Healthcare professionals, neonatal units, hospitals, and health services
Statement of standard
Standardised operating procedures are implemented to ensure the safe use of technical equipment in neonatal care, e.g. monitors, ventilators, incubators, infusion pumps etc.
Rationale
The goal is to assure safe equipment use in the complex environment of neonatal intensive care units (NICU). Both human factors (e.g. difficulties with handling under dimmed light, alarm fatigue) and technical errors may affect patient safety, and it is of utmost importance to understand these risk parameters for proper prevention. (1–4)In NICUs a large variety of different technological devices is used. Despite built-in safety systems, the occurrence of device use-related errors and their consequences for patient outcomes are still not well-defined. (1–12)In a recent prospective study using random safety audits, the rate of appropriate use of NICU equipment was only 34%, while critical incidents were reported in 2.3%.(13)For example,individual human aspects play an important role for the failure to detect relevant monitoring alarms (14), which may be explained by (i) lack of time (i.e., nursing staff’s high work load in the NICU), (ii) the fact that not all alarms are considered clinically relevant, or (iii) nurses using other sources of information (e.g., clinical assessment). System factors (e.g. staffing, crowding, team process, complexity of clinical workload, obsolete equipment) are also for the risk of critical events. (4)
Adverse events occur at 74 events/100 infants in NICUs, e.g. hospital-acquired infections, dislocation of catheters and accidental extubations.(15) Considering the high rate of short-term morbidity and long-term complications of extreme prematurity and the potential impact of equipment use, a safety culture is essential in the NICU environment and should be embedded in the organisation’s efforts to enhance resilience and to assure patient- and family-satisfaction.(15–19)
Benefits
Short-term benefits
Better informed parents on the benefits and risks of the use of equipment (consensus)
Facilitated systematic reporting of inappropriate equipment use(1,4,19)
Higher probability of safe equipment use by educated and well-trained staff (consensus)
Reduced incidents of errors/adverse events due to unsafe equipment use (consensus)
Reduced risk for second victims (staff feeling guilty after adverse events due to equipment failure) (consensus)
Long-term benefits
Reduced morbidities as a consequence of inappropriate exposure to medical equipment (consensus)
Improved healthcare professional training and understanding of the use of health technologies(1)
Improved care by implementation of a “just culture” (transparency, disclosure, feedback) (see Patient safety & hygiene practice) (6,19)
Enhancing the importance that employees have the responsibility to check their equipment/attend instructional sessions (consensus)
Components of the standard
Component
Grading of evidence
Indicator of meeting the standard
For parents and family
Parents are informed by healthcare professionals about key aspects of equipment use in an understandable fashion. (1,3,6)
A (Moderate quality) B (High quality)
Patient information sheet1
In situations where parents will use and interpret information from medical equipment and their possible side effects they are educated and updated regularly by healthcare professionals in its use. (16)
Education and training of new staff members on how to safely use equipment.
B (High quality)
Handbook on medical products, on-site and online tutorials, teaching videos
Providing checklists for safe use of equipment and regular updates.
A (High quality) B (High quality)
Guideline
Continuous training on reporting and learning from adverse events and inappropriate use of equipment is attended by all responsible healthcare professionals. (1,6,19)
A (Moderate quality) B (High quality)
Training documentation
Healthcare providers are involved in the design of medical equipment.
A (Moderate quality)
Regular meetings of manufacturers and healthcare providers
Healthcare providers are encouraged to plan and perform educational programmes on safe equipment use.
Training and educational programmes
For neonatal unit and/or hospital
A guideline for all intensive care equipment including checklists for development, implementation is available and regularly updated.
B (High quality)
Development and distribution of guidelines/Checklists on safe use of individual devices
Reporting and learning from adverse events.
A (Moderate quality)
Debriefing
Training of equipment use including simulation of clinical team working. (20)
B (High quality)
Training documentation
Equipment maintenance is specified and audited regularly. (7)
A (Moderate quality)
Audit report2
24/7 support hotline, in case of difficulties with equipment (provided by the manufacturers or experienced providers).
Adverse events and inappropriate use of equipment are audited and feedback is given on a regular basis. (19)
A (Moderate quality) B (Moderate quality)
Audit report2
For health service
Local safety investigations are collated nationally, monitored and reported. (3,6,19,21)
B (Moderate quality)
Audit report2
1The indicator “patient information sheet” is an example for written, detailed information, in which digital solutions are included, such as web-based systems, apps, brochures, information leaflets, and booklets.
2The indicator “audit report” can also be defined as a benchmarking report.
Where to go
Further development
Grading of evidence
For parents and family
Parents can be involved in the design of future equipment.
B (Moderate quality)
For healthcare professionals
Establish effective alarm management strategies to avoid alarm fatigue and ensure that alarms are promptly addressed. Clear policies should be in place for appropriate alarm settings, response protocols, and staff education regarding alarm sounds and prioritisation.
Promote research on monitoring data integration and artificial intelligence.
B (Moderate quality)
For neonatal unit
Develop a structure of critical incident root-cause analysis and feedback and communicate learning. (22)
A (Moderate quality)
For hospital
Provide dedicated medical technical support for neonatal equipment.
B (Moderate quality)
For health service
Develop a national network for benchmarking of safe equipment use including parent organisations, healthcare providers, industry, and other stakeholders.
B (Moderate quality)
Getting started
Initial steps
For parents and family
Parents are verbally informed by healthcare professionals about safe equipment use.
For healthcare professionals
Attend training on reporting and learning from adverse events and inappropriate use of equipment.
Report critical incidences.
Contribute to research on reducing unnecessary alarms in the NICU setting.
For neonatal unit
Develop and implement a guideline for all intensive care equipment including checklists for development, implementation including alarm settings and regular updates.
Develop educational programs regarding alarm sounds and prioritization.
Develop information material on safe equipment use for parents.
Implement a formal system to record errors/adverse events.
For hospital
Support healthcare professionals to participate in training on safe equipment use.
Provide time and resources for effective safety management and support.
For health service
Develop service wide sharing of information on equipment use.
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19. Chatziioannidis I, Mitsiakos G, Vouzas F. Focusing on patient safety in the Neonatal Intensive Care Unit environment. J Pediatr Neonatal Individ Med. 2017 Apr;(1):e060132.
20. Reed DJW, Hermelin RL, Kennedy CS, Sharma J. Interdisciplinary onsite team-based simulation training in the neonatal intensive care unit: a pilot report. J Perinatol Off J Calif Perinat Assoc. 2017 Apr;37(4):461–4.
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22. Hubertus J, Piehlmeier W, Heinrich M. Communicating the Improvements Developed from Critical Incident Reports is an Essential Part of CIRS. Klin Padiatr. 2016 Sep;228(5):270–4.
23. Ketko AK, Martin CM, Nemshak MA, Niedner M, Vartanian RJ. Balancing the Tension Between Hyperoxia Prevention and Alarm Fatigue in the NICU. Pediatrics. 2015 Aug;136(2):e496-504.
Second edition, December 2024. Previous edition reviewed by Dr. Daniel Vijlbrief.
Lifecycle
5 years/next revision: 2029
Recommended citation
GFCNI, Härtel C et al., European Standards of Care for Newborn Health: Safe equipment use. 2024.
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