Cardiac pacemakers are used for a number of purposes and in a wide variety of clinical settings, over a number of jurisdictions with varying privacy requirements. Yet the monitoring of the service life of these devices is essential — to project replacement dates and identify performance issues. The ISO 5841-2, “Implants for surgery – Cardiac pacemakers – Part 2: Reporting of clinical performance of populations of pulse generators or leads,” was developed to help manufacturers collect and use performance information for device monitoring and patient management protocols. And a new 3rd Edition has just been released.
First of all, the standard addresses the requirements for reporting of this type of information. Called post-market surveillance, data on performance is routinely collected by manufacturers. So the ISO 5841-2 describes reports to be generated from the collected information. You’ll learn how frequently you should update your reports, where and how you should publish them and what information should be included. This information for reporting is quite detailed, with tables on categories of confirmed malfunctions for leads and on leads performance reporting criteria, for example.
Data collection for this type of use means a dependence on statistical techniques. Annex A addresses the statistical method for survival analysis, as well as a discussion of the application of the results you’ve obtained. This includes a clause on the categorization of devices. And Annex B covers the rationale for the standard, noting the differences in the regulation of patient monitoring information in the U.S. and elsewhere. An additional 16 references for further review are found in the bibliography.
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