ISO 20417: What You Need to Know
This article is an introduction to ISO 20417 and details about the standards that make up the document itself.
Compliance
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This article is an introduction to ISO 20417 and details about the standards that make up the document itself.
ISO 20417:2021 is an international standard that defines requirements and gives information for medical devices throughout their life cycle. ISO 20417 caters to all types and all classes of medical devices and labeling. The standard applies to any organization involved in the life cycle of medical devices, including designers, manufacturers, distributors, service providers, and users.
According to ISO, ISO 20417 provides information for the requirements of medical device or a medical accessory supplied by the manufacturer. It includes the needed requirements for labels and identification on a medical device or accessory which include its packaging and any accompanying information.
The purpose of this standard is to ensure that medical materials and devices are safe and effective for their intended use. It also aims to ensure that these products are properly labeled so that consumers can make informed decisions about which products to use.
ISO 20417 is an essential standard for the medical industry and consumers of medical products. It will help improve the quality of health care and make it more accessible to people worldwide.
ISO 20417 is a quality management standard developed specifically for the healthcare industry. It helps organizations establish and maintain a quality management system and can be used to assess the overall quality of an organization’s healthcare services.
There are many benefits of using ISO 20417, including:
Improved patient safety
Increased efficiency
Reduced medical costs
Enhanced inventory management
Increased trust in the medical product
Stronger product information expertise
Smoother trade with other manufacturers
By implementing this standard, healthcare organizations can strengthen their quality management systems and improve the quality of their services.
ISO 20417 covers the requirements applicable for identification and labels on a medical device or accessory, including:
The name and/or trade name and address of the manufacturer
The identification number of the device
The CE mark, if applicable, and
Any other relevant information
ISO 20417 can be applied in many following ways in the medical field such as the following:
In keeping with the trend of storing medical records electronically, ISO 20417 can be used as a specification for the structuring and formatting of e-records. For example, the requirement for a name field in case history could be that it should never be an empty field. However, it does not restrict to the container format like XML or PDF, where you may store this information.
Reports need to be structured in line with the Digital Imaging and Communications in Medicine (DICOM) standards for transmission and reading by Picture Archiving and Communication System (PACS).
For example, an image report needs to consist of the following components:
Patient information
Study identifier
Accession number
Procedure description
Images acquired through medical devices need to follow specifications while they are archived. This helps doctors read and analyze the image without any trouble using different reader devices.
Implementing ISO 20417 can be a daunting task, but with Mitti (by SafetyCulture), you can be sure that you’re on the right track. Mitti (by SafetyCulture) is the perfect tool for helping you effectively implement ISO 20417. With Mitti (by SafetyCulture), you can easily create, edit, and share digital checklists, conduct audits remotely, and generate reports with detailed findings.
With Mitti (by SafetyCulture), you can do the following:
Utilize the relevant insights and data gathered from the medical device inspections to recommend improvements in manufacturing processes
Document internal processes in detail using digital media (photo and video) attachments.
Generate and share audit reports in Web, PDF, and other formats and communicate with teams using the Heads Up feature
Create and use checklists and templates to help your teams standardize their medical device audits and make the process faster and more efficient
Take note of compliance issues and create actions or workflows to address areas for improvement and stay on track with the proper guidelines for ISO 20417
