The Collective Little Things We Do To Make Products Safer For Patients 

Great things are done by a series of small things brought together.

Vincent Van Gogh

I am Tracey Cammish, Patient Safety and Clinical Intelligence Lead. Within NHS Supply Chain, patient safety is not just a thing that we do, it is a foundational principle of how we do business. Patient safety is everyone’s responsibility. As an NHS Arm’s Length Body whose role is the procurement and supply of high-quality, safe, and fit-for-purpose products which support the care, assessment, diagnosis, and treatment delivery to patients, the patient safety principle of “first, do no harm“ is crucial. 

When a patient safety issue occurs with any of the products we supply, we have a duty of care to respond, investigate and most importantly learn to mitigate issues from occurring again. 

Our product complaints process starts with our Product Complaint Form (See our Useful Links section). This blog highlights the steps taken following a product complaint to bring about change by working together. 

The product complaint (raised on 8 November 2023) was submitted by the trust on behalf of a child’s parent. It highlighted product quality inconsistency, with large variances of graduation measures, with several suction catheters from the same box of catheters.

Internal initial response

On reviewing the product complaint, it was risk stratified as high risk and an initial S.I.R.E.N (Safety InteRvENtion – Safety call to action containment response) was mobilised. 

Why high risk? 

Suction catheters are high volume low-cost items but the function they have is crucial in the care of patients with respiratory disorders. They are used on patients who are not able to remove secretions from their airways themselves (cough). The catheters are passed down into the upper and mid airways either via the nose or mouth, tracheostomy tube or Endo tracheal tube to remove secretions and clear the airways to support oxygenation. The graduations are there to provide healthcare professionals, guidance as to the depth of insertion based on the size of the patient and it is important to point out that airway suctioning is not without potential procedural complications. The graduation markings are a visual guide to support the human factor motor function considerations when carrying out this procedure. More and more patients with complex needs, especially children, are cared for at home by their parents and carers. The clinically technical role of providing airway suctioning, which is carried out in hospitals by trained health care professionals, is now a requirement of mums, dads, relatives and carers who are, in the main, not trained clinicians. Therefore, the need for accuracy in these markings to support safe technique becomes more acute. 

You might think, what is the big deal if it’s just a few millimetres on either side? However, when you think about the actual length of a human trachea (windpipe) the length varies. In newborn babies the tracheal length is between 4-5cm (1.5-2 inches), as the child grows, tracheal length average 7-9cm by the age of five into adulthood where the average length of the trachea is 10-11cm. 

When you think about a small child with a trachea that is 7cm a catheter with variations in catheter graduations of +/-1mm to +/- 7mm this is a serious risk. 

SIREN (Safety InteRvEntioN) call 

Collaborative multi-agency working: Colleagues from the Medicines & Healthcare Products Regulatory Agency (MHRA) and NHS England Patient safety team are routinely invited to SIREN calls. However due to the call-to-action approach they can not always attend. The NHS Supply Chain Patient Safety Team always follow up with both organisations to bring them up to speed with the actions that we are taking internally and subsequently what actions we need them to take. The call is also an opportunity to share data across the three organisations with product complaints being raised, not just with NHS Supply Chain but also via the MHRA yellow card route and NHS England incident report. From the SIREN call it was noted that no yellow card had been submitted so we took the action and submitted a yellow card.

Bonding our stock: It was identified that this item was a stocked item. Initially, NHS Supply Chain completed an initial stock check to identify if we had any of the affected lots cited in the complaints within our warehouses. We took the action to bond that stock pending decision from the MHRA regarding a product recall. 

Product recall initiated: MHRA along with suppliers agreed to a product recall of affected batches. An Important Customer Notice (ICN) was issued to the customer with a cut-off point for products to be returned to NHS Supply Chain to issue a credit and supply unaffected product lots. 

Driving change

These product complaints identified that there were no British Standards Institution (BSI) manufacturing standards for suction catheter gradient tolerances, from a manufacturing safety perspective, there was a gap. Manufacturers did not have an ISO standard to adhere to. This work is still ongoing between MHRA and the BSI. Running in parallel to this, we have addressed the opportunity to drive improvements within our sphere of influence to improve safety and drive quality and standards for the products that we procure. Our Clinical Engagement and Implementation Managers (CEIM’s) Ellie Addison and Sophie Brocklehurst within the Medical Surgical category were pivotal in designing our own procurement standards for graduation tolerances within the open suction catheter product specification in time for the new framework launch. See our Useful Links section for a link to the suction catheter framework.

Taking the information and lessons learnt from this complaint process and engaging with suppliers and doing hands-on catheter checking, over two hundred eaches from a variety of different batches within our warehouses were reviewed by Ellie and Sophie with the graduation metrics for each catheter captured. From this intelligence along with conversations with our suppliers, a tolerance level of +/-3mm as a standard specification for the graduations was deemed to be achievable from a manufacturing perspective

Communicating to customers

Running in tandem with this, the power of social media certainly had an impact on parent awareness to the graduation inconsistency issues. The product complaints increased and we had several complaints in quick succession from different trusts reporting the same issues. The graduation markings were inconsistent in measurement from tip to first marking anything from a difference of +/- 1mm up to +/-7mm. 

This activity also highlighted another challenge with the reporting of the graduation inconsistencies, in that there was a variation on how the product issue was being reported. Lessons from this intelligence drove the development of an SOP (Standard Operating Procedure) for our customer services team, to provide to customers, to enable them to submit product complaint information which allowed us to capture consistently the variances reported out in the field. Sophie Brocklehurst CEIM drove the development of this SOP.

We take patient safety seriously. Patient safety is a principle of how we do business and this example demonstrates that NHS Supply Chain’s response to product issues, is a multidisciplinary call to action, both internally and externally with established relationships we have with both the regulator, our commissioner NHS England, and our suppliers. 

We all have a small role to play. In health care, things can and do go wrong, the key thing is that we learn. This suction catheter issue is a great example of how we collectively responded, took action, listened and began driving the small incremental improvements, to make these small but vital pieces of clinical equipment safer for patient care.