RKI Legal Requirements
RKI 1: Legal Requirements & Overview 
RKI 2: Proper Pre-Cleaning 
RKI 3: Cleaning & Disinfection 
RKI 4: Instrument Care 
RKI 5: Instrument Packaging 
RKI 6: Sterilization in the Autoclave 
RKI 7: Release & Documentation 
RKI 8: Storage of Sterile Instruments 
RKI 9: Labelling After Sterilization 
RKI 10: Documentation After Patient Use 
RKI 11: Hygiene Room per KRINKO 
RKI 12: Initial Validation Klasse B Autoclave
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Instrument Reprocessing per RKI: Legal Requirements & Risk Classes
In Germany, the reprocessing of reusable medical devices is legally mandatory and clearly regulated. Anyone who uses instruments more than once must reprocess them using a validated procedure, follow the KRINKO recommendation issued by the Robert Koch Institute (RKI) and document every step in a verifiable manner. Responsibility always lies with the practice owner (§ 8 MPBetreibV).
This page is the starting point for our 12-part step-by-step guide to RKI-compliant instrument reprocessing. It explains – even without prior knowledge – which laws apply, how to assign each of your instruments to the correct risk class and which reprocessing procedure is mandatory as a result. By the end, you will know exactly what needs to be done in your practice.
1What does the law require?
Four regulatory frameworks interlock. You do not need to know the laws by heart – the important thing is to understand what they amount to:
| Regulation | What it covers | What this means for you |
|---|---|---|
| IfSG Infection Protection Act | Fundamental protection against infections in healthcare facilities. | You must actively prevent the transmission of pathogens – clean instruments are mandatory. |
| MDR & MPDG EU Medical Device Regulation 2017/745 + Implementation Act | Replaced the former Medical Devices Act (MPG) in 2021 and governs the safe handling of medical devices. | Reusable devices may only be reprocessed in a way that preserves their safety and function. |
| MPBetreibV Medical Device Operator Ordinance, § 8 | Specifies how reprocessing must be carried out – and expressly refers to the KRINKO/RKI recommendation. | The central compliance manual for your practice (see below). |
| KRINKO/RKI Recommendation "Requirements for hygiene in the reprocessing of medical devices" | Describes the actual reprocessing procedure step by step. | Your concrete working instructions – these are exactly what we implement across the 12 chapters. |
The core obligations under § 8 MPBetreibV
The decisive paragraph is § 8 of the MPBetreibV. It specifically requires you as the operator to:
1) Follow manufacturer instructions – reprocess every instrument as approved by the manufacturer (cf. DIN EN ISO 17664).
2) Validated procedure – cleaning, disinfection and sterilization must be demonstrably effective and reproducible.
3) Obligation to provide evidence – the success of each reprocessing cycle must be documented (batch documentation). This batch and release documentation can be completed in just a few clicks with the free ClavioSoft – including audit-proof archiving.
4) Follow the KRINKO/RKI recommendation – it represents the acknowledged state of science and technology.
5) Qualified personnel – anyone who reprocesses instruments requires the necessary expertise (training or qualification; cf. KRINKO Annex 6).
Good to know – the "presumption effect": If you follow the joint recommendation of KRINKO and BfArM, the law presumes that you are reprocessing correctly (§ 8 para. 2 MPBetreibV). In other words: whoever follows this guide is on the safe side – even during an inspection by the authorities.
