I have recently been involved in a situation concerning syringes supplied by a sponsor for a CTIMP and thought it would be useful to share this with the group. We are involved in an international trial with a US pharmaceutical company as the sponsor. As part of the trial, the sponsor provides sites with ancillary kits containing diluents and syringes (for reconstitution and administration by participants). When these kits arrived on sites, pharmacy noticed that the syringes provided did not have an expiry date (and subsequently worked out that they are not CE marked), and therefore does not meet the legal requirments in the UK.
- There are differences between FDA and EU requirements for medical devices such as syringes. Expiry date is not a requirement in the US.
- Despite being manufactured by an multinational corporation, products may not be approved for distirbution or use in all regulatory jurisidictions. Syringes available in the US are not always available in the UK.
- It was extremely challenging to find identical syringes in the UK (there are so many different standard syringes on the market). As well as ensuring that all of the syringes components are comparable in terms of materials, we had to consider gauge of needle, length of needle, and the insturctions on how to use the syringes.
- As the patient dosing guide, administration video, and other trial related documents were based on using 3ml syringe, a change to 2ml syringe required substantial admin. work on making the necessary changes to trial related documents as well as requiring an amendment to REC and the video remade.
The sponsor has certainly learnt a lot from the incident. Equally, we need to be viligent with such supplies as they bypass the governance process inherent in our routine supply chains. It would be useful to share this with our nursing colleagues as ancillary supplies like syringes are often sent directly to them.
Paediatric Clinical Trials Pharmacist, NIHR CRN: Children