Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI November 1999 Column

Although harmonization in European medical packaging legislation is taking time to come together, an examination of the work behind the EN and ISO standards can clarify questions and steer industry in the right direction.

The 1993 Medical Device Directive (93/42/EC) contained numerous requirements involving packaging. Detailed guidance on meeting these requirements has subsequently been developed in EN 868 Part 1, "Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized: General Requirements and Test Methods." This section of the guidance covers the selection and validation of packaging materials for terminally sterilized medical devices. As such, it covers the same topics as section 4 of ISO 11607. There are, however, some differences between the two standards. ISO/TC 198 Working Group 7 has therefore been redrafting the ISO standard so that while retaining its existing requirements, it will also include information concerning the CEN standard. Additional standards in the EN 868 series are scheduled for publication in 1999, and will provide examples of those materials which satisfy some of these requirements.

Another piece of European legislation is the 1994 Packaging and Packaging Waste Directive (94/62/EC), which covers primary, secondary, and tertiary packaging for all products, not just medical ones. European Committee for Standardization (CEN) standards, which will provide guidance on how to meet the directive's essential requirements, are currently being prepared.

THE EN 868 SERIES OF STANDARDS

Requirements. The introduction of European packaging standards for terminally sterilized medical devices has been driven by the need to satisfy two separate requirements—to clearly define how to satisfy the packaging elements of the Medical Device Directive (93/42/EEC) and to harmonize the national standards in use in various European Union (EU) member states that relate to specific materials.

The Medical Device Directive states that packaging materials must accomplish the following:

National standards used in various EU member states have been introduced during the past 30 years by organizations such as the French Pharmaco- poeia, the German DIN, and the UK Department of Health and Social Security. (Responsibility for the UK standards has been taken over by the British Standards Institute.) The standards specify physical requirements for such materials as papers for steam sterilization, papers for EtO or irradiation sterilization, heat-seal coated papers for EtO or irradiation sterilization, and paper-paper or film-paper pouches for sterilization by various methods. These standards provide users, particularly hospitals, with an easy means of validating commonly used packaging materials.

Structure and Contents. Standards within the EN 868 series fall into two distinct categories—horizontal and vertical. A horizontal standard such as EN 868 Part 1 specifies the requirements for a broad range of products—in this case, the materials and systems used to pack medical products that will be terminally sterilized in their own packaging.

The standard has to satisfy all the essential requirements of the Medical Device Directive that are relevant to packaging. The other standards in the EN 868 series are not so strictly regulated. EN 868 Part 1 must include:

These requirements are essentially the same as those covered in ISO 11607 section 4. It is important to note, however, that the ISO document contains additional sections covering package formation and the final package.

EN 868 Parts 2—8 and PrEN 868 Parts 9 and 10. As fully approved standards, EN 868 Parts 1 through 8 carry the EN prefix; Parts 9 and 10 have yet to receive final approval and therefore carry the PrEN prefix (preliminary Euronorm).

EN 868 Parts 2 through 8 were adopted for publication on June 23 this year. PrEN 868 Parts 9 and 10 have completed CEN inquiry (stage 40) and have been sent out for formal vote (stage 49).

PrEN 868 Parts 2 through 10 are vertical standards, providing relatively detailed specifications for individual materials or small groups of products. They specify limits for properties such as the wet and dry seal strength of pouches. Properties that are listed under the paper category include air permeance, wet and dry burst, wet and dry tensile, tear, water repellency, pore diameter, pH, and chloride and sulphate content.

The above standards are seen as trade barriers by many outside of Europe. However, they can be justified for several reasons. First of all, their use is optional. It is quite acceptable to follow the EN 868 Part 1 guidelines to validate both the final package and the materials used to produce it. The vertical standards are harmonized versions of various European national standards that have been used for many years by hospitals and small- to medium-sized medical device manufacturers. These users do not have the resources to validate materials and have thus relied on this type of standard.

These national standards will continue to exist unless they are replaced by ones from CEN. The benefit of the EN 868 standards is that there will be only one European standard for each material or packaging system rather than different ones from various countries.

The requirements and test methods vertical standards drafted to date include the following:

The Relationship between EN 868 and ISO 11607. The 1997 ISO 11607, "Packaging for Terminally Sterilized Medical Devices," was developed in parallel with CEN standards. It consists of three main sections that deal with packaging materials (section 4), package formation (section 5), and the final package (section 6). The materials section covers similar topics to those in EN 868 Part 1.

