In the report First Do No Harm, Baroness Cumberlege described the health system as disjointed, siloed and unresponsive. Many changes have taken place since the publication of her report in 2020, not least the establishment of my role as the Patient Safety Commissioner.
At the same time, there has been an increasing desire for new innovative technologies to be made available to patients through the MedTech Strategy published in February of this year. However without straightforward and reliable reporting routes in post-marketing surveillance of new technologies, patient safety could be put at risk.
The recent Health Service Safety Investigations Body (HSSIB) report Risks to medication delivery using ambulatory infusion pumps – design and usability in inpatient settings includes the following safety recommendation: ‘HSSIB recommends that NHS England and the Medicines and Healthcare products Regulatory Agency work together to develop an effective mechanism for sharing medical device related incident data, including where devices function as designed.’
The MHRA collects and monitors voluntarily reported information about suspected safety concerns for medicines and medical devices, via the Yellow Card system. It asks for any device involved in an incident to be reported, then gives examples of suspected safety concerns such as someone’s injured (or almost injured) by a medical device, either because its labelling or instructions are not clear, it is broken, or has been mis-used.
Other ways of escalating concerns about a medical device include reporting to NHS England and directly to the manufacturer. Hard pressed staff need a single reporting route that is reliable and shares relevant information for the purpose of patient safety rather than having to make duplicate reports to different regulators and to the manufacturer.
There was an aspiration for reports to NHS England to be shared with the MHRA but since 2014 this aspiration has not been realised due to a mismatch in data fields, which then do not meet the MHRA standard. Instead the MHRA has relied on NHS England to share safety data about devices. It is hoped that the new NHS England Learning from Patient Safety Events (LFPSE) will achieve the goal of direct sharing of information to improve cross-organisational learning and reduce the burden on staff to report multiple times.
Previous reports have flagged other concerns about reporting – that Yellow Card reporting is voluntary not mandatory; that the number of reports is associated with the reporting culture of the organisation rather than the number of incidents; and that people tend to under report, citing human error rather than equipment design.
So what does this mean for the government’s goal of supporting innovation and encouraging thriving, dynamic markets? The words disjointed, siloed and unresponsive apply to the current reporting systems. Until we have mandatory reporting including for devices that are working as designed, we will continue to see avoidable harm occurring to patients. It is vital that the voices and views of patients, clinicians, manufacturer, and health providers participate in the design and delivery of devices. For example, when staff say the device alarm is inaudible in a busy ward, particularly if the syringe driver is placed under the pillow or sheets, this information must be relayed to the manufacturers so they design a product for work as done, not work as imagined.
As a member of the MedTech Programme Board, I have called for the opportunity to bring together the voices of manufacturers, patients and clinicians so these conversations are had at all stages of the process. This is about identifying problems before people are harmed, both patients and staff, as part of developing a safety management system. After a near miss or incident is identified, effective and streamlined reporting systems must be able to detect signals early and then offer swift action through the work of regulators and manufacturers. in this way we will be able to prevent avoidable harm and keep people safe.
For further information see Medical technology strategy – GOV.UK (www.gov.uk)
For details on the Yellow Card scheme see Report Guide | Making medicines and medical devices safer (mhra.gov.uk).