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Medical Device Alert: All temporary pacemakers and pacing system analysers (PSAs) manufactured by Pace Medical Inc (MDA/2014/015)

This MDA has been issued as these devices are currently not on the EU market. Their CE-marking has been suspended because of quality system failings.

 

 

All temporary pacemakers and pacing system analysers (PSAs) manufactured by Pace Medical Inc.

These devices are currently not on the EU market. Their CE-marking has been suspended because of quality system failings.

In April 2014, Pace Medical's subcontractor Devices Ltd, was audited by its notified body, BSI, with MHRA present as the observer. The audit found significant quality system failings relating to processes for complaint handling, post-market surveillance and vigilance, which included failures to implement corrective actions agreed at previous audits. As a result of this, on 9 April, the notified body suspended the EC-certification covering all devices manufactured by Pace Medical, except the pacing cables. Servicing of devices already in the field is unaffected by the suspension of the EC certificate.

We are aware that UK hospitals use a range of temporary pacing cables and heart wires with temporary pacemakers. However, Pace Medical only holds validation data to confirm compatibility of their own cables with their pacemakers. Hospitals should continue to make a risk-based decision on the use of alternative, reusable or disposable cables or heart wires, based on availability and clinical need.

The manufacturer is working with its notified body to prepare a corrective action plan to address the identified issues. The notified body will need to complete follow-up audits of Pace Medical's actions before the EC-certification can be restored. If the situation changes, MHRA will issue further information.

Further details HERE.

Be aware that as of 9 April 2014 this manufacturer is not able to sell these devices.

However:
any remaining Pace Medical devices purchased by distributors before this date can still be sold to UK hospitals servicing of Pace Medical devices can continue as before.

Be aware that Pace Medical reusable temporary pacing cables, which have been validated by the manufacturer for compatibility with their temporary pacemakers, remain available for purchase.

Be aware that the compatibility of alternative disposable or reusable cables with these pacemakers has not yet been fully validated by the manufacturer.

Consult with the manufacturer or relevant distributors for further information on cable availability, where necessary.

Consider the implications this has for the future provision of new devices within your hospital.

Action by

All staff involved with the use of these external pacemakers.

 

 

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