Surgical Devices and Implants Register: GDPR information

Surgical Device and Implant information is administrative and clinical data.

This includes:

• details of the patient, the procedure undertaken on them and clinicians who performed it
• details of specific medical devices implanted, revised, or removed for a patient
• other medical devices used in the treatment of the patient
• post-operative outcome information collected from you by the clinician

The data supports improved patient safety through:

• surveillance of surgical devices and implants
• patient focused activities such as review or recall of specific devices
• quicker identification and investigation of poorer patient outcomes which could be related to a specific surgical device or implant and which may warrant investigation by appropriate bodies

Initially, the focus of data collection will be information relating to Class III and Class IIb implantable medical devices and patient outcome information.

The initial focus will be on pelvic floor procedure in relation to:

• surgical mesh used for pelvic floor surgery (pelvic organ prolapse and stress urinary incontinence)
• prolapsed bladder
• prolapsed uterus
• prolapsed rectum

Other surgical devices and implants used in other specialities may be reported on a voluntary basis.

NHS Digital collects the data and undertakes data quality and data linkage activity before making the data available. The data is made available to the Medicines and Healthcare products Regulatory Agency (MHRA), and other interested parties who have a business need and appropriate legal basis.

NHS Digital also supports reporting of associated clinical data and data relating to pelvic floor surgery. This applies both to surgery involving the use of surgical mesh and alternative procedures not involving surgical mesh. This will be used to analyse and compare patient outcomes relating to the use of surgical devices and implants against alternative procedures not involving a surgical device or implant.

None

• Be informed
  
• Get access to it
  
• Rectify or change it
  
• Erase or remove it
  
• Restrict or stop processing it
  
• Move, copy or transfer it
  
• Object to it being processed or used
  
• Know if a decision was made by a computer rather than a person
  

Consent is not the basis for processing.

Health and Social Care under section 254
GDPR:
Article 6(1)(c) - Legal Obligation (General Powers),
Article 9(2)(g) - Substantial Public Interest
DPA 2018:
Schedule 1, Part 1, paragraph 2 - Health or social care purpose

Further details can be found in the Surgical Devices and Implants Data Collection.