The Device History Record (DHR) is a collection of records containing the production history of all versions of a product. The DHR includes the serial and lot numbers of the products produced, and any complaints or issues that are lodged against the product.The DHR may include corrective action, preventative action (CAPA) records. These records describe any investigations, corrective and preventive actions and details about how the corrections were made.A DHR may be required to meet regulatory measures in the production of certain products including medical devices.
What is a Device History Record (DHR)?
A Device History Record (DHR), not to be confused with the device master record (DMR), is a pivotal document in the realm of medical device manufacturing, as it serves as a comprehensive repository of information that tracks the production and quality of medical devices throughout their lifecycle. DHRs are indispensable in maintaining critical regulatory compliance (such as CFR 820 standards), ensuring product traceability, and upholding the highest standards of quality assurance in the highly regulated medical device industry.
Key Elements of the Device History Record (DHR)
- Medical Device Manufacturing: DHRs are integral to medical device companies, providing a meticulous record of the manufacturing process, from the initial stages of product development to the production of finished devices.
- Regulatory Compliance: Compliance with stringent regulatory requirements, such as FDA 21 CFR Part 820, ISO 13485, and unique device identifier (UDI) regulations, is of paramount importance in the medical device industry. DHRs play a pivotal role in ensuring adherence to these standards.
- Traceability: DHRs facilitate the traceability of devices, enabling the identification of inputs, production units, and critical manufacturing dates. This traceability is vital for product recalls, investigations, and risk management.
- Quality Management System (QMS): DHRs are an essential component of the Quality Management System, serving as a foundation for quality assurance, validation, corrective and preventive actions (CAPA), and the management of non-conformances and deviations.
- Design History File (DHF): The DHR complements the Design History File (DHF), which documents the product design and development process, ensuring that the manufactured devices conform to the initial design specifications.
The Role of DHR in Regulatory Compliance
- FDA and Regulatory Framework: The FDA and regulatory bodies worldwide mandate the creation and maintenance of DHRs for medical device companies. Compliance with regulations such as FDA 21 CFR Part 820 is non-negotiable to ensure patient safety and product effectiveness.
- Acceptance Records: DHRs contain detailed records of acceptance criteria, providing evidence that each device has met the required quality and performance standards.
- Labeling and UDI: DHRs encompass labeling information, including the unique device identifier (UDI) and primary identification label, essential for tracking and traceability.
The DHR Lifecycle
Throughout the DHR lifecycle, various critical elements are documented, including the production process, control numbers, dates of manufacture, and device identification(s). Any non-conformances or deviations from acceptance criteria are meticulously recorded, investigated, and addressed through CAPA measures, ensuring that root causes are identified and resolved.
Webinars and educational resources play a vital role in disseminating knowledge about the significance of DHRs, especially for start-ups and emerging companies entering the medical device industry. Understanding the regulatory landscape and implementing DHR best practices are essential steps in achieving compliance and successful product development.
In conclusion, a Device History Record (DHR) is an indispensable document in medical device manufacturing, ensuring regulatory compliance, traceability, and adherence to quality standards. It is a critical component of the broader quality management system (QMS) and serves as a comprehensive record of the device's journey from design to production. DHRs play a pivotal role in upholding the highest levels of quality assurance, risk management, and patient safety in the medical device industry.