In our continuing series where we critique the DCB 0129/0160 standards ahead of the forthcoming revision, we turn now to the subject of incident management.

The DCB 0129 and 0160 standards both have requirements for addressing what is loosely referred to as ‘safety concerns’ and ‘safety incidents’. It’s here in particular that the requirements of the standards are relatively light and largely focus on the mechanics of logging issues and determining any impact on the validity of the safety case. Whilst those are perfectly reasonable expectations, one might expect a little more rigour here.

For me, there are at least of couple of key weaknesses. Firstly, let’s consider the following scenario:

  • Trust A identifies a significant safety-related defect in a supplier’s product.
  • The supplier acknowledges the defect and commits to fix it within a few weeks/months.
  • The supplier issues instructions to Trust A on how to minimise the clinical risk associated with the issue until it’s fixed.
  • The product is also used by Trusts B, C and D but the supplier provides no such information with regards the defect to those customers.

Unfortunately this scenario occurs all too frequently, much to the frustration of many Trusts. In contrast, when it comes to medical devices, this situation just doesn’t really occur. Manufacturers are required to issue notifications called Field Safety Notices and Field Safety Corrective Actions to raise awareness of important product issues. Whilst we’re not suggesting that a full-blown post-market surveillance strategy is warranted in DCB 0129, a requirement for suppliers to notify their customers of important safety-related defects would seem a sensible addition.

We’d also suggest that the traditional Clinical Safety Case Report is perhaps not the best primary vehicle for communicating newly identified issues. A lightweight and timely notification might be more practical in these circumstances setting out the nature of the issue, the potential impact on the patient, any available workarounds, the level of assessed clinical risk, the planned remediation and timescales.

We therefore suggest that the following requirement is added to the DCB 0129 standard:

“The manufacturer must, upon identifying any issues with the potential to adversely impact safety, promptly notify affected healthcare organisations. The notification shall include sufficient information to enable the assessment and mitigation of the associated clinical risk.”

Let’s turn now to the process of remediating safety-related issues and concerns.

The DCB 0129/0160 standards tell us that safety incidents must be ‘reported and resolved in a timely manner’. This is clearly open to significant interpretation. Most manufacturers, and indeed many healthcare organisations, quickly find themselves with a backlog of issues, defects and potential enhancements to address. The art of product management is to decide which of those to include in the next release cycle taking into account commercial objectives, customer priorities, issue severity, statutory changes, etc. For me, the piece that is missing in DCB 0129/0160 is a specific need to include consideration of clinical safety in that prioritisation process. Most reputable suppliers will of course actively prioritise issues with the potential to impact clinical safety. But I believe that this is a sufficiently important concept that it should be called out explicitly in the standard.

We therefore suggest that the current clause 7.2.4 is reworded to:

“The Manufacturer/Health Organisation must ensure that the resolution of safety-related incidents is conducted in a timescale which is proportionate to the assessed level of clinical risk.”

But do you agree? We’d love to know.