Re-Validation of Medical Devices

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In a constantly aging society, medical technology products are becoming increasingly important. The highest quality requirements are necessary in their production to guarantee their durability, reliability, and safety for the user, thereby not exposing the generally weakened patients to unnecessary risks. In this context, more and more purity aspects are coming into focus.

Despite the use of established cleanroom technology, critical contamination of medical devices cannot be completely ruled out. About one-third of all recalls of medical devices by the U.S. Food and Drug Administration (FDA) between 2001 and 2011 were due to insufficient purity. In Germany alone, the economic damage caused by rejection reactions of the body due to contaminated medical products such as hip implants amounts to around seven billion euros annually. Thus, contamination introduced by personnel, equipment, or process media can jeopardize patient safety as well as the future of a medical technology company.

The industry has been concerned for some time with the question of purity requirements that offer maximum patient protection while being feasible in production and reliably verifiable with validated methods. To initiate an open dialogue and derive the need for action, a workshop with experts from medical technology companies and their suppliers and service providers was held on July 3, 2014, at the Fraunhofer Institute for Production Technology and Automation IPA in Stuttgart (Figure 1).
 
Figure 1:     Workshop on July 3, 2014, at Fraunhofer IPA in Stuttgart (a) and composition of the participant circle (b)
A key result of the expert discussion was that the purity of medical devices encompasses much more than just biological issues: Participants identified chemical or film contamination (29%) as well as particles (27%) as equally critical contaminations in this context (Figure 2). This assessment also aligns with the analyses currently practiced in companies for the validation of cleanliness, according to the participants.
 
Figure 2:     Relevance of different contaminants in relation to medical devices from the perspective of medical technology experts
A sector-specific set of regulations with uniform methods and acceptance criteria, especially for evaluating particulate as well as film-chemical purity, is again missing (Figures 3 and 4).
 
Figure 3:     Identified need for action in the area of particulate contamination validation
 
Figure 4:     Identified need for action in the area of chemical/film contamination validation

On the way to an industry consortium

The ice has been broken; despite the sensitivity of the topic, an effective dialogue has been initiated through the openness and willingness to cooperate of numerous participants from various fields of medical technology.

The workshop showed that participants see a need for action in the area of validation of cleanliness of medical devices. The goal, according to the participants, is to establish a binding, industry-specific, and practical set of rules that will also be recognized internationally in the future. To achieve this, involving as many specialists as possible from medical technology companies and their suppliers in solving the open questions is advantageous, thereby fostering broad acceptance through consensus-building.

In this context, the formation of an industry consortium has proven effective, as demonstrated by the example of "Technical Cleanliness": here, automotive companies and their suppliers have come together to jointly define the particulate cleanliness of parts and components within a set of rules (VDA Volume 19).

Similar to this model, Fraunhofer IPA will prepare a meeting in the coming weeks for January 2015 as a start for the work of an industry consortium. This open meeting will give all interested parties the opportunity to learn about the drafted roadmap for the consortium's activities in 2015 without obligation and to help shape the specific content.

If interested in the detailed results and evaluation of the workshop, as well as the next steps toward forming a consortium, companies can contact Guido Kreck via email (guido.kreck@ipa.fraunhofer.de).

Interested parties are also welcome to share their opinions on the current state of cleanliness validation of medical devices by participating online in the survey "Does medical technology need new approaches to cleanliness validation?" at: www.ipa.fraunhofer.de/medizintechnik

All participants in the survey will receive a detailed evaluation if interested.

Fraunhofer IPA has been active for nearly 30 years in all sectors critical to cleanliness, from the semiconductor industry to aerospace and medical technology. This experience forms the background for knowledge transfer related to contamination-free production of sensitive components. For standardization and normalization of cleanliness, purity experts develop reliable procedures and a trustworthy framework for production. Their expertise is also used in services such as developing specific methods and conducting cleanliness analyses (Figure 5).