Pelvic Floor Registry and Surgical Devices and Implant data to support medical device safety vigilance

Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care (DHSC), requires access to the NHS England dataset Surgical Devices and Implants Data Set (SDIDS) to conduct exploratory data analyses for the purposes of assessing the value in the safety vigilance of pelvic mesh or tape devices.

This project explores the feasibility of the use of this data set to support MHRA’s vigilance and surveillance of pelvic mesh products. The results of this project will provide insight into the strengths and limitations of the data within the SDIDS and Pelvic Floor Registry for the purposes of supporting device vigilance.

The SDIDS was set up to address Recommendation 7 from the Independent Medicines and Medical Devices Safety (IMMDS) Review “First Do No Harm” in relation to the Review’s investigation of the medical device, pelvic mesh. The pelvic mesh was used to manage pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The pelvic mesh was used to support pelvic organs and each indication of use might involve a different type of device and operation to fit the device. Concerns were raised around the use of transvaginal POP mesh, leading to restrictions of use both in the UK and internationally. In 2017, all transvaginal POP mesh surgeries were stopped and have subsequently been restricted to use in research trials. In July 2018, a halt to mesh procedures for SUI was recommended by the IMMDS Review and this recommendation was implemented by NHS England and DHSC. The use of SUI mesh was restricted to use in exceptional circumstances and under high vigilance.

A key point identified by the Review was the limited information on the number of women fitted with a pelvic mesh product and missing information around the patient outcomes relating to these procedures, meaning the extent of complications is not fully known. Under the recommendation of the Review, NHS England undertook a retrospective experimental audit of pelvic mesh procedures conducted between April 2008 and March 2017 using Hospital Episodes Statistics (HES). The audit included follow-up of patients who had undergone these procedures, but it was acknowledged that this data was likely incomplete and did not include private healthcare.

The following NHS England data will be accessed:

· Surgical Devices and Implants Data Set (SDIDS) including the Pelvic Floor Registry module embedded within the SDIDS dataset - necessary to identify the number of surgical procedures conducted using pelvic mesh or tape devices [and/or the number of alternative non-surgical procedures] for the indication of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). The number of procedures recorded will enable the study investigators to assess the feasibility of conducting safety vigilance of pelvic mesh or tape devices in this dataset.

The Pelvic Floor Registry derived from SDIDS should provide valuable data on the usage of pelvic mesh and its alternatives, and on clinical outcomes associated with the use of such devices. This data source should provide a detailed record of the number of patients who have undergone pelvic mesh procedures and support monitoring of any clinical complications associated with the use of the pelvic mesh product.

The level of the data will be:

· Pseudonymised

The data will be minimised to all pseudonymised data.

Department of Health and Social Care (DHSC) is the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(i) - processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy.

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The data are processed for two different purposes: Effective regulation of medicines and medical devices (Article 9(2)(i)) and Exploratory Analysis for research purposes (Article 9(2)(j)).

MHRA (an executive agency of DHSC) is a processor acting under the instructions of DHSC. MHRA is responsible for the operation and management of the exploratory analyses described above.

NTT Data UK Limited provides IT infrastructure for MHRA. NTT Data UK Limited manages the Microsoft Azure Cloud technology at MHRA on which the data will be stored. They supply support to the system and therefore have access to the data. NTT Data UK Limited involvement in processing the data is limited to support.

Microsoft Azure Cloud provides IT backup services to MHRA and will store copies of the data as contracted by MHRA.

The data will only be accessed by permanent employees who work in the Epidemiology Unit within the Safety & Surveillance division at MHRA.

No data will flow to NHS England for the purposes of this Agreement

NHS England data will provide the relevant records from the SDIDS and Pelvic Floor Registry dataset to MHRA. The data will contain no direct identifying data items. The data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The data will not be transferred to any other location.

The data will be stored on servers at MHRA

MHRA stores data on the Cloud provided by Microsoft Azure Limited

The data will be accessed by authorised personnel within MHRA via remote access. The data will remain on the servers at MHRA at all times.

Personnel are prohibited from downloading or copying data to local devices.

The data will not leave the UK at any time.

Access is restricted to employees within the Epidemiology Unit of the Medicines and Healthcare Products Regulatory Agency (MHRA). The Principal Investigator is also an employee within the Epidemiology Unit at the MHRA.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The data will not be linked with any other data.

There will be no requirement and no attempt to reidentify individuals when using the data.

Analysts from the MHRA will analyse the data for the purposes described above.

The expected outputs of the processing will be:

• A data specification document from a researcher’s perspective will be drafted as a guide for the Epidemiology team in conducting analyses and interpreting the outputs of these analyses in future research projects using SDIDS data

• Submissions to peer reviewed journals

• Presentations to Devices Expert Advisory Group

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived

The outputs will be communicated to relevant recipients through the following dissemination channels:

• A data specification document from a researcher’s perspective will be drafted as a guide for the Epidemiology team in conducting analyses and interpreting the outputs of these analyses in future research projects using SDIDS data

• Devices Expert Advisory Group, the statutory committee providing the MHRA with advice on the safety, performance, benefits and risks of devices in the UK healthcare system.

• Patient Safety Commissioner

The proposed target date for conducting all analyses, the dissemination and communication of the results of the analyses (including recommendations for the use of the Pelvic Floor Registry and overall SDIDS) to the specified target audience is 12 months from receiving the data.

The analyses conducted under this project would provide MHRA with knowledge and understanding of the data captured in the SDIDS and specifically the Pelvic Floor Registry data module. Based on the evaluation of the data set, the SDIDS and the Pelvic Floor Registry could potentially be used in the MHRA’s routine vigilance activities to monitor the use and the safety of pelvic mesh devices and its alternatives and as such will inform ongoing refinement of the MHRA’s wider vigilance strategy.

The potential vigilance activities introduced include monitoring the number of pelvic mesh and tapes procedures conducted to put into context the adverse incident reports received via the Yellow Card Scheme (YCS), the strengthening of new potential safety signals identified in MHRA’s routine signal detection activities and the use of SDIIS as an additional data source to conduct signal detection activities in. The analyses seek to explore the feasibility of the SDIIS to fit the needs of the MHRA’s vigilance responsibilities in monitoring the safety of pelvic mesh usage in patients. The outcome of the study would assist MHRA in informing the decision-making process for identifying if the conditions outlined in the IMMDS review are met to allow for the pause in SUI operations using pelvic mesh to be removed. If the conditions were not met, it would assist in identifying the gaps in information captured in SDIDS and Pelvic Floor Registry from a regulatory perspective.

It is hoped that the overall impact of this project will provide long-term insights for monitoring the use and safety of other surgical medical devices and implants used in the UK and therefore the potential for strengthening the MHRA’s post-marketing vigilance strategy for medical devices.

Yielded Benefits is not a requirement for new applications.