EDANA (International Association Serving the Nonwovens and Related Industries)
Epidemics and pandemics have shaped our history, and today they continue to threaten us by causing death, suffering and fear, and in doing so also place sudden intense demands on national and international health systems throughout the world. The last 25 years have brought new diseases to the world, including human immunodeficiency virus (HIV), acquired immune-deficiency syndrome (AIDS), severe acute respiratory syndrome (SARS), ebola and, more recently, avian flu, all of which, with the globalisation of trade and travel, have rapidly spread.
In addition to this, the incidence of healthcare-associated infection (HAI), due to causes such as methicillin-resistant Staphylococcus aureus (MRSA), while by no means new, has apparently rocketed (perhaps due to increased awareness ) in the past decade and is today hitting the newspapers with headlines such as “Killer bugs”, “Menacing microbes” or “Superbugs”, and “Thousands of avoidable deaths”.
It is estimated that, in the European Union (EU) alone, HAI affects one out of every 10 patients, causing roughly three million infections, resulting in longer convalescence periods, increased suffering and some 50,000 deaths per year. It is estimated that about one-third of HAIs, of which roughly 30% are discovered after discharge from hospital, are preventable by improvements in infection control.
Whereas infection is making the headlines, infection prevention is not
There are a number of areas, especially in patient care practices such as hand hygiene, which, while not headline material, have proven to significantly contribute to decreased nosocomial infection.
In surgical procedures, where the potential of infection is high, risk can be greatly minimised by adopting best practices in several critical areas, ranging from the environment, design and preparation of the operating room to the preoperative preparation of personnel and the patient. Using the right surgical barrier and protective gowns, masks, head- and footwear are some of key means to achieving optimal protection from infection.
What are nonwovens, and what is their contribution to healthcare?
Nonwovens are uniquely engineered and versatile materials which are extensively used in the medical field and in protection against biological agents in other sectors. For example, they can be designed to deliver critical safety properties, such as protection against infections and diseases. With today’s multi-drug-resistant strains of bacteria and virus, nonwovens can help in the fight against cross-contamination and the spread of infection in a medical or surgical environment. Nonwovens are also increasingly a major component in the design of “smart” woundcare products, providing such functions as the creation of a moist wound healing environment, with controlled vapour transmission, absorbency and low skin adhesion.
Most recent nonwoven innovations include the design of new scaffolds for 3D biological tissue engineering, implantable fabrics that can reinforce natural tissues, and nanofibre nonwoven filtration media offering enhanced particle capture properties. New nonwoven materials with improved finishes including liquid repellent and bacterial barrier properties are also being developed for applications such as surgical masks, gowns and drapes, especially in view of the high demands of the new European Standard, EN 13795.
Nonwovens in the operating theatre
The majority of postoperative surgical site infections are acquired at the time of operation when there is a possibility for microorganisms to reach the open wound. Routes of infection are via contact (dry or wet) or airborne. Transfer of bacteria occurs mainly by the contact route via staff hands or clothing. A healthy individual may disperse thousands of skin particles per minute, and each particle can harbour an army of bacteria. The role of drapes and gowns is to minimise the spread of infective agents to and from patients’ operating wounds, thereby helping to prevent postoperative wound infections.
Nonwoven single-use gowns and drapes offer a variety of properties that provide a safe barrier against bacteria, such as repellency, self-adherent edges and aseptic folding.
Single-use = 100% certainty
The principal advantage of nonwovens is that they are used only once on one single patient, and incinerated after use, thus avoiding the need for handling and the consequent potential for spreading contaminants. As single-use fabrics are new for each procedure, there is no need to worry about the quality of the material. Because of their single-use property, the same level of barrier effect performance is always guaranteed, whereas it is possible that a multipatient reusable fabric may lose some level of performance after reprocessing.
Custom-made for the operating theatre
By using a combination of different fabrics, materials and designs, single-use operating room nonwovens are custom-made for the operating room staff by offering the following characteristics:
- Procedure-specific design.
- Optimum wearer comfort.
- Strong yet light in weight.
- Optimal fluid absorbency.
- Exchange of air, body heat and moisture.
Exceeding stringent European standards
A recent Frost & Sullivan report (2004) shows that the market for disposable surgical drapes and gowns in Europe has seen steady growth in the recent past owing to the high standards of infection control enforced by the new European Union Medical Devices Directive (MDD) and EU standard EN 13795.
The need to prevent the transfer of infection between patient and medical staff has never been greater. The introduction of the three-part European standard for surgical drapes, gowns and clean-air suits, used as medical devices, EN 13795, has been put in place for the protection of patients, clinical staff and equipment.
The norm, a globally recognised guideline, is designed to establish uniform standards for single-use and reusable surgical drapes and gowns, in order to minimise the spread of bacteria and other micro-organisms during invasive procedures, thereby helping to prevent postoperative wound infections.
After nearly 10 years of European standardisation work, the final section, Part 3 – relating to performance requirements – was approved in April 2006. This work was accomplished with the full support of EDANA’s Medical Devices Committee, “MEDECO”, whose experts fully contributed to and
participated in the CEN Working Group responsible for the development of the norm.
The EU standard emphasises the importance of the barrier performance of the materials used, insisting that: “The use of surgical gowns with resistance to the penetration of liquids can diminish the risk to the operating staff from contact with infective agents carried in blood or other body fluids.”
EN 13795 further outlines the need for rigorous standards in terms of manufacture and processing throughout a product’s useful life, as well as for the testing and re-validation of reusable materials.
Nonwoven fabrics have excellent liquid resistance, tensile strength and hydrophobic/hydrophilic properties and are, therefore, highly suitable for surgical drapes and gowns. On the other hand, the use of traditional multipatient cotton and cotton/polyester mixed textiles has gradually been decreasing, and once the standard comes into operation they will no longer be on the market as their low performance, will not meet the stringent requirements of EN 13795.
More information on EN 13795 is available in the new EDANA brochure To do a job right, dress right which can be downloaded from www.medeco.edana.org.
Better economics for hospitals
Infection prevention must be seen in a holistic way, so cost should not be the main factor in making decisions regarding products to reduce the risk of infection. By looking at the whole picture, preventing infection will ultimately save money.
Single-patient operating room nonwovens contribute to reduced healthcare spending. Not only is a patient significantly less likely to acquire a nosocomial infection, with all its associated medical care and treatment costs, but when compared to all the hidden costs of re-processing, single-use nonwoven products quickly prove to be a cost-effective solution.
The choice of materials, in both single-patient-use and multi-patient-use drapes, gowns and apparel, is wide-ranging. The degree to which they resist penetration by potentially infective material is a crucial factor, and should be the major concern when different material options are being considered.
Despite growing infection rates in hospitals, there are effective ways to combat this alarming trend. New and innovative applications of nonwovens are increasingly being used by healthcare professionals as they provide efficient and cost-effective solutions in many critical applications. As today’s surgical techniques become more and more complicated and save lives in ways that could never have been imagined, even a decade ago, it is imperative that this technical progress is matched with a similar quantum leap forward in infection prevention.