Washer-disinfector
A cleaning and disinfection device ( WD ), (also known as a thermal disinfector ) is used for the automated reprocessing of reusable medical products . The requirement for standardization and reproducibility is achieved through the integrated process monitoring . In addition, a thermal disinfector contributes to increasing work efficiency and occupational safety.
The cleaning and drying results are achieved through the coordinated use of process chemicals (cleaner, neutralizer and rinse aid). In order to avoid recontamination and corrosion and to increase the value retention of the instruments, the use of active drying is also recommended. The measure for the disinfection effect is the Ao value, a temperature-time relation. An established combination of a water temperature of 90 ° C with an exposure time of 5 minutes leads to an Ao value of 3,000.
Classification of medical devices before reprocessing
Medical devices are classified into risk groups before they are reprocessed in the practice. The pre-classification ends in the categories uncritical, semi-critical and critical. Semi-critical medical devices (contact with mucous membrane or pathologically altered skin ) and critical medical devices (penetration of the skin or mucous membrane or intended for the use of blood or sterile drugs ) are, depending on their further classification, preferred or, in principle, mechanically cleaned and disinfected with a washer-disinfector. The further specification in A, B, C relates to the processing requirements.
| classification | Medical device (example) |
RDG application |
|---|---|---|
| Uncritical | EKG electrodes | |
| Semi-critical A) | Speculum | |
| Semi-critical B) | Flexible endoscope ( gastroscope ) | prefers |
| Critical A) | Retractor | prefers |
| Critical B) | MIS trocar | basically |
| Critical C) | ERCP catheter |
Working method
A combination of mechanical, thermal and chemical treatment is used for cleaning and disinfection , which roughly corresponds to the model of a dishwasher . If necessary, heated water, enriched with chemicals, is applied with pressure to the objects to be cleaned. The process is adapted to the requirements of the respective medical devices following the model of Sinner's Circle .
Additional ultrasonic cleaning may be necessary beforehand. The multi-step procedure includes program-controlled cleaning, disinfection, rinsing and drying of the goods brought in. Its different properties are discussed with different rinsing and cleaning attachments. Even areas that are difficult to access, such as the inside of hoses, have to be covered by the treatment. Depending on the sensitivity of the items to be washed, disinfection can take place at temperatures of 55 to 105 ° C and is supported by disinfectants at lower working temperatures. Cleaning agents and disinfectants used one after the other within the same process must be coordinated with one another.
Differentiation from sterilization
Treatment in the washer-disinfector is only one of several steps in the process of reprocessing medical devices . Disinfection is not yet a sterilization ; this takes place afterwards if necessary.
Thermal disinfector
Steam sterilizer
Chemiclav
Areas of application
Cleaning and disinfection devices are used in hospitals , especially in their central sterile supply departments, but they can also be found in specialized departments, such as those for endoscopy or the surgical departments, and as bedpan washers in every hospital ward. They are also used in medical practices .
The operator of a cleaning and disinfection device must be able to prove suitable requirements with regard to the installation site, the quality of the water supplying the machine and the use of suitable chemicals, maintain the device, instruct the operating personnel and provide them with work instructions, and document all important issues.
When reprocessed Well, it can, for example, surgical instruments whole, surgical instruments , endoscopes or tubing and valve systems of ventilation and anesthesia devices act.
Dental offices
For dental practices, the RKI guideline (full name: Recommendation of the Commission for Hospital Hygiene and Infection Prevention ( KRINKO ) at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices ( BfArM )) for the reprocessing of medical products "basically" requires machine reprocessing of medical devices with the classification "critical B". These are medical devices for the use of blood, blood products and other sterile drugs and medical devices that penetrate the skin or mucous membrane and come into contact with blood, internal tissues or organs, including wounds, for example transmission instruments for surgical , periodontal or endodontic treatments. "Basically" means that a deviation is only permitted in justified exceptional cases. The results of the automated reprocessing of medical devices must be documented in such a way that they can be traced back to the respective batch (for medical devices of groups Critical A) and Critical B) .
In April 2014, the Higher Administrative Court for the State of North Rhine-Westphalia (OVG NRW) dealt with the permissibility of the manual reprocessing of medical devices classified as "Critical B". The guiding principle in the justification for the procedure mentioned reads: “In a dental practice, mechanical procedures in particular can be validated and used with priority when cleaning and disinfecting critical medical products. A manual cleaning process regularly does not meet the requirements of the Medical Devices Operator Ordinance (MPBetreibV) if it is not ensured that it continuously leads to the required cleaning success in a safe and reproducible manner. ”According to Section 4 (2) MPBetreibV,“ proper reprocessing is assumed if the joint Recommendation of the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices on the hygiene requirements for the reprocessing of medical devices is observed. The source is published by the Federal Ministry of Health in the Federal Gazette ”. The RKI guideline, to which the OVG NRW referred, was published in the Federal Law Gazette in October 2012 .
Quality control and validation
To ensure consistent cleaning and disinfection quality, the functionality of the devices and their effectiveness must be regularly checked, verified and documented. This procedure is known as validation and can also serve to defend against possible claims for recourse and lawsuits.
