ISO 5841-2:2014
(Main)Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads
Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads
ISO 5841-2:2014 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, hereinafter referred to as devices. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate.
Implants chirurgicaux — Stimulateurs cardiaques — Partie 2: Établissement d'un rapport concernant le fonctionnement clinique de populations de générateurs d'impulsions ou de fils-électrodes
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INTERNATIONAL ISO
STANDARD 5841-2
Third edition
2014-08-01
Implants for surgery — Cardiac
pacemakers —
Part 2:
Reporting of clinical performance of
populations of pulse generators or
leads
Implants chirurgicaux — Stimulateurs cardiaques —
Partie 2: Établissement d’un rapport concernant le fonctionnement
clinique de populations de générateurs d’impulsions ou de fils-
électrodes
Reference number
©
ISO 2014
© ISO 2014
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ii © ISO 2014 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 5
4.1 Frequency of publication . 5
4.2 Method of publication . 5
4.3 Report organization . 5
4.4 Criteria for inclusion and removal of reported models and device families . 5
4.5 Source of performance report data . 5
4.6 Product performance report — Required content . 6
4.7 Adjustment for underreported events. 8
5 Particular reporting requirements . 8
5.1 Reporting pulse generator performance . 8
5.2 Reporting lead performance . 9
Annex A (normative) Statistical method for survival analysis and discussion of application of
results obtained .13
Annex B (informative) Rationale .22
Bibliography .26
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 6,
Active implants.
This third edition cancels and replaces the second edition (ISO 5841-2:2000), which has been technically
revised.
ISO 5841 consists of the following parts, under the general title Implants for surgery — Cardiac pacemakers:
— Part 2: Reporting of clinical performance of populations of pulse generators or leads
— Part 3: Low-profile connectors (IS-1) for implantable pacemakers
iv © ISO 2014 – All rights reserved
Introduction
ISO 14708-2:2012, 28.19 requires the clinician’s manual to document the projected service life using
defined settings. Expectations of available power-source energy are not always fulfilled, and changes
in pulse-generator components and assemblies have resulted in an actual service life which is different
from the projected service life. Defined production groups of pulse generators or leads have required
closer follow-up or replacement due to changes in performance exhibited in clinical use.
Programmed settings and differing or changing patient therapy needs might also result in a device
having more or less than the projected service life as defined by ISO 14708-2. In addition, clinical
management and implant technique can have a significant impact on long term performance of lead and
pulse generators. These variables are reflected in the product performance report data.
These factors underscore the value of maintaining an accurate and discriminating view of clinical
performance of a population of devices within the scope of this part of ISO 5841, so as to aid patient
management. In order to do this, it is necessary to collect implant and explant information as allowed
by local law. Physicians and clinicians are encouraged to report their complaints and return associated
explanted devices to the device manufacturers to support the accuracy of product performance reports.
It is recognized that certain devices are marketed in geographies where device implant and explant data
are not available due to patient privacy laws. This situation requires manufacturers to apply alternative
methods to calculate survival probability.
The primary purpose of this part of ISO 5841 is to describe the reporting responsibilities in sharing clinical
performance information for patient management. When clinical performance reports discriminate by
production group and focus on recent experience, they are of value in patient management.
This part of ISO 5841 concerns the clinical performance of devices, not the clinical reasons for their use.
It is realized that reasons for use can be a guide in the design of future products.
Reporting parties can give cumulative clinical-experience information based on a variety of assumptions
and statistical techniques. This part of ISO 5841 provides a method for categorizing devices, requirements
for the statistical techniques (see Annex A) that shall be used to obtain the most benefit from the data
and a statement of the rationale (see Annex B) for this part of ISO 5841.
Clinicians have emphasized that a device whose performance has changed, either expectedly or
unexpectedly, is sometimes left implanted due to other medical considerations. Instances exist where the
performance of a device has changed to stable but out-of-specification performance that is considered
safe and effective by the attending clinician. This is an important reason why the term “failure” is
avoided throughout the classification.
“Failure” is not sufficiently specific to express the significance of a change in performance. In addition,
“failure” implies a negative connotation for pulse generators that meet all longevity claims and cease
functioning due to normal power-source depletion.
INTERNATIONAL STANDARD ISO 5841-2:2014(E)
Implants for surgery — Cardiac pacemakers —
Part 2:
Reporting of clinical performance of populations of pulse
generators or leads
1 Scope
This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of
population samples of cardiac pulse generators or leads, intended for long-term implantation, hereinafter
referred to as devices. Devices to be reported has to be market approved in one or more geographies. It
includes general requirements for all reports and supplementary requirements for reports on cumulative
experience with devices and estimates of future clinical performance for devices, when appropriate.
Annex A provides requirements for categorizing devices. It also provides normative requirements
for statistical calculations, including a discussion of application of the results obtained. As with other
statistical methods, the benefit of the analytical methods in this part of ISO 5841 is limited by the size of
population under consideration. Annex B gives the rationale for this part of ISO 5841.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 14708-2:2012, Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14708-2 and the following
apply.
3.1
advisory notification
any action taken to inform the clinicians concerned by a manufacturer who has become
aware that a device might fail to conform to any claims made relating to effectiveness, benefits,
performance characteristics, or safety
3.2
clinical performance period
calendar period, defined by the reporting party, during which the clinical performance of a specific
population sample of devices is assessed
3.3
complaint
any written, electronic, or oral communication that alleges deficiencies related to the identity,
quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for
[15]
distribution
3.4
confirmed malfunction
malfunction of an implanted device, confirmed by returned product analysis, not including induced
malfunctions
3.5
damaged
having characteristics which have changed outside the limits stated by the manufacturer,
due to some external agency
3.6
device
cardiac pulse generators or leads, intended for long-term implantation
3.7
device family
specified group of device model numbers with the same indications for use and designs that differ only
with respect to parameters not reasonably expected to significantly affect malfunction incidence or
longevity, such as pulse generator header differences or lead length
3.8
follow-up centre
medical centre, hospital, clinic, or individual responsible for the care of a patient after the implantation
of a device
3.9
implanted
status of a device after the surgical incisions are closed (implant pocket closed); if relevant clinical details
are not available to the manufacturer, at least one calendar day shall have passed after the implant date
in order to classify the device as implanted
3.10
implant damage — leads
damage which occurred after opening the lead package and during an attempt to implant the lead, i.e.
the implant was not completed using the lead in question
3.11
induced malfunction — pulse generators
device malfunction caused by external factors (e.g. therapeutic radiation, excessive physical damage,
etc.) including but not limited to hazards addressed in product labeling
Note 1 to entry: Damage to a pulse generator caused by a
...
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