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THINGS TO KNOW

Are you a manufacturer of medical products? Or generally interested in guaranteeing technical hygiene in the field of medical product validation? We have summarized the most important questions and answers in a detailed FAQ to clarify potential uncertainties and offer possible solutions. You will also find the legal requirements in the form of norms and guidelines that serve as a basis for medical product manufacturers’ preparation instructions.

FAQ

  • WHAT REQUIREMENTS OF THE NEW MDR APPLY TO MANUFACTURERS OF REUSABLE SURGICAL INSTRUMENTS?

    Reusable surgical instruments are now classified in the new class of "IR products". From a regulatory point of view, they are thus on the same level as those of the previous Class I and must now be subjected to a conformity assessment procedure. During certification, the notified bodies examine aspects and documents related to the validated preparation according to DIN EN ISO 17664.

  • HOW CAN THE MANUFACTURER DETERMINE OR VALIDATE INFORMATION ON POSSIBLE NUMERICAL LIMITATIONS ON THE RE-USE OF A MEDICAL PRODUCT? (ANNEX I TO MDR AND GUIDELINE 93/42/EWG, AND DIN EN ISO 17664?

    The manufacturer can base the required information, for example, on a simulation of the last possible moment of use (multiple soiling and preparation of the medical product for several cycles) and comparisons of the test results with a medical product that has only been reprocessed once.

  • WHAT IS THE VALUE OF THE JOINT KRINKO/BFARM RECOMMENDATION ON THE PREPARATION INSTRUCTIONS FOR MANUFACTURERS OF MEDICAL PRODUCTS?

    The KRINKO/BfArM recommendation is mentioned by name in the Medical Product Operator Ordinance (MPBetreibV) and thus acquires legal character. If the instructions of a manufacturer contradict this recommendation, the operator is obliged to provide evidence that proper preparation is nevertheless carried out if the preparation instructions are followed. This is usually only possible by means of time-consuming and cost-intensive expert assessment and is therefore generally not desired by the operator.

  • DO ALL MEDICAL PRODUCTS (INCLUDING PRODUCTS WITH THE SAME PRODUCT CHARACTERISTICS) HAVE TO BE VALIDATED INDIVIDUALLY?

    A manufacturer's medical products may be grouped into one or more product families. If the medical products within a product family have common characteristics relevant to preparation, they can be validated within a product family. The manufacturer must demonstrate the commonalities between the different medical products. The tests for the respective product family can be performed on a medical product or on a test specimen. Care must be taken to ensure that the "worst-case" characteristics for the sub-processes, e.g. cleaning, disinfection and/or sterilization, are represented.

  • IS IT NECESSARY TO PROVIDE VALIDATED INFORMATION FOR BOTH MECHANICAL AND MANUAL PREPARATION PROCESSES (CLEANING AND DISINFECTION)?

    At least one mechanical cleaning procedure (which may include a validated manual pre-cleaning procedure) and one mechanical disinfection procedure must be specified. Exception: The medical product is not suitable for these automated procedures. If this is the case, the user must be informed. Manual procedures for cleaning and disinfection must be indicated where mechanical cleaning and disinfection is not possible or impractical.

  • WHICH INFORMATION MUST BE VALIDATED ACCORDING TO THE REQUIREMENTS OF DIN EN ISO 17664?

    The manufacturer of the medical product must validate each procedure defined in the information provided with the medical product. This is because the validation is intended to serve as proof that each method is suitable for preparation of the medical product. The medical product manufacturer must have objective evidence available that the validation of the preparation instructions has been carried out. This is to confirm that the medical product is cleaned, disinfected or sterilized when prepared as described in the instructions. A detailed preparation instruction should include the following activities: Initial treatment at the place of use; preparation prior to cleaning; cleaning; disinfection; drying; inspection and maintenance; packaging; steriliszation; storage; transport. The medical product manufacturer must carry out a risk analysis to determine the content and details of the information to be provided to the user. The risk management carried out by the medical product manufacturer must comply with DIN EN ISO 14971.

  • TO WHICH MEDICAL PRODUCTS DOES DIN EN ISO 17664 STANDARD APPLY? / FOR WHICH MEDICAL PRODUCTS MUST THE PREPARATION INSTRUCTIONS BE VALIDATED ACCORDING TO DIN EN ISO 17664?

    The standard applies to reusable medical products intended for invasive or other direct or indirect contact with the patient and requiring cleaning and disinfection and/or sterilization to ensure that the product is safe and effective for its intended purpose.

    The standard does not apply to

    • non-critical medical products that are not intended for direct contact with the patient. 
    • textiles for use in patient covering systems or surgical clothing
    • medical products that are specified by the manufacturer for single use only and are supplied ready for use.

NORMS AND GUIDELINES

DIN EN ISO 17664

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Krinko BfArM Empfehlung

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MDR (Medical Device Regulation) - Verordnung (EU) 2017/745

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HAK 3 RDS 007

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FDA Guidance 2015 - Reprocessing Medical Devices in Health Care Settings

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Validierungsleitlinie von 2017

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AAMI TIR30

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DIN EN 13727

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DIN EN ISO 13485

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DIN EN ISO 14971

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DIN EN ISO 15883-1

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DIN ISO/TS Preliminary standard 15883-5

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RKI Mitteilung zu vCJK

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DIN EN ISO 17665-1

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DIN EN ISO 17665-2

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DIN EN ISO 15883-4

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DIN EN ISO 15883-2

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Infektionsschutzgesetz

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Preliminary standard DIN ISO/TS 17665-2

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DIN EN 285

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DIN EN ISO 14937

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DIN EN ISO 11737-1

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DIN EN ISO 11737-2

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DIN EN ISO 11138-1

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DIN EN ISO 11138-2

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DIN EN ISO 11138-3

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DIN EN ISO 13060

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DIN EN ISO 11607-1

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