Medical Packaging

By Tim Wright, Editor | February 18, 2014

The medical package, also known as the sterile barrier system, plays an important role in preventing healthcare associated infections.

The key trends driving the medical nonwovens sector are infection prevention and healthcare economics. In addition to the increased awareness of infection prevention there is a greater awareness among healthcare providers regarding their responsibilities around HAIs and the impacts of the Patient Protection and Affordable Care Act of 2010, also know as the Affordable Care Act (ACA) or Obamacare, which says Medicare/Medicaid may not cover HAIs. This makes the healthcare provider responsible and as a result more vested in prevention.

In 2008, the Centers for Medicare and Medicaid Services implemented a non-payment policy to hospitals for the additional costs associated with treating patients for certain HAIs. Provisions were included in the ACA that will penalize hospitals with the highest rates of HAIs. Beginning in 2015, these hospitals will be penalized one percent of their Medicare payment. Similarly, Medicaid will stop reimbursing facilities for preventable infections acquired in the course of treatment. Many private insurance companies have also implemented their own non-payment policies.

The increasing pressure to drive down the rate of HAIs is happening because these infections are currently estimated at $26-33 billion annually in the U.S. alone. According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 70% of HAIs are resistant to at least one drug commonly used to treat them.

In response to these new penalties and non-payment policies, hospitals have started to develop and implement multifaceted approaches to monitor and prevent HAIs. As one of the first lines of defense against infection during surgery, the sterile barrier system is a key component to the prevention of HAIs and surgical site infections.

In addition to preventing HAIs with a greater societal awareness and concern with ‘germs’ lead to more hygienic healthcare procedures and therefore an increase in medical nonwovens and cleaning wipes. As the awareness of the importance of hygiene in healthcare facilities and operating rooms continues to increase through education and communication the acceptance and usage of medical nonwovens should increase.

According to data from INDA, Association of the Nonwoven Fabrics Industry, the global medical nonwovens market in 2012 consumed 355,000 tons, with 170,000 in North America, 116,000 in Asia and 69,000 in Europe. In terms of dollars in North America for 2012 the medical nonwoven roll goods market was valued at $755 million. In tonnage, the medical nonwovens market represents 8.9% of the North American market, making it the fourth largest segment.

The market is dominated by surgical gowns and drapes. In North America alone, disposable surgical gowns, operating room drapes and their pack parts account for 80% of the medical nonwoven category the INDA data says. The remaining categories include: other apparel—scrub suits, caps, masks, shoe covers, patient apparel and isolation gowns—at 8%; sterile packaging—CSR sterilization wrap—at 7%; and wound care—sponges, tapes, non-adherent dressings and pads—at 5%.

DuPont investment focuses on entire medical packaging value chain

In an effort to prove its commitment to the medical packaging market and make bringing products to market easier for its customers, DuPont is embarking on a $30 million investment in its medical packaging business. Known as the company’s Tyvek Medical Packaging Transition project, these efforts will not only modernize the technology behind Tyvek flash spun nonwovens used for medical packaging, it will also allow DuPont to stabilize and create a strong foundation within the medical packaging market.

Through industry collaboration and work with regulatory labs, DuPont is targeting the entire value chain within medical packaging by requalifying work with the FDA and other regulatory agencies around the world. DuPont is working with several global medical device manufacturers in advance of the commercialization of several new product grades, which is scheduled for early 2015.

DuPont announced last year that transition protocol amendments have been made and accepted by the Center for Devices and Radiological Health at the FDA in the U.S. Additionally, Europe’s four largest regulatory bodies have received a copy of the amendments. In Japan, regulatory bodies are reviewing the data and in China testing criteria has been established.

From a technical standpoint, DuPont has completed development of material assessments, has successfully produced and tested transition protocol materials, shipped materials to participating sterile packaging manufacturers for conversion and conducted a formal DuPont product stewardship review.

According to Diego Boeri, a senior executive with DuPont’s Tyvek business, the key goal is making the transition protocol material available in advance of full commercialization, which is estimated for early 2015. This will support MDM efforts to complete internal risk assessments prior to commercialization and enable them to qualify material for new device packaging, he says.

“We are really optimistic about the project. It’s not just an internal operation effort. It’s a massive activity where we are working with the whole value chain in medical packaging market,” says Boeri. “We are requalifying our work with the FDA and other regulatory agencies around the world so that our customers have to do less work to bring their products to market.”