2How to proceed in practice – in 4 steps
Before you reprocess a single instrument, you must define in writing whether, with what and under what conditions each product is to be reprocessed. The KRINKO explicitly requires this – this determination is also a central component of your hygiene plan and easier to implement than it sounds:
Source: KRINKO/BfArM Recommendation 2012, Sect. 1.2.1 "Risk assessment and classification".Step 1: List all reusable instruments
Start by creating a complete list of all products you intend to reuse – without any evaluation, simply list everything. For example:
| Name | Quantity (example) |
|---|---|
| ECG electrodes | 12 |
| Ear speculum | 5 |
| Ear irrigation syringe | 2 |
| Speculum | 3 |
| Flexible endoscopes (e.g. gastroscope) | 2 |
| Scissors | 5 |
| Surgical forceps | 5 |
| Anatomical forceps | 5 |
| Wound retractor | 5 |
| Pean clamp | 5 |
| Curette | 5 |
| Needle holder | 5 |
| MIC trocar | 4 |
| ERCP catheter | 2 |
Step 2: Assign the risk class to each instrument
The risk class depends on what the instrument comes into contact with on the patient. The KRINKO distinguishes three main classes:
| Contact with the patient | Risk class | Sub-classification |
|---|---|---|
| Contact with intact skin only | Non-critical | – |
| Contact with mucous membranes or pathologically altered skin | Semi-critical (A or B) | A: without areas difficult to access for steam |
| B: with lumens / areas difficult to access | ||
| Penetrates skin/mucous membranes and comes into contact with blood, internal tissues or organs (also: application of blood/sterile medicinal products; contact with urine inside the body) | Critical (A, B or C) | A: without areas difficult to access for steam |
| B: with lumens / areas difficult to access | ||
| C: particularly high requirements per the manufacturer (e.g. not steam-sterilizable) |
Mnemonic for A vs. B: A = steam reaches all surfaces easily (solid instruments such as scissors, forceps). B = there are narrow lumens or cavities that steam can only reach with difficulty (e.g. transmission instruments, trocars with channels). It is precisely these "B" products that place the highest demands on your autoclave.
Here is how the classification looks using an example:
| Name | Quantity (example) | Risk classification per RKI |
|---|---|---|
| ECG electrodes | 12 | Non-critical |
| Ear speculum | 5 | Semi-critical A |
| Ear irrigation syringe | 2 | Semi-critical A |
| Speculum | 3 | Semi-critical A |
| Flexible endoscopes (e.g. gastroscope) | 2 | Semi-critical B |
| Scissors | 5 | Critical A |
| Surgical forceps | 5 | Critical A |
| Anatomical forceps | 5 | Critical A |
| Wound retractor | 5 | Critical A |
| Pean clamp | 5 | Critical A |
| Curette | 5 | Critical A |
| Needle holder | 5 | Critical A |
| MIC trocar | 4 | Critical B |
| ERCP catheter | 2 | Critical C |
Most surgical instruments fall under "critical A/B" – they must be reprocessed wrapped in a Class B steam sterilizer. Not sure which autoclave suits your instrument range?
Find the right Class B autoclave
Find the right Class B autoclave
Step 3: Determine the correct procedure for each risk class
The risk class determines which reprocessing steps are mandatory – from pre-cleaning to sterilization. This table translates each class into specific actions:
| Risk class | Reprocessing |
|---|---|
| Non-critical | Pre-cleaning: no · Cleaning and disinfection: yes (manual or automated) with a proven effective disinfectant or method; automated processing is preferred due to better reproducibility · Packaging: no · Sterilization: no · Labelling: no |
| Semi-critical A | Pre-cleaning: optional · Cleaning followed by effective disinfection with a proven spectrum of activity (bactericidal including mycobacteria, fungicidal, virucidal) – manual or automated. An ultrasonic cleaner only supports cleaning and does not replace disinfection; a washer-disinfector (WD) performs cleaning and disinfection in a single step. · Packaging: no · Sterilization: optional only · Labelling: no |
| Semi-critical B | Pre-cleaning: yes, immediately after use (e.g. immersion) · Cleaning and disinfection preferably automated/thermal in a washer-disinfector (WD); ultrasonic cleaning is at best a preliminary cleaning step and not a disinfection method. Manual processing only if automated processing is not possible · Packaging: no · Sterilization: mandatory when used in a sterile body cavity · Labelling: no |
