Device Pre-priming - Considerations When Pre-priming Medical Devices
Does The Joint Commission have any guidelines regarding pre-priming devices, such as extra-corporeal membrane oxygenation (ECMO) circuits, cardio-pulmonary bypass (CPB) circuits and continuous renal replacement therapy (CRRT) circuits ?
Any examples are for illustrative purposes only.
No, The Joint Commission does not publish standards specific to management of such devices. Any care, treatment or service provided needs to be well-designed, based on evidence-based guidelines, research and comply with law/regulation. While the following discussion focuses on ECMO circuits, the same concepts would apply to other such devices.
Although pre-priming an ECMO circuit and related activities are NOT subject to USP 797, organizations must establish requirements for managing pre-primed systems based on evidence-based guidelines and accepted standards of practice. This would include compliance with instructions for use (IFU) for the machine, pump, circuit and fluid used for priming. Be sure to include your Infection Preventionist in establishing requirements.
ECMO circuits must be assembled and primed using strict, aseptic technique. Advance priming limits the length of time a circuit may be kept on standby. For example, a saline-primed circuit may be kept on standby for immediate deployment for a longer period of time than one primed with a hypertonic solution. It is the organization's responsibility to define an acceptable 'standby' timeframe based on all of the above factors.
Once an organization has established their requirements, close monitoring for compliance is critical to reduce the risk of patient harm. For example, documenting the date, time and initials of the individual completing the priming process. Consider also a process that ensures that the equipment is readily available and has not extended beyond the defined timeframe for use.
In addition to device and product manufacturers, organizations are encouraged to reach out to the FDA, professional organizations, such as The American Academy of Cardiovascular Perfusion (AACP), the American Society of Extra-corporeal Technology (AmSECT), the American Board of Cardiovascular Perfusion (ABCP), etc., for guidance. Additionally, conducting an internet search for examples of such policies, research studies, etc., may be helpful.
No, The Joint Commission does not publish standards specific to management of such devices. Any care, treatment or service provided needs to be well-designed, based on evidence-based guidelines, research and comply with law/regulation. While the following discussion focuses on ECMO circuits, the same concepts would apply to other such devices.
Although pre-priming an ECMO circuit and related activities are NOT subject to USP 797, organizations must establish requirements for managing pre-primed systems based on evidence-based guidelines and accepted standards of practice. This would include compliance with instructions for use (IFU) for the machine, pump, circuit and fluid used for priming. Be sure to include your Infection Preventionist in establishing requirements.
ECMO circuits must be assembled and primed using strict, aseptic technique. Advance priming limits the length of time a circuit may be kept on standby. For example, a saline-primed circuit may be kept on standby for immediate deployment for a longer period of time than one primed with a hypertonic solution. It is the organization's responsibility to define an acceptable 'standby' timeframe based on all of the above factors.
Once an organization has established their requirements, close monitoring for compliance is critical to reduce the risk of patient harm. For example, documenting the date, time and initials of the individual completing the priming process. Consider also a process that ensures that the equipment is readily available and has not extended beyond the defined timeframe for use.
In addition to device and product manufacturers, organizations are encouraged to reach out to the FDA, professional organizations, such as The American Academy of Cardiovascular Perfusion (AACP), the American Society of Extra-corporeal Technology (AmSECT), the American Board of Cardiovascular Perfusion (ABCP), etc., for guidance. Additionally, conducting an internet search for examples of such policies, research studies, etc., may be helpful.
Manual:
Hospital and Hospital Clinics
Chapter:
Infection Prevention and Control IC
First published date: August 20, 2020
This Standards FAQ was first published on this date.
This page was last updated on October 28, 2021
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