Transvaginal mesh implants independent review: final report

Chapter 8: Adverse event reporting

Update Since Interim Report

A National Safety Alerts Oversight Group met for the first time in February 2016, managed by Healthcare Improvement Scotland ( HIS) with multiple stakeholders. The aims are to:

• support improvements in implementing safety alerts and
• provide an overview of the improvements that have been implemented as a result of these alerts.

In Scotland there is a statutory duty of candour procedure which was enacted as part of the Health (Tobacco, Nicotine, etc. and Care) (Scotland) Act 2016, receiving Royal Assent on 6 April 2016. This provides the legal basis for the procedures that will be followed by organisations providing health and social care in Scotland when an unintended or unexpected incident that results in death or harm has occurred.

http://www.legislation.gov.uk/asp/2016/14/part/2

The use of the unique device identifier in NHSScotland for patients who receive implants remains an active project. The new consent form included in the SUI leaflet prompts the consultant to provide information on the specific device implanted, so that the patient can refer accurately to their device in future.

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, to inform local learning systems, and to add to the information necessary for the regulation of medical devices. It is recognised that there is under-reporting, and there are therefore a number of work programmes in development to improve the situation. This chapter describes the background to adverse event reporting, the on-going work programmes, and the specific requirements for reporting incidents that concern 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 members involved in that care. The learning is best managed locally but must be shared more widely if there are more generalised lessons. As there was a diversity of systems and definitions in place in 2012, the Scottish Government tasked HIS to develop a framework, examine current practice, and support developments. The framework included a definition ^[12] , which must be clear, be 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 be 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/pages/information/reporting-device-complications-to-the-mhra/104
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, i.e. 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 ( i.e. not routinely collected) reporting systems such as the Yellow Card scheme suggest that only around 20-25% of serious and severe reactions, and around 5% of less serious events ^[13] are 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.

There is a range of reasons adverse events may occur during or after surgery; these include characteristics of the patient, expectations, pre-and post op care, the surgeon, the hospital, and the device itself, where one is used.

Some events are very rare, for example the association of breast cancer with breast implants. This cancer type accounts for less than 1% of all breast malignancies. Such rare events (in this example there were less than 150 cases worldwide and between 5-10 million breast implants used) require the accumulation of data on very large numbers of patients in order to establish an association between a medical device and an adverse event.

In contrast, some adverse events, whilst rare in themselves, may occur commonly with particular procedures. For example, using a connector that is intended for venous access to inject drugs into the spinal cord led to immediate deaths; this was the rationale for the production of new small tube connectors for health services around the world.

From the studies on adverse event reporting on devices and drugs ^[14] 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; and
• undergraduate and postgraduate training.

In NHSScotland all organisations should have a management system for reporting, reviewing and learning from all types of adverse events. This includes clinical events involving patients, families, staff and carers (including health and safety, accidents or incidents) and non-clinical events (including information governance, health and safety at work and finance).

Adverse event reviews are not about apportioning blame. The aim is to review the care provided to determine whether there are learning points for the organisation or organisations to improve the service. Organisations then need to implement the improvements identified to support a greater level of safety for all people involved in its care systems.

Leaders should make a clear, public commitment to staff that the organisation fully supports an open and fair culture. When things go wrong, staff need to feel able to be open, that they will be treated fairly and they are supported to identify the failures in the system and improve service delivery.

The process must be transparent and include all those involved in the adverse event: patients, service users, families and carers, and staff. To support this, significant adverse event review reports should be shared with everyone involved in the event, and a one-page learning summary completed and published in order to share key learning points more widely. 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; and simple online reporting to national bodies.

A number of countries in Europe have voluntary 'bottom-up' reporting systems for orthopaedic adverse events which reportedly show useful outcomes, but the examples have not been demonstrated.

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/services/incident-reporting-and-investigation-centre-iric-1/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. When patients report an adverse event they may not know which type of implant they received, and this information therefore needs to be shared and made 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 Health 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 the MHRA is aware of a report from a resident in Scotland, it 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 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 the present job plans of consultants.

