(Pace Medical Inc) CE-marking suspended due to quality system failings. (MDA/2014/015)
Action underway: 21 May 2014, action complete: 30 May 2014
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.
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.
All staff involved with the use of these external pacemakers.
This MDA has been sent to:
- Care Quality Commission (CQC) (headquarters) for information
- Clinical commissioning groups (CCGs)
- HSC trusts in Northern Ireland (chief executives)
- NHS boards and trusts in Wales (chief executives)
- NHS boards in Scotland (equipment co-ordinators)
- NHS England area teams for information
- NHS trusts in England (chief executives)
Please bring this notice to the attention of relevant employees in your establishment.
Below is a suggested list of recipients.
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- Adult intensive care units
- All wards
- Cardiac laboratory technicians
- Cardiac pacing technicians
- Cardiology departments
- Cardiology nurses
- Cardiology, directors of
- Cardiothoracic departments
- Cardiothoracic surgeons
- Cardiothoracic surgery directors
- Coronary care departments
- Coronary care nurses
- EBME departments
- Equipment stores
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Medical directors
- Nursing executive directors
- Paediatric intensive care units
- Purchasing managers
- Resuscitation officers and trainers
- Risk managers
- Supplies managers
- Theatre managers
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
- Hospitals in the independent sector
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Manufacturer’s authorised representative
Steven Hanson or Catherine Rose
28 Fiddlebridge Industrial Centre
Tel: 01707 327 641
Fax: 01707 266 677
If you have any comments or feedback on this Medical Device Alert please email us at: firstname.lastname@example.org
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/015 or 2014/002/027/401/003
Guido Fumagalli or Simon Holmes
Medicines & Healthcare products Regulatory Agency
151 Buckingham Palace Road
Tel: 020 3080 7144 or 7240
Fax: 020 8754 3965
Medicines & Healthcare Products Regulatory Agency
151 Buckingham Palace Road
Tel: 020 3080 7248
Fax: 020 8754 3965
How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices
Further information about CAS can be found on the CAS website
Alerts in Northern Ireland will continue to be distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Health Estates Investment Group, Room 17
Annex 6, Castle Buildings
Tel: 02890 523 704
Fax: 02890 523 900
How to report adverse incidents in Northern Ireland
All requests regarding return, replacement or modification of the devices mentioned in this alert should be directed to the relevant supplier or manufacturer.
Other enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
NHS National Services Scotland
1 South Gyle Crescent
Edinburgh EH12 9EB
Tel: 0131 275 7575
Fax: 0131 314 0722
Enquiries in Wales should be addressed to:
Improving Patient Safety Team
Cardiff CF10 3NQ
Tel: 029 2082 5801