Guidance on the decontamination of equipment prior to inspection, service and repair, plus information on the reporting of adverse incidents.

Further advice should be obtained from your local Infection Control Team or Sterile Services Manager.

Click here to view web links

Click here to view references
Click here to view Scottish references

The Medicines and Healthcare Products Regulatory Agency (MHRA) defines an adverse incident as, ‘an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of patients, device users or other persons’¹. Causes may include poor design, user instructions, training, practice, maintenance, storage or conditions of use. Reporting adverse incidents to the MHRA enables the agency to take co-ordinated action to protect all patients and staff. This may involve the agency recalling a product or issuing a product safety warning.

You must report any adverse incident involving a medical device to the MHRA as soon as possible (usually within 24 hours), even if the incident occurred due to misuse or a mistake by the user rather than a fault with the device. If the incident arose from misuse or user error, it does not necessarily mean the user is to blame. The operating instructions might be misleading and need to be changed. You must report serious incidents (i.e. incidents involving death, serious injury or serious public health concern) to the MHRA by the fastest means available (usually by telephone).

Each Trust, Health Authority and Social Services Department should have an appointed liaison officer to co-ordinate adverse incident reporting¹. You can access further guidance on reporting incidents from the agency's website (www.medical-devices.gov.uk). You can also download copies of report forms from this site.

The MHRA prefers to receive incident reports on-line. If you are in doubt about the reporting procedure, seek advice from your line manager, liaison officer or contact the MHRA Medical Device Adverse Incident Centre. Make sure you include the names and contact details of people who the MHRA can contact if they need further information. You should follow up a telephone report as soon as possible with a written report.

When an adverse incident occurs, follow the basic principles below.

• Before you do anything else, make sure your patient and other people are safe.
• Keep the device involved in the incident, including any packaging and instructions.
• If the device involved is a machine, try to leave all the controls as they were at the time of the incident. If you must change the controls, record the position of the switches and dials.
• If the item involved is part of a batch, check the remaining stock to see if the defect resulted from incorrect storage, time expiry or another obvious reason. If so, you may need to withdraw the rest of the stock from circulation.
• Make sure you clearly identify, quarantine and securely store any withdrawn stock while the investigation proceeds.
• Do not repair, discard or return the device involved to the manufacturer, until the MHRA has investigated the incident.
• If you intend to send the device concerned to the MHRA, you must ensure it is decontaminated (refer to Decontaminating medical devices prior to inspection, service or repair). It is illegal to send contaminated items through the post.

Staff should report all adverse incidents involving non-medical equipment, engineering machinery, installed services or building fabric, according to the guidance issued by NHS Estates². You can download copies of report forms from the NHS Estate’s website (www.nhsestates.gov.uk). If you are in doubt about the reporting procedure, seek advice from your line manager.

You should report all incidents to:
Head of Engineering
NHS Estates
1 Trevelyan Square
Boar Lane
Leeds
LS1 6AE.
Telephone: 0113 254 7000 or out of hours: 020 7210 3000.

The Medicines and Healthcare Products Regulatory Agency (MHRA) requires that all reusable medical devices and equipment to be inspected, serviced, repaired, returned to a lender or disposed of must be decontaminated (where possible) beforehand⁴. The MHRA Device Bulletin provides guidance on how to decontaminate these items, so that staff who subsequently handle them are not put at risk from microbiological hazards⁴. However, other methods of decontamination may be required to rid the item of any chemical or radioactive substances that could also present a hazard. The Health and Safety at Work, etc., Act (1974) requires that there should be a written safety policy⁵. Your local policy should include details of the procedures required. The Control of Substances Hazardous to Health (COSHH) Regulations (2004) applies to chemical and biohazards⁶.

Where possible, all equipment must be decontaminated prior to inspection, service, repair, return to a lender, or disposal. Cleaning is essential. If the device has been in contact with blood or body fluids, you will also need to disinfect or sterilise it according to the manufacturer’s instructions. If you suspect or know the device has had contact with a transmissible spongiform encephalopathy (e.g. Creutzfeldt-Jakob Disease), contact your Infection Control Team before taking any action.

Once you have decontaminated the device or equipment, you will need to complete a Declaration of Contamination Status form that must accompany the equipment. The MHRA guidance provides a flow chart of the procedure you should follow and a copy of the appropriate form⁴.

In some circumstances, for example when the condition of an item is the subject of a complaint or if decontaminating the item would affect the outcome of the investigation, the investigator may wish the item not to be decontaminated. In such situations, seek advice from the investigating body and, if you have to dispatch the contaminated item to the investigator:

• give prior warning to the intended recipient
• clearly label the package so that the condition of the item is apparent before opening the inner packaging
• make sure the packaging is robust enough to withstand transport
• ensure that the contents of the inner package cannot contaminate the outer packaging
• obtain agreement of any carrier used to transport the contaminated item.

Guidance from the Advisory Committee on Dangerous Pathogens and the Spongiform Encephalopathy Advisory Committee specifies that instruments used on a patient suspected of having Creutzfeldt-Jakob Disease (CJD) of any type must be quarantined until a diagnosis is confirmed⁷. It also states that instruments and equipment used in procedures involving the brain, spinal cord or eyes of a patient presenting a potential risk (i.e. a recipient of hormones derived from human pituitary glands, a recipient of human dura mater grafts or someone with a family history of vCJD) should be destroyed by incineration.

On completion of any surgical procedure on a patient suspected of suffering from CJD of any type, separate out single-use instruments and dispose of them by incineration. Wearing appropriate personal protective equipment, wash any reusable instruments to remove obvious soiling. Take care to avoid splashing and spraying by holding the instruments below the water surface in a sink into which water is running and draining out continuously. Do not hold the instruments directly under running water as this can cause splashing.

Place the reusable instruments in a disposable instrument tray and allow them to air dry. Then, seal the instruments inside a leak-proof, rigid, plastic container with a close-fitting lid. Seal the lid with strong tape and label the container with:

• the patient’s identification (i.e. hospital number, name and date of birth)
• the surgical procedure for which the instruments were used and the date which this was performed
• the name of the responsible person (e.g. theatre superintendent).

Quarantine the sealed box in a suitable designated place until you know the outcome of any further investigation. Dispose of the instrument tray by incineration. If the patient is confirmed to be suffering from CJD of any type, incinerate the box and its contents without further examination. If an alternative diagnosis is confirmed, the responsible person (or a named deputy) may remove the instruments from the box and send them to the Sterile Services Department for reprocessing in the usual manner. However, you must keep records of any decisions and inform the Sterile Services Department before you return the instruments to them for routine reprocessing.

Guidance from the Advisory Committee on Dangerous Pathogens and Spongiform Encephalopathy Advisory Committee published in 2003 describes the present state of knowledge on the risks of transmission of variant Creutzfeldt-Jakob Disease⁷.