The possibility of combining EN 868 Part 1 and ISO 11607 was the subject of debate during the early stages of their preparation. However, by 1993 it became obvious that a merge was unlikely, mainly because of the dilemma of how to reference the material-specific Parts 2 through 10 of the CEN series in the ISO standard. The committees responsible for them, CEN TC 102 Working Group 4 and ISO TC 198 Working Group 7, therefore agreed to review the situation after both standards had been published.

Other differences are generally minor. Some examples include the following:

There are also differences in some definitions. For example, a final package is defined by ISO as the primary containment system in which the product is sterilized, excluding shelf cartons and shipping containers. The system functions as a barrier to physical, microbial, or chemical changes to the contents during a specific period of time. For CEN, a primary pack is a sealed or closed packaging system, enclosing a medical device, which forms a microbial barrier. A final pack is the pack in which a medical device is sterilized. This can include the primary, secondary, and/or transport pack.

Following publication of both standards in 1997, the ISO working group agreed to revise section 4 of ISO 11607 to incorporate the requirements of EN 868 Part 1. The revision is currently out for ballot as a Draft International Standard. The following guidelines were used to prepare the draft:

The draft document has only a few minor differences from the current standard. It does provide guidance to those companies that need to meet the requirements of EN 868-1 in addition to those contained in the ISO standard.

The CEN committee, while welcoming this move, has decided that it would prefer to gain some experience in the operation of the two standards before revising EN 868 Part 1. The committee has therefore decided to wait until the standards come up for review in 2002.

There is undoubtedly pressure on the ISO committee to bring the materials requirements contained in section 4 of ISO 11607 in line with EN 868 Part 1. This pressure is coming from non-European companies that, after ensuring that they comply with

the ISO standard, are being told that such action does not guarantee approval for use in Europe. An ISO standard that eliminates this problem would be widely welcomed, even in Europe.

Microbial Barrier Testing. The development of the ISO and CEN standards for terminally sterilized medical packaging has highlighted the lack of a suitable method for determining the microbiological barrier properties of permeable materials. Although a number of tests exist, none of them has achieved universal acceptance, and many are not suitable as a manufacturing control. The need to satisfy this requirement has resulted in a number of company members of the European Sterilization Packaging Association (ESPA) joining together to form the Barrier Test Consortium, an independent company with the specific objective of funding research into the development of a rapid, reliable, and reproducible microbial barrier challenge test. Following a call for proposals to develop such a test, the consortium has signed a two-year contract with Air Dispersions Ltd. (Manchester, UK), and it is hoped that a method suitable for consideration by European and international standards bodies will be achieved within this time period.

THE PACKAGING AND PACKAGING WASTE DIRECTIVE

The stated objective of the Packaging and Packaging Waste Directive (94/62/EC) is to reduce the overall environmental impact created by packaging. This goal was to be achieved by focusing on the following four points:

The work required to satisfy these requirements can be broadly divided into two main areas of activity—the selection of materials and pack design, and recovery and recycling. In this context, recovery means not just collection of material but also material recycling, energy recovery or composting, and biodegradation. Most EU member states now have recovery and recycling programs in place to meet the requirements for used packaging, but the procedures for the selection of materials and pack design have yet to be finalized.

The following targets were set for member states:

Recovery and Recycling. One of the stated aims of the directive was to harmonize member states' legislation to ensure a high level of environmental protection while trying to avoid trade obstacles and distortion and restriction of competition within the community. To meet their obligations, member states were required to set up return, collection, reuse, and recovery systems for packaging waste. Most have now done this. For example, no specific targets were set for reusable packaging or for landfill reduction. However, member states have been increasing landfill taxes to act as a disincentive and also to encourage recovery and recycling.

Unfortunately, each member state was given the responsibility of deciding how to meet these obligations, which has resulted in different approaches being adopted. Various EU members operate independent green dot recycling systems. Money paid to one system goes to fund recovery and recycling in that country alone. A few examples are given below.

Germany. Manufacturers and distributors of packaged goods are responsible for the reuse and recycling of their packaging that does not enter the public waste system. Distributors must remove secondary packaging before offering a product for sale or provide collection facilities for buyers to leave both primary and secondary packaging at the store. Suppliers must take all the materials back and ensure that they are recycled, or they may join a Dual System that collects, sorts, and passes on used sales packaging for recycling. This system is financed by payments from its members, which entitle them to place a green dot symbol on their packs. Manufacturers are required to take back transit packaging from both systems.

The green dot can be applied to both consumer and hospital products but not to industrial ones. Since January 1999, manufacturers and distributors have been required to collect packaging that has contained, and may be contaminated with, hazardous materials. The Dual System will only be permitted to accept such packaging if the manufacturers can assure the authorities that it is compatible with their system.

