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An MD&DI November 1998 Column

HELP DESK

Fred Hooten, a regulatory and compliance issues consultant (Damascus, MD), explains some of the terms relating to original and updated device history records.

May the device history record be removed from its file for use in rework or alteration of the device? The record would be updated to reflect any changes.

The quality system regulation does not prohibit removing an original device history record from its files. In fact, device history records are accessed frequently during FDA inspections and complaint investigations. However, controls should exist to prevent loss of records before any device history records are removed, and someone should be responsible for maintaining and monitoring use of the files. One way to guard against loss is to scan each device history record into a documentation program with read-only access. Anyone in-house who needs to review a device history record could then do so without creating a situation in which records could be lost.

A device in distribution without a device history record is technically adulterated. Distributing an adulterated device, or causing a device in distribution to be adulterated, is a prohibited act under section 301 of the Federal Food, Drug, and Cosmetic Act. Anyone who violates a provision of section 301 may be imprisoned for not more than one year or fined not more than $1000, or both. The guilty party doesn't get to choose between the penalties.

The original query uses the terms rework and alteration, both of which have implications that should be clarified. The quality system regulation requires that rework be documented in the device history record (21 CFR 820.90(b)(2)), and rework is specifically defined. According to 21 CFR 820.3(x), rework means action taken on a nonconforming product so that it will fulfill the specified device master record requirements before it is released for distribution. Therefore, the rework activity would be included in the original device history record before it is completed and filed. If the rework mentioned in the question is actually repair or servicing after distribution, additional service records must be established to meet the requirements of section 820.200 of the quality system regulation, as these records would not be included in the original device history record.

According to the regulation, remanufacturing occurs when alterations are made to a device so that it no longer meets the original specifications. A remanufacturer is anyone who processes, conditions, renovates, repackages, restores, or does anything else to a finished device that significantly changes the device's performance, safety specifications, or intended use (21 CFR 820.3(w)). Remanufacturers are subject to all applicable requirements of the quality system regulation, and a device history record that documents the remanufacturing activities would be required. Remanufacturers usually file such information in a location separate from the original device history record.

I'm assuming that the question relates to upgrades or corrective action taken after distribution. Usually, upgrades or corrective actions involving distributed devices are initiated using an engineering change order, corrective action record, or similar documentation to obtain approvals and document the activities. This documentation need not be part of the original device history record, but there should be traceability—for example, lot number—to the original device history record to facilitate any necessary investigations. For example, some firms initiate a corrective action with a corrective action form and make any necessary changes to the device master record using an engineering change order. If the changed devices no longer meet the original device master record specifications or are resterilized, new lot or serial numbers may be generated or a designation added to the original lot or serial numbers to indicate that the devices have been modified or reprocessed. The new numbers are linked to the old numbers through the engineering change order or corrective action form. When this information is computerized, traceability is usually not a problem.

Can a manufacturer alter devices to correct quality problems, or upgrade to the latest changes, without being considered a remanufacturer? Technically, if the device no longer meets its original performance or safety specifications after the alterations, it's considered to have been remanufactured. But it really shouldn't make a difference, since the documentation needed to show compliance with the applicable requirements of the quality system regulation would presumably be in place. For example, if there were alterations, the change control records would document the change to the device master record, and there would be records of the inspections and tests conducted after the alterations. Any training required would be documented in the individual training files. All applicable parts of the quality system regulation that applied to the original device—for example, calibration or documentation controls—would also apply to the remanufactured one.

The quality system regulation states that the records it requires—including archived records—must be readily available to an FDA investigator whether or not they are stored at the manufacturing facility. FDA has defined readily available in the preamble (comment #180) as available "during the course of the inspection" or within "the next working day or two, at the latest." However, as long as relations are good between the investigator and the manufacturer, FDA is usually reasonable concerning the time allowed to retrieve original records.

Removing original device history records from the files is not prohibited but should be limited. Once an original device history record is filed, there should be no additions. If there are changes to a device after distribution, the record of the changes should be maintained with traceability to its original records. There will be occasions when device history records must be removed from the files. It is the responsibility of the manufacturer to make sure that the complete device history record goes back into the files.

"Help Desk" solicits questions about the design, manufacture, regulation, and sale of medical products and refers them to appropriate experts in the field. A list of topics previously covered can be found in our Help Desk Archives. Send questions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, fax 310/445-4299, e-mail [email protected]. You can also use our on-line query form.

Although every effort is made to ensure the accuracy of this column, neither the experts nor the editors can guarantee the accuracy of the solutions offered. They also cannot ensure that the proposed answers will work in every situation.

Readers are also encouraged to send comments on the published questions and answers.

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