Page 218 - Safety Risk Management for Medical Devices

Production and Postproduction Monitoring 197

Postmarket risk management may determine measures to control the discovered risks.
These Risk Controls may be in the form of design changes, labeling, or training. Naturally,
the new Risk Controls must be verified for effectiveness. The risk management file may
need to be updated. The manufacturer may also issue advisory/field safety notices.
For medical devices currently installed and used in the market, the Risk Control
measures may be different from those applied to devices that are currently in produc-
tion. For example, for products in the field, Risk Control measures may include send-
ing information to doctors or patients, removing product from the field and providing
replacement product. For products that are in production, Risk Control measures may
include identification and collection of product, and rework or discard of product.
If a recall or field product update/revision is decided, speed of action will be mate-
rial to the effectiveness of risk reduction activities.

24.2 FREQUENCY OF RISK MANAGEMENT FILE REVIEW

As postmarket surveillance continues to bring in new information about the product
field performance, the risk management file should be periodically reviewed to deter-
mine need for update. The frequency of risk management file review depends on:
• the risks of the device
• the novelty of the device
• the duration of time that the device has been in the market

For a new, novel, and high-risk device do more frequent reviews; perhaps as much
as monthly or bimonthly. The longer the device has been on the market and the
more that has been learned about it, the review frequency can be reduced, e.g., every
year or every other year. For low-risk, old-technology devices, the review frequency
could be even lower, e.g., every 4 5 years.
Whatever frequency the manufacturer chooses should be recorded in the Risk
Management Plan. Document the rationales for your decision on review frequency.

24.3 FEEDBACK TO PREPRODUCTION RISK MANAGEMENT

There is a connection between the postmarket and preproduction risk management.
Knowledge gained from product performance after it is manufactured and released must be
fed back to preproduction risk management in a drive to add veracity to the preproduction
predictions and estimations of the risks of a medical device. The types of information that
postmarket risk management can provide to preproduction risk management are:

• Is there evidence of new Hazards that were previously not foreseen?
• Are the P 1 and P 2 estimations still valid?