The DCB 0129 and DCB 0160 standards were first published in 2012. And since then, only a couple of minor updates have been made. It’s not surprising therefore that a revision is long overdue, and NHS England has recently committed to a consultation exercise in 2025.
So thinking ahead, what might need to be updated? At Safehand, the standards govern just about everything we do. Weaknesses and ambiguities present a challenge to us and indeed, the entire industry. To that end, we’re going to write a few blog articles on some of the issues that we feel need to be resolved during the update. These ideas are in no way prescriptive, but they are intended to start what I’m sure will be an interesting debate.
Let’s start by looking at a couple of issues, firstly the registration of the Clinical Safety Officer and then some thoughts on document sharing.
The concept of a Clinical Safety Officer or CSO is a fundamental feature of both DCB 0129 and 0160. And, for me, it’s one of the standards’ major strengths and successes. The need for a registered clinician to approve safety documentation adds a very personal sense of jeopardy to the governance process. As clinicians, it certainly makes us think hard when faced with a product whose risk profile appears to be suboptimal.
But there’s a potential ambiguity in the standard with regards who can operate as a CSO. The standard tells us:
“A Clinical Safety Officer MUST hold a current registration with an appropriate professional body relevant to their training and experience.”
This is a perfectly reasonable requirement and implies a strategy for ensuring that the individual is in good standing and has something at stake. But it’s the term ‘professional body’ which often stimulates debate. The term ‘professional body’ is used in everyday life to mean an organisation that represents individuals working in a particular profession, industry or trade. But not all professional bodies are the same.
For example, as a doctor I might be registered with both the General Medical Council and the British Medical Association. Both might qualify as a ‘professional body’. But what we know, through conversations with NHS England, is that the intention here is for the requisite body to possess the power to prevent the registered individual from practising – and of course, that makes sense. The GMC indeed have that power, but the BMA do not. Yet in theory I could be registered only with the BMA and still theoretically meet the requirement.
This nuance has very real implications for some practitioners. For example, there are some health professions such as ‘Psychotherapists’ who may or may not be registered with a body with the power to strike them off. This raises the question as to whether these individuals should be allowed to operate as a CSO.
We propose that NHSE should clarify that the need for registration should extend to a governing or regulating body who has the power to prevent the individual from practicing should the circumstances arise. This could be done by providing a definition accordingly for ‘Professional Body’.
“Professional Body - An organisation authorised to regulate and oversee the conduct and qualifications of healthcare professionals within a specific field.”
Another thorny issue in this area is in relation to the country in which the registration is held. Currently the standard does not specify whether registration must be in the UK or whether a foreign registration is permissible. NHS England have previously indicated that registration outside the UK is acceptable, but personally I have mixed feelings about this. Is it realistic for a CSO, with no knowledge of the NHS and it’s working practices, and with no ability to practice in the UK themselves, to be able to preside over a UK safety assessment? And particularly where the UK has no oversight with regards the rigour or authority of the overseas professional body. Has the time come perhaps to mandate UK registration?
Let’s turn now to a different area in the standard.
“The Manufacturer MUST make available each Clinical Safety Case Report to a receiving organisation, which may be a Health Organisation or another Manufacturer.”
The term in question here is ‘make available’. Now, many manufacturers will faithfully and routinely deliver safety documentation by email to each of their customers and repeat that exercise whenever it is updated. Others are, shall we say, less forthcoming. It can often take a significant amount of effort for Trusts to detect when new releases are coming along and then request and obtain the revised safety case.
A small modification could improve this situation substantially - primarily a need for manufacturers to proactively share new versions of their safety deliverables. Essentially a ‘push’ of the documentation rather than the current ‘pull’. And of course, that is only useful if the documentation is provided in good time ahead of the release to give Trusts the space they need to digest the content and impact their DCB 0160. If this is not practical, then an alternative strategy would be for manufacturers to share an electronic link which always provides access to the most up-to-date version of the reports.
A revised version of the requirement might read something like:
“The Manufacturer MUST share in good time prior to the associated release or make continually available each Clinical Safety Case Report to a receiving organisation, which may be a Health Organisation or another Manufacturer.”
A weakness here of course is that ‘in good time’ is subject to some interpretation but equally it’s important to allow for a degree of flexibility in a project and I wonder if setting an absolute timeframe might be too prescriptive.
That’s it for now. Let us know your thoughts.