4. "DGKH, DGSV® / SGSV, "Guidelines for validation and routine monitoring in the automatic cleaning and hot water disinfection process of medical devices" and "Quality Management System" created by AKI
DGKH (Deutsche Gesellschaft für Krankenhaushygiene / German Hospital Hygiene Society), DGSV (Deutschen Gesellschaft für Sterilgutversorgung / German Society for Sterilization Supply Business), SGSV (Schweizerische Gesellschaft für Sterilgutversorgung / Swiss Society for Sterilization Supply Business) and AKI At the beginning of the preface to the Guidelines for Validation and Daily Monitoring [i] in the automatic cleaning and sterilization process for medical devices compiled by the Working Group for Medical Device Regeneration Processing), the following is stated.
Die Medizinproduktebetreiberverordnung fordert in § 8, dass die Aufbereitung von keimarm oder steril zur Anwendung kommenden Medizinprodukten unter Berücksichtigung der Angaben des Herstellers mit geeigneten validierten Verfahren so durchzuführen ist, dass der Erfolg dieser Verfahren nachvollziehbar gewährleistet ist und die Sicherheit und Gesundheit von Patienten, Anwendern oder Dritten nicht gefährd et wird.
In Article 8 of the Healthcare Provider Regulations Ordinance, medical device regeneration processing is carried out using procedures that are appropriately validated based on the instructions and information provided by the medical device manufacturer and distributor, and these procedures are clarified. It must be kept and must not threaten the safety and health of patients, healthcare professionals and third parties.
“Patienten, Anwendern oder Dritten nicht gefährdet wird.”
Is quoted from the famous "Oath of Hippocrates", "Do not harm the patient".
Those involved in the remanufacturing process of medical devices are encouraged to engage under this "policy".
Mit dieser überarbeiteten Leitlinie bieten die beteiligten Fachgesellschaften die Umsetzung der Norm DIN EN ISO 15883 «Reinigungs-Desinfektionsgeräte» auf dem aktuellen Stand.
The revised guidelines are stated to comply with the latest international standards, European standards and German standard 15883 << Automatic Cleaning and Disinfecting Equipment >>.
This means that the guidelines are based on international standards and are prepared in accordance with European and German standards.
In addition, the importance of a quality management system is stated.
Grundsätze der Leitlinie
Guidelines Principles
– Der Betreiber hat die Verantwortung, ein Qualitäts management ein zu führen und aufrecht zu erhalten.
-Businesses (including medical institutions) are responsible for introducing and maintaining a quality management system.
The guidelines do not necessarily require compliance with all quality management systems and quality management systems in the manufacture of medical devices as set forth in the International Organization for Standardization, ISO 9001 and ISO 13485. Instead, we must follow the essential part of the quality management system, build and maintain a quality management system that is suitable for medical institutions and their organizations.
Continuing the principles of the guidelines,
– Der Betreiber hat die Verantwortung, dass das mit der Aufbereitung beauftragte Personal die erforderliche Sachkenntnis besitzt (z. B. Fachkundelehrgang I der DGSV).
– The operator is responsible for the necessary expertise of the person responsible for the medical device remanufacturing process. (Example: Acquisition of DGSV certification course I qualification)
– Der Betreiber hat die Verantwortung, dass die Validierung und die Erneute Leistungsqualifikation durchge führt werden.
– The operator is responsible for performing validation and revalidation updates.
– Der Betreiber ist für die Einhaltung der periodisch durchzu führen den Routinekontrollen, die im Rahmen der Validierung und bei der Erneuten Leistungsqualifikation definiert und dokumentiertwerden, verantwortlich.
– The operator is responsible for defining and documenting and complying with validation, periodic revalidation and periodic inspections.
It has been described as.
Qualifications certified by an accreditation body that has received some external evaluation at a medical institution or organization that is a business operator (for example, DGSV accreditation course I) / RUMED Academy Level 1 equivalent) is appointed as the person in charge, and validation, re-validation, and periodic inspection are ensured under the appointed person in charge. It means that you are responsible for the fact that the procedure is documented and recorded in its entirety.
As with ISO 9001 and ISO 13485, the core part of the quality control system for regenerative processing in medical institutions is that top management appoints a person in charge, and the appointed person in charge "risk assessment" based on that responsibility and authority. And prepare a procedure manual for quality control, and regularly carry out objective validity confirmation and re-validity confirmation, and report the result or take corrective action or request as necessary. Top management appointed. The guidelines require that you have to make a suggestion to.
In addition, the first part of the guideline of the guideline also states as follows.
Qualitätssicherung bei der Aufbereitung von Medizinprodukten (MP) ist nicht nur eine gesetzliche Verpflichtung, sondern auch von wirtschaftlicher Bedeutung.
Quality assurance in the recycling process of medical devices is not only legally obligatory, but also economically important.
Die Prävention nosokomialer Infektionen stellt eine interdisziplinäre Herausforderung aller Beteiligten dar.
Prevention of nosocomial infections is also a permanent challenge for all businesses.
Die sachgerechte Aufbereitung von Medizinprodukten ist hierbei ein wichtiger Baustein.
Appropriate regenerative treatment of medical devices is an extremely important factor in the prevention of nosocomial infections.
Die Vorgehensweise in allen Aufbereitungsschritten muss durch die Prozesssicherheit eine korrekte und nachvollziehbare Aufbereitung ermöglichen.
Medical device remanufacturing should use reliable, documented remanufacturing procedures and be accurate and traceable in all procedures.
Der Betreiber der Einrichtung trägt die gesamte Verantwortung und muss unter anderem da für sorgen, dass das mit der Aufbereitung beauftragte Personal die erforderlichen Kenntnisse und Qualifikationen zur ordnungsgemä
The business operator bears all responsibilities, and it is necessary to confirm that the person in charge of the regeneration process has the knowledge and qualifications necessary for proper processing.
It has been with.
Clarify that the business operator has legal responsibility for quality assurance in the remanufacturing of medical devices, as well as economic and management responsibilities so that the business can be sustainable. doing.
It is necessary to take preventive measures against nosocomial infections that occur in the facility, build a quality control system to realize it, and appoint and authorize the person in charge of its operation. increase.
Also, create reliable and valid runbooks and maintain accurate and traceable records. In addition, it is stated that the responsible person must ensure that he / she has the necessary expertise and qualifications, that is, that he / she must be educated and trained to do so.
Similar to the quality management system shown in ISO 9001 and ISO 13485, it is required to aim to build and maintain a system that is sustainable and brings about quality improvement and improvement centered on "people".
[i] DGKH, DGSV and AKI; Leitlinie von DGKH, DGSV und AKI für die Validierung und Routine überwachung maschineller Reinigungs- und thermischer Desinfektionsprozesse für MedizinprodukteGuideline 5 Auflage 2017.mph