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Challenging times for sterile barrier industry

Tim Galekop employed by Ahlstrom and a member of the Sterile Barrier Association talks about the difficulties facing sterile barrier manufacturers in an increasingly demanding market.

The Sterile Barrier Association is a European trade association representing manufacturers of single-use sterile packaging materials for the healthcare market. Through its technical, environmental and educational work, the association acts as the voice of the European sterilization packaging industry. It works to influence the adoption of the highest possible manufacturing, product and systems standards for the ultimate benefit of the end-user: the patient.

Medical Device Developments

Manufacturers of packaging materials (Sterile Barrier Systems) for the European/Global medical device market and Health Care Facilities are facing a dilemma. Hospitals are driving down the amount they spend on medical devices, sterile equipment and Medical Packaging as central government funding falls, while at the same time, European regulations have been introduced that require sterile barriers to be stronger and more effective than ever. The Sterile Barrier Association (SBA previously ESPA), a Europe-wide packaging materials group was established in the early 1990s to act as the voice of the European industry on all relevant matters and at all levels. To achieve these objectives SBA endeavors to develop strong links with other like-minded industries and end user groups. To this end SBA will respond favorably to any reasonable approach. The industry is working hard to modify these European rules to the benefit of patients and its members. Key figures from sterile barrier manufacturing firms meet regularly to discuss the implications of the EU regulations and use the Sterile Barrier Association to lobby the European CEN Committees. They hope that by emphasizing the importance of sterile barriers in patient care they can influence the adoption of the highest possible manufacturing product and system standards for the ultimate benefit of the end user "the patient", increase safety and to protect the revenue streams that will allow for further research into the packaging materials of tomorrow. Senior industry figures argue that single use products have drastically reduced the incidence of pre- and post-operative infection, and that the cost savings being sought in hospitals should not be made at the expense of patient safety.

These challenging market conditions have a major impact on the day-to-day work of Tim Galekop. As Director of Global Business Development for the Finnish firm Ahlstrom FiberComposites medical fabrics business, he has been heavily involved in in-house working groups that meet to discuss how to do business within an increasingly regulated market. Ahlstrom makes sheets of packaging materials for the instrument trays used in operating theatres, as well as the materials from which surgeons' gowns, surgical drapes and facemasks are produced. One of the pieces of legislation that has a significant influence on Mr Galekop's and other members of the SBA department is the EU's Medical Device Directive (MDD 93/42/EEC), a document covering the manufacture of both medical devices and the materials used to keep them sterile. The European Committee for Standardisation (CEN) mandated TC 102 to harmonize existing European Sterilisation packaging standards.

CEN TC 102 WG 4 (Convenor Tim Galekop) was established on May 3rd 1988 to deal with European Standards concerning single use and reusable packaging, Document EN 868-1 has been ratified and was published in the official European Journal in February 1997. This document is in line with the Medical Device Directive and all packaging materials having to fulfill EN 868-1 "Packaging Materials and Systems for Medical Devices which are to be sterilized - Part 1 General Requirements and Test methods". Documents EN 868-2 and subsequent parts deal with the requirements and test methods for different kind of packaging materials and can be used to show compliance with these particular requirements (A tool to prove compliance to part 1) Non compliance to these parts of the standard does not mean or infer non-compliance to part 1. Parts 2-10 have been ratified and have been published in June 1999.

Globally we have the Organisation For Standardisation (ISO). Within the ISO there is the Technical Committee 198 Working Group 7. This WG has published document ISO 11607 "Packaging for terminally sterilized medical devices". The big difference with the EN 868 documents is that the ISO document deals with forming and sealing and was not conform to the Medical Device Directive. EN 868-1 and subsequent parts are typically for materials and final packages like pouches / sheets and re-usable containers.

ISO/TC 198 WG 7 has agreed in Kyoto Japan May 2002 that a joint combined revision of ISO 11607 and EN 868-1 will be developed under the Vienna agreement, with an ISO lead, to create one global packaging standard.

