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Hygiene--The First Amendment For Infection Prevention
The news is filled with updates on the spread of new viruses and bacteria that can develop severe human threats and become pandemics. A few years ago it was SARS, the Severe Acute Respiratory Syndrome that, according to WHO (World Health Organization) in August 2003, had caused 8422 cases causing 916 deaths, mostly in China. The most recent threat comes from the influenza pandemic caused by the HIN1 virus, or the swine flu that, as of July 2009, had caused 429 deaths and 94,512 cases, as reported by WHO.
But, one does not need to go so far. The risk of getting a hospital-acquired infection, HAI, while being treated in a hospital can be as much as one in vie. In connection to surgical interventions, numerous patients suffer from wound infections aider surgery. While the simplest discipline, proper hand hygiene, can help prevent transmission of disease, it does not always seem so easy.
Recent information from the European Center for Disease Prevention and Control (ECDC) claims that 4.1 million patients are estimated to acquire healthcare-associated infections in the EU every year. The number of deaths occurring as a direct consequence of these infections is estimated to be at least 37,000, and they contribute to another 110,000 deaths. The result of these infections represents 16 million additional hospital days per year at a cost of 5.5 billion [euro].
In addition, an estimated 20-30% of healthcare-associated infections are considered to be preventable by intensive hygiene and control programs. Therefore, in a nutshell, the most cost-effective infection prevention programs are education, hygiene protocols and antibiotic policy.
People of all ages are vulnerable to infection, although risk groups, like elderly people or people with various illnesses, are more prone to disease and accidents. The risk of contracting infections is also greater due to a slower healing process. Broken or replaced hips and knees require surgery with heightened risk of bacteria and virus attacks, not to mention heart surgery and all kinds of less invasive surgery. Other risks relate to wound infections, especially because of the increasing rates of obesity, diabetes and hard-to-heal wounds.
The New Regulation
During the last decade the European authorities have, together with trade associations, health organizations and companies, developed a new regulation EN 13795, "Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment" that mandate rigorous testing procedures.
The regulation, which consists of three parts, defines the requirements for design, processing, assessment and selection of products, test methods and performance requirements and levels. For example, standards range from resistance to microbial penetration in wet and dry conditions, microbial cleanliness, resistance to liquid penetration, bursting and tensile strength and linting. In the future this regulation will only be in one part and apply to surgical drapes and gowns, while clean air suits will have their own standard.
The EN 14683, "Surgical Masks--Requirements and Test Methods," was also created to develop face mask performance standards.
Inside and Outside the Operating Room
In the operating room (OR), the use of single-use nonwoven surgical gowns and drapes is becoming state-of-the art. The North American market is more or less penetrated by nonwovens with an over 80% share while growth continues in Europe. Susan Harley, director of marketing at CareFusion, shared her views: "The Nordic markets, France and Germany have been leading the European conversion to single-use surgical drapes and gowns for many years. Now we see a growing trend in the U.K., Italy and Spain, as well as Eastern Europe. First and foremost, the protection of care givers, especially when meeting one patient after another, is of utmost importance. Drapes are key as they must provide a barrier and preserve aseptic technique during the surgical procedure. And, the new regulation definitely is one of the driving factors. The confidence level disposable products provide versus re-usables is increasing, especially when the cost of fighting super-bugs is escalating."
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There are of course other benefits to using single-use drapes and gowns. The latest developments protect patients and staff not only against bacteria but also against viruses due to the Breathable Viral Barrier effect, but they are also easy to use and flexible. Breathability, comfort and softness, combined with multiple designs are important for surgical staff.
Partly due to the impact of the various new flu-viruses and other contaminants, it is also becoming more important to protect care givers in non-sterile environments. For example, a new segment that has rapidly developed in the U.S. includes disposable products like gowns, glows and face masks to be used when doctors and healthcare personnel meet one patient after another.
About Customized Procedure Trays
New techniques and technological development provide a platform for more efficient medical treatments and the use of Customized Procedure Trays (CPTs) is evolving. Such trays contain everything needed for certain interventions, i.e. instruments, syringes, drapes, swabs and wound care products to name a few, many made of nonwovens.
The Art of Wound Care
The skin is the body's largest organ. Its size is about 1.8 square meters. The skin also sheds some 300 million particles every day and it takes five weeks to replace them. In addition, we are carrying 100 trillion microbes on us, most of them unknown. Any damage to this surface is an opportunity for infection, like Methicillin Resistant Staphylococcus Aureus (MRSA) or HAI.
Diabetes, one of the major health issues in many parts of the world, can cause hard-to-heal wounds and infections that actually can lead to serious consequences such as foot amputations. While wound treatment is very complex, nonwovens play a major role with numerous variations in technology and material combinations.
Both woven and nonwoven products are used in traditional wound dressings. Advanced wound dressings, on the other hand, are developed to increase or decrease moisture levels depending on required wound treatment. There are hydrophobic wound care products that clean up the wound by binding and eliminating bacteria and fungus from the wound surface or absorbent pads for the absorption of larger volumes of body fluids. Some wounds heal more efficiently with antimicrobial silver treated wound pads, while hydrogels and hydrocolloids are used to create a moist environment.
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The Case for Nonwovens
The changes in medical care provide a foundation for the use of nonwovens in all kinds of applications and the market is steadily growing. Uses range from band-aids supporting the healing of small wounds to patches for drug distribution through the skin to the more complicated items used during critical procedures in orthopedic surgery.
A plethora of nonwovens naturally includes various combinations like SMS, spunbond and meltblown, spunlaced and chemically bonded, laminates and composites. Fibers such as viscose, wood pulp, polyester and polypropylene are the most commonly used and because of their different properties they are used in a wide range of applications. Materials can be made hydrophilic or hydrophobic, treated or non-treated, colored or white. However, independent of technology, the quality requirements remain the same and as indicated, single-use products such as nonwoven drapes and gowns are only to be used once.
The alternatives, re-usable surgical products, i.e. drapes and gowns, can be made of textile materials ranging from cotton or cotton/polyester to reusable high-tech breathable and fluid repellent materials that can be washed up to 50-80 times. That said, the strict guidelines apply to these materials and products, and they also have to fulfill the EN 13795 with each use.
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The Cost Factor ... What is Really True?
When budgets are shrinking and costs are escalating, the need for a more global view on supply chain issues remains. The cost of fighting super bugs and other contaminants is an increasingly important share of any healthcare budget. Medical organizations, hospitals and health authorities are all searching for effective treatments and want to keep costs low. Looking at the whole picture, the use of single-use products is advantageous in that there is less handling of products. There is no repeat sterilization. Less waste water is generated. And, at the same time, energy is re-used.
Tim Galekop, director of Global Business Development Medical Fabrics at Ahlstrom, has repeatedly addressed the many issues related to single-use and reusable products. His conclusions are: "Many hospitals are still treating wound infections rather than proactively avoiding infections. And, although governments dramatically are reducing healthcare budgets, there is an absolute need to reduce/eliminate hospital infections and mortality rates. Here single-use nonwoven products can fully comply with global standards, provide patients and healthcare professional safety in a cost-effective manner and not least--they are always clean."
What Does The Future Hold?
Because of the increasing awareness by healthcare professionals and medical advisors and the still untapped potential in many European markets, single-use products are becoming commonplace. Patient, staff and care-provider safety are on the forefront for these developments. Organizations like WHO, ECDC, EORNA (European Operating Room Nurses Association) and local health authorities emphasize stricter hygiene protocols when dealing with infection prevention.
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