Adapt or die

30 November 2000



Suppliers of hospital linen must take a much more proactive approach and prepare for changes in EU standards argues Shaun Deneen.


There has been much discussion about the use of linen in surgical procedures, and even some talk of eliminating it altogether. With my experience, both as a theatre nurse and now as a senior manager, I believe such talk is misguided.

It has arisen because customers do not have adequate information about future EU standards for theatre drapes and gowns, although the Institute of Sterile Services Management published an excellent, unbiased article.

I have been fortunate enough to obtain a draft copy of the proposed directive, but my current supplier had not even seen it, a matter for some concern, particularly as failure to prepare for the changes could lead to loss of future business.

I appreciate the difficulties and conflicts of interest that face working groups and committees in the EU and realise that discussion documents do not always reach those most likely to be affected by them. The linen standard is no exception.

Having had to implement a new EU directive within Sterile Services, I am acutely aware of both the difficulty and expense of doing so and that the consequences of legislation do not always appear to have been fully thought through at operational level.

It is essential to provide clear, concise information to allow informed and sensible debate. Manufacturers of disposable products have gone to great lengths to produce informative leaflets and research articles for potential customers, but have linen suppliers taken similar steps? If not, will existing or future customers see the full picture? If you do not take a proactive approach, your customers may be beguiled by glossy adverts extolling the virtues of disposable systems and you may well go the way of the dodo.

Linen suppliers must make sure they know the advantages and disadvantages both of their own product and of the disposable alternative so that they will be able to present a balanced view of the debate to the customer.

In favour

Remember that disposables do have the benefits of convenience, proven standards and in some cases, safety. They are:

• CE marked, proving compliance with the Medical Devices Directive.

• Items are already packaged and sterile freeing both technician time and steriliser time and capacity.

• Drapes and gowns, purchased as sterile, do not require further validation.

• Disposables deliver guaranteed standards each time. Patient and theatre staff are protected, especially from strikethrough. (Clinical Governance, Controls Assurance).

• Products are easier to handle and store.

•Instrument sets may be lighter, as linen is not included.

• Items can be delivered direct to the end-user from stores, avoiding the need for dedicated stores administration.

• Particle counts in theatres may be reduced, cutting the bacteria counts and lowering risk of wound infection.

• Drapes often have adhesive tapes so instrument sets do not need to include towel clips and so are lighter and safer to handle. Badly placed clips can be risky for the patient.

• Overnight or same day delivery may be available in emergencies.

• Prices are becoming competitive. Bulk discounts can be negotiated. There are no ongoing replacement costs.

• Well-packaged goods make receipts and invoicing easier.

• Reserve stock may be held in warehouses.

Disposable problems

But disposables do have a downside. They are more expensive, although the higher prices must be weighed against the potential costs of wound infections from poor quality reusables. Prices may also rise unexpectedly. Raw material may be sourced from abroad so costs may be affected by fluctuations in exchange rates.

Other disadvantages include:

• Standardised pack contents.

Unnecessary contents are wasted.

• Raw material supply problems can cause delivery delays and sudden spec changes.

• Some surgeons do not like disposables.

• Some disposable drapes do not lie nicely on the patient and adhesive tape and borders can cause skin problems.

• Clinical waste disposal costs will rise.

• Disposal of packaging can be difficult.

• Where there is no dedicated stores administration, products may run out unless a standing order is in place.

• Disposables that use latex can cause an allergic reaction.

The reusable case

Linen suppliers should also make sure that they can present the case for their own product, clearly and concisely and see where they can take action to counter some of the difficulties.

Many of the advantages for using reusables relate to price. Reusables are often cheaper on a like-for-like basis, although they may also carry higher ongoing costs such as staff handling and replacements. However, reusables can often be rented, so here the service provider takes responsibility for replacements. Prices for reusables are normally fixed for the duration of the contract and the customer has more control over budgets.

Linen also has practical benefits in use.

• Drapes are very flexible and lie well on the patient. Gowns are comfortable, especially for long surgical procedures.

• Packs can be customised, with a mix of fabrics.

• Products are generally well known and accepted by end users. (Some barrier fabrics are non-absorbent, causing fluid to run-off into the surgeon’s boots.)

• Drapes do not usually use adhesive tapes, reducing risk of skin reactions.

• Reusables have little effect on the customer’s clinical waste costs and have an environmentally-friendly image.

• Minimal packaging means low waste handling costs.

• No need for dedicated stores admin.

A further advantage is that some suppliers have now realised the benefits of being CE marked and can prove compliance with the Medical Devices Directive. In future, this is likely to be essential.

Reusable problems

While the new directive will not mean the end for linen, suppliers will have to be ready to adapt and with this in mind they should also consider the problems and where possible take remedial action.

• Many suppliers are still not CE marked, this could affect purchasing decisions.

• Not all suppliers offer a sterilisation service. The customer has to use more manpower as well as steriliser time.

• Bioburden testing of linen may be necessary to prove compliance with the Medical Devices Directive. This increases customer costs.

• Quality can vary. Damage may not be obvious (eg pinholes) increasing risk of wound infection.

• Materials may be heavier than disposables. Packing linen with instrument sets can make them difficult to handle.

• Fabrics are often bulkier to store and take up more storage space.

• Inadequate monitoring of barrier fabrics can lead to strikethrough on gowns, an unacceptable risk to theatre staff and patients.

• Obtaining extra stock at short notice may be difficult, particularly for tailor-made drapes.

• Laundries may not have adequate contingency planning for emergencies.

In the absence of informed debate, some users believe that the forthcoming EU Directive will outlaw reusables. This is not the case and never has been. The standard will seek to clarify and recommend test methods for patient drapes and operating gowns, whether reusable or disposable.

This article is intended to show suppliers the need to research the subject more thoroughly and become more proactive, ie taking steps such as becoming CE marked or considering a sterilising service. It may also persuade customers to think again by drawing their attention to points they may not have considered.

Shaun Deneen is the manager for sterile and textile services at the Royal Hampshire County Hospital, Winchester and is also involved with the Medical Devices Agency. His article is based on a paper given to the Society of Hospital Laundry Managers and Linen Services.



Privacy Policy
We have updated our privacy policy. In the latest update it explains what cookies are and how we use them on our site. To learn more about cookies and their benefits, please view our privacy policy. Please be aware that parts of this site will not function correctly if you disable cookies. By continuing to use this site, you consent to our use of cookies in accordance with our privacy policy unless you have disabled them.