EN standards have to be revised every 5 years. EN 868-1 is at that stage at this moment of time. It is very important that the future new packaging standard has to show compliance with the essential requirements or other provisions of the European directives. On October 29 and 30 2002 a task-group meeting was held in London. This group existed of 11 persons from different companies including the FDA and myself to prepare the draft document. These meetings are very intense and even with all the hard work, we did not manage to finalize the two documents. A new Task-group meeting was held at the AAMI on January 14 - 15 in Arlington / Washington. After this meeting a formal meeting took place between the CEN TC 102 WG 4 and ISO TC 198 WG 7 working group members in June 2003 in Frankfurt. The final joint documents (ISO/CD 11607-1 and ISO/CD 11607-2) have been discussed at the ISO TC 198 meeting in December 2003 held in New Orleans. As a result of these the documents will send out as DIS.

The new harmonized standards will exist of two parts.

EN ISO 11607-1

Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and packaging systems.

Scope
This International Standard specifies the requirements and test methods for materials performed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of the terminally sterilized medical device to the point of use.

EN ISO 11607-2

Packaging for terminally sterilized medical devices - Part 2:
Validation and requirements for forming, sealing and assembly processes.

Scope
Part 2 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

Parts 1 and 2 do not cover all requirements for packaging medical devices that are manufactured aseptically and additional requirements may be necessary.

These International Standards are applicable to industry, health care facilities, and wherever medical devices are packaged and sterilized.

CSSD in hospitals will as well be considered as industry, as far as I am concerned this is the right decisions. Where is the difference between hospitals and manufacturers? Let us not forget that we are talking about the safety of the patient.

The Sterile Barrier Association was instrumental in providing a forum for manufacturers to formulate their response to the EU / CEN rules and to help to create the new global ISO framework.

Key task

One of the Sterile Barrier Association's major tasks for the future is to try to convince Brussels that the materials used to wrap medical devices should be exempt from recycled content targets contained within the Packaging and Packaging Waste Directive (94/62/EC).

Tim Galekop explains: 'The Sterile Barrier Association, Eucomed (European Confederation of Medical Devices Associations) and EDANA (European Disposables and Nonwoven Association) are trying to get medical packaging manufacturers exempt from the Packaging and Packaging Waste Directive (94/62/EC) because it includes rules on waste recycling and we don't think that it is safe to use recycled packaging materials in a sterile barrier if you don't know where they have come from. They could have been in contact with viruses, human tissue or any other contaminant. You don't even know if the product has been damaged. Under the new rules manufacturers also have to reduce the amount of packaging material they use by a certain percentage each year. These rules contradict the standards governing the safety of the patient.'

EUCOMED (European Confederation of Medical Devices Associations) and SBA (Sterile Barrier Organisation previous ESPA) have a joint Position paper:

For the reasons outlined above, EUCOMED and SBA considers that sterile barrier systems used to maintain a sterilized medical device in its intended state fall fully within the scope of the Medical Devices Directive (93/42/EEC). Equally, as they are an integral part of a sterilized medical device. EUCOMED and SBA consider that they do not fall within the scope of the Packaging and Packaging Waste Directive (94/62/EC).

In Part EN 868-2 it is noted that:
Raw materials used for the manufacturer of packaging materials may be virgin or reclaimed materials, provided the source, history and traceability of all raw materials, especially recycled materials, are known and controlled to ensure that the finished product will meet the requirements of this standard.
NOTE: With current commercial technologies it is unlikely that reclaimed material other than manufacturing waste will be sufficiently controlled to allow its safe use for medical device packaging

Barrier basics

Bacteria can only travel in two ways: by particles or humidity. By i.e. using polyester and cellulose-based fibers, manufacturers can create materials that block bacterial movement and maintain sterility. Louis Pasteur stated that bacteria can only move in straight lines, and without a carrier can go nowhere. However, we should not forget that the loss of sterile package integrity is usually regarded as event related rather than time related.

