Transvaginal mesh implants independent review: interim report

Chapter 8: Adverse event reporting

8.1 Situation

Reporting adverse events in NHSScotland occurs through a range of statutory and governance procedures. The reports can be initiated by a number of healthcare professionals and patients. The aim of reporting on medical devices is to improve patient safety and for two different functions: to aid local learning and to add to the information necessary for the regulation of medical devices. It is recognised that there is under reporting so there are a number of work programmes in development to improve the two functions. This chapter describes the background to adverse event reporting; the on-going work programmes and specific requirements for reporting incidents with respect to transvaginal mesh implants.

8.2 Background

What Every patient is an individual and as such may react to medical treatment in different ways. All interventions in healthcare carry a measureable risk. Reporting adverse events from clinical care is the responsibility of the individual team involved in the care. The learning must be managed locally but shared if there are generalisable lessons. As there is a diversity of systems and definitions in place in 2012, the Scottish Government tasked Healthcare Improvement Scotland (HIS) to develop a framework, examine current practice and support developments. The framework included a definition^[15], which must be clear and agreed with patients, and consider near misses. http://www.healthcareimprovementscotland.org/our_work/governance_and_assurance/management_of_adverse_events1.aspx

For the purposes of this paper an adverse event should be considered as adverse signs and symptoms recorded by the patient or the clinician and considered as a consequence of the insertion of transvaginal mesh. To help identify what should be reported the British Society of Urogynaecology (BSUG) lists adverse events from the use of synthetic meshes for prolapse and incontinence at http://bsug.org.uk/MHRA.php i.e.

• Vaginal exposure
• Erosion into the urinary tract
• Erosion into the bowel or rectum
• Infection
• Pain
• Fistulae
• Mesh shrinkage
• Organ perforation
• Nerve or vascular injury
• Sexual difficulty

Why The main function of adverse event reporting is early detection of new, rare or serious problems with a device. Manufacturers have a statutory duty to conduct post market surveillance ie follow-up, via their sales, complaints, research and reports data. Clinicians and patients using the devices provide individual feedback. Reporting is however not universal. Research on the reporting of adverse drug reactions to spontaneous (ie not routinely collected) reporting systems such as the Yellow Card scheme suggest that around 20-25% of serious and severe reactions are commonly reported, with around 5% of less serious events^[16] officially reported. This research found that a number of clinicians did not report if the reaction was known at the time the drug was on the market.

When a problem occurs after surgery there are a range of reasons why including characteristics of the patient, expectations, pre-and post op care, the surgeon, the hospital, as well as the device.

Some events are very rare, for example the association of a type of breast cancer, and breast implants. The cancer accounts for less than 1% of all breast malignancies and is found in association with breast implants. This rare event (there were less than 150 cases worldwide and between 5-10 million breast implants used) needs the accumulation of lots of data on adverse events in association with a medical device.

In contrast, single cases of using a wrong connector to inject drugs into the spinal cord area as opposed to the vein led to immediate deaths and now is the rationale for a whole new production of small tube connectors for health services around the world, including in the NHS.

From the studies on adverse event reporting on devices and drugs^[16] mechanisms to improve reporting are:

• improved feedback - why the report mattered, what else has been reported
• peer acceptance and training in practice
• easy electronic methods of reporting
• greater range of notifiers, including patients
• Undergraduate and postgraduate training

These mechanisms are in variable practice in NHSScotland. Examples are professional groups working with data in quality assurance schemes, for instance in general surgery; the enhanced appraisal system all doctors must have for their revalidation to discuss their outcomes; Yellow Card promotion for reporting by patients; simple on line reporting to national bodies.

In addition a number of countries in Europe have voluntary 'bottom-up' reporting systems for orthopaedic adverse events, demonstrating good outcomes.

How Notification of adverse events is used for the trend analysis work of the regulator and investigators. There is a simple online process to MHRA (Yellow Card) and the Incident Reporting and Investigation Centre (IRIC) in NHSScotland. The Yellow Card is a reporting mechanism used for over 50 years for gathering adverse events associated with medicines and has been extended to medical device users https://yellowcard.mhra.gov.uk/.

MHRA has recently embraced media technology to improve functionality and reporting of medicines events https://www.gov.uk/government/news/digital-evolution-for-ground-breaking-yellow-card-scheme

In Scotland it is currently expected that professional groups will report to IRIC via this link (also on the MHRA webpage) http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/how-to-report-an-adverse-incident/

Once an event is notified it will be examined electronically for necessary information such as the device type and symptoms. If patients report they may not know which implant they received. This information needs to be shared and easily accessible. The track and trace element of medical devices is currently managed through details entered into the operation note. It is a legal duty to keep these records. Most commonly these are still kept in paper form and full details are not necessarily communicated to a patient or their GP. An improvement to the track and trace is the unique device identifier (UDI) work to store this information in a patient electronic record (either the hospital record, SMR01 or the GP record).

Where The long term aim is for one report on an adverse event to be made locally when it happens and fed into local learning systems and at the same time transmitted to all other necessary users (patient safety groups, IRIC and MHRA in terms of the medical device). Adverse events ideally should be reported through a local NHS Board's incident report form which feeds into all necessary databases but currently this is not the case due to IT and confidentiality issues.

Where reports are made to IRIC by professionals, these are shared on a regular basis with the MHRA as the UK regulator. Equally if MHRA is aware of a report from a resident in Scotland, they will inform IRIC so both systems have comparable and timely information.

