The COVID-19 pandemic has led to many unprecedented challenges for both governments and businesses in the past few weeks. One of the most pressing issues for the National Health Service (NHS) and the United Kingdom (U.K.) Government is the lack of ventilators to assist in treating the most severe cases of COVID-19. The NHS is reported to currently have around 5,000 ventilators, but according to the Department for Health and Social Care (DHSC), the NHS would need three times that amount in the worst-case scenario. The government has therefore asked manufacturers to “rise to the challenge” to manufacture components for the ventilators.
Carmakers such as Rolls-Royce, Jaguar Land Rover, Vauxhall, Honda and Ford, airplane manufacturer Airbus, and many other specialist engineering companies and manufacturers have all indicated that they would like to help where they can. As manufacturers begin shutting down production of their usual products, the government believes this could free up expertise and capacity to make these necessary medical products. Any company, whether a large corporation or a small- or medium-sized enterprise (SME) that is willing and capable to assist should fill out the form on the U.K. Government website. Additionally, teams from the University of Oxford and King’s College London are reportedly building prototypes of ventilators that can be manufactured using techniques available to well-equipped university and SME workshops.
The DHSC Specification
The DHSC has released a specification for a clinically acceptable, but basic, functional ventilator to be used in U.K. hospitals. It sets out the clinical requirements of what is minimally acceptable performance in the opinions of the health care professionals. The specification is for devices that will confer therapeutic benefit on a patient who is suffering from the effects of the virus. The specification envisions that the ventilators created by manufacturers would be for short-term stabilization over a few hours (extended to up to a day in extremis) for the minimum function. However, if possible, the ventilator would be able to support a patient through a number of days if that was necessary. An important part of the specification is that the ventilator must be usable with little to no training for the person tasked with using the machine.
Since the need for these ventilators is urgent, the government acknowledges that demonstrating compliance with the normally very stringent safety standards would be unrealistic. However, compliance with essential safety standards would have to be demonstrated for patient safety.
The “CE” Mark
In usual circumstances, a medical device must meet certain essential requirements and be marked with a Conformité Européene (CE) mark before it is placed on the market to show that the medical device has met the EU Directive requirements in relation to safety and is fit for its intended purpose. It also shows that the device can be freely marketed anywhere in the European Economic Area (EEA). Depending on the category of medical devices, manufacturers either self-assess and declare conformity of their products with the medical device rules or rely on notified bodies to conduct conformity assessment and issue certificates of conformity. Certain medical devices also require registration with the national competent authority before the device may be marketed. The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for checking that medical devices in the U.K. comply with legal requirements.
The “Exceptional Use” Route
For these unprecedented circumstances, the specification acknowledges that the devices likely will not be able to be CE marked, and approval for the devices will happen through the “Exceptional use of non-CE marked medical devices” route. A manufacturer can apply to supply a medical device that does not comply with the law to protect a patient’s health if there is no legitimate alternative available.
The criteria for use of devices under this route will be satisfied if the clinician responsible for treatment supports the manufacturer’s application, there is no alternative CE-marked device available for the treatment, and it can be demonstrated that mortality or morbidity is significantly reduced if the device is used compared to alternative compliant treatment.
Under this route, it must be understood that after the emergency has passed, the devices will not be usable for care unless they have gone through the regular CE process. Therefore, the device should display labelling to this effect. Additionally, usability testing at both prototype and final production stages will be required. The test should be done as a short Formative Usability Test (which can be done in a day) in an environment that is as realistic as possible. For example, the user must be able to instantly see the settings selected on the device and easily operate all controls while fully dressed in protective gear.
The manufacturer must apply for permission to supply the non-compliant medical device. However, the manufacturer and the clinician must both complete the required forms listed on the application and submit them to MHRA. Separate applications are required for different patients on a case-by-case basis. However, in rare cases, MHRA may consider approval to supply without prior identification of a named patient or to hold an emergency stock for use at short notice. This is especially the case for a device that’s likely to be applied for on multiple occasions. It is possible that MHRA believes the COVID-19 pandemic to be a case where this is useful.As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.