PEER REVIEW
Section 3.9. The healthcare institution has a procedure to ensure that the purchased medical equipment does function in accordance with the supplier’s specifications and with the program of requirements of the healthcare institution prior to the initial use of the medical equipment.
Section 3.10. The healthcare institution has a procedure in place that ensures that prior to installation and/or initial use of medical equipment, this medical equipment connects correctly with the existing infrastructure of medical gasses, electrical power and IT networks and with other infrastructure such as ventilation systems and sewerage systems.
Section 6.1. If there is reason to deviate from a specified procedure, the Executive Board may decide to apply a different procedure, while providing reasons for any decisions taken. Deviations from the aforementioned procedure are only possible after the Executive Board has been advised by a competent officer of the healthcare institution. A record is kept of the deviations occurring and the reasons for them.
Figure 2. Section 3 – Implementation stage of medical technologies and equipment. Figure 3. Section 6 – Deviations.
l Which ventilation facilities are necessary? (e.g. filtering, ventilation rate, pressure hierarchy, cooling, heat removal, but also of smoke/double mask/anaesthetic gases removal)
l Are special power supplies also required? For example CEE form mains connector, or medical equipment that require high power or a dedicated electrical circuit breaker.
l Does the equipment need to be connected to the hospital IT network? If so, how many data outlets are required and what infrastructure is needed? This also includes alarms and monitoring of vital functions, for example.
l Which systems/equipment should communicate with the building management system (BMS)?
l Are ‘empty’ pipes for electrical connections needed for future developments?
l Are video connections expected, live or otherwise? If so, do they involve image and/or sound?
l Does an emergency nurse call system need to be installed? (e.g. for a resuscitation team)
l Which medical gas connections are necessary?
l Is any additional construction work necessary? If so, which?
l Are interlock measures or occupancy indicator lights needed?
l Should intercom or similar two-way communication equipment be installed?
l Are sound carriers used? If so, what facilities are needed?
l Are there special requirements for the lighting, both emergency and otherwise? If so, which?
In addition to the above-mentioned primary facilities around the individual patient, we would also like to ask some space related questions: l What is the maximum number of people in the room at the same time? (patient, staff and visitors)
l Within which operating hours is the room used?
l What fixed equipment must be present in the room? Think of permanent joinery and furniture, for example.
l Should it be possible to darken the room?
IFHE DIGEST 2023
l Do you work with hazardous substances in the room? If so, which?
l Is there a risk of heat, moisture, odour, chemical contamination, radiation, gas formation?
l Are there requirements for wall/ceiling finishes?
l What workstation facilities are expected in the room?
l Are monitors used? If yes, which ones and state the application.
l What fire-extinguishing facilities are needed?
l Should the room be equipped with access control?
l To what extent must acoustics be taken into account? (dBA)
l Which sanitary facilities are necessary (water, demi-water, steam, toilet, washbasin, etc.)?
It goes without saying that the healthcare professionals and the domain leaders are jointly responsible for the questions to be answered and for any additions. This requires a multidisciplinary approach, always, everywhere and with every change in the care process.
Suggestions for optimising the Dutch covenant for safe application of medical technology The Dutch covenant ‘Safe application of medical technology’ focuses on risk management and safe application of medical technology in curative care in The Netherlands. The NVTG working group suggests that the Dutch Covenant for Safe Application of Medical Technology should also include a focus on the incorporation of additional check questions when more of the same medical equipment is deployed within the healthcare environment but may serve a different treatment method. Figure 2 states The Safe Application of Medical Technology Covenant in specialist medical care. It is always wise to review a document with additional check questions before proceeding to purchase, use or alternative use. Depending on the outcome of the check questions, a new risk assessment may or may not have to be made. The check questions will have to relate to the use and deployment of the medical equipment and, of course, the points mentioned in Section 3.10
of the Covenant. This applies both in ‘normal situations’ and in crisis situations (see Fig 3).
If in a crisis situation there is a
deviation from the procedures in the Covenant, Section 6.1 shall apply. The deviation and the reasons for it must be described and recorded, for example in Ultimo.
Who is responsible?
Running a hospital during a pandemic can lead to situations that sometimes involve serious risks. Who plays a role in this? How can we prevent situations from arising that involve a potential risk? Where in the chain – from setting the task by the crisis team to realisation/implementation – should a link be included for a risk analysis? And who is allowed to make any adjustments? The risk and the resulting effects may
be assessed by different people and thus come from different sources. Where this should lead once triggered is another question. There are several process owners involved and it can vary from hospital to hospital who these key figures are. Anyone working anywhere in the chain can be a trigger: for example, a nurse or someone from the Building Services & Real Estate department. In our example, a clinical physicist – or similar role – is available to make a decision. In the working group, it was suggested that the clinical physicist should be put in charge because he/she is a logical link between care and technology. However, we also note that the clinical physicist often does not have a seat at the table when decisions are made, so perhaps a temporary position should be made available in the CPT. In a crisis situation, information transfer is essential. See Figure 4 for some examples: There is a need to combine knowledge
into a process-oriented guideline on how to act in a crisis situation and what thus requires extra attention in the coordination between technology, equipment and human action. In a work process, it might look like Figure 5.
Conclusions and recommendations Cooperation Technology in healthcare facilities and the technical staff responsible for it can be empowered and involved more closely in
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