8.3 Assessment

There is a range of current activities to support and improve adverse event reporting in NHSScotland and across the UK. This includes:

• local system improvements;
• electronic track and trace methods;
• multi-professional guidance;
• mandatory systems of candour; and
• MHRA and NLRS initiatives.

8.4 Professional guidance and feedback to clinicians and patients

Research has shown that if those making a report gain feedback on the value and use to which reports are put, further reporting is encouraged. The Chief Medical Officer endorsed the British Association of Urological Surgeons' ( BAUS) letter of March 2016, which required the collection of data including SUI to six national urological databases. The guidance was addressed to all urological surgeons practicing in Scotland, and required data input by surgeons as an extension to the 'op note'. A letter was also issued to the Medical Directors and Chief Executives of the Health Boards.

Providing feedback on the value of a report, as opposed to merely acknowledging a notification, requires additional systems to be in place. The MHRA is presently working with manufacturers to investigate the release of data to external bodies, including those who submit reports.

IRIC provides regular reports on the annual number of incidents it has reported. The detail is high level, and dependent on the quality and completeness of information received. The feedback needs to be used at quality assurance meetings and shared among Health 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 Health Board's incident reports.

The development of the NHS England patient safety incident management system is currently managing a change scenario with the move to NHS Improvement ^[15] . The aims were to 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 to improve the quality of support provided by the national patient safety function, in order to enable more learning and improvement in all organisations at all levels.

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

NHSScotland is committed to making reporting easier and to increasing clinicians awareness of what to report. This is intended to encourage clinicians and patients to report more often and to increase their confidence in the system. For clinicians this may need:

• further training on adverse events reporting in addition to the letters already sent describing mesh adverse events;
• inclusion of physiotherapists in reporting information;
• discussion on pathways and administrative support to ensure that 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 Legislation

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 effect 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 IR, there are pros and cons to this approach. The policy development process would assess the pros and issues, based on available evidence.

Pros

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 (penalties are contrary to the Scottish Patient Safety Programme and the policy position on duty of candour).
• 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 IR 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). The data would need to be examined locally for actionable learning and change.

Pros of routine data

Routine data on a range of health interventions in Scotland is gathered by trained data collectors (in hospitals), and by electronic systems in primary care, and is then analysed by ISD. This system has been in place for decades (for example the cancer registry has been running since 1958). The systems are regularly updated and funded. ISD is working on data for the IR and this level of information could be provided on a regular basis to multi-disciplinary teams or the Expert Group. In addition, 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 presently set-up to analyse all areas that are of interest to mesh implant patients. In addition, routine data may not be 100% completed. Changing coding can take time and place demands on 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 Health Boards' IT systems do not currently allow access.

Summary

Adverse event reporting and analysis for clinical care in general remain a key aspect of the Patient Safety Programme and local learning methodologies. The reporting of adverse events is therefore mandatory, in line with The General Medical Council's Good Medical Practice which states that, to help keep patients safe, clinicians must:

"report adverse incidents involving medical devices that put or have the potential to put the safety of a patient, or another person, at risk."

http://www.gmc-uk.org/guidance/good_medical_practice/systems_protect.asp

Further, in paragraph 47 of the Prescribing guidance, the GMC states that the MHRA must be informed.

Clinical activities must be recorded, in accordance with Good Medical Practice paragraph 19.

There is a range of activities being undertaken in NHSScotland and the UK to further improve the current levels of reporting, including:

• additional training on what and how to report;
• exploring quality indicators and additional data requests led by multi-disciplinary teams and shared across Scotland;
• implementation of the UDI/ implant systems including access to this information by patients;
• devising guidance for enhanced appraisal;
• improving the use of the current BSUG database and noting CMO's guidance on the use of the BAUS database;
• pathways guidance which must include time allocated in job planning;
• legislation for reporting; and
• a standalone data system.