True Safety in the Operating Room

By Helena Enqvist, Contributor | August 9, 2011

Security and safety are key features driving the growth of single-use surgical drapes and gowns in Europe and beyond.

Over and over again one can read in the news that many European hospital patients have been infected and are even recalled to be tested for bacterial or viral infections – like hepatitis or HIV – that could have been transmittedduring their hospital stay by dirty instruments. Not long ago, a hospital in the Netherlands had to close its intensive care unit due to fungi. Also, a Dutch TV show recently broadcast a documentary taken with a hidden camera about the unclean situation in several hospitals. Oftentimes, this is due to less efficient cleaning, a lack of resources and cost cutting, and it’s leaving patients’ lives at risk.

The current situation
According to the European Center for Disease Prevention and Control (ECDC), hospital-acquired infections affect some 4.1 million people in the EU every year. Of these, surgical-site infections (SSIs) are affecting just below 700,000 people. These infections lead to unnecessary patient suffering and doubled mortality rates for admitted patients that are undergoing surgery. Besides hard-to-treat infections and increased vulnerability, SSIs also add costs to healthcare budgets. Infected patients require longer hospital stays and care. In 2008, hospital-acquired infections added some €7 billion in direct costs to the bills at healthcare facilities in Europe and SSIs were estimated to account for over €1.2 billion of these costs. In addition, healthcare workers are put at risk and reports in the UK (Health & Safety Executive data, HSE) indicate that infection rates among nurses are as high as 30 per 100,000 workers per year. So, is there a solution?

Single-use versus textiles
The recent regulation EN 13795 for surgical drapes and gowns has created demanding conditions for testing and approval of materials and products in many countries. Conventional textiles cannot meet this standard due to no resistance to microbial penetration in wet and dry circumstances. In other words, conventional textiles cannot be considered bacterial barriers. Linting is another problem that needs to be monitored. Additionally, used single-use contaminated products are intended to be incinerated, which eliminates the danger of contact with blood or body fluids outside the operating room.

Market development in Europe
Some of the European markets, specifically in the Nordic Rim, are highly penetrated with close to 100% single-use drapes and gowns made of nonwovens. Altogether, penetration is increasing in the EU, driven by the aforementioned regulation and is reaching 65-70% in the Western European countries, compared to approximately 95% in the US. The growth potential lies in the Southern and Eastern European markets. [Improved knowledge and awareness about the benefits with single-use products by both professionals in the operating room and purchasing departments are key.]

Large nonwoven volumes, as well as converted products, are produced in Asia and elsewhere, and then exported back to Europe. The question is whether this trend can remain, or will “Made in Europe” increase its mark of higher quality. Another aspect is efficiency and logistics in the operating room, combined with the development of “specialist” hospitals and clinics focusing on specific types of surgeries – bringing the most of their expertise and become high-technology centers. Here, it is necessary to effectively use resources and provide a high success rate combined with optimal workflow.

The current European business environment
Despite the last years’ difficult business environment, businesses are improving and nonwovens for medical applications like surgical drapes and gowns continue growing. New markets are opening and awareness about infection prevention is increasing, thanks to training by organizations like EDANA, EORNA and individual companies. Many companies are reporting increases in sales and profitability, together with extended global reach.

According to the most recent updates from EDANA, the European production of nonwovens for medical products is increasing, most recently up more than 10% in volume by weight per year and is now reaching 55,000 tons. For comparison, nonwovens for medical products corresponds to 3.1% of total European nonwovens production.

In regard to technology, deliveries in the medical segments show that spunmelt/meltblown maintains its dominance, now at 42.9%, while 16.9% of the materials are spunlaced. Additionally, some chemical bonded nonwovens keeps its position, and new materials and technologies are being introduced.

Prevention is key
According to Jörg Enk, director of product development – operating room management, at Hartmann, the prevention of “Nosocomial Infections,” also called Hospital Acquired Infections (HAI) will play a major role in surgical and patient care. He says, “The use of effective single-use products like surgical drapes and gowns are important in the OR-field to build up a sterile barrier between the surgical field and

Photo courtesy of Tim Galekop, director of global business development, medical fabrics, Ahlstrom Medical Fabrics
potential sources of bacteria with the target to reduce surgical side infections during operation. The comfort and ease of use of surgical single-use products will support the acceptance by the user. But due to the high cost pressure in the healthcare sector, there is the trend that these products will become commodities and in several European countries these products are listed already in tenders with requested low prices.

“The number of ambulatory or outpatient surgeries will increase, based on the cost pressure and the possibility to perform a higher number of surgical interventions by minimally-invasive technology. On the other side, the number of surgical procedures will increase based on the demographic change and increased life expectancy. The use of customer-individual sets or Customer Procedure Trays (CPTs) will help to improve the process and handling in surgical care and could help to make the intervention safer and cost effective. In markets like Germany, France and Spain, the market share of CPTs are increasing and the trend will follow in other European countries,” Enk says.

