BS EN ISO 16054:2019 - Implants for Surgery: Minimum Data Sets for Surgical Implants

In the ever-evolving field of medical technology, ensuring the highest standards of safety and efficacy is paramount. The BS EN ISO 16054:2019 standard is a crucial document for professionals involved in the design, production, and implementation of surgical implants. Released on July 17, 2019, this standard provides comprehensive guidelines for the minimum data sets required for surgical implants, ensuring that all necessary information is available for safe and effective use.

Key Features of BS EN ISO 16054:2019

• Standard Number: BS EN ISO 16054:2019
• Pages: 16
• Release Date: July 17, 2019
• ISBN: 978 0 580 92055 4
• Status: Standard

Comprehensive Guidance for Surgical Implants

The BS EN ISO 16054:2019 standard is meticulously crafted to provide a detailed framework for the minimum data sets required for surgical implants. This ensures that all stakeholders, from manufacturers to healthcare providers, have access to the critical information needed to make informed decisions regarding the use and management of surgical implants.

Why is this Standard Important?

Surgical implants play a vital role in modern medicine, offering solutions for a wide range of medical conditions. However, the complexity and diversity of these devices necessitate a standardized approach to data management. The BS EN ISO 16054:2019 standard addresses this need by outlining the essential data sets that must be maintained for each implant, thereby enhancing patient safety and improving clinical outcomes.

Who Should Use This Standard?

This standard is indispensable for a variety of professionals in the medical field, including:

• Medical Device Manufacturers: Ensures compliance with international standards, facilitating market access and enhancing product credibility.
• Healthcare Providers: Provides essential information for the safe and effective use of surgical implants, aiding in patient care and decision-making.
• Regulatory Bodies: Offers a benchmark for evaluating the safety and efficacy of surgical implants, supporting regulatory compliance and oversight.

Enhancing Patient Safety and Clinical Outcomes

By adhering to the guidelines set forth in the BS EN ISO 16054:2019 standard, healthcare professionals can significantly enhance patient safety and improve clinical outcomes. The standard ensures that all necessary data is readily available, facilitating informed decision-making and reducing the risk of complications associated with surgical implants.

Structured Data for Improved Traceability

One of the key benefits of the BS EN ISO 16054:2019 standard is its emphasis on structured data. By maintaining comprehensive and organized data sets, healthcare providers can improve the traceability of surgical implants, ensuring that any issues can be quickly identified and addressed. This not only enhances patient safety but also supports ongoing research and development in the field of surgical implants.

Conclusion

The BS EN ISO 16054:2019 standard is an essential resource for anyone involved in the field of surgical implants. By providing clear guidelines for the minimum data sets required, this standard ensures that all necessary information is available to support safe and effective use. Whether you are a manufacturer, healthcare provider, or regulatory body, the BS EN ISO 16054:2019 standard is a valuable tool for enhancing patient safety and improving clinical outcomes.

Invest in the future of medical technology by embracing the standards that drive innovation and safety. The BS EN ISO 16054:2019 is more than just a document; it is a commitment to excellence in the field of surgical implants.

BS EN ISO 16054:2019

This standard BS EN ISO 16054:2019 Implants for surgery. Minimum data sets for surgical implants is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry.

This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event.

This document is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up.

It is not the intent of this document to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.