| Critical A | Pre-cleaning: optional · Cleaning and disinfection: preferably automated in a washer-disinfector (WD); an ultrasonic cleaner serves only as a supporting cleaning step (e.g. pre-cleaning) and does not replace disinfection · Packaging: yes · Sterilization: yes, wrapped · Labelling: yes |
| Critical B | Pre-cleaning: yes, immediately after use · Cleaning + disinfection: yes, in a washer-disinfector · Packaging: yes · Sterilization: yes, wrapped (Klasse B) · Labelling: yes |
| Critical C | Pre-cleaning / cleaning + disinfection / sterilization: each according to the instrument manufacturer's instructions · Packaging: yes · Labelling: yes |
Step 4: Combine everything into a comprehensive overview
Finally, merge both tables into one overview. It shows at a glance which equipment and steps are required for each instrument – and simultaneously serves as your documented specification in accordance with the KRINKO:
| Name | Quantity | Risk classification | Pre-cleaning | Cleaning + disinfection | Labelling | Sterilization |
|---|---|---|---|---|---|---|
| ECG electrodes | 12 | Non-critical | No | Yes | No | No |
| Ear speculum | 5 | Semi-critical A | Optional | Yes | No | Optional |
| Ear irrigation syringe | 2 | Semi-critical A | Optional | Yes | No | Optional |
| Speculum | 3 | Semi-critical A | Optional | Yes | No | Optional |
| Flexible endoscopes (e.g. gastroscope) | 2 | Semi-critical B | Yes | Yes | No | When used in a sterile body cavity |
| Scissors | 5 | Critical A | Optional | Yes | No | Yes |
| Surgical forceps | 5 | Critical A | Optional | Yes | No | Yes |
| Anatomical forceps | 5 | Critical A | Optional | Yes | No | Yes |
| Wound retractor | 5 | Critical A | Optional | Yes | No | Yes |
| Pean clamp | 5 | Critical A | Optional | Yes | No | Yes |
| Curette | 5 | Critical A | Optional | Yes | No | Yes |
| Needle holder | 5 | Critical A | Optional | Yes | No | Yes |
| MIC trocar | 4 | Critical B | Yes | Yes | Optional | Yes |
| ERCP catheter | 2 | Critical C | Yes | Yes | Yes | Yes |
This is your roadmap. From this overview you can directly determine which equipment your practice needs: an ultrasonic cleaner and/or washer-disinfector for cleaning & disinfection and a Class B autoclave for the wrapped sterilization of critical instruments. The following 11 chapters guide you through each of these steps.
3Templates & documents for download
These templates and original sources help you implement the steps described above directly – ready to print and adapt to your practice:
KRINKO Recommendation (RKI)The official recommendation for the reprocessing of medical devices – the foundation of everything.
Instrument Risk Assessment (template)Table for classifying your instruments (Step 2) – simply fill in.
Standard Operating Procedure "critical B"Ready-made operating procedure for the most demanding instruments.
Sample tray listDocuments the contents of each tray/set including the packing scheme.
Autoclave loading patternReference load for reproducibly successful sterilization cycles.
Batch release (handwritten)Release record per batch – for the documentation obligation.
Dental Chamber operating proceduresPractice-ready instruction set for the entire reprocessing workflow.
Important additional points per RKI & standards
These points are frequently overlooked in practice but are important for correct and legally compliant implementation:
- Extension of the referenced standards per process step: In addition to DIN EN 13060 and DIN EN ISO 17664, supplement with the standards relevant to each individual step: DIN EN ISO 15883 (washer-disinfectors/thermal disinfection), DIN EN ISO 17665 (validation of steam sterilization) and DIN EN ISO 11607-1/-2 and DIN 58953 (sterile barrier systems/packaging). These standards are listed as applicable in the standards annex of the KRINKO/BfArM Recommendation 2012.Source: KRINKO/BfArM 2012, Standards Annex (lists DIN EN ISO 15883, 17665, 11607, DIN 58953)
- Pre-treatment/collection at the point of use: Include proper pre-treatment at the point of use as the first step: remove gross contamination immediately after use, prevent drying of blood/tissue (e.g. wiping, flushing working channels, defining disposal timeframes) and avoid fixating procedures before cleaning. The KRINKO explicitly counts pre-treatment, collection and pre-cleaning as the first working step of reprocessing.Source: KRINKO/BfArM 2012, Sect. 2.2.1 'Preparation of reprocessing (pre-treatment, collection, pre-cleaning ...)'
