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GUIDE TO INSPECTIONS OF ELECTROMAGNETIC

COMPATIBILITY ASPECTS OF MEDICAL DEVICE

QUALITY SYSTEMS

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instruments that generate static electricity, or simple battery-operated devices. Problematic use environments can be hospitals, doctors' offices, ambulances or other emergency vehicles, even in homes or outdoors. Keep in mind that even cellular telephones used nearby (but even in other rooms) can trigger faulty reactions in electronic monitors, diagnostic devices, wheelchairs, pacemakers, and computers.

EMC Testing: What EMC testing does the manufacturer perform during manufacturing, and are all units tested? Do they intend to conform to IEC 60601-1-2? Partially or completely? Identify the specific sections to which the design/device must conform, and the options chosen (e.g., immunity pass/fail criteria, modulation frequencies, test levels for patient-coupled devices). How do they verify and validate the conformance and how often will they have the device tested? Will the testing be in-house or by a testing laboratory? If the manufacturer only tested a prototype and from that determined the device would not be affected by EMD, get a copy of the test record to determine whether adequate tests were performed. Will the firm be changing their testing with regard to EMC? Will the changes extend to other devices they make?

Device Changes: If the firm has decided to improve the product design to reduce the chance of EMI in use environments, try to determine:

New Environment: Was the design change based on a new intended use environment, such as in clinics rather than hospitals, or was it based on recent changes in the same environment, such as more cellular telephones being used by visitors in hospital patient rooms? A new premarket notification (510(k)) might be needed if the device is now being marketed for a different environment, such as it is now portable and can be mounted in a new kind of emergency vehicle, or it is now being marketed to cosmetologists to be used in health and beauty salons.

Device Modifications: What changes are being made? For example, different electronic components, modified software, additional shielding, warnings/labels, or use instructions.

Reason for the change: Is the design or labeling change motivated by an indication of EMI from user accidents, device malfunctions, or complaints?

Corrective Action: Determine whether the firm intends to repair or upgrade existing units in the field, mail new user guidance to the purchasers, or simply introduce the upgrade as an improved device. Also, will they discontinue the problematic model or just limit its distribution to certain use environments? How will labeling be changed and to whom will it be distributed?

Recall or Upgrade: Has there been a market withdrawal/upgrade, a safety alert, or recall? If so, what was the reason for the modification? Provide information on how the problem leading to the modification was determined, any injuries resulting from the problem, the level of risk, and to whom and under what circumstances was safety information distributed?

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