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Manufacturer Responsibilities With Remote Monitoring
Manufacturers' role to optimize individual patient care
COR LOE Recommendations
1 C-EO 1. For the care of patients with CIEDs on RM, manufacturers should
provide clinic staff with adequate training, education, and technical
support to optimize individual patient connectivity.
1 C-EO 2. In patients with CIEDs on RM, the manufacturer should provide
an RM system that is reliable, safe, accurate, and meets the needs
of the patient.
1 C-EO 3. For the care of patients with CIEDs on RM, manufacturers
should include key stakeholders in the design and development of
technologies for RM.
1 C-EO 4. For the care of patients with CIEDs on RM, manufacturers
should provide prompt notification of disconnection to the clinic,
and to the patient to restore connectivity.
Manufacturers' role in the management of patient safety
advisories via RM
COR LOE Recommendations
1 C-EO 1. For the care of patients with CIEDs on RM, manufacturers
should contact the managing clinics with details of a safety
advisory and assist in identifying affected patients both
immediately and on a regular basis.
1 C-EO 2. For the care of patients with CIEDs with an advisory and on RM,
manufacturers should provide guidance to clinics on optimal alert
settings to manage the safety advisory.
Support surrounding implantation from manufacturers
COR LOE Recommendations
1 C-EO 1. For patients undergoing CIED implantation, it is recommended
that manufacturers provide adequate resources, including
personnel as appropriate, to ensure enrollment and connectivity
to RM platforms before discharge or within 2 weeks of
implantation.
1 C-EO 2. For the care of patients undergoing CIED implantation, it is
recommended that manufacturer representatives provide the
clinic staff with adequate training to properly program remote
alerts specific to the clinical indication to minimize inappropriate
alerts and need for consequential reprogramming.