Nordic, Baltic and new markets
OneMed Group, a Nordic conglomerate, currently owned by the private equity investment firm 3i, was established five years ago, but has more than 40 years of experience in the medical sectorwith companies like Tamro MedLab, FMAB Förbandsmaterial, Selefa Trade and Simonsen. Tor Schye, product area director, surgery and disposables, shares his company’s views on the developments in Eastern Europe. “The Baltic region is growing rapidly and we have been operating there for a number of years already,” Schye says. “The Estonian market is quite similar to the Nordic countries and already well penetrated, while Latvia and Lithuania still are growing.

“In Poland, currently one of the fastest growing markets, hospitals are increasingly turning to single-use products. Other expanding markets where OneMed is present are the Czech Republic and Slovakia. Although single-use surgical products are becoming commonplace in many Eastern European countries, competition is also significant and a lot of low-cost products are imported directly from China and other Asian countries,” Schye says.

Innovative new products for niche markets
At the recent INDEX show in Geneva, RKW presented a new unique surgical drape material that is now being tested by customers. Sophie Litt, sales manager – medical at RKW Ace, explains: “Because we understand the needs of our customers and the end users, we have developed a unique material, particularly designed for high performance in critical surgical areas. The material has a very fast fluid absorption combined with a low wet-back feature, which offers a dry surface to the drape. Due to its construction, there is no linting of the material, nor loose particles. It incorporates a plastic film laminated to an absorbent nonwoven layer, which is then covered by an apertured film. The absorbent nonwoven can be adapted to customers’ needs, specifically targeting higher fluid retention, and the top layer can be designed to control the rate of fluid absorption. In addition, the friction of this top layer is low, which is an added benefit to the personnel around the operating table,” Litt says.

Photo courtesy of Tim Galekop, director of global business development, medical fabrics, Ahlstrom Medical Fabrics
RKW also produces materials for surgical gowns and Lott says these materials are like drapes, made of laminates. “Here, we talk about two nonwoven layers, one on each side of a breathable film. Although doctors, for example heart-surgeons, are used to reinforced gowns, this is not necessary because the laminate prevents fluid transmission and is a complete barrier.” Litt, who is also chair of EDANA’s Medical Marketing Group, also emphasizes how important it is to understand the market, be it the needs and preferences of the OR staff and surgeon, the medical standards and norms or the financial restraints of hospital budgets.

A tour around the globe
A tour around the globe to some of the hottest markets – China, India and Brazil, by Tim Galekop, director of business development – medical fabrics, at Ahlstrom, revealed some interesting insights. “In specific hospitals in China, cleanliness was meticulous,” he says. The sterilization department used color-coding and the hospitals used the most modern technology and up-to-date equipment. “That said, conventional textiles were much used in the operating room, with very little single-use, showing huge development potential.”

In India, there is an increase in the use of single-use products, adds Galekop. “However, as patients have to pay for their operations, this is only possible for a select group of people. They also have to buy the utensils and products for the operation. There are specific self-service medical device shops like, for instance, iH-X, the Healthcare Exchange, where patients – or their families – can buy stickers, syringes, gowns, drapes and all other products needed. Big, private hospital chains are making major steps in using single-use drapes and gowns.

“In South America, like in many other regions, single-use products are increasing rapidly. In Brazil, with its special competencies in cosmetic surgery, single-use drapes and gowns are important to avoid any risk of infection in sensitive body parts,” Galekop says.

Besides the global perspective, Ahlstrom is working actively in introducing various high-performing medical fabrics, like the breathable viral barrier materials for surgical gowns.

Future aspects
Despite the slow population growth in the European countries compared to other regions, the over-65 population will soon exceed 15% of the total, led by Germany, where this demographic exceeds 20%. In addition, age-related surgeries are on the rise. For example, hip and knee replacements mainly impact people older than 65 years. Hip replacements are increasing between 1-5%, and knee replacements between 4-11% per year in the five largest European markets. And other examples will follow. The most recent data also shows steady increases in ambulatory or same-day surgeries. In fact, the number of same-day surgeries vary in different countries and is reaching between 25-55%. One can only imagine the impact on the healthcare systems and the need for efficient medical service and support.

The drastic increase of raw material prices and the cost pressures in the healthcare sector also has a big impact on business with nonwovens in the medical field. However, with single-use products, every patient can be offered new, secure, barrier, clean, and unused fabrics – every time.

Helena Engqvist is a European-based nonwovens industry consultant. She can be reached at helena@engqvistconsulting.com

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