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Standards of Practice

Standards of Practice

In November 2013, Professor Sir Mike Richards, Chief Inspector of Hospitals, spoke about his model for hospital inspections  and how the model should be robust, transparent, fair and helpful in order to drive quality improvement.  Sir Mike expressed his support for accreditation and peer review and reiterated the important role accreditation plays in improving the quality, safety and outcomes of healthcare, the patient experience as well as service dlivery.   He cited the information generated by the process of service accreditation, as needing to feed directly into Care Quality Commission (CQC) monitoring processes and inspections.  

The processes of accreditation (such as self-assessment and peer assessment) encourage multidisciplinary healthcare teams to review processes, service delivery and outcomes against professionally agreed standards. Achieving accreditation provides confidence and reassurance to both healthcare professionals and the patients who receive the service: for patients and commissioners it can provide reassurance of the quality of the service and for healthcare teams it is a ‘badge’ of quality indicating confidence in their work and the service they provide. The best example of this process is the Royal College of Physicians Joint Advisory Group on gastrointestinal endoscopy and the Cancer Peer Review.

An additional group relevant to TPFS is Improving Quality In Physiological diagnostic Services (IQUIPS) which has undertaken pilot projects in the following:

  • Audiology, Paediatric audiology
  • Cardiac physiology
  • Gastrointestinal physiology (pilots started in 2012)
  • Neurophysiology
  • Ophthalmic science
  • Respiratory and sleep physiology
  • Urodynamics (accreditation started in 2014)
  • Vascular science

IQIPS has four domains of quality

  • Patient experience
  • Facilities, resources and workforce
  • Safety
  • Clinical

These domains are populated with standards against which services will be assessed. For each specialty, these standards are supported by indicative evidence, guidance and a knowledge management system developed in partnership with the professional bodies, societies and colleges.

The entry point for IQIPS Accreditation is the Self Assessment and Improvement Tool (IQIPS-SAIT) which can be used by services to assess accurately their level of performance in relation to established standards and to continually improve the service delivered. IQIPS service accreditation will involve a peer assessment process that validates adherence of a service to the standards providing assurance of quality to patients and commissioners. Accreditation will set a badge of quality.

This programme will raise the profile of physiological services across organisations, with commissioners and patients. It will validate and recognise success as well as seek to drive up quality - aspiring towards excellence. The programme will also promote sharing of good practice and cooperation across physiological services. The work on the audiology Quality Enhancement Tool (QET) has embedded a culture of self improvement within the audiology community and IQIPS has retained this focus on quality and the philosophy of self improvement. There is huge value and knowledge within QET that IQIPS has built upon to maintain the momentum and success. The experience of working with the QET will help services on their accreditation journey.

The IQIPS model is a four-year Accreditation cycle with an annual self assessment and improvement process (SAIT). A copy of the model can be found in the downloads section below. IQIPS is now open for all physiological services. 

IQUIPS Standards and Criteria 2014

IQUIPS census report 2014

Association GI Physiologists Guidelines on use of HRAM

NICE & Other Guidance

Faecal incontinence

Medical managements constipation/IBS

NIHR guidance on Incontinence Jan 2014

NICE Quality Standards FI Feb FI 2014

NICE guidelines FI 2007

NICE guidelines injectable bulking agents for FI 2007

NICE guidance SNS for FI 2004

NICE guidance on PTNS 2011

NICE Fenix bead bands for FI March 2014

Prucalopride 2010

Lubiprostone 2014

Linaclotide 2013


Uterine/Vault Prolapse

NICE guidance PPH 2004

NICE guidance HALO 2010

NICE guidance Botox for Chronic Fissure 2010

NICE guidance STARR for ODS 2010

NICE guidance biologic fistula plug 2011

ASCRS guidelines on treatment of rectal prolapse 2017

RCOG guidelines on Rx post hysterectomy Vault prolapse 2006

Infracoccygeal sacropexy with mesh 2009

Infracoccygeal sacropexy with mesh for VAULT prolapse 2009

Sacrocolpopexy with hysterectomy 2009

Chronic Pelvic Pain

Urinary Incontinence

Chronic Pelvic Pain Terminology (ICS) November 2014

Guidelines on Chronic Pelvic Pain (EAU) 2012

NICE Guidelines/Quality Standards for Urinary Incontinence Jan 2015

Reporting Adverse Mesh Complications to MHRA

There have been significant concerns about the safety of synthetic meshes for prolapse and incontinence surgery. The MHRA {this is not a Govt agency} have a similar reporting system for medical devices to the “yellow card” drug adverse event reporting system. To date the MHRA have received few reports of adverse events from medical practitioners. 

What is an adverse incident?

The MHRA define an adverse incident as "an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons." In other words any actual or potential adverse event which occurs when employing a device which affects the patient, healthcare professional or other user

What to report

Any adverse incident involving a device should be reported to the MHRA, including problems with the instructions for use or difficulties with deployment, especially if the incident has led, or might have led to:deterioration in health or permanent impairment of body structure or function the necessity for medical or surgical intervention (including implant revision) hospitalisation or prolongation of existing hospitalisation, death, life-threatening illness or injury

For synthetic meshes for prolapse and incontinence this may include:

  • 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
  • These may present to the original operating surgeon but may present later to other gynaecologists, urologists or colorectal surgeons.

Who should report

Adverse incidents can be reported by:

  • Clinicians and healthcare workers
  • Patients and members of the public
  • Device manufacturers
  • Role of medical device liaison officers in NHS trusts

NHS trusts and primary care trusts in England have all designated a member of staff as their medical device liaison officer (MDLO). Their role is to promote and coordinate adverse incident reporting and help to manage the dissemination of medical device alerts. When a device related adverse event is reported to MHRA, the MDLO and/or risk manager should also be informed in line with local protocol.

Confidentiality and data protection

The MHRA does not require patient names or other identifying information in order to carry out an investigation. Healthcare staff reporting incidents should, therefore, ensure that such details are deleted or redacted from their reports, from accompanying attachments and from any subsequent correspondence. The details required by the MHRA are specified on the report forms. The reporter's full contact details (name, post held etc.) are essential, as this allows the MHRA to contact the reporter to acknowledge receipt of the report and request any further information that may be needed.

How to report

The preferred and simplest way to report adverse incidents within England  is via the on-line forms on the MHRA website.

Click here

This also provides facilities for copying the incident through to MDLOs, risk managers or other local relevant staff in compliance with any good practice in local reporting policies. You may however also fax, email or post a downloadable form instead.

Each devolved administration has its own guidance on reporting adverse incidents, available on the respective websites.? Click below:

  1. Follow links to "Devices" then "Medical device adverse incident reporting forms"
  2. Complete form
  3. Inform Trust medical devices liaison officer or equivalent in your Trust. 

Enhanced Consent

Ventral mesh rectopexy 

Preperation and recovery ventral mesh retopexy 

Mesh information 

Ventral Mesh Rectopexy Consent Checklist