Modern sterile barriers are for instance made from very long polyester fibers that are chemically bonded to cellulose fibres. Many are also manufactured to repel liquids like blood, water and low tension liquids. Repellent products avoid contamination by preventing bacteria from wicking through a wet area. Conventional textiles absorb liquid and are therefore not considered a barrier. In some countries, sterile barriers for instrument trays are made from re-usable conventional textiles sometimes in combination with a crepe layer, but single use barrier manufacturers are trying to replace all conventional textile components with single-use systems. New textiles have been introduced which may be more effective, such as micro-fibres, but it is still not known whether these will remain effective barriers after having been laundered hundreds of times. A majority of the sterile barriers used in Europe are made from so-called ‘nonwoven' materials, which can be manufactured in a number of ways. Spun-laced nonwovens are made using a base web of polyester, through which high-pressure water jets force cellulose. The material is then finished with the addition of colors, binders and water-repellent chemicals to create an extremely soft product, ideal for drapes and gowns. So-called wet-laid materials are made by spraying cellulose and polyester fibres onto a wire a form of conveyer belt while at the same time water is removed. Other nonwovens include spun-bonded products, which are made by melting chips of i.e. polyester or polypropylene to make very long fibres. These fibres are then laid down on a kind of conveyer belt and than thermal bonded using a heat-sealing roll. A spun-bond material on its own cannot form a bacterial barrier, but the addition of a melt-blown layer in between creates barrier properties. All these nonwovens can be used in conjunction with one another and they have some advantages over 100 per cent cellulose materials such as crepe paper. Nonwovens are much softer and don't have a 'memory' - ideal in an operating theatre where freedom of movement for surgeons is essential.

Evolving market

The science that has brought about the development of modern nonwoven sterile barrier materials is not cheap. And as hospital managers try to drive down their expenditure in response to falling budgets, the capital available to invest in R&D is being squeezed. It is in these difficult market conditions that firms such as Ahlstrom - which developed the first Nonwoven sterilization wraps, facemask filter media, the tea bag and stencil paper, to mention a few - are being challenged to continue innovating in order to comply with rigorous EU rules. Older products are being phased out and new replacements must be found. To maintain a dominant position, a firm must be at the forefront of scientific research to introduce new fabrics or be quick to market with a generic copy of a competitors new material. Add to this the inertia among purchasing managers and the task of finding revenue streams to renew and enhance existing product lines appears particularly difficult.

Tim Galekop says: 'European hospitals are currently still using drapes and gowns made from conventional textile (cotton or cotton polyester). But the new standards being introduced from Brussels mean these conventional textiles will have to be phased out. It has been proven that they are not a bacterial barrier. Our company is looking into developing new packaging materials, but it can be difficult to get hospitals to adopt new products or systems. Which sterile barrier system is used for a particular task depends on the type of device being wrapped or packed, i.e. the stability of the medical device, whether the device changes during sterilisation and whether anything could come out of it that could compromise the barrier properties of its packaging material. This is why it is so important that the Global packaging industry conforms to a set of universal standards -- there are so many different variables.'

The development of the ISO standard made by ISO TC 198 WG 7 (convenor Mike Scholla), the draft of which is currently out for FDIS consultation within the industry and National bodies, and should make life easier for Global sterile barrier manufacturers. As mentioned before the joint combined revision of ISO 11607 and EN 868-1 has been developed, to create one global Sterile Barrier System standard.

With this single document it will be easier to interpret and will cover both materials and forming & sealing processes something the original EN 868-1 did not cover The overall goal is to improve patient care and the quality of sterile barrier products, something Ahlstrom has traditionally focused on. 'The uptake of single-use drapes and gowns is increasing strongly at the moment, primarily because the development of standards by CEN TC 205 WG 14 (Convener Prof.Werner) the so called 13795 series says Mr Galekop. 'In principle you cannot re-use a conventional cotton or cotton-polyester product because it is ineffective as a bacterial barrier. The cost of single-use products made from effective materials has fallen, and this has helped, and will continue to help, reduce the spread of HIV, CJD,MRSA, SARS and Hepatitis in the clinical environment. For a long time, people have realized that conventional textile used for medical packaging and drape and gown fabrics are not effective barriers, and this has seen the number of nonwoven products on the market increase.