- Release for use as a separate, documented step: Include the documented release for use as the conclusion of reprocessing: comparison of recorded process parameters with validation reports, performance and documentation of routine tests, inspection of the packaging for integrity and dryness as well as labelling; the persons authorized to release must be designated in writing. Only then may the sterile goods be used. The associated release documentation can be managed traceably and paperlessly with the free ClavioSoft.Source: KRINKO/BfArM 2012, Sect. 2.2.7 'Release for use'; MPBetreibV § 8
- Specify validation of procedures (initial and re-validation): The article mentions 'validated procedure' but does not explain its implementation: cleaning/disinfection and sterilization processes must be validated before first use and re-tested at regular intervals; changes to loading, programme or packaging require a renewed assessment. Specific test intervals are determined by the manufacturer and/or standard requirements (do not state a blanket interval).Source: KRINKO/BfArM 2012, Sect. 1.3 'Validation'; Standards Annex (DIN EN ISO 17665, DIN EN ISO 15883)
- Daily routine tests and indicators in sterilization operations: Include the ongoing routine tests for the Class B autoclave: vacuum/leak test and steam penetration test using a suitable test device (hollow device) as well as batch control with process indicators. These tests are a prerequisite for batch release.Source: DIN EN 13060 (Class B sterilizer tests, Annex B); KRINKO/BfArM 2012, Sect. 2.2.7
- Water quality for steam sterilization and automated reprocessing: Include the water quality requirement: the small steam sterilizer requires feed water in accordance with DIN EN 13060 (Annex C); treated water is also needed for the final rinse in the washer-disinfector to prevent staining, corrosion and equipment damage.Source: KRINKO/BfArM 2012, Annex 4 'Feed water quality: DIN EN 13060, Annex C'
- Structural/zonal separation of clean and soiled areas and personnel protection: Include the KRINKO requirement for separated work areas (soiled: receiving/cleaning – clean: packaging/release – storage) as well as personal protective equipment in the soiled area (suitable gloves, protective eyewear, protective clothing) to prevent cross-contamination and protect personnel.Source: KRINKO/BfArM 2012, Annex 5 (zone/area separation soiled-clean-storage) and Sect. 2.2.1 (occupational safety, TRBA 250)
- Verification of cleaning effectiveness (cleanliness/residual protein): Include the verification of cleaning effectiveness: visual/magnification inspection for cleanliness and integrity; for non-automated (manual) procedures the cleaning effectiveness must be separately verified (e.g. spot-check protein determination; the KRINKO specifies a warning value of 100 µg protein per instrument).Source: KRINKO/BfArM 2012, Sect. 2.2.2 (inspection for cleanliness; warning value 100 µg protein)
- Risk-class-specific expertise requirements: Specify personnel requirements in detail: for 'critical B' the KRINKO additionally requires proof of recognised training for the person carrying out the reprocessing; for 'critical C' a certification of the quality management system (DIN EN ISO 13485 by a recognised body) is also required.Source: KRINKO/BfArM 2012, Table 1 (footnotes to critical B/C) and Annex 6 'Personnel expertise'; DIN EN ISO 13485
Required equipment, consumables & accessories
Checklist for this work step – what you should have ready (shopping list):
Equipment
- Class B small steam sterilizer (autoclave) per DIN EN 13060 for the wrapped sterilization of critical instruments Order here in the shop
- Washer-disinfector (WD) per DIN EN ISO 15883 for preferred automated cleaning and disinfection Order here in the shop
- Ultrasonic cleaner as a supporting cleaning/pre-cleaning device (does not replace disinfection) Order here in the shop
- Water treatment/demineralization system for demineralized feed and rinse water Order here in the shop
