The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device alert (MDA) concerning temporary pacemakers and pacing system analysers, manufactured by Pace Medical Inc.
In April 2014, the subcontractor of the manufacturer was audited by its notified body, with the regulatory agency 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 issued to the manufacturer for all devices, except the pacing cables. Any remaining Pace Medical devices purchased by distributors before this date can still be sold to UK hospitals. Servicing of devices already in the field is unaffected by the suspension of the EC certificate.
According to the MHRA MDA, as the manufacturer only holds validation data to confirm compatibility of their own cables with their pacemakers, users are advised to 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. Furthermore, users should consult with the manufacturer or relevant distributors for further information on cable availability, where necessary. 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 the manufacturer's actions before the EC-certification can be restored.
For details, please refer to the following link:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00536-2
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 16 May 2014