Q&A: VOLKMAR HIERNER
ESPA Proposes Energy Recovery as Alternative to Recycling
Volkmar Hierner, secretary general of the European Sterilization Packaging Association (ESPA), has announced the release of the organization's environmental policy statement, which proposes incineration with recovery of energy as an alternative to recycling for primary medical packaging. Hierner spoke with EMDM about the Packaging and Packaging Waste (PPW) Directive and its impact on medical packaging manufacturers, suppliers, and converters.
Q: Could you briefly explain how ESPA defines medical packaging?
A: To be deemed medical packaging, a product must meet several conditions. Medical packaging must protect the device and also be compatible with it. It must also be suitable for use with the sterilization process, and capable of maintaining an acceptable level of sterility.
Q: There has been some difference of opinion between industry and the European Commission over the definition of medical packaging. Has an agreement been reached?
A: Among industry there is a consensus; however, the outlook of the Article 21 Committee which advises the European Commission differs. We at ESPA believe that primary medical packaging, whose function is necessary for the integrity and stability of the device, is an integral part and, in some cases, an accessory to the device. Accordingly, such primary packaging is covered by the Medical Devices Directive and is outside the scope of the PPW Directive. For example, the commission says that blood bags are packaging. We disagree with this statement because blood without the bag is not a product. Another example is the syringe--a medical device that can be called a package when it is filled. This does not make sense, of course, for one cannot do anything with a shot without the syringe. We are working closely with EUCOMED to mend this difference of opinion.
Q: Another industry concern of the moment is the PPW Directive's mandates for recycling.
A: ESPA and the device industry are concerned that recycling may compromise patient safety. For instance, if hospitals are asked to recycle or reuse they will probably want to reduce the amount of packaging that they use. In an attempt to cut back, a manufacturer might use only one layer of a packaging product or material when using two layers would be the safer option. While we don't see any problem with recycling secondary and tertiary products such as cartons or cardboards, we don't recommend it for primary packaging.
Q: So how does ESPA propose to handle primary packaging?
A: Primary packaging should be single use. And the most environmentally effective method for handling single-use medical packaging is incineration with recovery of energy.
Consider the tricky question of recycling contaminated waste. What if a material has been contaminated with hepatitis, for example? Who will take the responsibility for recycling such contaminated waste, and who will bear the cost? Moreover, should a producer that does recycle take back the material of its competitor? If the answer to this question is no, then how can we separate that?
Also remember that industry uses composites and coextruded films with the aim of using the least amount of material. Such materials are difficult to recycle and can be impossible to separate when combined in layers. This would call for using a single material whenever possible, but it is often technically preferable to have several different layers. So, we don't see much benefit in recycling. ESPA's proposal of incineration is a much safer option.
Q: What is the status of the PPW Directive with respect to the Medical Devices Directive? Do they conflict?
A: They must be applied in parallel, and one does not take priority over the other. As for conflict, I can't say that I see one at the moment but I will say that, if there were one, the utmost concern would remain a high degree of safety and hygiene. There shouldn't be any recycling at all if there is any danger involved.
Q: A couple of years ago, ESPA hosted the Medical Packaging Conference and Exhibition in Vienna. Are you planning any such events for the future?
A: People have suggested that we come up with such an event again. Although we don't have anything planned for the time being, this does not mean that the idea does not appeal to us. We are, of course, very committed to establishing control over the quality of medical packaging, and we may plan another such conference one day.
