Safety recommendation
HSIB recommends that the Medicines and Healthcare products Regulatory Agency works with the manufacturers of electronic prescribing and medicines administration systems to provide guidance on their obligations under the Medical Devices Regulations 2002 (as amended).
Response:
The Medicines and Health products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care which is responsible for ensuring that medicines, medical devices and blood components for transfusion meet relevant standards of safety, quality and efficacy. We help to educate and inform the public and healthcare professionals about the risks and benefits of medical devices leading to safer and more effective use.
We welcome this report and thank the HSIB for drawing this patient safety event to the attention of manufacturers and users of electronic prescribing and medicines administration systems (ePMAS).
Depending upon the how the product is intended to be used, ePMAS are likely to be regulated as a medical device and to need to comply with the Medical Device Regulations (2002).
We have already published guidance on software as a medical device and we welcome enquiries from manufacturers about their products and the requirements of the Medical Device Regulations, in order to provide guidance in interpreting the rules. However, it remains the responsibility of the manufacturer to ensure that medical devices placed on the market meet the regulatory requirements and that they are registered with the MHRA.
We will proactively review the ePMAS market to assess the regulatory status of products supplied to the NHS and identify those manufacturers who may need specific guidance from MHRA to ensure that their products, the labelling and the instructions for use are in conformity with the Regulations and in particular where the product is indicated for use in special populations such as children for example. This may result in the need for the manufacturer to work with a Notified Body or UK Approved Body or to take account of this population in risk management procedures and when generating clinical evidence.
We have embarked upon an ambitious programme of regulatory reform to ensure that medical device regulation is fit for purpose for software, which will provide further clarity on some of these matters.
Actions planned to deliver safety recommendation:
- Work with NHSX to identify suppliers of ePMAS to the NHS in England. MHRA will then contact those manufacturers and review the regulatory status of their devices, by 31 May 2022 with other dependency NHSX.
- Consider the most appropriate way to provide additional guidance to those manufacturers who may need to undertake remedial work to ensure that their products comply with the regulations. This could be through a webinar or workshop or on a one to one basis.
- The MHRA have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, which should provide further clarity on some of these matters. Published 26 September 2021.
Response received on 26 May 2022.
Actions delivered:
The MHRA produced a drug safety update in January 2023 in response to this safety recommendation.
The MHRA has been undertaking work with manufacturers of ePMAS devices to improve reporting of potential errors with ePMAS to MHRA, to reduce these risks. ePMAS products and other software, apps and Artificial Intelligence intended to be used for a medical purpose are likely to be medical devices.