1. Overview and Purpose
Coast Medic are committed to providing a high standard and efficient independent ambulance service. As part of this, Coast Medic are committed to using high quality medical devices and equipment which is fit for purpose and appropriate to the service provision of Coast Medic.
This policy document outlines a far as is reasonably practicable, the purchase, decontamination and use of medical equipment and supplies within Coast Medic. This policy will also outline the actions required by Coast Medic in relation to Medical Devices.
This policy is considered a live document and will be updated and changed to reflect the current practices of the company. This document is also subsidised by additional supporting documents which will also be updated as required in line with this policy to ensure currency and accuracy within current standards.
2. Scope
This policy applies to all employees, staff, contractors and others who are involved with Coast Medic. This encompasses staff who are contracted from other organisations to provide services on behalf of Coast Medic.
3. Principles
All employees, staff, contractors and others who provide services on behalf of Coast Medic are expected to conduct themselves within organisational policies, procedures and the Coast Medic code of conduct as well as where applicable Professional Code of Conducts.
Under no circumstances should any personal device be used without expressed consent of the management team. Should the use be agreed, personal devices will need to be serviced and calibrated as per the manufacturers guidance and the appropriate markings applied.
It is the responsibility of all employees, staff, contractors and others who provide services on behalf of Coast Medic to ensure that all medical devices are clean and ready for use, reporting any concerns through the Reporting feature on Salus3cloud.
All employees, staff, contractors and others who provide services on behalf of Coast Medic only use equipment which is within their current scope of practice and that they have been appropriately trained in any medical device.
Coast Medic will provide enough equipment and medical devices to meet the requirements of the business and to meet service users need. This will always be kept in full working order and available.
Coast Medic will ensure that there is appropriate equipment and medical devices available which are considered necessary to meet an individual service user needs when they move between service providers.
4. Definition
Medical Device is any instrument, apparatus, appliance, material or other article, whether used alone or in a combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease.
- Diagnosis, monitoring, treatment or alleviation of or compensation for an injury or handicap.
- Investigation, replacement or modification of the anatomy or of a physiological process.
- Control of conception and which does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.’’
Single Use only is a medical device that is intended for only one episode of use on one patient only. Note: the international symbol, which is a figure 2 with a diagonal line drawn through it may be used on medical device packaging to indicate ‘Do Not Reuse’ and may replace any wording.
Single patients use only is a medical device that is intended for more than one episode of use on one patient only, the device may go through some sort of processing between each use.
Re-usable medical device is a medical device that may be re-used on either the same or different patient after it has been through decontamination processing or reprocessing. Note: some accessories of re-usable medical devices may be either for single use or single patient only.
5. Procurement of Medical Devices
All medical devices which are used by Coast Medic will be procured centrally. The purchase the responsibility of the management team.
All new devices will be serviced prior being placed into service for use by any Coast Medic Staff. Prior to use all new medical devices will be added to the Medical Device Asset Log along with the following information:
- Date of Purchase
- Make and Model
- Asset Number
- Serial Number
- Service Date
- Equipment allocation (if applicable).
6. Maintenance of Medical Devices
Coast Medic will use appropriately and suitably trained and qualified members of staff and contractors to undertake maintenance, inspection and repair of all medical devices. These will be regularly reviewed to ensure both quality and value for money.
All medical devices which are checked and serviced in line with manufacturers recommendation and at a minimum of one yearly.
Where required by a MHRA alert, maintenance will be undertaken outside of the annual servicing to ensure that any actions are undertaken to ensure compliance with the alert.
Annual Servicing will be arranged on a yearly basis, this will include:
- A comprehensive inspection.
- Changing of any components or parts which require regular replacement.
- Calibration
- Performance tests as required.
- Final functional and configuration check
- Safety Check
All devices will be marked with the appropriate sticker showing that annual servicing has been completed. No medical devices whose sticker has gone out of date must be used under any circumstances.
7. Equipment Failure or Damaged Medical Equipment
Coast Medic are committed to ensuring that all medical devices and equipment is fit for purpose through ensuring that it is regularly serviced, cleaned and maintained.
All repairs, servicing and maintenance to medical devices will be reviewed to ensure that it is in line with the manufacturers as well as any legal guidance and best practice recommendations.
Any equipment which is either found as broken, damaged or faulty or if equipment becomes unusable whilst operationally must be removed from service immediately. An incident form must be submitted within twenty-four hours.
Coast Medic will use appropriately and suitably trained and qualified members of staff and contractors to undertake maintenance, inspection and repair of all medical devices. These will be regularly reviewed to ensure both quality and value for money.
8. Decontamination
The decontamination of medical devices using the correct process is essential to prevent the spread of infection.
Single use devices must not be re-used under any circumstances.
Single patient devices must not be used on different service users. This includes any appropriate accessories which may be used with the device. These should be changed between patients.
All other reusable medical equipment should be cleaned and disinfected in line with the manufacturer’s instructions and within the Coast Medic Infection Control Policy.
It is the individual responsibility of the user to ensure that medical equipment is decontaminated after each use and left in an operational state.
Any medical devices which are unable to be cleaned due to heavy contamination should be removed from service immediately, appropriately bagged up and returned to Coast Medic Office for disposal. An incident form should also be completed on salus3cloud.
9. Reporting Adverse Incidents
Central Alert System (CAS) Bulletins highlight problems arising from the use or misuse of medical devices when health or safety, have been put at risk, these include Medicines and Healthcare Products Regulatory Agency (MHRA) and Department of Health (DOH) notices.
Coast Medic are subscribed to receiving alerts from the Central Alert System (CAS) via the Management Team. Coast Medic response to alerts which have been received through the Central Alerting System is outlined within the supporting procedure entitled: ‘Management of Central Alerting System Alerts Procedure’.
10. Disposal
All medical equipment must be disposed of in a safe and appropriate manner. Any disposal of medical equipment will be recorded appropriately against the asset database. A full record will be made when any medical equipment is disposed of and its method of disposal.
It is however noted that the disposal of medical equipment is currently not specifically covered under any legislation.
11. Training
All staff must work within their current ‘Scope of Practice’ when providing services on behalf of Coast Medic. Staff should only use, maintain or manage equipment that they can demonstrate competency in through specific training or through professional knowledge and skills.
All employees will receive training on the medical devices relevant to their individual role.
An up-to date record of training for each employee will be maintained.
Should an employee require additional or specific training on a specific medical device, it will be the responsibility for the individual employee to highlight this to the Clinical and Governance Lead at the earliest convenience.
12. Medical Device Audit and Database
All medical equipment will be audited prior to the annual servicing, and as part of the audit the following:
- Equipment has been tested for electrical safety
- Equipment has an Coast Medic asset number
- Equipment has been logged on to the Medical Device Database
- Equipment appears fit for purpose and has been serviced within the last twelve months.
As part of the Medical Device Audit, the cleanliness of devices will also be audited to ensure that these are compliant with the Infection Control Policy
The results of the audit will be made available to the Governance Committee.