Ahlstrom being on the forefront of scientific research has developed a new advanced tri-laminate viral barrier composite fabric, which reduces and/or eliminates cross-contamination and liquid contact between the medical staff and a patient's body fluids. It offers superior barrier against real world viruses causing infectious diseases as the ones mentioned above. This new light weight, comfortable, breathable, practically lint free, impervious protection fabric fulfils the Viral Barrier Protection test (ASTM 1671) and High Liquid Barrier (ASTM 1670) test methods. We are convinced that this fabric will have a glorious future especially when we see what is happening in Thailand, Indonesia and China concerning the bird pest disease.

'To ensure that what it produces is of the highest standard, Ahlstrom has quality control procedures in place to check products when they come out of the manufacturing process.

Why is quality so important:

Better control over your process.
Increasing and improved productivity and quality.
Less cost
Satisfied customers.

So the hospital can satisfy their customers "the patient"

Under the MDD, Packaging materials are considered a class 1 accessory and manufacturers of packaging materials are allowed to certify themselves that they comply with the guidelines. Ahlstrom has gone a step further and contracted monitoring to an independent, external lab which tests all its packaging materials (sterile barrier systems) and produces a statement of conformity to confirm that Ahlstrom's products comply with the rules.'

Vital forum

The Sterile Barrier Association has proved itself an essential forum for decision makers working in a heavily regulated environment, and it will continue to prove a vital tool for the industry. By keeping its members updated on new standards and future European directives, and by providing background information about potential changes to the regulations, details of different packaging materials and the direction in which the market is moving, senior executives can accumulate intelligence from their peers and hopefully prevail in spite of unfavorable economic conditions. Future issues likely to be discussed in detail include the arguments for and against single-use barriers, and how the industry can respond to the reusable packaging material targets contained within the latest version of the MDD.

In an uncertain market, the Sterile Barrier Association has provided manufacturers with the opportunity to join together and present a united front to the threats they face. Forward-looking firms are investing in the development of new products, and all senior decision makers in the industry are determined to educate their buyers in the vital role sterile packaging plays in every hospital. The message seems to be that if there are cuts to be made, look elsewhere first. Mr Galekop says: 'At the moment, I think it is wrong for hospitals to budget or cut costs on something as vital to patient care / safety as sterilization packaging. It is used as a transport medium, it is essential in the sterilisation cycle and in storage, and sterile barriers have a massive impact on patient care. Hospitals are trying to drive down prices, yet still want top-quality products, and I find this unacceptable. Cost control is the biggest challenge facing the sterile barrier industry, particularly when new standards being introduced demand that our products do more to protect the safety of patients. Hospitals want a Rolls-Royce for the price of a Fiat 500.'?

A lot of things have changed over the last years. The Sterilisation department has increasingly become much more important. The Sterilisation department is the hart of the hospital, if that does not pump e.g. the O.R. can not operate. In the past CSSD staff members have been considered the dishwashers of the operating room, or the CSSD was treated, as the "social workshop" of the hospital where employees have been parked which were not fit for anything else.

I certainly would like to bring to the attention of the readers the interesting websites of the SBA, the EFHSS (European Forum for Hospital Sterile Supply) and Ahlstrom FiberComposites:

Let us not forget that we are talking about the safety of the patient and its staff.

The SBA is a quality association with about 20 company members. Some of the members are: Amcor Flexibles Europe, Arjo Wiggins, Dupont, Kimberly-Clark, Pactiv Sengewald, Perfectsiel, Vereinigte Papierwarenfabriken - Stericlin, Westfield and Wipak.

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