- Sealing device for transparent sterilization packaging (validatable, per DIN EN ISO 11607-2) Order here in the shop
- Digital documentation software or printer/data logger for batch and release documentation Order here in the shop Create digitally with ClavioSoft
Consumables
- Cleaning and disinfection agents with a proven spectrum of activity (bactericidal incl. mycobacteria, fungicidal, virucidal) Order here in the shop
- Transparent sterilization packaging/sterile barrier system and nonwoven/crepe per DIN EN ISO 11607-1 / DIN 58953 Order here in the shop
- Process/chemical indicators and indicator tape for batch control Order here in the shop
- Test device/test system for vacuum and steam penetration testing (hollow device test piece) Order here in the shop
- Demineralized/distilled water as feed and final rinse water Order here in the shop
- Care/lubricant for hinged instruments (sterilizable, manufacturer-approved) Order here in the shop
- Residual protein test/cleaning indicators for verification of cleaning effectiveness (especially for manual reprocessing)
- Personal protective equipment: fluid-resistant disposable gloves, protective eyewear, protective clothing
Accessories
- Writable labels/pen or label printer for content, batch and expiry labelling Order here in the shop Create digitally with ClavioSoft
- Instrument trays, cassettes and storage aids matching the validated reference load Order here in the shop
- Sorting/transport containers with lids for collection and transport (clean/soiled separated) Order here in the shop
- Templates/forms: risk assessment list, standard operating procedure 'critical B', sample tray list, loading pattern, batch release record Create digitally with ClavioSoft
- Magnifying glass or illuminated magnifier for visual inspection of cleanliness and integrity
- Separate and labelled work surfaces for soiled and clean areas
- Current manufacturer reprocessing instructions (DIN EN ISO 17664) for each instrument as an accessible reference
Sources & legal basis
- Infection Protection Act (IfSG).
- Regulation (EU) 2017/745 on medical devices (MDR) and Medical Device Regulation Implementation Act (MPDG).
- Medical Device Operator Ordinance (MPBetreibV), in particular § 8 "Reprocessing of medical devices" (presumption effect para. 2).
- KRINKO/BfArM: "Requirements for hygiene in the reprocessing of medical devices", Bundesgesundheitsbl. 2012; 55:1244–1310 – in particular Sect. 1.2.1 (risk assessment & classification) and 2.2 (implementation); Annex 6 (personnel expertise).
- DIN EN ISO 17664 (manufacturer reprocessing instructions); DIN EN 13060 (small steam sterilizers, Klasse B).
This article summarises the cited legal and standards sources in a practice-oriented manner and does not replace the study of the original documents. In case of doubt, the respectively current versions of the laws, ordinances and recommendations apply.
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Frequently Asked Questions
RKI Legal Requirements – key questions answered clearly.
Which laws govern the reprocessing of medical devices in a practice?
Four regulatory frameworks interlock: the Infection Protection Act (IfSG), the EU Medical Device Regulation (MDR 2017/745) together with the MPDG, the Medical Device Operator Ordinance (MPBetreibV) Section 8 and the KRINKO/RKI recommendation. The latter describes the procedure step by step.
Is instrument reprocessing legally mandatory?
Yes. Anyone who uses reusable medical devices more than once on patients must reprocess them using a validated procedure, follow the KRINKO/RKI recommendation and document every step in a verifiable manner. The legal basis is Section 8 of the MPBetreibV.
What does Section 8 MPBetreibV require of the practice owner?
Section 8 MPBetreibV requires: following manufacturer instructions, using a validated (demonstrably effective and reproducible) procedure, documenting each reprocessing cycle, following the KRINKO/RKI recommendation and deploying only personnel with the necessary expertise.
