This article aims to assist with decision making for commissioning of medical devices that are required for rapid emergency use. The development of a strategy for commissioning these devices will deliver improved efficiency and better use of limited resources.
Devices can be analysed from a risk point of view, to decide how, or whether, full commissioning (in line with OEM procedures) is actually required.
The risk-based decisions of the commissioning manager are very important and need to be pragmatic. We have very limited resources to get a lot of equipment commissioned as quickly as possible. This must also be done safely. When considering emergency commissioning it is vital to use a ‘stripped down’ procedure, and to minimise administration and pre-use testing.
Key questions for the commissioning manager:
- Do we need to keep a computerised asset management system?
- Which devices do we need to electrically safety test?
- Do we need to carry out a physical inspection before use?
- Do we need to functionally test?
- Yes, we need to keep a computerised asset management system. For example, what if a safety alert / safety notice is issued? How will you know where the devices are located? What if the devices are rented, on loan and need to be returned? If a fault is reported, you will need to find/repair/replace the device, and keep a record of a work done. In principle, workflow management doesn’t require software, but in practice a computerised maintenance management systems (CMMS) will help to keep track of the work and to automate some processes.
- Class 1 (earthed) equipment should receive an automated safety test. (IEC 62353 – see https://www.ebme.co.uk/articles/electrical-safety/electrical-safety-testing-in-accordance-with-iec-62353). Where equipment is double insulated (class 2) equipment, the risk is very low, and there is no need to electrically safety test.
- A physical inspection to check for any obvious signs of damage must be done by the person unpacking the device. This doesn’t need to be an engineer.
- All equipment should receive a functional test, but in many instances, this can be done without test equipment by the user, especially for small battery powered items such as thermometers, Oxygen flowmeters, Air flowmeters, Suction regulators, etc.
Adopting these methods will stop large quantities of equipment being built up in the good in areas where there will already be limited storage space. In times of emergency, clinical engineering commissioning managers must adapt to the situation at hand, and find solutions that are safe, efficient, and get the equipment to the clinical users quickly, for the benefit of patient care.
When making urgent but sensible decisions, we must also look at the complete picture. This will include the impact on:
- Clinical services
- Patient safety
- Equipment performance
- Expected clinical activity (patient volumes)
If rapid commissioning is not adopted, will it have an impact? How will that impact manifest itself.
- Will the commissioning schedule slip?
- Will patients die?
Equipment must be risk-assessed for commissioning and separated into ‘device groups’. Each group, e.g. Ventilators will be commissioned in line with the rapid commissioning process. We must look to reduce the time taken to a safe minimum. Commissioning equipment in an emergency (Covid-19) ITU field hospitals requires medical equipment engineers and technicians on site plus support staff to:
- Unpack the equipment, quick physical inspection for transit damage
- Add it to the computerised asset management database
- Take it to the designated bed space
- Install onto bed, wall, drip stand, etc.
- Connect to electrical and/or compressed air and/or O2 supplies
- Electrical safety test (Class 1 patent connected equipment only)
- Functional test (Basic checks)
- Sign off on database for use
NB: All of this assumes there are already sufficient electrical and/or medical compressed air and/or Oxygen supplies.
Actions 1 to 4 can be done by the armed forces or semi-skilled volunteers. Assuming an average of 15 minutes per device, and Items 5 to 8 should be done by medical equipment engineers and technicians. Again, assuming an average of 15 minutes per device. In total this equals 0.5hrs of commissioning time per device. Now calculating the time this will take across 10 field hospitals across the UK with potentially 15,000 beds and 225,000 assets for unpacking and commissioning, this equals 112,500 hours of hands on time to get the devices to the patient.
We must accelerate the implementation, which means we must change our traditional working practices if we are going to succeed in making these emergency facilities ready in a short space of time. In order to provide an efficient working environment for staff, the layout should also take account of key functional relationships between activity spaces, such as goods in/out, storage, and bed areas.
We have considered the equipment type and class, this influences the decision of whether to carry out an electrical safety test. Deciding ‘not to safety test’ saves time. Asset tagging, adds time but maintains efficiency and safety. Physical inspections are important due to potential for damage in transit. Full functional testing will take up a lot of time, but should be carried out on life support equipment such as ventilators and CPAPs. Quick functional tests should be done before taking to the bed space. The user should carry out a final user inspection.
|Equipment||Class||Asset tag||Physical check||Electrical safety test||Full functional test||Quick functional test|
This article is meant to challenge the traditional methods commissioning and engineering managers adopt. We must learn and then adopt safe ‘shortcuts’ when commissioning emergency field hospitals.