Inspection and Testing of Pediatric and Neonate Incubators

  • Lejla Gurbeta
  • Sebija Izetbegović
  • Alma Badnjević-Čengić
Chapter
Part of the Series in Biomedical Engineering book series (BIOMENG)

Abstract

Infant incubators revolutionized the way medical care is provided to prematurely born infants or infants born with different kind of diseases and health problems. Due to development of technology infant incubators have been significantly improved from the time they were invented, but the main functions remained the same. Infant incubators provide optimal environmental conditions for infants to recover. This is achieved by controlling parameters such as temperature, relative humidity, air flow rate, oxygen concentration, suitable for medical treatment of certain conditions. Increased sophistication of medical devices, including infant incubators raises numerous questions regarding safety of device and reliability of controlled parameters within medical device. Regulatory bodies define requirements for infant incubators in manufacturing process, distribution and disposal. However, questions on requirements and methods for inspection of safety and performance of these devices are addressed more frequently. These inspections are most usually performed by trained clinical professionals who use specialized devices, analysers (phantoms). Using these calibrated analysers, traceability to international (SI) units of medical device measurement is ensured, which raises reliability of medical device treatment. This chapter describes types of infant incubators that are used in today’s healthcare system, as well as requirements on infant incubators stated in international standards and medical device directives. Description of infant incubator analysers is given at the end of this chapter.

List of abbreviations

AAP

American Academy of Paediatrics

AAMI

Association for the Advancement of Medical Instrumentation

AC

Alternating current

ACOG

American College of Obstetricians and Gynaecologists

CM

Corrective maintenance

DC

Direct current

FDA MAUDE

US Food and Drug Administration Manufacturer and User Facility Device Experience Database

IEC

International Electrochemical Commission

ISO

International Organization for Standardization

NICU

Neonatal intensive care units

PM

Preventive maintenance

SI

International System of Units

UNESCO

United Nations Educational, Scientific, and Cultural Organization

UNICEF

United Nations International Children’s Emergency Fund

UPS

Uninterruptable power supply

UV

Ultraviolet

WHO

World Health Organization

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Copyright information

© Springer Nature Singapore Pte Ltd. 2018

Authors and Affiliations

  • Lejla Gurbeta
    • 1
  • Sebija Izetbegović
    • 2
  • Alma Badnjević-Čengić
    • 3
  1. 1.Medical Devices Verification LaboratoryVerlab Ltd SarajevoSarajevoBosnia and Herzegovina
  2. 2.Clinical Center University of SarajevoSarajevoBosnia and Herzegovina
  3. 3.Canton Hospital ZenicaZenicaBosnia and Herzegovina

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