France. Manufacturers and importers of packaged goods are responsible for the recovery of packaging waste from households. They may discharge this obligation either by joining an industry-run, government-approved central organization or by setting up their own government-approved collection or deposit scheme. Eco-Emballages was the first central scheme to be approved and has responsibility for a range of materials, for example, plastics, paper, glass, and aluminum. Other schemes are material specific.

France's green dot system accepts only consumer products. Schemes also operate in France for industrial packaging such as drums. Transit packaging is the responsibility of either the manufacturer or the subsequent owner.

The UK. The cost of recovery and recycling is shared between the members of the packaging chain as follows: raw material manufacturers (6%), converters (11%), packer/fillers (36%), and retailers (47%).

Importers are responsible not only for their own packaging activities but also for those performed prior to importation. For example, a company selling packaged goods that it has imported into the UK is responsible not only for the retailer's obligation but also for those of the packer/filler, the converter, and the raw material manufacturer. Packaging exported from the UK is excluded from the obligation even if the company involved does not export it directly.

UK companies can choose whether to join a collective recycling scheme, such as Valpak, or to go it alone. If they register independently, they can satisfy their obligation by:

Packaging supplied to hospitals is covered by the legislation. However, since hospitals are considered to be end-users, they are not obligated to recover and recycle packaging. This responsibility rests with the other members of the packaging chain.

The draft regulations included a proposal that primary medical packaging should be exempted from the above requirements for recovery and recycling, but this did not appear in the final version. The only clause of any relevance refers to special waste. The regulations state that such waste does not have to be included when calculating the obligation. Materials that fall within this category are mainly those contaminated with hazardous chemicals, such as primary pharmaceutical packaging. One section refers to materials contaminated with infectious waste, but the UK Environment Department has ruled that this section shall be limited to waste that has been in contact with highly contagious World Health Organization category 4 infections such as bubonic plague.

Requirements for Pack Design. Member states are now required to ensure that companies meet the essential requirements of the directive. However, the regulations that have been prepared so far, such as the UK "Packaging (Essential Requirements) Regulations 1998," only repeat what is written in the directive. They do not provide procedural details necessary to demonstrate compliance with the requirements, as the procedures have yet to be established and are currently the subject of much debate. The available information is contained in Annex II, section 1 of the directive titled "Requirements Specific to the Manufacturing and Composition of Packaging." This section states that packaging shall be:

Conformity Assessment. The directive provided only limited information concerning the data that would be necessary to demonstrate compliance with the essential requirements that are set out in Annex II. Proposals were therefore included in a European Council draft directive that was published in the EC Journal on December 18, 1996. The requirements for conformity assessment contained in the draft were:

CEN Standards. Standards, which provide guidance on the criteria required to meet the essential requirements, are being prepared by working groups within CEN TC 261 SC4. Five standards and two CEN reports are intended to assist in ensuring compliance with the essential requirements as defined in articles 9 and 11 and Annex II of the directive. The five standards cover requirements for source reduction, reusable packaging, recycling, energy recovery, and composting and biodegradation. The two CEN reports cover noxious substances. Part 1 examines the measurement and verification of the four heavy metals, and Part 2 details the measurement and verification of other dangerous substances.

An umbrella or foundation standard is intended to govern the relationship between the above documents and to provide a structured approach to their use. The introduction states that "its purpose is to establish the overall methodology for a set of measures that will enable those responsible for the placing of packaging or packed products on the European market to do so with a presumption of compliance with the essential requirements of the directive." An example of the way in which the standard seeks to define the relationship among the other standards is provided in the draft document (Table I).

Table I. Example from the draft document describing how the CEN umbrella standard can be used to define the relationship among the other standards.

Standards and reports related to Article 10 of the directive are essentially supporting documents for the five main standards. They cover criteria for life cycle analysis, recycling methods, rate of use of recycled material, and composting.

For many of these documents, the closing date for the final (formal) vote on whether to publish was scheduled for June 1999. This date is now likely to be sometime between March and May 2000 because DGXI (the environmental arm of the European Commission) and the Article 21 Committee objected to the drafts for the five main standards because they are based on the principle of procedural assessment, i.e., they provide a structured approach for evaluating the directive's essential requirements. DGXI, on the other hand, favored clear-cut specifications that would provide easy pass/fail criteria to determine whether a packaging material should be removed from the market. The CEN committee agreed that such standards benefit both industry and society, as the standards would establish a simple means of providing a statement of conformance. They were, however, convinced that such an approach was not practicable because of the diversity of materials, packaging systems, and products; the logistics of storage, distribution, and marketing; and consumer needs. The committee also believed that the draft procedures provided the basis for a system of continuous improvement. As such, they would be fairly easy to integrate with the ISO 9000 and ISO 14000 quality and environmental management systems that are increasingly being used by industry.