Who is responsible for correct instrument reprocessing?
Responsibility always lies with the practice owner (Section 8 MPBetreibV). They must ensure that reprocessing is carried out using validated procedures, that everything is documented and that only qualified personnel are deployed -- even if the task is delegated.
What does the presumption effect under Section 8 para. 2 MPBetreibV mean?
If you follow the joint recommendation of KRINKO and BfArM, the law presumes that you are reprocessing correctly (Section 8 para. 2 MPBetreibV). Anyone who follows the recommendation is therefore on the safe side, even during an inspection.
What is the KRINKO and what role does it play in reprocessing?
The KRINKO is the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute. Its recommendation 'Requirements for hygiene in the reprocessing of medical devices' is the concrete working instruction and is regarded as the acknowledged state of science and technology.
What does the RKI recommendation on instrument reprocessing cover?
The KRINKO/RKI recommendation describes the actual reprocessing procedure step by step -- from risk assessment through cleaning, disinfection, packaging and sterilization to release and documentation. It is your concrete working instruction.
What does the MDR mean for the reprocessing of reusable instruments?
The EU Medical Device Regulation (MDR 2017/745) together with the MPDG replaced the former MPG in 2021. Reusable products may only be reprocessed in a way that preserves their safety and function.
Does the old Medical Devices Act (MPG) still apply?
No. The MPG was replaced in 2021 by the EU Medical Device Regulation (MDR 2017/745) and the Medical Device Regulation Implementation Act (MPDG). These have since governed the safe handling of medical devices.
What does a validated procedure mean in instrument reprocessing?
A validated procedure is demonstrably effective and reproducible: cleaning, disinfection and sterilization must reliably achieve the required result under real on-site conditions. This is required by Section 8 MPBetreibV.
Do I have to document the reprocessing of every instrument?
Yes. Section 8 MPBetreibV requires an obligation to provide evidence: the success of each reprocessing cycle must be recorded as batch documentation. This batch and release documentation can be completed in an audit-proof manner using, for example, the free ClavioSoft.
How do I assign my instruments to the correct risk class?
The risk class depends on what the instrument comes into contact with on the patient. The KRINKO distinguishes three main classes: non-critical (intact skin), semi-critical (mucous membranes/pathologically altered skin) and critical (penetrates skin/mucous membranes, contact with blood/tissue).
What do the sub-classifications A, B and C in the risk classes mean?
Semi-critical and critical products are further divided: A (without areas difficult to access for steam), B (with lumens, cavities or joints) and -- only for critical -- C (particularly high requirements per the manufacturer, e.g. not steam-sterilizable).
What are non-critical medical devices?
Non-critical medical devices are those that only come into contact with intact skin, such as ECG electrodes. For these, cleaning and, where applicable, disinfection is generally sufficient; sterilization is not required.
What does semi-critical mean for instruments?
Semi-critical instruments are those that come into contact with mucous membranes or pathologically altered skin, e.g. a speculum or ear speculum. Semi-critical A has no areas difficult to access; semi-critical B has lumens or cavities and requires more demanding reprocessing.
When is an instrument classified as critical?
Instruments are classified as critical when they penetrate skin or mucous membranes and come into contact with blood, internal tissues or organs -- as well as when used with blood/sterile medicinal products or in contact with urine inside the body. They must be sterilized wrapped.
What is the difference between critical A, B and C?
Critical A: no areas difficult to access for steam (e.g. scalpel). Critical B: with lumens, cavities or joints that steam reaches only with difficulty (e.g. transmission instruments, trocars). Critical C: particularly high requirements per the manufacturer, e.g. not steam-sterilizable.
Why do instruments with lumens or cavities require special reprocessing?
With narrow lumens, cavities or joints (classification B), steam reaches the internal surfaces only with difficulty. These products place the highest demands and require a Class B autoclave with fractionated vacuum for reliable steam penetration.
Which instruments belong to risk class critical B?
