Glossary

Device History Record

Device History Record

Within a medical device quality management system (QMS), a device history record (DHR) serves as a detailed record of a specific medical device unit’s or batch's production history. This record ensures the device was manufactured according to the device master record (DMR) specifications and adheres to regulatory requirements. DHRs typically include details like manufacturing date, quantity produced, equipment used in production, operator identification, component materials, quality control checks, and final approval signatures.

Frequently Asked Questions

Who is responsible for maintaining the device history record?

The responsibility of maintaining an accurate and complete device history record typically falls on the manufacturing company, under the supervision of their quality assurance or regulatory compliance personnel.

Are electronic device history records (eDHRs) acceptable for regulatory compliance?

Yes, electronic device history records are acceptable and increasingly common due to their efficiency and ease of access. However, they must meet specific requirements regarding electronic signatures, data integrity, and accessibility to ensure regulatory compliance.

What are common issues found in device history records during audits?

Common issues include incomplete records, lack of proper documentation of production changes, discrepancies between the DHR and the device master record, and inadequate inspection and testing records.

How can device history records be used in product recalls?

Device history records provide detailed information about each batch or lot of a product, allowing manufacturers to trace and identify potentially defective products quickly during a recall process, thereby minimizing potential risks to patients and users.

Can the absence or incompleteness of a device history record lead to regulatory penalties?

Yes, the absence or incompleteness of device history records can lead to regulatory penalties, including warning letters, fines, and legal actions, as these records are essential for verifying compliance with manufacturing standards and ensuring product safety and efficacy.

Reviews

[ { "key": "fid#1", "value": ["Everything else"] } ]