The other issue that has been the subject of considerable debate is that of noxious substances. Until recently there was just one CEN report on this subject. It was mainly concerned with the four heavy metals identified in the directive and made little mention of noxious and other hazardous substances. DGXI was expecting the report to identify other unacceptable packaging materials, but CEN TC 261 did not feel that this was necessary since other dangerous substances had not been previously identified by other standardization groups as being common in packaging materials.

In an attempt to clarify these and other smaller issues, two consultants have been appointed. Fred Soomers is employed by the commission (DGXI) and is required to attend all relevant meetings of the CEN TC 261 committees and report back to the commission on the reasoning behind their decisions. David Perchard is employed by CEN and is responsible for ensuring that the standards meet its mandates, and that there is no overlap between them.

Perchard's main activity since being appointed has been to prepare a detailed analysis of DGXI's comments, criticisms, and concerns. This analysis has been produced in chart form that attempts to provide an answer to each point. In some cases, the criticism has been accepted and CEN has made modifications; in other situations changes were not made, although reasons have always been provided. This analysis has now been discussed with DGXI.

CEN TC 261 has now prepared a second report regarding noxious and other hazardous substances other than the four heavy metals identified in the first report. This new report refers to lists of hazardous substances that appear in existing EC Directives concerned with dangerous substances. The lists will be used to identify those substances that need to be minimized in ash, leachate, etc., that originate from packaging. It is also planned to incorporate the methodology and assessment procedure from the report as a normative annex to the Source Reduction standard. DGXI has not objected to this approach.

Strong support for the CEN TC 261 position has now been received from both DGIII (the sector of the commission that represents the interests of large industrial companies) and also the CEN secretariat. There was also a large positive vote for the standards at the CEN enquiry, which was completed in May of this year. Given this support, DGXI now appears ready to accept the standards. They will, however, wait for a positive response from the Article 21 Committee before finally agreeing. This is unlikely to be a problem. DGXI now realizes that its expectations were too high, that the standards do fulfill the mandate, and that standards cannot be a substitute for a lack of agreement at the political level when the Packaging and Packaging Waste Directive was drafted. However, it is still quite possible that they may decide not to publish the standards in the official journal, leaving them unharmonized and allowing member states to interpret them as they wish.

Yet another point of concern is that the commission is already considering what amendments it would like to see made to the Packaging and Packaging Waste Directive when it comes up for review.

Package Design. Although the details for qualifying materials and packs have yet to be finalized, companies need to start considering what they intend to do. The information contained in the essential requirements of the Packaging and Packaging Waste Directive and the draft CEN standards provide plenty of guidance in this area. In many cases, companies have already done much of the work and they just need to assemble it into a suitable format, one that is easy to understand and to operate. The many issues involved make it easy to complicate matters and generate excessive work, which is precisely the reason why the European Parliament initially refused to accept the proposed procedure for conformity assessment. The message must therefore be to start assembling information but to keep the procedure for assessment as simple as possible.

Secondary Legislation: Marking (and Conformity Assessment). Article 8 of the Packaging and Packaging Waste Directive obliged the European Council to decide on matters of package marking within two years of the directive's enactment (i.e., before December 31, 1996). Their proposal for a directive was published in the official journal on December 18, 1996, but was subsequently suspended by the Environmental Committee of the European Parliament in October 1997, as discussed above.

Figure 1. Recyclable packaging and reusable packaging marks proposed by the European Council in December 1996 but subsequently put on hold by the Environmental Committee of the European Parliament.

The proposal for marking consisted of two different symbols to indicate recyclable and reusable packaging (Figure 1). Their usage was to have been voluntary. Because of registration problems, the symbol for recyclable packaging was different from the one to be used by ISO. This difference created some confusion because Article 4 stated that the use of other reusability and recyclability symbols would be prohibited, followed by the statement "This is without prejudice to the application of internationally agreed and adopted standards for indicating reusability and recyclability." A symbol to indicate recycled content was not included because of concerns as to how such claims would be substantiated.

The European Parliament's reasons for not supporting the proposed directive included the following:

The European Parliament continues to be critical of the proposed symbols, and it seems likely that the Commission will allow them to be superseded by ISO standards.

Figure 2. The Möbius loop proposed by ISO to be used in connection with recycling. Its use can show that an item is made of recycled matter or that the package itself can be recycled.

ISO is proposing to use only one symbol—a Möbius loop (Figure 2) to be used in connection with recycling. As with the European proposal, its use will be voluntary. There is currently no plan for a symbol for reuse, although the organization reserves the right to introduce other symbols.