Critical B instruments are those with lumens, cavities or joints that steam reaches only with difficulty -- such as transmission instruments, trocars with channels or hinged instruments. They require a Class B autoclave with fractionated vacuum.
What risk class do scissors, forceps and needle holders fall into?
Solid instruments without difficult-to-access areas such as scissors or forceps are critical A. Hinged instruments such as scissors with joints or needle holders are usually classified as critical B due to the difficult-to-access joint surfaces.
What risk class do periodontal probes fall into?
Periodontal probes are classified as critical A instruments. They are cleaned and disinfected in a WD or ultrasonic cleaner, then sterilized wrapped in a Class B autoclave and stored sterile. Multiple instruments may be placed in a single package.
Why does reprocessing depend on the risk class?
The risk class directly determines the required procedure. The higher the infection risk from patient contact, the stricter the requirements -- from simple cleaning (non-critical) to wrapped sterilization in a Class B autoclave (critical B).
Which reprocessing procedure follows from each risk class?
Non-critical products are cleaned/disinfected; semi-critical products are cleaned and disinfected (semi-critical B with higher requirements); critical products are always cleaned, disinfected, wrapped and sterilized. Critical B requires a Class B autoclave; critical C follows the manufacturer's instructions.
Do I need to prepare a written risk assessment before reprocessing?
Yes. Before you reprocess an instrument, you must define in writing whether, with what and under what conditions each product is to be reprocessed. The KRINKO/BfArM Recommendation 2012 in Section 1.2.1 explicitly requires this.
How do I carry out the risk classification in practice?
First create a complete list of all reusable instruments. Assign each one a risk class based on the patient contact, derive the procedure from that, and record everything in writing. This produces your documented risk assessment.
Who is allowed to reprocess instruments in the practice?
Only personnel with the necessary expertise may reprocess instruments. This expertise is acquired through training or qualification (cf. KRINKO Annex 6). The operator must ensure that the person carrying out the reprocessing is appropriately qualified.
Do I need specialist training for instrument reprocessing?
Yes, reprocessing personnel require demonstrable expertise through training or qualification (KRINKO Annex 6). If at least one person in the practice is appropriately trained, this is generally sufficient for operations.
What must be recorded in writing in the risk assessment?
For each reusable product, whether, with what and under what conditions it is to be reprocessed must be recorded -- including the risk class and the derived procedure. The KRINKO/BfArM Recommendation 2012 (Section 1.2.1) explicitly requires this documented classification.
Do I need to prove that I received an induction on the autoclave?
Yes, an induction on the medical device is required. It can be booked separately or is included with the initial validation together with installation and commissioning. One trained and inducted person is sufficient.
What does it mean to follow manufacturer instructions?
Section 8 MPBetreibV requires that every instrument be reprocessed as approved by the manufacturer (cf. DIN EN ISO 17664). The manufacturer's instructions specify suitable procedures, agents and limitations -- for example whether a product is steam-sterilizable.
What happens during a health authority inspection?
During an inspection, it is checked whether you reprocess according to KRINKO/RKI and document this. Anyone who follows the recommendation benefits from the presumption effect (Section 8 para. 2 MPBetreibV) and is considered to be reprocessing correctly. Complete documentation is the key factor.
How do I prove correct reprocessing to the health authority?
With your written risk assessment, the validation report and the complete batch and release documentation. You receive corresponding reports for maintenance and validation, which you can present to the health authority.
When is an autoclave mandatory in a practice?
An autoclave is required as soon as you reprocess critical instruments -- i.e. instruments that penetrate skin or mucous membranes or come into contact with blood or blood products. These must be sterilized wrapped.
Is validation of the autoclave legally mandatory?
As soon as you reprocess critical instruments that come into contact with blood on humans, a validated sterilization procedure is mandatory -- the legal basis is Section 8 MPBetreibV. If no critical instruments are reprocessed, there is generally no validation obligation.
