While this probability can be reduced to a very low number, it can never be reduced to zero. A lot of single-use medical devices, such as cannulas, surgical gloves and plasters, must be processed, or to be more precise sterilized, before they can be used. This processing is usually performed by the manufacturers or their service providers. However, reusable medical devices, such as bedpans, surgical gowns, surgical instruments e. This also applies for endoscopes, patient supports and handpieces for dental instruments.
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Manufacturers of medical devices are required to provide EN ISO compliant instructions for use. These instructions must contain validated reprocessing processes for the respective medical device. There are 1 million hospital infections annually in Germany. We say: That's 1 million too much.
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. 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 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.
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:. 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:. Does the instructions for use meet the legal requirements?
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 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. The harmonized standard EN ISO 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 The renaming implies additional obligations for manufacturers , purchasers and preparers.
In general, the validation of the reprocessing process becomes more important. HygCen also checks your product for FDA compliance. For this, the testing laboratory has to create an individual validation plan. 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 specifies how detailed the reprocessing process must be described in the instructions for use. 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!
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:. We want to offer you the best possible service. We store information about your visit in so-called cookies.
Check instructions for use. State a reprocessing process As a manufacturer, you must state one reprocessing process. Method of detection As a manufacturer, you must ensure a valid reprocessing process by demonstrating the cleaning an disinfection efficacy.
Criteria for efficacy As an manufacturer, you must specify how and often your medical device can be effectively processed by the user. Safe reprocessing process HygCen validates your stated process. Only then you as a manufacturer may recommend it. Prove of patients safety HygCen determines verifiably the cleaning and disinfection efficacy.
Duration of use HygCen checks how often your medical device can be processed without damage. Pre-treatment at the site of use before processing Preparation before cleaning Cleaning Disinfection Drying. Inspection, maintenance and functionality testing Packaging Sterilization Storage Transportation.
To ensure this, the preparers have to: Follow the manufacturer's instructions for reprocessing. This must be retracable and ensure that neither patient, user or third parties are at risk.
Be qualified for the reprocessing of medical devices. Furthermore, the reprocessing is subject to the recognized rules of technology and the occupational safety and accident prevention regulations. Requirements for purchasers Purchasers of medical devices are subject to a high degree of responsibility.
Request a quote from us - by phone or via online request. Please tell us for this, which medical device and application area it is. Is there already a reprocessing manual?
And what type of reprocessing manual, mechanical or sterilizing procedures should we test? You send us your product including instructions for use, as soon as you have accepted our offer. Immediately after receipt of the goods, we will initiate the testing of the specified reprocessing procedure for your medical device. We will be happy to validate your reprocessing process even before it is included in the instructions for use.
Depending on the reprocessing process, we are bound by other standards. You will receive a test report incl. Our scientific director classifies the results of the test report for you in this assessment. The classification includes an overall assessment and, if applicable, a rating in accordance with EN ISO as well as other standards and acceptance criteria.
What are the consequences of the new MDR for manufacturers? In addition, MDR specifies specific requirements: For the content of the technical documentation. These are regulated in more detail in Annex 2 of the MDR. The identifiability of medical devices. Each product must have a unique device identification number UDI.
To the labeling of medical devices. To the new responsible person. Each manufacturer names a responsible person who has qualified specialist knowledge of the respective medical device. The European database for medical devices will be greatly expanded.
To clinical reviews and exams through post-market data. Clinical evaluations need to be updated using post-market data of the post-market surveillance. For high-risk products. As part of the MDR, "special notified bodies" are used for high-risk products. In the future, only these specially designated bodies will be able to carry out conformity assessments for high-risk products. To "special notified bodies".
These bodies would have to report any new application for conformity assessment for a high-risk product of this Medical Device Coordination Group. To products with hazardous substances. Medical devices containing carcinogenic, mutagenic or reproductive toxicants must meet higher requirements.
To the classification of some products. Software hardly falls into class I.
DRM is included at the request of the publisher, as it helps them protect their copyright by restricting file sharing. Visit FileOpen to see the full list. October Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices. January Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. March Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices.
This includes information for processing prior to use or reuse of the medical device. The provisions of this document are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:.
BS EN ISO 17664:2017
ISO specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable, and medical devices intended to be sterilized by the processor. ISO specifies requirements for the information to be provided by the medical device manufacturer, so that the medical device can be processed safely and will continue to meet its performance specification. Requirements are specified for processing that consists of all or some of the following activities:. When providing instructions for these activities, medical device manufacturers are expected to be aware of the training and knowledge of procedures, and of the processing equipment available to the persons likely to be responsible for processing. It is likely that some processing procedures will be generic and well known and will use equipment and consumables conforming to recognized standards.
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