The Möbius loop may be used to denote the following:

Unlike the EC proposal, the ISO symbol is intended for all products, not just packaging materials. The draft states that "if there is any potential for confusion about whether it applies to the product or the packaging, the symbol shall be accompanied by an explanatory note."

The simplest option for companies operating on a global basis would appear to be to avoid using these symbols rather than using different ones in different parts of the world. However, companies that wish to indicate recyclability would be better off waiting until the situation concerning the use of the ISO symbol is clarified.

Material Identification. A commission decision of January 28, 1997, established a system of abbreviations and numerical codes that can be used on packaging to indicate its content for recovery and recycling purposes. For example, polyethylene terephthalate (PET 1), high-density polyethylene (HDPE 2), and polyvinyl chloride (PVC 3).

Composites will be marked with a "C" followed by the predominant material and a number. For example, a plastic/aluminum construction in which the metal was the main material would be C/ALU 90. The identification of composites is generating opposition. Apart from the technical problems of establishing a meaningful system of identification, there appears little doubt that materials falling into this category will be difficult to recycle and therefore will be viewed as environmentally unacceptable. Unfortunately, often it is only through the use of a composite that a technical solution is possible. Composites generally represent the most effective use of materials.

The commission has stated that use of the identification system will initially be voluntary, but it has reserved the right to review the system at a later date. To date, it has rarely been seen because it was intended to be used in conjunction with the symbol for recyclable packaging. As this has now been dropped, the material identification system is likely to start being used either by itself, or in parallel with well-established graphic symbols for material type.

Database Format. A commission decision will decide the format in which member states have to report data to the commission concerning packaging waste, recovery, and recycling.

Requirements for Medical Packaging. All categories of medical packaging are expected to comply with the requirements of the Packaging and Packaging Waste Directive. However, Article 20 states that the commission "shall determine the technical measures necessary to deal with any difficulties encountered in applying the provisions, in particular to primary packaging for medical devices and pharmaceutical products, small packaging, and luxury packaging."

The European Confederation of Medical Devices Associations (EUCOMED) and the European Sterilization Packaging Association (ESPA) have been pressing for primary medical packaging to be exempted from the recovery and recycling obligations when its function is to ensure the integrity and stability of the medical device up to the point of use. They reason that the Medical Device Directive classifies packaging as either an integral part of, or an accessory to, the medical device. As such, they feel that primary packaging should be considered outside the scope of the definition that is used in the Packaging and Packaging Waste Directive.

Although this argument is a strong one, the thought is that the commission is worried that if an exemption is given to primary medical packaging then others would seek out additional exemptions. Whatever the final outcome of the debate, some member states will exclude primary medical packaging from their national legislation on the grounds that it may be contaminated with infectious materials and should therefore be treated as hazardous waste. It is important to note that even if primary medical packaging is excluded from the recovery and recycling requirements, secondary and tertiary (transport) packaging will definitely be covered. Also, all packaging will have to demonstrate compliance with the essential requirements of the Packaging and Packaging Waste Directive as detailed in Annex II.

EUCOMED also requested that items such as prefilled syringes and blood bags should be excluded on the grounds that they are medical devices rather than packaging. To date, the organization has been successful regarding blood bags but has made little progress elsewhere.

EUROPEAN FOOD PACKAGING LEGISLATION

When evaluating the toxicological attributes of a packaging material for use with a medical device, one of the criteria frequently used is its status under food packaging regulations such as those published by FDA. In Europe, national regulations for food packaging are being replaced by those from the EC. This has been a very protracted process because detailed toxicological information is needed for each material. Materials are not accepted just because they have previously been approved by individual member states. Approval for materials listed under national regulations is only withdrawn if they are evaluated by EC experts and found to be unacceptable. Until such time, they can be used. Efforts so far have concentrated on plastics, and a number of directives have been published. Work on other materials, such as papers, is still at an early stage.

Unlike the other areas covered in this article, medical device companies are not obliged to use European legislation to evaluate the toxicological attributes of their packaging materials. A few companies do prefer to use them. For others, the legislation can provide a convenient means of validating materials that have not been submitted to authorities such as FDA.

CONCLUSION

Medical packaging legislation is taking shape in Europe. Manufacturers of both packaging materials and medical devices need to ensure that they are ready to meet the various requirements. The main intention is to harmonize regulations and thus reduce trade barriers. Companies that are not yet prepared still have time to do so, because the rate of progress in the preparation and enactment of this legislation has been slow.

Paul Fielding is a packaging consultant based in Bristol, UK.

Illustration by Ken Corral