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Authors

Härtel C, Tissières P, Helder O, Mader S, Trips T

© Quirin Leppert

User group

Healthcare professionals, neonatal units, hospitals, and health services

Statement of standard

Safe use of equipment in neonatal care is ensured using standardised operating procedures and systematic monitoring and reporting of incidents.

Rationale

The goal is to assure safe equipment use in the complex environment of neonatal intensive care units (NICU). It is important to understand factors that contribute to failures in patient safety. (1–4) In NICUs a large variety of different technological devices is used, and their inappropriate use may lead to unplanned, critical events. Despite built-in safety systems, the occurrence of device 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) Besides individual human aspects (inexperience, fatigue (14)), system factors (e.g. staffing, crowding, team process, complexity of clinical workload, obsolete equipment) play an important role for the risk of adverse 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 patient 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)

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 “safety culture” (transparency, disclosure, feedback) (6,19) (see TEG Patient safety & hygiene practice)

Components of the standard

Component Grading of evidence Indicator of meeting the standard
For parents and family    
1. Parents are informed by healthcare professionals about equipment used. (1,3,6) A (Moderate quality)
B (High quality)
Patient information sheet
       
2. 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) A (High quality)
B (High quality)
Training documentation
       
3. Appropriate equipment use is included in discharge planning (see TEG Follow-up & continuing care and TEG Infant-and family-centred developmental care). B (Moderate quality) Guideline
       
For healthcare professionals    
4. A guideline for all intensive care equipment including checklists for development, implementation and regular updates is adhered to by all healthcare professionals. A (High quality)
B (High quality)
Guideline
       
5. 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
       
For neonatal unit and/or hospital    
6. A guideline for all intensive care equipment including checklists for development, implementation is available and regularly updated. B (High quality) Guideline
       
7. Training on reporting and learning from adverse events and inappropriate use of equipment is ensured to optimise the use of equipment, including simulation of clinical team working. (20) A (Moderate quality)
B (High quality)
Training documentation
       
8. Equipment maintenance is specified and audited regularly. (7) A (Moderate quality) Audit report
       
9. 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 report
       
For health service    
10. Local safety investigations are collated nationally, monitored and reported. (3,6,19,21) B (Moderate quality) Audit report
       

Where to go

Further development Grading of evidence
For parents and family  
  • Parents are involved in the design and delivery of education about medical equipment.
B (Moderate quality)
For healthcare professionals  
  • Healthcare professionals are involved in the design and delivery of education about medical equipment.
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.
For neonatal unit
  • Develop and implement a guideline for all intensive care equipment including checklists for development, implementation and regular updates.
  • 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.
 

Sources

  1. Mattox E. Medical devices and patient safety. Crit Care Nurse. 2012 Aug;32(4):60–8.
  2. Antonucci R, Porcella A. Preventing medication errors in neonatology: Is it a dream? World J Clin Pediatr. 2014 Aug 8;3(3):37–44.
  3. Steering Committee on Quality Improvement and Management and Committee on Hospital Care. Principles of Pediatric Patient Safety: Reducing Harm Due to Medical Care. PEDIATRICS. 2011 Jun 1;127(6):1199–210.
  4. Donchin Y, Gopher D, Olin M, Badihi Y, Biesky M, Sprung CL, et al. A look into the nature and causes of human errors in the intensive care unit. Crit Care Med. 1995 Feb;23(2):294–300.
  5. Samra HA, McGrath JM, Rollins W. Patient safety in the NICU: a comprehensive review. J Perinat Neonatal Nurs. 2011 Jun;25(2):123–32.
  6. Raju TNK, Suresh G, Higgins RD. Patient safety in the context of neonatal intensive care: research and educational opportunities. Pediatr Res. 2011 Jul;70(1):109–15.
  7. Ursprung R, Gray J. Random safety auditing, root cause analysis, failure mode and effects analysis. Clin Perinatol. 2010 Mar;37(1):141–65.
  8. Stavroudis TA, Shore AD, Morlock L, Hicks RW, Bundy D, Miller MR. NICU medication errors: identifying a risk profile for medication errors in the neonatal intensive care unit. J Perinatol Off J Calif Perinat Assoc. 2010 Jul;30(7):459–68.
  9. Suresh G, Horbar JD, Plsek P, Gray J, Edwards WH, Shiono PH, et al. Voluntary anonymous reporting of medical errors for neonatal intensive care. Pediatrics. 2004 Jun;113(6):1609–18.
  10. Gray JE, Goldmann DA. Medication errors in the neonatal intensive care unit: special patients, unique issues. Arch Dis Child Fetal Neonatal Ed. 2004 Nov;89(6):F472-473.
  11. Li Q, Melton K, Lingren T, Kirkendall ES, Hall E, Zhai H, et al. Phenotyping for patient safety: algorithm development for electronic health record based automated adverse event and medical error detection in neonatal intensive care. J Am Med Inform Assoc JAMIA. 2014 Oct;21(5):776–84.
  12. Bergon-Sendin E, Perez-Grande C, Lora-Pablos D, Moral-Pumarega MT, Melgar-Bonis A, Peña-Peloche C, et al. Smart pumps and random safety audits in a Neonatal Intensive Care Unit: a new challenge for patient safety. BMC Pediatr. 2015 Dec 11;15:206.
  13. Bergon-Sendin E, Perez-Grande C, Lora-Pablos D, De la Cruz Bertolo J, Moral-Pumarega MT, Bustos-Lozano G, et al. Auditing of Monitoring and Respiratory Support Equipment in a Level III-C Neonatal Intensive Care Unit. BioMed Res Int. 2015;2015:719497.
  14. Brockmann PE, Wiechers C, Pantalitschka T, Diebold J, Vagedes J, Poets CF. Under-recognition of alarms in a neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F524-527.
  15. Sharek PJ, Horbar JD, Mason W, Bisarya H, Thurm CW, Suresh G, et al. Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Pediatrics. 2006 Oct;118(4):1332–40.
  16. van Pul C, V D Mortel HPME, V D Bogaart JJL, Mohns T, Andriessen P. Safe patient monitoring is challenging but still feasible in a neonatal intensive care unit with single family rooms. Acta Paediatr Oslo Nor 1992. 2015 Jun;104(6):e247-254.
  17. Lester BM, Hawes K, Abar B, Sullivan M, Miller R, Bigsby R, et al. Single-Family Room Care and Neurobehavioral and Medical Outcomes in Preterm Infants. PEDIATRICS. 2014 Oct 1;134(4):754–60.
  18. Kugelman A, Inbar-Sanado E, Shinwell ES, Makhoul IR, Leshem M, Zangen S, et al. Iatrogenesis in neonatal intensive care units: observational and interventional, prospective, multicenter study. Pediatrics. 2008 Sep;122(3):550–5.
  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.
  21. Ortenstrand A, Westrup B, Broström EB, Sarman I, Akerström S, Brune T, et al. The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity. Pediatrics. 2010 Feb;125(2):e278-285.
  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.

November 2018 / 1st edition / next revision: 2023

Recommended citation

EFCNI, Härtel C, Tissières P et al., European Standards of Care for Newborn Health: Safe equipment use. 2018.

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