Medical Device Link.

Originally Published EMDM January/February 2004

INDUSTRY NEWS

Pending European legislation on chemicals and packaging may have important implications for medical device OEMs. The possible ramifications were reviewed at a technical forum held in Brussels at the end of October. The meeting was organized by Eucomed.

If sterile barrier systems (SBSs) are treated as primary packaging in the proposed Packaging and Packaging Waste (PPW) Directive, device manufacturers could face increased costs. The status of SBS will depend on the outcome of a conciliation procedure between the European Parliament and the Council, according to Nancy Van Lent. She is an advisor at the Belgian medical device association UNAMEC and chair of the PPW task force. The conciliation process was due to start in November 2003.

“Eucomed’s position is that SBSs form an integral part of a sterile medical device or accessory,” Van Lent told attendees. “They are not primary packaging.” Their main purpose is to maintain sterility of the device up to the point of use and to ensure patient safety. As such, they should be regulated only by the Medical Devices Directive (MDD). (The PPW requirements are focused on environmental protection by reducing packaging and encouraging the use of recyclable materials.)

The status of SBSs in the European Union is unclear, as national legislation is not harmonized. “In France and Spain, an SBS is not regarded as packaging. In Germany and Sweden, it is. In Belgium and the United Kingdom, there is no official decision,” said Van Lent. The European Commission is also ambivalent. The Enterprise Directorate General (DG) supports Eucomed’s position (although it has made no clear statement on the issue). Conversely, the Environment DG believes that SBSs constitute primary packaging as set out in the PPW draft directive.

If they have to satisfy the requirements of both the MDD and the PPW, device OEMs could face conflicting requirements. The financial impact also could be significant. A take-back obligation for all packaging could increase the total fee by 50 to 70%. In some countries, the highest fee would apply to materials such as laminates, which are not recyclable, said Van Lent. Furthermore, companies would incur a double payment for SBSs that are mixed with medical waste and incinerated by healthcare providers. The same penalty would apply to waste that is not collected but recycled.

Jeanette Marchant

Copyright ©2003 European Medical Device Manufacturer