Ventilators used in the treatment of COVID-19: Information collated by the HPRA
As the competent authority for medical devices in Ireland, the HPRA aims to support healthcare workers and the MedTech sector in their efforts to overcome COVID-19. We are keen to facilitate the continued supply of medical devices to the Irish market by engaging with the relevant stakeholders. The HPRA welcomes meaningful contact and contributions from interested organisations.
The COVID-19 pandemic has increased global demand for the supply of many different medical devices, in particular, ventilators and other critical care equipment. As such, in certain scenarios, some devices may need to be repurposed for the treatment of seriously ill patients. Examples include transport ventilators and anaesthetic machines, which may need to be configured to provide longer-term ventilation to patients. Generally, such use would be considered off-label use, i.e. not in accordance with the intended medical use specified by the manufacturer prior to CE marking. The HPRA is aware, however, that for the duration of the COVID-19 outbreak the repurposing of such devices may be deemed necessary by healthcare professionals to treat patients in need.
It remains preferable that, in as far as possible, health care facilities should use approved CE-marked devices to support patients with respiratory failure. In situations of off-label use, it may be helpful to contact suppliers/manufacturers for information on how best to use their devices. Through our activities as the competent authority, the HPRA is aware of certain manufacturer information which might be relevant for healthcare professionals working with ventilators. This information is summarised in the Healthcare Professional Section below.
In addition, the HPRA would like to highlight specific information which may also be of assistance to the manufacturers of ventilators and anaesthetic machines. This information can be found in the Manufacturer Section below.
Information for Healthcare Professionals
The HPRA acknowledges that the above list provided is not an exhaustive listing of all manufacturers placing ventilators on the Irish market. For further information relating to specific devices, please refer to the manufacturer’s website and consider contacting them directly with any COVID-19 queries.
On-going Field Safety Corrective Actions
It is important to be aware of ongoing field safety corrective actions relating to ventilator devices. Where you are impacted by such actions, you should receive a notification from the manufacturer/distributor. Please see the HPRA Safety Communications page for further details. The HPRA advises that where devices are being recommissioned or repurposed, that the safety history of the device is considered and that necessary FSCA upgrades are implemented where practical. Requests for information in relation to ongoing and previous FSCAs relating to specific devices can be submitted to the manufacturer and to the HPRA at firstname.lastname@example.org.
Please be advised that during the COVID-19 pandemic, delays may occur in relation to implementation of some FSCAs due to worldwide shortages of certain components. The HPRA is also aware that allowing manufacturers on-site or off-site access to critical care devices or taking those devices out of service for a period of time may be challenging in the current circumstances. Where upgrades are not immediately feasible, we advise highlighting awareness in relation to the risks associated with the issue and implementation of workarounds suggested by the manufacturer, to the extent possible.
Information for Manufacturers
The HPRA is cognisant of the challenges associated with manufacturing to meet the increasing demand for ventilators. We are aware that a number of companies are exploring various possibilities, examples include device manufacturers offering to scale up production; general manufacturers offering to make parts and accessories; manufacturers making available design specifications for their ventilators; proposals for novel manufacturing practices (such as additive manufacturing / 3D printing), etc. The Government is collecting all offers of support on behalf of the whole of the public service, including the HSE, in a single location. Any offers of support should be directed to the office of government procurement at gov.ie/covidsupplies where details can be submitted about the support that you are offering to provide.
The HPRA has published guidance on our dedicated COVID-19 webpage, which includes information on market access for non-CE marked medical devices.
The Anesthesia Patient Safety Forum in the USA has produced a ‘Frequently Asked Questions’ document relating to the use of anaesthesia machines as critical care ventilators.
FDA Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
European Commission guidance document on conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19.
TGA COVID-19 information for clinicians on ventilators and alternative strategies when in short supply.
MHRA information – Anaesthetic machines: off-label use during the COVID-19 pandemic.
Contacting the HPRA
Please refer to the HPRA website for further information and guidance in relation to the regulation of medical devices in Ireland. Should you wish to contact HPRA Medical Devices please do so via email@example.com.
Incidents or concerns relating to a medical device can be submitted through the HPRA’s online reporting system.