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Manufacturers of medical devices are required to provide EN ISO 17664 compliant instructions for use. These instructions must contain validated reprocessing processes for the respective medical device. HygCen is an accredited and accepted testing laboratory and we test your reprocessing processes stated in your instructions for use according to EN ISO 17664 and all related standards (eg EN ISO 15883 series - washer-disinfectors, EN ISO 17665 sterilizers or EN ISO 10993 series on biocompatibility). There are 1 million hospital infections annually in Germany. We say: That's 1 million too much. With EN ISO 17664 compliant instructions you protect patients and users. Involve HygCen at an early stage in the review of your healthcare reprocessing process. So you can hedge yourself as a manufacturer. Avoid unnecessary risks and costs!
Recycled medical devices must be as safe for the patient as first or single used.This means that the products must not be microbially contaminated or functionally impaired. As a manufacturer, you are required to recommend a validated reprocessing process.This ensures that the medical device is free from any viable microorganisms when reused.
The reprocessing of medical devices requires every responsible preparer and user. Legislation requires manufacturers to specify an optimal reprocessing process for each medical device. HygCen validates these instructions for use in accordance with EN ISO 17664. The testing laboratory ensures that the medical device can be effectively processed using the manufacturer's instructions. It is necessary to consider individual work steps, their interactions with each other and the foreseeable sterility level.
Manufacturers of medical devices must provide specific reprocessing information. EN ISO 17664 specifies the requirements for this. If you would like to introduce a new product on the European or international market, this international standard will serve as an important aid. The reprocessing cycle of medical devices is subdivided according to EN ISO 17664 as follows:
If you provide such detailed information as the manufacturer, the legislator assumes that you comply with EU Medical Device Regulation (MDR).
Preparers of medical devices are also subject to legal obligations. Not only do you need to clean, disinfect and, if necessary, sterilize the medical device. The preparer also checks the technical-functional safety or restores it. To ensure this, the preparers have to:
* RKI-BfArM Recommendations: Joint Recommendations of the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices.
Purchasers of medical devices are subject to a high degree of responsibility. You should coordinate with the users and preparers and check the following questions:
1. Does the instructions for use meet the legal requirements?
2. Can the prescribed reprocessing process be technically and personally implemented by the operator?
If the reprocessing instruction is defective, the purchaser must ask the manufacturer for an EN ISO 17664 compliant user manual. If the manufacturer does not deliver then, it may violate the medical device law. For example, if the product has been in circulation for a long time.
As a purchaser, inform the relevant monitoring authority to prevent yourself from being infringed. If the missing instructions for use have already led to an incident *, this must be reported to the Federal Institute for Drugs and Medical Devices (BfArM) (in accordance with the Medical Product Safety Plan Ordinance).
* An "incident" has occurred when a patient, user or a third party has been harmed due to a lack of instructions for use.
HygCen validates the manufacturer's instructions for use in accordance with EN ISO 17664. The harmonized standard EN ISO 17664 for the sterilization of medical devices has been bearing the new title "Preparing healthcare products - Information to be provided by the medical device manufacturer for the reprocessing of medical devices" since 2018. The renaming implies additional obligations for manufacturers, purchasers and preparers. In general, the validation of the reprocessing process becomes more important.
Medical devices to be approved in the US must meet the requirements of the Food and Drug Administration (FDA). HygCen also checks your product for FDA compliance. For this, the testing laboratory has to create an individual validation plan. Please order this separately for testing in accordance with EN ISO 17664.
As a manufacturer, you are required to provide all necessary information for reprocessing. Staff members should be able to properly reprocess medical devices before each use using the instructions for use. EN ISO 17664 specifies how detailed the reprocessing process must be described in the instructions for use. HygCen validates your instructions for use according to EN ISO 17664 compliance and other standards, if applicable (eg EN ISO 10993 series on biocompatibility). In doing so, we check all available reprocessing processes. For example, the manual reprocessing by cleaning and disinfection, the mechanical reprocessing (thermal) and various sterilization processes (steam, H2O2, ethylene oxide (EO), formaldehyde, etc.).
We will establish an individual validation plan for the reprocessing process of your instructions for use!
Since mid-2017, the revised Medical Device Operator Ordinance (MPBetreibV) has been in force. The regulation regulates the construction, operation and use of medical devices. The currently valid MPBetreibV now includes 19 instead of 15 paragraphs. The regulation is based on the Medical Devices Act (MPG). Thereafter, it is precisely defined what medical devices are and are not (for example, medicines and cosmetics). In medical practice, (reprocessable) instruments are medical devices in the sense of the MPG. These are classified according to the use and risk to the patient in accordance with Directive 93/42 / EWG. For reprocessing, medical devices are additionally classified according to the specifications of the RKI BfArM Recommendation. If an instrument is classified as semi-critical or critical, this can have significant consequencesfor the quality and documentation of the reprocessing processes.
Since 2002, the MPBetreibV regulates the obligations of the operators and users of medical devices.
According to the ordinance, eg. only trained personnel may use medical devices. If medical devices are used repeatedly, they must always function correctly and be sterile. For active medical devices MPBetreibV sets further framework conditions. These include the provision of a suitable infrastructure and the development of a documentation system.
For the Medical Device Operator Ordinance, important changes came into force in 2014 and 2017.
Previously, the Medical Device Regulation (Directive 93/42 / EWG) applied to medical devices and the Active Implantable Medical Device (Directive 90/385 / EWG) to active implantable medical devices.
Currently, a significantly higher documentation effort for manufacturers is emerging. This applies especially to products with increased risk. Market surveillance authorities can determine, according to MDR, whether products are legally compliant. If no EU declaration of conformity has been issued, the declaration is incomplete or technically not documented, the medical device can be described as officially non-compliant. If the manufacturer does not restore compliance within the time limits, the medical device may be prohibited from entering the market.
The Medical Device Regulation combines two independent medical device directives. In addition, MDR specifies specific requirements: