In this monthly update, we highlight selected Medical Device Alerts that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.
The following alerts were recently issued:
FreeStyle Libre flash glucose sensor – Use of barrier methods to reduce skin reactions to the sensor adhesive (MDA/2019/003). Issued 29 January 2019. Manufactured by Abbott – some users who are experiencing an immune response (including skin hypersensitivity reactions) to the adhesive are applying creams, patches, or sprays under their sensor to reduce skin reactions, which may affect device performance.
Actions given in the alert:
- Identify patients who have reported or may be experiencing skin reactions to their glucose sensor, which may include erythema, itching, and blistering
- Consider if continued use of this device for patients with skin reactions is suitable.
- Consider use of alternative glucose monitoring systems for these patients.
Arjo Minstrel passive floor lift (portable hoist) – risk of spreader bar detachment from lifts without a scale (MDA/2019/004). Issued 30 January 2019. Manufactured by ArjoHuntleigh AB – spreader bar may detach from the lift arm during patient transfer with the potential for serious injuries to the patient.
Article citation: Drug Safety Update volume 12, issue 7: February 2019: 5.
Published 18 February 2019