Page 214 - Safety Risk Management for Medical Devices

CHAPTER 24

Production and Postproduction

Monitoring

Abstract
ISO 14971 requires that manufacturers collect and evaluate information about the medical device
or similar devices, in the production and postproduction phases. The US CFR, title 21, part 822 has
similar requirements. Patient/user safety is enhanced by active surveillance of production and post-
production information about marketed products. The manufacturer also receives significant benefit
from the surveillance, namely, the opportunity to quickly identify and rectify product/process
defects. This in turn leads into reduced customer complaints, reduced field corrective actions,
improved reputation and customer loyalty, which means higher sales. And if that’s not enough
motivation, failure to perform product surveillance could result in substantial fines, criminal prosecu-
tions, seizure of product, and closure of the business.
Keywords: Postmarket risk management; production and postproduction monitoring; surveillance;
CAPA; HHA; risk management file review

Clause 9 of ISO 14971 [3,7] requires that manufacturers collect and evaluate
information about the medical device or similar devices, in the production and
postproduction phases. Similarly, under section 822 of CFR 21 the FDA requires
the manufacturers and distributors of medical devices to perform postmarket
tracking and reporting of device malfunctions, serious injuries, or deaths.
The term “postmarket” is used by the FDA in the United States. ISO 14971 [3,7]
uses the terms “production” and “postproduction.” These terms are roughly equiva-
lent. Fig. 24.1 shows the contrast between these terms.
In the rest of this chapter we’ll use the term “postmarket” interchangeably with
“production and postproduction.”
Production information is collected during the manufacturing process, and post-
production information is collected on all the phases of lifecycle after the product has
been manufactured. The most significant postproduction lifecycle phase is product-
use where majority of the feedback is generated.

Figure 24.1 Postmarket versus postproduction.

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00024-6 All rights reserved. 193