Best Practices for Maintaining Device Master Records (DMR) for Medical Devices

By: Staff Editor
Date: September 30, 2011

The Food and Drug Administration (FDA) requires manufacturers of medical devices to create and maintain a device master record (DMR). Section 820.3(j) of the Federal Code defines device master record. DMR is a set of documents containing procedures and specifications for a finished medical device. Simply put, device master record (DMR)is acollection of all the documents required to manufacture and test a medical device.

The need to maintain DMR

DMR is a part of the Quality System Regulation (QSR) of FDA to maintain standards in the manufacture and maintenance of medical equipment. It ensures the safety of the end-users, namely, patients. It is mandatory for a manufacturer to maintain DMR. The DMR is prepared and approved in accordance with section 820.40.

Preparation and approval of DMR’s

Each manufacturer should maintain device master records (DMR’s). The manufacturer should ensure that each DMR is prepared and approved as prescribed in Sec. 820.40. The DMR for each type of device should include or refer to the location of the following:

Specifications of the device including appropriate drawings, composition, formulation, component specifications, and software specifications.
Details about production methods including appropriate equipment specifications, production procedure, and production environment specifications.
All the quality assurance criteria, procedures, and specifications. It also includes the criteria and equipment used to check quality.
Specifications for packaging and labeling with details of methods and processes.
Procedures and methods for installation, maintenance, and servicing.

Device Specifications the DMR should show:

The device specifications that the DMR should furnish are given in the following Table:

Name of the Product	Performance Characteristics	Classification	Physical Characteristics	Environmental Limitations	Important Components	User Safety and Performance Considerations
Trade name Trademark Generic name Chemical name Official name Common name	Description/Intended use Accessories Functional parameters Limitations Contraindications Input/Output requirements Human interface Other	Regulatory Commercial Functional Other	Weight Size Color Form/Shape Consistency Packaging Power requirements Other	Operating temperature range Storage temperature range Vibration and shock range Voltage range Humidity range Moisture protection Pressure, altitude limits Electromagnetic interference Electrical transients Shelf life/Other	Active ingredients Major subsystems Diagnostic kit materials Accessories Labeling Service labeling Components/items supplied by user Software Periodic Warranty/Other	Chemical Electrical Thermal Mechanical sharp, moving parts Personnel training Periodic testing Maintenance

Outline of best practices in DMR

At present regulations in the medical device industry are coming under high scrutiny with product recalls. Research continues to enhance levels of consumer safety. The proactive regulatory bodies are responding with meetings on notifications for markets before commencement of production. Investments in medical device safety are increasing. Leading providers of global quality and compliance management systems recommend that companies act together to get devices quickly to the market. Companies also need to see that devices are compliant with regulations, both current and future ones. The recommended best practices are:

Managing quality of suppliers: Give priority to global suppliers who offer the highest quality and track them consistently.
Electronic medical device reporting (eMDR): Create a single simplified system to maintain and manage the reports.
Managing change: Whenever there is a change in the process, strict controls and tracking is to be done.
Handling complaints: Recording and tracking of all complaints is to be done regularly. The authorities are to be notified regarding the number and the type of such complaints.
Corrective and preventative action (CAPA) management: Get to the source of the problem, do the needful corrections, and see that they do not happen again.


	Need to gain a better understanding of complying with regulatory requirements for medical device DMR? Attend any of the following ComplianceOnline webinars: What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained Device Master Record & Device History Record – requirements, contents and implementation Design History Files, Device Master Records, Device History Records, and Technical Files / Design Dossiers - Interrelationships Understanding Acceptance Activities for Medical Devices

Many industry players suggest that every company document its DMR policy. This will result in product consistency, document organization, and easy reference. Today, several automated solutions are available to help companies organize, maintain, and communicate about device master record (DMR), design history file (DHF) and bill of materials (BOM)—and succeed with reduced manpower in a competitive and highly regulated environment. The following Table explains how automated solutions score over the manual system.

Manual system	Automated solution
Product changes documented manually resulting in errors and delay	Automation ensures accuracy and speed.
Multiple bills of material and records in various departments	The solution maintains one version centrally
Manual quality monitoring and auditing result in high overheads	Automatic monitoring of quality reduces labor costs.
Use of different sources like internet, phone, and fax for data exchange prevents effective collaboration	Collaboration is made easier for the team.
Regulations, which change often, lead to duplication of data and requires time and personnel	Duplication is eliminated by using the solution
Maintaining large amount of data physically in files is difficult	The solution easily manages any amount of data

Conclusion

Since patient safety is of paramount importance, manufacturers of medical devices should adhere to best practices, duly supported by automated solutions. This will help them to comply with the changing regulatory requirements effortlessly.

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