Trade inspection: practice inspections
The maintenance of the devices and compliance with the regulations are increasingly being checked by trade supervisory authorities by means of practical inspections. The main focus of the exam is:
- Is the medical device classified into the classes "uncritical", "semi-critical A", "semi-critical B", "critical A" and "critical B"?
- Is sufficient cleaning and disinfection of all medical devices guaranteed (for medical devices classified as "critical B" only machine cleaning)?
- Are suitable, validated processes used to reprocess medical devices?
- Is there a documented release of the medical devices?
- Are the spatial requirements for processing complied with?
- Are the processes used laid down in writing in standard operating procedures?
- Are there current validation reports of the reprocessing processes (cleaning, disinfection, packaging, sterilization)?
Legislation and standards
Cleaning and disinfection devices are themselves energetically (here: electrically) operated, i.e. active medical products and are therefore subject to the German and Austrian medical product laws and the associated operator regulations , which, as implementation of the EEC Directive 93/42, ensure standardization within the EU . They may only be used by persons who are qualified and instructed in the use of the respective device type. The requirements for cleaning and disinfection devices are formulated in the DIN EN ISO 15883 standard .
Web links
- Hygiene requirements for the reprocessing of medical devices : Recommendation of the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute (RKI) and the BfArM , 2012
- Guideline from DGKH, DGSV and AKI (PDF; 3.2 MB) for the validation and routine monitoring of mechanical cleaning and thermal disinfection processes for medical products and on the principles of device selection, 2008
- German industrial association for optical, medical and mechatronic technologies: (PDF; 97 kB) Guide for process validation for cleaning and disinfection devices, 2003
- German Society for Sterile Supply e. V .: Technical information
- Fachvereinigung Krankenhaustechnik e. V .: (PDF; 423 kB) New legal requirements for cleaning a. Disinfection devices, 2009
- Operate outpatient 1/2008: Validation concept for cleaning and disinfection devices without standard-compliant retrofitting
Individual evidence
- ↑ "Yellow Brochure": Instrument reprocessing done right in the dental practice. , P.16 Instrument reprocessing working group, 4th edition 2016.
- ↑ Recommendation for monitoring the reprocessing of medical devices (RKI Medical Devices Working Group). (PDF; 115 kB) (No longer available online.) Archived from the original on November 22, 2010 ; Retrieved June 1, 2011 . Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
- ↑ German Society for Sterile Supply: Flow chart for risk assessment and classification of medical devices. (PDF; 407 kB) (No longer available online.) Archived from the original on December 27, 2013 ; Retrieved June 1, 2011 . Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
- ^ Christian Jäkel: Legal framework for the reprocessing of medical products . In: Hygiene & Medicine . tape 33 , no. 7/8 , 2008, p. 296-298 . Online ( page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice.
- ↑ a b Martin Kröger: Instrument reprocessing in compliance with the RKI guidelines. (PDF) (No longer available online.) Archived from the original on June 26, 2011 ; Retrieved June 1, 2011 . Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
- ↑ a b Hygiene requirements for the reprocessing of medical products Robert Koch Institute
- ↑ a b Government of Swabia 2009: Processing of medical products (MP) in clinics, OP centers, OP practices; Essential requirements. (PDF; 103 kB) Accessed June 3, 2011 .
- ↑ Markus Wiedenmann: Hygiene in the rescue service, p. 90 ff. Elsevier, Urban & FischerVerlag, Munich 2011, ISBN 978-3-437-48790-3 . Online: limited preview in Google Book search
- ↑ a b Government of Swabia 2009: Essential requirements for the operation of RDG. (PDF; 84 kB) Retrieved June 3, 2011 .
- ↑ Preparation of products of the groups semi-critical and critical B ZWP-online
- ↑ Hygiene requirements for the reprocessing of medical devices. In: Federal Health Gazette - Health Research - Health Protection. 55, 2012, pp. 1244–1310, doi: 10.1007 / s00103-012-1548-6 , p. 1257. Recommendation of the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM )
- ↑ Decision of the Higher Administrative Court for the State of North Rhine-Westphalia Az .: 13 A 106/13 of April 7, 2014
- ^ Government of Swabia 2009: Information on routine and batch controls at RDG. (PDF; 73 kB) Retrieved June 3, 2011 .
- ↑ a b Government of Swabia 2009: Validation of cleaning / disinfection processes. (PDF; 160 kB) Accessed May 21, 2011 .
- ↑ Checklist of the trade supervisory authority, comments ( memento of the original from 23 September 2015 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. , Bavarian State Dental Association . Retrieved March 19, 2015.
- ↑ Dietmar Kirchberg: The Medical Devices Act: what nurses need to know; Regulations, examples, consequences, S58 ff. Schlütersche Verlagsanstalt, 2003, ISBN 978-3-87706-878-6 . Online: limited preview in Google Book search
- ^ German Society for Sterile Supply; Legal requirements: Current standards and recommendations. (PDF; 217 kB) (No longer available online.) Archived from the original on March 6, 2016 ; Retrieved June 1, 2011 . Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
