Surgical textiles include surgical gowns, drapes and clean air suits that are used to protect patients and hospital staff from infections. They are made from highly sophisticated new barrier fabrics which provide a high level of comfort and protection in operating rooms.
The performance characteristics of reusables may decrease during their product life through continuous care and maintenance. In order to compensate for this and to guarantee full compliance, reusable fabrics begin their service life with significantly higher performance than the stipulated level. In a hospital environment, the superior performance of reusable surgical gowns and drapes over disposables ensures additional safety for patients and the surgical team. Reusables are engineered to last and are of excellent quality, typically exceeding user requirements so that they can meet unexpected challenges which can occur during any surgical procedure.
It is imperative that surgical textile fabrics are strong enough to withstand medical stresses during surgery. Tensile strength testing confirms that the innovative high-tech materials from which reusables are made not only exceed the requirements of the European standard EN 13795 but are also much stronger than disposables.
Reusable surgical gowns contribute to safety in the operating theatre, throughout a long service life with many users. In order to ensure they comply with requirements, reusable surgical products are subjected to extensive quality management measures. These include validating products and processes, monitoring relevant process parameters and inspecting/testing products to ensure that quality and performance expectations are met.
All surgical gowns and drapes available on the EU market must comply with the following European legislation and EU standards:
This core legal framework aims to ensure a high level of protection for human health and safety and a good functioning of the Single Market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC of 5 Sep 2007.
EN 13795 is a mandated European standard which specifically addresses the essential requirements and test methods for disposable and reusable materials.
Comfort is not just a convenience but a physiological requirement. In an operating theatre, the challenge is not only to keep anesthetised patients warm, but also to keep the surgical team cool so that they stay alert and efficient. As the human body maintains its temperature by vaporising sweat, clothing should be breathable and its resistance to water vapour should be low. Scientific studies confirm that technologies available in reusable fabrics solve this problem. The micro-porous laminates used in today's reusables provide better comfort characteristics than single-use films.
Single-use laminates with films were shown to be unsuitable in this respect. They do not, or barely, allow vaporised sweat through and thus create an unacceptable burden for the surgical staff. In addition, design considerations and the flexibility of the materials used in reusable surgical gowns improve surgeons' ease of movement. Reusable surgical gowns are also designed with fenestrations and openings which are simple and easy to use without compromising safety.
Surgical gowns and drapes reduce the transfer of infective agents to and from a patient's wound, and also protect the surgeon. Barrier performance for wet and dry surgeries indicates the degree to which a surgical textile inhibits the spread of infection.
When tested in compliance with EN 13795, reusables have excellent performance in comparison to standard disposables.
A Life Cycle Assessment carried out by an independent consultant for ETSA compared five different types of surgical gowns.
The study assessed the environmental impact of the gowns based on energy consumption, global warming, acidification (of water and soil), eutrofication (nutrient discharges to water) and post-consumer waste.
The results showed that not only do reusable surgical textiles outperform disposables, but that they have a distinctly lower impact on the environment. Clear evidence that reusables are a better option than disposables when considering environmental impact.
Particles are considered carriers of infective micro-organisms and a cause of foreign body reactions. In a hospital setting, it is important to limit these particles to ensure as sterile an environment as possible. EN 13795 requires surgical gowns (reusables and disposables) to have a limited release of these particles, also referred to as low linting. Compared with disposables, reusables release significantly fewer particles, cutting the risk of infection.
Reusables also have superior performance in barrier protection over disposables. This is because disposables' resistance to liquid penetration performance (sometimes even within the same product) may vary, leading to equally varying degrees of performance in barrier protection. The homogeneity in the manufacture of reusables is therefore superior.
To determine the economic implications of choosing between using reusables and disposables, a cost-benefit analysis was conducted by Prof. Dr. Wilfried von Eiff at the Centre for Hospital Management at the University of Muenster.
Considering all factors such as production, transport cost, waste disposal, number of times used etc., the comparison shows that reusables are 3.6% less expensive than disposables.
The study also found that reusables are more cost-effective than disposables because:
reusables have no hidden costs, such as waste disposal and incineration
reusables have more consistent quality and absorbency so that surgeons are required to use fewer during a surgical procedure
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