The Medical Devices Directive 93/42/EEC dated 13th June 1993 became law within European Union member countries in July 1998.
It states that surgical gowns and drapes are medical devices as they are used for the prevention of disease (Art 1, no 2a of the Medical Devices Directive 93/42/EEC).
As such, gowns and drapes must fulfil the essential requirements of this directive which are that they must not compromise medical conditions / safety of patients and the safety and health of the surgical team.
In a paper written for the British Journal of Theatre Nursing dated November 1998, Prof H.P. Werner, convener of the CEN /TC205/WG14, D. Urech of the Swiss Mirror Group and Dr S.R.Patel state:-
“Surgical gowns and drapes are made from disposable or reusable materials. Each type of product has advantages and disadvantages. There are also significant differences in design, criteria for function, comfort, and specific requirements, so users face a complex choice in selecting the optimal system.”
In the same paper, it was also be noted that “the use of single-use disposable gowns and drapes will also be limited to products which comply with the requirements of the new standard. The future is for quality reusable products processed properly or quality single-use ‘disposable’ products.”
A report produced in Germany noted that the increasing problem of waste disposal requires an ecologically driven reorganisation that must begin with purchasing, where disposable articles are replaced by reusable or alternative products, as long as the requirements for hygiene and patient safety are maintained.
In principle disposable products such as disposable linens, including drapes, should be replaced by reusable products and long-lasting alternatives.
Fact from fiction
The European committee, CEN / TC205/ WG14, met for the first time in 1996 to develop a European standard for surgical gowns and drapes that would comply with the Medical Devices Directive, (MDD 93/42/EEC). The scope of this CEN Standard is as follows:-
The European Standard EN 13795-1 specifies the information to be supplied, in addition to the usual labelling of medical devices, concerning manufacturing and processing requirements.
The standard gives general guidance on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air-suits used as medical devices for patients, clinical staff and equipment that are intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. It is important to establish the terms to be used and set out the criteria against which the comparisons are to be made.
In recent marketing literature from the disposable industry the word ‘linen’ has been used. It is misleading. Linen is a fabric in its own right and has never been used within the operating theatre environment. Its primary use is in the manufacture of table linen and fashion wear.
In current practice reference to reusable fabrics refers to hi-tech microfilament synthetic materials. As a result it is very inappropriate to compare cotton and polycotton gowns and drapes, so called linen, with single-use products.
It is unlikely that cotton or polyester cotton gowns and drapes will meet the performance requirements of the forthcoming European Standard EN13795.
The following comparisons have been set out in a simple, easily understood format. No actual costings have been included as they vary from hospital to hospital.
It must also be remembered that both the reusable and single-use systems need contingency costings to allow for accidental damage and other unforeseen occurrences that can happen both before and during surgical procedures.
When making assessments it is important to establish what type of gown and drape is being offered. It is very easy to compare the low cost per use of reusable with the high cost of single-use products. However, one should consider that the high cost of single-use is even more expensive when one has also to pay for the disposal of the product.
Reusable gowns
Comfort with performance in use:
1. For Wet Procedures the provision of liquid proof panels in critical areas i.e. gown fronts and seams sealed sleeves up to the elbow. This will help to keep the user cool during use.
2. Gowns are soft and pliable to assist movement and not restrict surgeons dexterity. A soft fabric aids comfort.
3. The fabric remains strong when wet.
4. The inside of the garment will be dry and prevent liquid penetration.
5. Non-critical areas of gowns must also have fabric which acts as an airborne particle and bacteria filter. Usually lighter microfilament fabrics are used for back panels of gowns to keep the user cool during use.
Linting
1. Microfilament polyester fabrics are very low linting unlike cotton and polyester cotton which creates lint during laundering and in the operating room.
2. Liquid repellent and liquid proof fabrics are non-linting.
Specifications for reusables
1. Can be produced in a variety of fabric weights and sizes.
2. Replacement drapes made from computer generated specifications assure accurate shapes and sizes and individual barcoded items.
3. Made to individual design to meet needs of surgeon and procedure.
4. Good drapability. Fabric is soft and conforms to body shape
5. Liquid absorbency panels can be attached at fenestration or to any part of the drape.
Quality Control for reusables
1. Fabric bar coded at point of manufacture
2. Permanent individual bar code attached to the fabric history, manufacturing and processing history for medical device legislation.
3. Fabric specification to suit procedure.
Recycling reusables
1. All fabric can be put to other uses at end of useful life.
2. After laundering fabric can be sold to rag trade for recycling into differing fabric trades.
Costing reusables
1. Microfilament fabric is more expensive than cotton and polycotton but has a longer life with barrier properties when processed correctly.
2. The cost of laundering this type of fabric is less than conventional fabric.
3. Inspection costs should be added into the price.
4. A top-up system to maintain adequate supplies can be installed.
5. Items can be delivered direct to the designated department in sealed containers.
6. Old fabric can be sold for recycling.
7. Instruments sent to the laundry can be reclaimed and used.
Single-use gowns
Comfort with performance in use:
1. Loss of strength can cause tearing during Wet Procedures. The whole gown needs to be strengthened rather than the critical areas only. This causes an undue build up of body heat.
2. Single-use fabrics are less pliable and therefore can restrict movement. The crispness of single-use gowns lessens the comfort factor particularly during long surgical procedures.
3. The fabric loses strength when wet .
4. Only the most expensive plastic laminated gown will stop liquid penetration.
5. Low breathability can lead to build up of moisture inside the gown.
Linting
1. Only a few single-use gowns are low linting, some like spun lace (woodpulp and polyester blend based) are single-use fabrics that create lots of lint. There are clinical references available on the effect of lint on infection from disposable gowns and drapes.
2. High amounts of lint and particles are generated during use and when these gowns and drapes tear.
Specification for single-use
1. Mass produced with limited variety of weights.
2. Mass produced to a list of standard design specifications.
3. No modifications possible from the standard range once produced.
4. Poor drapability because of fabric type.
5 Liquid absorbency panels attached according to standard designs.
Quality control for single-use
1. Quality dependent on material source.
2. No reprocessing allowed or possible.
3. Only basic fabric specification.
Disposal
1. All single-use items must be incinerated at very high temperature. This is a continuing cost that must be included into the cost of each procedure.
Costing
1. Contingency costs. An amount of money must be set aside to cover accidental damage to both gowns and drapes.
2. Used single-use fabrics must be stored safely until collected for incineration.
3. Daily ordering of single-use items is necessary.
4. Adequate storage facilities must be available.
5. Porterage to the sterilisation department and theatre is necessary.
6. Special yellow bags are required for the disposal of single-use items as clinical waste
7. When the two systems are in use the linen or instruments sent to the incinerator cannot be reclaimed and used again.
Budget holders
It is helpful for users, budget holders and finance departments within the hospital that when the new European Standard comes into the public domain to consider the critical comparison prior to the final decision on the types of gowns and drapes to be used in the hospital.
Use of disposable gowns and drapes will be limited to where absolute need justifies the cost and they must comply with the requirements of the European Standard. For reusable gowns and drapes made from high-tech synthetic material it is important that these are processed correctly and their performance monitored regularly during their useful life.
In a hospital, or contract laundry, a meaningful condemnation policy must be in operation so that items are replaced when failing any performance test.
To purchase cheap for the sake of cheapness, whether single-use or reusables, or to continue to launder reusables after their useful life, is to put at risk not only the patient but also the hospital staff. In the event of a complaint from a patient it could also render the hospital trust liable to legal action.
