University Hospitals Birmingham NHS Foundation Trust (UHB) completed a merger by acquisition of Heart of England NHS Foundation Trust (HEFT) on 1st April 2018. UHB includes Birmingham Heartlands Hospital, the Queen Elizabeth Hospital Birmingham, Solihull Hospital and Community Services, Good Hope Hospital in Sutton Coldfield and Birmingham Chest Clinic.
Due to historical differences in data collection/reporting across UHB and the former Heart of England NHS Foundation Trust some responses have been provided by hospital site.
Queen Elizabeth Hospital
I am hopeful that you are able to help in my request for information.
The nature of enquiry is related to your organisation’s process for using medical devices outside of the use of manufacturer’s recommendation / licence / CE mark.
Specifically, I am interested in enteral feeding tubes such as gastrostomy and jejunostomy tubes that may be used for feeding and / or drainage. In particular;
1. Does your organisation have an overarching policy or procedure to advise on risk assessment process for devices used outside of the manufacturer’s licence / CE mark?
No, we do not purchase any medical devices without CE mark.
2. If so, can you share this document and the risk assessment for information?
Not Applicable
3. If a risk assessment is done, who is responsible for this? (E.g. Dr, Specialist Nurse)
If we needed to approve use of medical devices that do not have a CE mark this would be done via the Equipment Strategy Group, the Novel Therapies Group or the Medical Director.
4. Is a record/log/database kept for devices that are used outside of the manufacturer’s licence / CE mark?
No
Heartlands, Good Hope and Solihull Hospital
I am hopeful that you are able to help in my request for information.
The nature of enquiry is related to your organisation’s process for using medical devices outside of the use of manufacturer’s recommendation / licence / CE mark.
Specifically, I am interested in enteral feeding tubes such as gastrostomy and jejunostomy tubes that may be used for feeding and / or drainage. In particular;
1. Does your organisation have an overarching policy or procedure to advise on risk assessment process for devices used outside of the manufacturer’s licence / CE mark?
No, we do not purchase any medical devices without CE mark.
2. If so, can you share this document and the risk assessment for information?
Not Applicable
3. If a risk assessment is done, who is responsible for this? (E.g. Dr, Specialist Nurse)
If we needed to approve use of medical devices that do not have a CE mark this would be done via the Medical Devices Group or with the Medical Director’s approval in cases of urgent clinical need.
4. Is a record/log/database kept for devices that are used outside of the manufacturer’s licence / CE mark?
No
