Medical device manufacturers are liable for their products by law. They are obliged to minimize the risks to patients when their products are used as intended. In this context, the requirements for considering the cleanliness of medical devices are also increasing. There is a conflict between product liability on the one hand and the often inadequate standardization on the other. The self-responsible handling of cleanliness by medical technology companies and their suppliers has led to a wide variety of approaches being used to evaluate and assess cleanliness. The resulting gap is closed by the new VDI 2083 Sheet 21 "Cleanroom technology - Cleanliness of medical devices in the manufacturing process".
The new VDI Guideline 2083 Part 21 is a generally applicable and superordinate standard for evaluating the cleanliness of medical devices in the manufacturing process and thus forms a basis in the absence of product-specific regulations.
On the one hand, it contains the procedure for determining a suitable test method. On the other hand, it provides guidance on the structural approach for deriving acceptance criteria for critical contaminants, based on a risk-based approach. Case studies illustrate the topic.
The new VDI Guideline 2083 Part 21 does not yet answer all questions. Manufacturers are still left to their own devices when it comes to product-specific implementation. Depending on the approach chosen, different acceptance criteria may be the result for comparable products. To further improve the status quo, an industry alliance is a suitable solution.
Within the framework of the new industrial alliance "Cleanliness of Medical Devices", the parties involved are working closely together. The aim of the industrial alliance is to develop a strategy for deriving acceptance criteria on the basis of medical aspects and to determine the status quo that can be achieved in terms of production technology.
The network offers a communication platform and enables a professional and open exchange of knowledge within the group of medical technology producers. Project start date is April 21, 2020.
The result should be an action aid that enables the derivation of product-specific acceptance criteria. This will simplify the dialog with notified bodies, as well as the discussion with suppliers and service providers. In order to further specify the derivation of acceptance criteria for product-specific cleanliness requirements, the approach described in VDI 2083 Part 21, which describes the structural path according to the current state of the art, is to be further specified for particulate and chemical contamination.
The department Ultraclean Technology and micromanufacturing has a wide range of services for the evaluation and determination of the cleanliness of medical devices: