Tissue Engineering and Risk Management

Munich. The “Tissue Engineering and Risk Management” project is the winner of the 2013 DIN Prize for Innovation. In this project, an international group of experts developed the ISO 13022 standard governing risk management for medical products containing human cells. The award was accepted by Prof. Dr. Dr. Sabine Kloth from TÜV SÜD Product Service GmbH, who has been in charge of the project since 2007. The cash prize of EUR 3,000 accompanying the award was donated to the Munich charity lichtblick hasenbergl.

Recent years have seen an array of innovations in the field of surgical implants based on tissue engineering. However, the market launch of these products has been severely hampered by the extensive differences in regional regulatory systems. “Our aim in developing the ISO 13022 standard was to streamline the evaluation criteria for the approval of these implants and thus to improve safety for both patients and medical staff”, explains Prof. Dr. Dr. Sabine Kloth, Senior Product Specialist at TÜV SÜD Product Service GmbH. The standard was developed from 2008 by a board of international experts headed by Prof. Kloth.

The ISO 13022 standard supports innovative methods of regeneration to replace diseased and destroyed tissue by implanting products based on human cells. The standard covers a range of products which differ widely from a regulatory perspective. A further special feature is that the risk assessment for cell-based products is placed within the context of benefits for the patient. “Risk/benefit assessment is the focus of the standard”, stresses Prof. Kloth. At present only a very small number of documents worldwide address this connection.

The development of the ISO 13022 international standard has now created a standardised global instrument which supports product approval throughout a variety of economic regions. The group of experts is now working on further projects concerning standards for production and storage of materials, requirements for bioreactors, matrices for biologised heart valves and quality control testing systems.

The German Ministry of Education and Research is supporting these projects, awarding a cooperation project to DIN and TÜV SÜD aimed at improving standardisation work in university environments, start-ups and SMEs.

More information on Medical and Health Services from TÜV SÜD Product Service is available at www.tuev-sued.de/mhs.