SN EN ISO 17664-2:2024

Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten - Teil 2: Nicht kritische Medizinprodukte (ISO 17664-2:2021)

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)

INB

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. 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: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation.

Publikation: 2024-01-0139 SeitenICS: 11.080.01

Compliance with ISO 17664-2:2021 is crucial for organizations adopting SN EN ISO 17664-2:2024, ensuring the effective processing of non-critical medical devices while adhering to regulatory standards. This guide outlines the essential steps and best practices for achieving compliance.

Why implement SN EN ISO 17664-2:2024 now

Implementing SN EN ISO 17664-2:2024 is driven by several key factors within the Healthcare Technology industry. Firstly, customer requirements often mandate compliance with established standards to ensure product safety and efficacy. Secondly, regulatory pressures, particularly from the EU Regulation (EU) 2017/745, necessitate adherence to recognized guidelines for medical device processing. Lastly, internal quality goals push organizations to enhance their operational processes, ensuring that non-critical medical devices are handled correctly to minimize risks. By aligning with ISO 17664-2:2021 compliance requirements, manufacturers can uphold quality assurance while fostering trust among healthcare providers and patients alike.

Prerequisites and readiness check

Before initiating the transition to SN EN ISO 17664-2:2024, organizations should ensure they have the following foundational elements in place:

• Management commitment: Leadership should endorse the initiative and allocate necessary resources.
• Resource allocation: Dedicate personnel, time, and budget to support compliance efforts.
• Current process documentation: Review and document existing procedures related to the processing of non-critical medical devices.
• Risk analysis: Conduct a preliminary risk assessment to identify potential gaps in current practices.
• Training programs: Prepare to educate staff on the new standards and compliance requirements.

Step 1: Gap analysis

Conducting a gap analysis against SN EN ISO 17664-2:2024 involves several key steps. Start by gathering inputs such as existing process documentation and compliance records. Next, assess current practices against the specified requirements of ISO 17664-2:2021. This process typically involves:

1. Identifying discrepancies: Compare your current processes with the ISO standards to highlight areas lacking compliance.
2. Engaging stakeholders: Involve relevant staff and departments to understand practical challenges and insights.
3. Utilizing tools: Employ tools like checklists and compliance software to streamline the gap analysis process. The outputs should clearly outline the areas needing improvement and provide a roadmap for aligning with ISO 17664-2:2021 compliance requirements.

Step 2: Design and documentation

The design and documentation phase is critical for establishing a robust management system aligned with SN EN ISO 17664-2:2024. Key components to document include:

• Scope statement: Clearly define the boundaries of your compliance efforts, including the specific non-critical medical devices covered.
• Policy formulation: Create an overarching policy that reflects the organization’s commitment to compliance.
• Objectives: Set measurable goals to guide your compliance efforts and track progress.
• Procedures: Develop detailed procedures for each processing stage, such as cleaning, disinfection, and storage, directly linking them to relevant clauses in ISO 17664-2:2021.
• Records management: Establish a system for maintaining records that demonstrate compliance, including training logs and process validations. By meticulously documenting these elements, organizations can ensure a systematic approach to achieving ISO 17664-2:2021 compliance.

Step 3: Implementation and training

The implementation phase is where theoretical plans come to life. Engage in change management practices to facilitate the transition, ensuring that staff are informed and prepared for the new procedures. Key actions include:

• Staff training: Conduct comprehensive training sessions to equip employees with the necessary skills and knowledge regarding the new standards.
• Process adoption: Encourage a culture of compliance within the organization, emphasizing the importance of following new procedures diligently.
• Addressing resistance: Be prepared to encounter resistance to change; actively listen to concerns and provide solutions to ease the transition. Common pitfalls during this stage often include insufficient training and lack of clarity in new processes, which can hinder effective implementation.

Step 4: Internal audit and certification

An internal audit is essential for evaluating the effectiveness of the implemented management system. The audit should be structured as follows:

• Timing: Schedule audits periodically to assess ongoing compliance.
• Stage 1 - Documentation review: Verify that all required documents and records are in place and meet ISO 17664-2:2021 standards.
• Stage 2 - Implementation assessment: Evaluate whether the documented procedures are being followed in practice. Outcomes from the internal audit will inform necessary adjustments and prepare the organization for external certification, ensuring adherence to ISO 17664-2:2021 compliance requirements.

Common pitfalls

1. Inadequate management support: Ensure leadership is actively engaged in the compliance process.
2. Poor documentation: Maintain thorough records to demonstrate compliance efforts.
3. Insufficient employee training: Provide ongoing training to keep staff updated on best practices.
4. Neglecting risk assessments: Regularly review and update risk analyses to reflect current practices.
5. Failure to engage stakeholders: Involve all relevant parties in the compliance process for a comprehensive approach.