Safety recommendation
It is recommended that NHS Supply Chain and the British Standards Institution work together (engaging other system leaders as appropriate, such as the Medicines and Healthcare products Regulatory Agency and NHS England and NHS Improvement), to develop and publish an agreed standard to minimise the risks relating to human errors in the use of pH strips designed for testing human gastric aspirate at the bedside. The standard should consider product design, regulatory standards, procurement practices and human factors engineering to provide a consistent approach that can be embedded within NHS Supply Chain product specifications.
Response:
Summary: BSI, as the UK’s National Standards Body (NSB), fully supports the Safety Recommendation 2020/108 made by the HSIB in report I2019/006, covering placement of naso-gastric tubes. We fully recognize the problem highlighted in the draft report that there is little that can be changed in terms of existing products that are placed on the market, and that the variation in pH strips from different manufacturers will remain a risk for patient safety. We are committed to work with NHS Supply Chain and wider partners to develop and publish an agreed standard to minimize the risks relating to human errors in the use of pH strips designed for testing human gastric aspirate at the bedside. Detailed actions and timescales for completing this are outlined below. We will keep the HSIB informed of the results of these meetings and discussions.
Action: NHS Supply Chain are taking immediate action to mitigate the risk of error in the use of inconsistently manufactured strips which will need to be endorsed by NHS England and Improvement (NHSE/I) along with agreement of a plan of implementation being agreed in respect of narrowing the products available in Trusts and supporting such an approach with guidance and/or training. NHS Supply Chain will work with NHSE/I to achieve this, as required, including on products supplied through the Supply Chain but noting that direct purchasing by Trusts would also need to be addressed in line with any agreed approach. MHRA will also need to endorse the new standard and include as a requirement in future regulations for products supplied for the identified indication. Timeline: Q2 2021.
Action: BSI and NHS Supply Chain will collaborate with NHSE/I and MHRA to facilitate a forum that will address how industry can provide a standardized approach as part of a wider solution that mitigates the risk and ensure all products supplied for this indication meet the defined standard to ensure consistent application of the standard by suppliers/manufacturers with an interest in this product category. The stakeholders working directly with BSI’s invitro-diagnostic standards committee represent industry professional bodies, regulators, NHS, charities and patient groups (via our consumer network). For the purposes of the forum BSI will draw on their expertise where appropriate. This initiative will be cognisant of user need, changing UK regulations and industry capacity given the international nature of manufacturing. This is likely to require changes in manufacturing process, supply chain procurement frameworks and potentially also have cost impacts which will equally need to constitute key elements of the consideration of the forum. Timeline: Q3 2021.
Action: Based on the outcomes, BSI, NHS Supply Chain and other relevant stakeholders will work to develop and publish a national standard addressing the safety issues highlighted in this recommendation, ensuring robust and rigorous process and timeframe. Where possible we will align to international standardization activities that are relevant to this topic. Timeline: from Q4 2021.
Response received on 13 March 2021.