Constraints/Criteria
Constraints
There are various constraints for the vital signs monitor. The first constraint is that it must be adjustable so that it can fit kids from neo-natal babies, to five-years-old kids. While the device should take many different vitals, it has to be able to take temperature, heart rate, and respiration rate. The device has to be easily cleaned with bleach, and be immersible. The adjustable strap must be made of locally-sourced materials. The device also has to be rechargeable.
Criteria
There are several different criteria we must consider when designing the vital signs monitor. The monitor must be comfortable, so that kids do not mind wearing it throughout the night. While there is not a set budget that the device must stay under, it does have to be affordable, as it is being designed for low-income hospitals. The device also needs to be able to take as many different vitals as possible.
Standards
ISO 10993
ISO 10993:2018 requires medical devices to be free of biological contaminants that could be hazardous to the patient. The device must not cause infection or compromise the health and safety of the patient. The medical device has to be biocompatible.
ISO 14155
ISO 14155:2020 addresses good practices of design, production, and use for medical devices. The safety and privacy of the patient must be protected
HIPAA
HIPAA is the standard set by the Office for Civil Rights in 2004, it deals with confidential health information of a patient. The patient controls how their personal health information is used and shared. HIPAA protects the transmission of information and requires it to be protected well.
ISO 13485
ISO 13485:2016 ensures that medical devices are produced to meet quality and safety requirements. The risks must be well managed throughout design and production.
References
ISO. (2018) 10993: Biological evaluation of medical devices. Geneva, Switzerland: ISO.
ISO. (2016) 13485: Medical devices. Geneva, Switzerland: ISO.
ISO. (2020) 14155: Clinical investigation of medical devices for human subjects.
Geneva, Switzerland: ISO. Office for Civil Rights. (2004) HIPAA. Washington, D.C.: U.S. Dept. of Labor.