When Reports can be made at any time in the life of an implant. Most patients who receive surgery are discharged to the care of their GP and are not routinely followed-up in hospital outpatient departments. Even new symptoms seen in patients in outpatient departments may not be recognised as adverse events. New symptoms will require primary and secondary care knowledge of adverse events that should be reported and the requirement to report. In future, once the unique device identifier (UDI) system is in use, a change to or removal of an implant will also be noted. Once an adverse event report has been fully reviewed, it is a legal duty of the regulator to share this with the manufacturers who will respond with a further range of questions, which can require extensive review of the notes. This additional work is unlikely to be accounted for in current consultant job plans.

8.3 Assessment

There are a range of current activities to support and improve adverse event reporting in NHSScotland and across the UK. They include:

• local system improvements
• electronic track and trace methods
• professional guidance
• mandatory systems of candour
• UK initiatives

8.4 Feedback to clinicians and patients

Research has shown that if those making a report gain feedback on the value and use of it, more reporting is encouraged. To get a response on the value of a report, as opposed to just an acknowledgement of the notification, requires additional systems to be in place to give summary information. MHRA are taking forward work with manufacturers to release data to external bodies including those who send in reports.

Currently it is possible to get annual figures of events reported to IRIC but the detail is high level, dependent on the information received which may be incomplete and not useful for specific implant analysis. The feedback needs to be used at quality assurance meetings and shared among NHS Boards. The community of practice on adverse events developed by HIS http://www.knowledge.scot.nhs.uk/adverse-events/sharing-learning.aspx

is gathering interest but it is not yet clear whether individual clinical groups receive feedback on a regular basis from a Board's incident reports.

The development of the NHS England patient safety incident management system has two relevant objectives:

• Improve efficiency by introduction of a single process for reporting patient safety incidents, capturing high quality, standardised data about safety and harm with reduced duplication and omission; and
• Improve the quality of support provided by the national patient safety function to enable more learning and improvement in all organisations at all levels.

http://www.england.nhs.uk/wp-content/uploads/2014/12/nrls-dev-stakeholder-update-dec14.pptx

The Scottish Government remains in dialogue with NHS England as to whether the development would fit our system.

8.5 Resources to report mesh adverse events - staff and follow-up

The NHSScotland is committed to improving the ease and knowledge on reporting so clinicians and patients report more often and have confidence in the system. For clinicians this may need:

• further training in addition to the letters already sent describing mesh adverse events,
• discussion on pathways and administrative support so longer term events are recorded,
• involvement of the multi -disciplinary teams in knowing what and when to report,
• additional guidance on how enhanced appraisals can use better indicators of work in this area for the revalidation assessments, and
• in the longer term, one reporting system (using all forms of communication including apps) that serves a number of purposes and provides regular feedback.

8.6 Legalisation

One of the key requirements from the public petition is a mandatory system of reporting adverse events. In considering a legislative route, we need to demonstrate that we have used all the levers at our disposal to try to affect change and assess to what extent these have been effective. We need to have regard to enforcement, and consider inspection, monitoring and evaluation regimes. As noted in discussions in the Independent Review there are pros and cons to this approach. The policy development process would assess the pros and issues, based on available evidence.

Pros

• The pros are there would be a statutory duty to report.

Issues

• Legislation requires development of the policy. All polices need to be tested against their impact and equality ensuring that one area does not disadvantage another. Policy development needs to take account of current legal frameworks and demonstrate additional benefit.
• Agreement on the rules to enforce the policy with penalties for not reporting.
• Parliamentary time
• Resources (which then would not be available for other services) to develop and to ensure the impact.

Routine data collection versus standalone system

The Independent Review has discussed whether there should be a new mesh database (registry) to collect all the implant data and/or improve the data capture for NHSScotland's routine data collection and analysis (SMR data).

Pros of routine data

Routine data collection on a range of health interventions for the population of Scotland is gathered by trained data collectors (in hospitals) and by electronic systems from primary care and analysed by the Information Services Division (ISD). This system has been in place for decades. The systems are regularly updated and funded. ISD is working on data for the Independent Review and this level of information could be provided on a regular basis to multi-disciplinary teams or the Expert Group. In additional new indicators for performance can be developed for specific topics, and are currently in use for certain cancers.

Cons of routine data

Routine data is not set-up to analysis all areas of interest to mesh implant patients. Routine data may not be 100% completed. Changing coding can take time and other resources.

Pros of a new mesh database / standalone data system

A new mesh database could concentrate on mesh implants and potentially collect more detailed information. The BSUG database is an example of a standalone system which collects a range of information and can be completed in theatre or outpatient departments. It also has the advantage of enabling comparison across Scotland and throughout the United Kingdom.

Cons of a new mesh database / standalone data system

Setting up a new single issue database takes substantial time and resources and therefore requires justification that it is covering an area that has no other support. Having a single issue database does not guarantee all the information of interest can be included, depending on the IT infrastructure used. Setting up a system and then ensuring coverage by clinicians and administrative staff, ensuring confidentiality, transparency and use for patient groups as well as independent analysts is complicated. Standalone data may not be 100% completed. The current BSUG database can only be accessed by members, is not available to general practice and some NHS Boards IT system do not currently allow access.

8.7 Summary

Adverse event reporting and analysis is important for mesh implants and together with adverse event reporting for clinical care in general, requires on-going improvement. There are a range of activities in NHSScotland and the UK to keep improving the current levels of reporting, including:

• Additional training led by the Expert Group
• Exploring quality indicators and additional data requests led by multi-disciplinary teams overseen by the Expert Group
• Implementation of the unique device identifier (UDI)/implant systems including access to this information by patients
• Devising guidance for enhanced appraisal
• Improve the use of the current BSUG database
• Pathways guidance which must include job plan requirements
• Legislation for reporting
• Standalone data systems