DuPont says its Tyvek is recognized as a standard of excellence for sterile barrier systems because it provides a high degree of protection for medical devices and supplies compared to porous material used for sterile packaging applications.

The unique structure of Tyvek allows it to even under the most rigorous conditions in highly contaminated environments remain resistant to penetration by bacterial spores and other contaminating microorganisms. Tyvek provides superior puncture resistance and tear strength, which means that it does not puncture easily and tears do not readily propagate if a package is nicked.

DuPont’s portfolio for medical packaging includes Tyvek 1073B, which is ideal for strong, tear-resistant medical device packaging for heavy, sharp or bulky products; Tyvek 1059B, which provides robust protection for medium-risk, sterile medical packaging applications. Lighter weight than Tyvek 1073B, this product is ideal for smaller devices and those with rounded edges; and Tyvek 2FS is a high puncture-resistant substrate that outperforms paper in terms of toughness and microbial barrier. The lightest form of Tyvek, it is well suited for form-fill-seal, less demanding or cost-sensitive applications.

Ahlstrom expands sterilization range

For the medical market, Ahlstrom offers a diverse range of single-use medical fabrics and includes materials designed for conversion into drapes, gowns, facemasks, protective apparel and sterilization wrapping of medical devices. With over 40 years of experience in the medical market its portfolio is constantly evolving and offers a number of customized products however the most well known products in the market place are the Reliance range for sterilization wrap, BVB (breathable viral barrier), a bulletproof viral barrier gown, and its facemask coverstock.

Ahlstrom recently introduced its expanded interleaved sterile barrier systems (SBS) offering with Ahlstrom Reliance Tandem. This expansion introduces SMS (spunbond-meltblown-spunbond) technology into the company’s offering. The company aims to better meet customers’ needs and provide unique SBS solutions.

Ahlstrom’s sterile barrier systems are a trusted and an integral part of the central sterilization department in hospitals. Previously, the company’s interleaved offering consisted of crepe and wetlaid technologies. To help customers stay ahead, Ahlstrom now offers a complete interleaved portfolio with the introduction of SMS into its Ahlstrom Reliance Tandem portfolio. Ahlstrom Reliance Tandem uses its newest technology, SMS, in combination with its existing technologies to provide an optimal combination of sterile barrier system sheets for sequential wrapping.

Ahlstrom Reliance Tandem or interleaving is the concept of combining two layers of SBS sheets, each offering specialized performance for sequential wrapping. The two layers are used together to offer a high degree of flexibility in terms of performance, technology and cost for different applications.

“The medical nonwoven market is currently going through a transformation, but overall is healthy,” says Valeria Erdos is product manager for drape, gown and apparel at Ahlstrom. “There are several simultaneous dynamics occurring at the moment and include cost pressures in mature markets, growth in emerging markets, marketers reducing dependency on China and increasing competition among nonwoven producers especially in SMS technology.

Additionally, Ahlstrom’s newest plant in Longkou, China opened in November 2012 and provides local supply to wrap, overwrap and pouch paper. This investment shows Ahlstrom’s commitment to the medical papers and fabrics, offering the widest range of products in the market.

Kimberly-Clark signs new single-source agreement with Novation

Kimberly-Clark has been awarded a single-source, three-year purchasing agreement with Novation for its Kimguard Sterilization Wrap products. Under the terms of this agreement with Novation, the highest quality sterilization wrap with demonstrated clinical advantages and favorable cost benefits will be available to more than 65,000 members and affiliates of VHA Inc., UHC, Children’s Hospital Association and Provista, LLC.

The agreement begins December 1, 2013 and includes all Kimguard Smart-Fold, One-Step, Quick-Check and Sequential Sterilization Wrap. Kimberly-Clark is the global leader in sterilization packaging innovation as evidenced by the recent introduction of Smart-Fold Sterilization Wrap, a revolutionary product designed to protect sterilized surgical instruments in the most challenging applications.

“This new agreement is a testament to our long-standing relationship with Novation and our commitment to provide world class products and services to hospital organizations,” says Chris Lowery, vice president, sales and marketing, Kimberly-Clark Health Care.  “We are excited about the opportunity to continue to provide the members served by Novation with our full line of Kimguard Sterilization Wrap products as well as access to our clinical education offerings.”

Earlier this year, Kimberly-Clark was honored by Novation as Med-Surg supplier of the year and named the recipient of the second annual Mark McKenna award as overall supplier of the year in recognition of the company’s outstanding service to Novation’s Alliance members in 2012.

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