Dr Diana Mansour on the Introduction of National Safety Standards for Invasive Procedures to Patient Safety Incidents

Posted 27 Apr 2018

Date: 27 Apr 2018

Author: Dr Diana Mansour

Improving patient safety, NHS campaigns and the WHO checklists of 2009.

Improving patient safety has been one of the main focuses of the FSRH Clinical Standards Committee and the FSRH Clinical Effectiveness Committee over recent years. The NHS has also initiated a number of campaigns since the launch of the Never Events Framework in 2009 with the goal of increasing patient safety ‘by encouraging greater transparency and accountability following serious patient safety incidents’. WHO checklists were introduced in 2009 to reduce morbidity and mortality in the theatre setting, but there are still a significant number of preventable events reported each year.

The National Safety Standards for Invasive Procedures guideline (1) (NatSSIPs) discusses national standards for all invasive procedures during which a never event might occur. These are not limited to the operating theatre setting. Providers of clinical services are now expected to produce ‘localised standards that satisfy the new national guidance’, for all invasive procedures to further improve patient safety. For Sexual and Reproductive Health this will include localised standards for the fitting and removal of intrauterine contraceptives and implants. The FSRH Clinical Standards Committee will be looking to provide examples to help clinicians in primary and community services.

FSRH Tech ImageThe NatSSIP guideline states that education is a key component of each local guideline, to ensure uniformity in how staff are trained to perform these different procedures. Clinicians performing each procedure should be identified and there should be regular assessment of their capability to undertake this procedure with it being documented and provided at the clinician’s appraisal. The FSRH qualifications, such as the FSRH Letters of Competence in Intrauterine Techniques or Sub-dermal Implants, along with the updating of these qualifications, provide that assurance.

The publication (1) also suggests that a local Action Log is maintained to record the complications and problems encountered during each procedure to monitor safety and provide information about important learning points that can be disseminated through teaching sessions.

Never events have also been redefined (2) and now give examples of sexual and reproductive health events that will now be classified as a ‘Never Event’. Never Events are now defined as ‘Serious Incidents that are wholly preventable because guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and should have been implemented by all healthcare providers.’

The revised framework goes on to say that ‘each Never Event type has the potential to cause serious patient harm or death. However, serious harm or death does not need to have happened as a result of a specific incident for that incident to be categorised as a Never Event.’

The sexual and reproductive health example listed (3) is where there is ‘the implantation of an intrauterine contraceptive device that differs from the one in the procedural plan.’ The rationale given for this is that ‘the existing barriers to prevent implantation of the wrong implant/prosthesis also apply to intrauterine devices.’ Therefore if a copper intrauterine device (IUD) is fitted instead of a levonorgestrel-releasing intrauterine system (IUS) or vice-versa without the agreement of the patient to this change this will be seen as a Never Event. One might argue that severe harm is unlikely if an IUD is fitted rather than an IUS but if this results in heavy menstrual bleeding and anaemia results this will impact the health of the woman. For others with religious or cultural objections to infrequent menstrual bleeding or amenorrhoea fitting an IUS rather than an IUD may result in a second procedure to change the device and the potential small risks associated with this unnecessary procedure. The list of ‘Never Events’ have also been corrected so that the fitting of a contraceptive hormone in the wrong arm will no longer be a Never Event as ‘severe harm/death is extremely unlikely.’


1. National Safety Standards for Invasive Procedures 7 September 2015  
2. Never Events Policy and Framework Revised January 2018  
3. Never Events List 2018