achieved via regular management information, contract review meetings etc).
         Suppliers should be asked not only if they can meet the specifications, but how they will meet them, providing
         evidence where appropriate (via references etc).
2.   Identify and contact potential suppliers with a view to discussing and refining the draft specification
     prior to placing an advertisement in the Official Journal of the European Communities (OJEC) and
     inviting tenders.
3.   Establish detailed specification, based on 2. above.
4.   Initiate tendering process, with involvement of Procurement Department. The value of the contract
     and the trust’s own standing financial instructions will determine what form the tender should take.
5.   Shortlist suppliers.
6.   Conduct product evaluations/open days. These should strike a balance between gaining enough
     information from shortlisted suppliers, and avoiding too much disruption to the smooth running of
     theatres.
7.   Decide on supplier and make contract award.


Phase Three:
1. Implement planned change. The chosen supplier should be integral to this process, and should in
   fact facilitate the whole activity with the support of the Theatre Manager. This takes the pressure off
   theatre staff, and gives a good indication of the suppliers’ capability at managing the contract.
2. Develop partnership with agreed supplier for life of contract to deal with:
   - Training
   - Specification
   - Keeping within budget
   - Flexibility

The partnership agreement should be drawn up when implementation is finished, via a meeting
between the supplier account manager and key trust staff. The agreement should resemble the contract
specification but may include amendments based on learning gained by both parties during the
implementation phase.


 Phase Four:
1. Monitor and evaluate. The partnership agreement should include key performance indicators that
   the supplier can be measured on. These should be measured and evaluated on a regular basis, e.g.
   quarterly or six monthly.
2. Maintain flexibility to reflect changing needs.




                                                                                              7
    APPENDIX ONE


       DECISION FLOWCHART
                                            Consider Benefits/Constraints
                                             of Single-Use or Reusable
                                                 and make decision



                          If reusable in-house                             If single-use
                            or contracted out                          material specification




                                                 Build Business Case




                                                 Identify and
                                             Involve Stakeholders




                              Tendering                       Establish Specification




                                           Contract




                                                  Implementation/Training




                                                               Monitoring and Follow-Up




    In Conclusion
    Allocating budgets and deciding priorities in today’s NHS is a real challenge for us all and long term
    benefits versus short term needs have to be carefully balanced. We hope this document helps you to
    assess your needs and that you benefit from the contributors’ collective experiences.




8
APPENDIX TWO

 DRAPE AND GOWN COSTING TEMPLATE

 Cost                                                     Cotton   Synthetic     Single-use
                                                                   Reusable
 Purchase Price
 Should be cost per procedure for ease of comparison
 Capital Investments
 - updating of laundry / sterilisation equipment
 - bulk linen purchase
 Repair
 To include wages of staff undertaking repair
 and cost of repair
 Losses
 To include rejects from laundry and theatre, cost
 of replacement
 Laundry
 - Pre-sorting - employee hours / wages
 - Electricity
 - Laundry chemicals / detergents
 - Quality checking - employee hours / wages
 - Ironing - employee hours / wages
 - Folding - employee hours / wages
 - Packing - materials, employee hours / wages
 - Distribution costs - transfer between departments
 Sterilisation
 - Quality checking - employee hours / wages
 - Tray packing - employee hours / wages
 - Additional packaging materials
 - Sterilisation cost per cycle (including energy used,
 depreciation, efficiency savings if only process
 instruments etc)
 Existing Single-use items
 - cost of waterproof macs for use under cotton drapes
 - cost of stock for "infected cases"
 - cost of stock for cotton supply contingency
 Distribution
 - Cost of transport and handling around the site
 Storage
 - Energy - heating, lighting
 - Inventory management costs
 Disposal
 - Incineration / landfill costs
 - Transportation costs
 "Invisible" Costs
 - Ease of use
 - Clinical performance: risk assessment
 - Clinical preference




                                                                                 9
 TOTAL:




 NB: For synthetic reusable system, in-house cost elements will vary depending on the level of
 contracting out.
REFERENCES
1. Plowman, R. et al. 1999, ‘The Socio-Economic Burden of Hospital Acquired Infection’,
    PHLS, London.
2. Mölnlycke Health Care data on file: Recent Growth in Wearing of Single-Use Surgical
    Gowns.
3. Werner HP. 1998, ‘Quality of Surgical Drape and Gown Material’, Germany.
4. PHLS. 1997 – 1998, ‘Surgical Site Infection, Analysis of a Year’s Surveillance in English
    Hospitals’.
5. CEN. ‘Surgical Clothing and Drapes Used as Medical Devices in Healthcare Facilities’.
    Second Draft CEN/TC/205/WG 14 N 61.
6. Mölnlycke Health Care data on file: European Market View.
7. EU directive 93/42/EEC.
8. APF, June 1996. ‘French People Fear to Contract Infections in Hospital’, Survey Paris cited in
    Bell 1998 NATN, Vol. 8, No. 1.
9. NHS Magazine, June 2001. "Learning from Experience".
10. Pharma Strategy Group Ltd, May 1996. ‘Surgical Instrument Survey, Summary Report for UK.’
11. Hospital Infection Society Working Party, "Behaviours and Rituals in the Operating Theatre".
    Draft January 2001.
12. Werner, H.P., Feltgen, M. & Schmitt, O. 2001,‘Quality of Surgical Drapes and Gowns –
    Investigation in England, Wales and France’. HygMed, vol. 26, pp. 62-75.
13. Bell, S. 1998, ‘Multiple Patient Use Versus Single Patient Use Products’, British Journal of
    Theatre Nursing, vol. 8, no. 1.
14. Moylan, J.A., Fitzpatrick, K.T. & Davenport, K.E. 1987, ‘Reducing Wound Infections -
    Improved Gown and Drape Barrier Performance’, Arch Surg; vol.122, pp.152-7.
15. Muller, W., Jiru, P., Mach, R., Polaschek, F. & Fasching W. 1989, ‘The use of Disposable
    Draping Materials in the Operating Room and its Effect on the Post Operative Wound
    Infection Rate’, Weiner Klinische Wochenschrift, vol.101, no. 23, pp. 837-42.
16. Johnson and Johnson. 1996, ‘Sustaining a World Wide Environmental Commitment’.
    New Bruswick, New Jersey, Vol. 08, no. 9, pp. 33




                       Sponsored by an educational grant from
                               Mölnlycke Health Care

				
DOCUMENT INFO