Fifteen medical device manufacturers have been given ‘exceptional use authorisations’ to sell to the NHS and social care sector, as the Government moves to ensure a continued supply of vital equipment throughout the COVID-19 pandemic.
The list, which is updated every two months, covers 15 companies and 18 medical devices.
These include Becton, Dickinson & Company’s BD Vacutainer SST Blood Collection Tubes; BREAS’s CO2 Leakage Port with CPAP Connections; GasArc Group’s Oxygen Gas Supply Regulators; and three MagnifEye products from Sensyne Health Group.
Medical devices granted an exceptional use authorisation can be sold to the NHS and within the social care setting to ensure a continued supply of medical devices.
Authorisations will be issued directly to the manufacturer of the medical device and normally do not allow for distributor sales.
And applications are only considered where there is a clear clinical need and no available supply of CE-marked or already-derogated alternatives.
Also included on the newly-released list is Zhejiang Orient Gene Biotech’s Rapid COVID-19 Antigen Self Test; Vygon’s catheters and other single-use medical devices; Venus Medtech’s Transcatheter pulmonary valve and valve delivery systems; Survitec’s Sterile Surgical Gown; SureScreen Diagnostics’ SARS-CoV-2 Antigen Rapid Test Cassette Lateral Flow Device; Perspectum’s Coverscan MD; Numed’s special use of CP covered stents for treatment of sinus venosus ASD; Mercedes AMG and University College London Hospitals NHS Foundation Trust’s Ventura CPAP; Medline Scientific’s Oropharyngeal Swab; the Equinoxe humeral reconstruction prosthesis system from Exactech; the COVID-19 self test to detect infection in asymptomatic individuals from the Department of Health and Social Care; and the M.scio Telemetric Sensor Reservoir from Christoph Miethke & Co.
The list will be updated again in March.
- Companies:
- Vygon
- Becton Dickinson
- Numed Cardiac Diagnostics
- Surescreen Diagnostics Ltd
- Department of Health
- UCLH NHS Foundation Trust
- Mercedes-Benz
- Sensyne Health
- Survitec
- Zhejiang Orient Gene Biotech
- Christoph Miethke and Co