Do I need to validate if I do not reprocess critical instruments?
If no critical instruments that come into contact with blood are reprocessed, there is generally no validation obligation. However, as soon as critical instruments are reprocessed on humans, validation is required.
Does the reprocessing obligation also apply in veterinary medicine?
The legal reprocessing and validation obligation under MPBetreibV applies to the reprocessing of instruments used on humans. In a purely veterinary context it is not mandatory; however, voluntary reprocessing to these standards is sensible and possible.
Is reprocessing mandatory in podiatry and foot care?
As soon as instruments that come into contact with blood are reprocessed, the same obligations apply in podiatry and foot care as in human medicine: validated reprocessing and documentation. In pure foot care without critical instruments, this often does not apply.
What obligations apply to tattoo and piercing studios?
Tattoo and piercing studios reprocess instruments that penetrate skin and come into contact with blood -- i.e. critical products. This means the reprocessing, validation and documentation obligations apply analogously to human medicine.
How are the individual reprocessing steps per RKI carried out?
Reprocessing per RKI follows defined steps: risk assessment, preparation/pre-cleaning, cleaning, disinfection (thermal or chemical), care/function check, packaging, sterilization and release with documentation. Each step builds on the previous one.
What is batch documentation and why is it mandatory?
Batch documentation proves for each sterilization batch that the procedure was successful and the batch was released. Section 8 MPBetreibV requires this evidence for every reprocessing cycle. It can be maintained in an audit-proof manner digitally.
How long must reprocessing and release records be retained?
The KRINKO/BfArM recommendation requires retention for at least 5 years. Further civil and criminal law deadlines may be longer; long-term, preferably digital archiving of the entire documentation is therefore recommended.
Which standard governs the reprocessing information to be provided by the manufacturer?
DIN EN ISO 17664 specifies which reprocessing information the manufacturer of a reusable medical device must provide. Section 8 MPBetreibV refers to these instructions when requiring compliance with manufacturer specifications.
What does 'acknowledged state of science and technology' mean in reprocessing?
This means that the KRINKO/RKI recommendation reflects the current professional consensus for safe reprocessing. Anyone who follows it acts in accordance with the required standard and benefits from the legal presumption effect under Section 8 para. 2 MPBetreibV.
What are the consequences of non-compliant instrument reprocessing?
Deficient or missing reprocessing can lead to findings during inspections, mandatory corrective measures, in serious cases fines or liability consequences, and a patient risk through pathogen transmission. Responsibility lies with the operator under Section 8 MPBetreibV.
Does the reprocessing obligation apply to every practice size?
Yes. The obligations under IfSG, MDR/MPDG and MPBetreibV apply regardless of practice size to everyone who uses reusable medical devices on humans -- from a solo practice to a hospital.
How must non-critical instruments be reprocessed?
Non-critical products with contact only to intact skin are cleaned and, where applicable, disinfected, for example by wipe disinfection. Sterilization and therefore an autoclave are not required for these -- these apply only to critical and semi-critical B instruments.
Who decides on the classification of an instrument in case of doubt?
In case of doubt about the classification, the operator with the required expertise makes the decision and, when in doubt, classifies into the higher risk class. Aids such as classification lists from professional chambers support correct assignment.
What distinguishes the KRINKO recommendation from a law?
The KRINKO/RKI recommendation is formally not a separate legal norm but is legally incorporated via Section 8 MPBetreibV. Anyone who follows it fulfils the legal obligation and benefits from the presumption of correct reprocessing.
Do I need to update the risk assessment when new instruments are added?
Yes. The written risk assessment must cover every reusable medical device. When new instruments are added or procedures change, the assessment must be supplemented and kept up to date accordingly.
Does a Class B autoclave meet the RKI requirements?
Yes, a Class B autoclave per EN 13060 meets the applicable requirements and can be validated in accordance with MPBetreibV/RKI. It is also suitable for critical B instruments with lumens and is accepted in both human medical and podiatric practices.