Why have these services been recommended?

Research has shown patients most at risk of becoming very unwell from coronavirus are best identified by oxygen levels. Because of this, the use of a pulse oximeter to monitor oxygen levels, including at home, is recommended for this group. Using a pulse oximeter means rapid deterioration and silent hypoxia (occasionally misleadingly referred to as ‘happy’ hypoxia) are more likely to be identified and people can get the help they need as quickly as possible. Silent hypoxia is where people have low oxygen levels in the absence of significant shortness of breath, and has been noted in some coronavirus patients.

What is the difference between COVID virtual wards and COVID Oximetry @home?

COVID virtual wards are for adults being discharged from hospital who have a primary diagnosis of coronavirus but with an improving condition. On discharge to the virtual ward, patients are provided with a pulse oximeter in addition to any other treatment and support they may require, as outlined in the standard operating procedure. COVID Oximetry @home services are primarily implemented in general practice and are for adults diagnosed with coronavirus in the community, who are at risk of becoming seriously unwell but who do not require immediate hospital admission. They are provided with a pulse oximeter and supporting information to help monitor their condition at home. Key differences between the approaches are summarised in the table on this page.

Published guidance on COVID Oximetry @home and COVID virtual wards set out a base standard for these approaches. These should not supplant existing local arrangements where already established and working well.

What support is given to patients to interpret the pulse oximeter readings correctly and act on results appropriately?

Patients being supported by these services should be provided with supporting information to use oximeters correctly as per the published standard operating procedures for COVID Oximetry @home and COVID virtual wards. To help facilitate this, relevant staff are recommended to:

• Familiarise themselves with the equipment before use
• Ensure that patients know the difference between oxygen saturations and heart rate on the oximeter
• Make sure they respond to changes from baseline, rather than a single reading in isolation
• Use clinical judgement when interpreting readings provided by patients.

How can we be assured that patients have equality in access to pulse oximeters and home monitoring?

Pulse oximetry has the potential to benefit those most at risk of coronavirus, therefore ensuring equal access is a priority. Health and care professionals should tailor their support based on their patient’s and any carers’ individual needs and circumstances, following the principles of personalised care. This includes clinicians proactively seeking to engage patients from all groups and being aware that language and health literacy may be a barrier. Where digital monitoring options are available, all patients should be offered a paper alternative. Alternative versions of patient resources are available and include translated and easy read versions of the patient diary. Alternative language subtitles are available on both the animated and clinician-led versions of patient videos, and audio translations are also available. NHS Volunteer Responders or other local voluntary organisations may support distribution of oximeters as appropriate and where required.

What quality standards do pulse oximeters from the national supply meet?

Pulse oximeters being provided by the NHS through COVID Oximetry @home and COVID virtual ward services have been secured through the NHS Supply Chain Framework and are therefore CE marked and meet the ISO standard 80601-2-61:2017. All medical devices on the UK market must meet a series of requirements for safety and performance under the UK Medical Device Regulations 2002 (SI 2002 No 618, as amended).

How accurate are pulse oximeters?

Pulse oximeters secured through the NHS Supply Chain Framework are stated by manufacturers as providing an estimation of blood oxygen level within a range of 2-3% accuracy. Pulse oximeters enable patients and carers to estimate and monitor blood oxygen levels quickly and conveniently at home, thereby supporting the detection of silent hypoxia and rapid deterioration.

How can patients be supported who may have concerns about the accuracy of pulse oximeters because of skin colour?

Pulse oximeters work by shining light through the skin to measure the amount of oxygen in the blood. There have been reports that pulse oximeters can be less accurate for people with darker skin because they may show higher readings of the oxygen level in the blood. This is also noted in guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA).

Patients with darker skin who have been provided with a pulse oximeter should continue to use it to monitor changes to their readings. By looking at changes in readings rather than just one reading, it means that even if an oximeter is not completely accurate, it is still possible to see if oxygen levels are going down.

Because pulse oximeters may be affected by several factors including skin colour, it is important for everyone offered an oximeter by the NHS to:

• Speak to a health or care professional before using the pulse oximeter and tell them if they have any concerns and questions
• See if there are changes to oxygen levels over time, rather than just looking at one reading. Patients should be advised to take readings when they are first given the oximeter and regularly afterwards.

NHS England and NHS Improvement are keeping this situation under review and the National Institute for Health Research has been asked to support further research so that we can understand more about how this may apply to people with darker skin who have COVID-19 and are using pulse oximetry. This will help ensure everyone is able to get treatment from the NHS when they need it as quickly as possible. National advice will be updated as further information becomes available.

Pulse oximeters can provide an important early warning sign if people are becoming more unwell with coronavirus but it is important not just to rely on them on their own. Patients should be advised to seek help if they feel more unwell with any relevant COVID symptoms and to act immediately if their condition worsens. Summary information for patients is also available on NHS UK.

Existing guidance for professionals on COVID Oximetry @home and COVID virtual wards takes this potential factor into account by recommending recording of baseline readings and monitoring trends, as well as using clinical judgement to remain vigilant for other signs of deterioration.

Can people use their own devices or smartwatches to monitor their oxygen saturation levels?

All oximeters for home use should be CE marked and must meet the international standard (ISO 80601-2-61:2017). Some new devices such as smartwatches can measure blood oxygen levels, however these devices are generally not medically accurate and therefore should not be used for monitoring oxygen levels of someone with coronavirus.

Do NHS organisations need to apply asset tracking to pulse oximeters?

Clinical Commissioning Groups and NHS Trusts may wish to apply their own asset tracking and identification procedures to oximeters in accordance with local policies.

How can oximeters be safely decontaminated and/or returned for future use?

Cleaning procedures for oximeters must follow manufacturers’ instructions where available. Liquids should generally not be used on these devices due to the risk of fluid ingress. Disinfectant wipes should be used where possible.

NHS organisations may have their own procedures for decontamination and how patients can return their oximeters for reuse. NHS Volunteer Responders, or other local volunteer organisations, may be available to help with transportation of oximeters and supporting information. Oximeters must not be sent via postal services due to contamination risks to staff and the general population.

How can I report concerns about oximeters?

As with other medical devices, safety concerns regarding pulse oximeters should be reported to the MHRA via the COVID Yellow Card scheme (select ‘other devices/equipment’ from the drop-down list) and details sent to the national team at NHS England and NHS Improvement. Local clinical engineering departments and medical device safety officers (MDSOs) should also be informed.