Robust alarm design strategy for medical devices: Application to air-in-line detection and occlusion management
Open accessAbstract
Alarm fatigue in the hospital environment is a recurring problem that can be solved through technical, human, or organizational considerations. The use of technical factors to get a robust alarm management system is illustrated here by two case studies related to air-in-line detection in peritoneal dialysis and insulin pump occlusion management. Air-in-line sensors are usually very sensitive to the presence of small bubbles stuck on tubing and may therefore deliver false alarms. To provide a reliable estimate of the cumulated air volume pumped an IR sensor technology that is insensitive to small bubbles was implemented and tested. Another strategy was used to limit false occlusion alarms in an insulin patch pump. The piezoelectric actuator of this micropump was servo-controlled to the pressure sensor signal to allow insulin to flow into the patient despite the presence of a partial occlusion. The false alarm rate is thus reduced by using a self-adaptive occlusion detection threshold that has been evaluated using numerical simulations.
AI snapshot
Written from the paper’s full text.
TL;DR
This paper argues that robust alarm design should reduce false alarms by matching sensor selectivity and alarm thresholds to therapy-specific risk, illustrated with air-in-line detection in peritoneal dialysis and occlusion management in an insulin patch pump. It presents an IR bubble sensor insensitive to small bubbles and a self-adaptive MEMS micropump occlusion strategy, with bench and simulation results but no clinical validation yet.
Key findings
- Alarm fatigue context: healthcare professionals may be exposed to over 1000 alarms per shift; the FDA MAUDE database identified 566 alarm-related patient deaths between January 2005 and June 2010; in one intensive therapy unit study, only 8 of 1455 alarms represented a potentially critical risk; 80 to more than 90% of physiologic monitor alarms are false positives.
- IR air-in-line sensor: using 1450 and 1550 nm LEDs gives strong water/air selectivity; through 4 mm of water, transmitted power is 64% at 1300 nm, 0.001% at 1450 nm, and 1.5% at 1550 nm. The sensor is insensitive to small bubbles (typically a few microliters) but detects bubbles greater than 40 microliters, with signal constant above 50 microliters, corresponding to an entire tube section filled with air.
- MEMS insulin micropump: occlusion detection time is about 12 minutes at 0.1 U/h; stroke volume is 0.2 µl, compression ratio is larger than 0.8, and chamber pressure typically varies between -800 mbar and +800 mbar. A self-adaptive piezo voltage profile adjusted to pressure allows insulin to flow during partial occlusion, reducing false alarms; simulations show the outlet valve takes longer to close as fluid restriction increases, and if restriction is greater than 4R the piezo must remain activated longer.
- Design implication: over-sensitive, non-patient-specific alarms cause false alarms; design input should specify cumulated air volume and patient-specific occlusion thresholds, since settings for a 100 kg adult with type II diabetes must differ from those for a 10 kg infant with type I diabetes.
Methods
- Two case studies: (1) IR air-in-line detection for peritoneal dialysis, and (2) adaptive occlusion management for a MEMS-based insulin patch pump.
- IR tests used an InGaAsP LED1450-03 emitter and an InGaAs PIN PD1450-35T52 receiver, with a constant 7 mm source-detector distance, through PVC tubing with ID 4 mm and OD 6 mm; bubbles were generated with a 100-microliter Hamilton precision syringe, and sensor signal was measured as a function of bubble volume.
- Occlusion management used numerical simulations based on the Fournier et al. model to simulate pressure dynamics and outlet valve displacement for outlet fluid restrictions that are multiples of R = 1.24×10^14 Pa·s/m^3; no clinical trial data are reported.
Limitations
- Stated: human and organizational factors to improve alarm safety are not discussed; the IR air-in-line sensor and occlusion management system were in the design transfer phase; next steps include analysis of healthcare professional and patient feedback during clinical trials to refine the alarm management system.
- Evident: no clinical validation or patient outcomes are reported; IR sensor performance is limited by parasitic signal transmitted through the transparent tubing and limited collimation that does not completely prevent crosstalk; occlusion findings rely on numerical simulations rather than clinical occlusion data.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
0 of 16 cited sources checked · 0 supported · 0 flagged
- Findingreasoning
Above 50 microliters, which corresponds to an entire tube section filled with air, the IR sensor signal is constant.
“Above 50 microliters, which corresponds to an entire tube section filled with air, the sensor signal is constant.”
Quote in the paperNot a substantial claim - Findingown data
Through an infusion line in PVC (ID=4 mm, OD=6 mm), the IR air sensor shows a steep increase in the monitored signal and a transition between low and high state for air bubbles greater than 40 microliters.
“Through an infusion line in PVC (internal and external diameters of ID=4 mm and OD=6 mm respectively), this all-or-nothing air sensor shows a steep increase in the monitored signal and thus a transition between low and high state for air bubbles greater than 40 microliters (see Fig. 4).”
Quote in the paperSubstantial claim - Findingown data
As expected, the outlet valve requires more time to close as fluid restriction increases.
“As expected, the valve requires more time to close as fluid restriction increases.”
Quote in the paperSubstantial claim - Findingreasoning
In bolus mode, the built-in pressure at the delivery site reaches 1 bar within a few seconds in case of total occlusion.
“The built-in pressure at the delivery site is thus very fast (a few seconds to reach 1 bar in case of total occlusion)”
Quote in the paperSubstantial claim - Findingown data
If fluid restriction is greater than 4R, the piezo must remain activated longer to allow insulin to flow into the patient.
“If fluid restriction is greater than 4R, the piezo must remain activated longer to allow insulin to flow into the patient.”
Quote in the paperSubstantial claim
- Premisenone given
Occlusion detection is difficult, notably at a low delivery rate, because the in-line build-up pressure varies slowly over time.
“However, occlusion detection is difficult, notably at a low delivery rate, because the in-line build-up pressure varies slowly over time.”
Quote in the paperSubstantial claim - Interpretationreasoning
The IR bubble sensor is a technological response to the high false alarm rate due to the presence of small bubbles that do not represent, for a given therapy, any risks to the patient.
“This IR bubble sensor is therefore a technological response to the high false alarm rate due to the presence of small bubbles that do not represent, for a given therapy, any risks to the patient.”
Quote in the paperSubstantial claim - Premisenone given
Injection of sterile air during peritoneal dialysis has lower severity than during intravenous therapy.
“Injection of sterile air during PD is a risk that shows lower severity than during IntraVenous (IV) therapy.”
Quote in the paperSubstantial claim - Premisecitation
Over the 1455 alarms recorded in an intensive therapy unit, only eight represented potentially a critical risk to the patient.
“Furthermore, a study showed that over the 1455 alarms recorded in an intensive therapy unit, only eight represented potentially a critical risk to the patient [6].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [6]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisecitation
PD patients with intra-abdominal free air have a higher risk of peritonitis.
“PD patients with intra-abdominal free air have indeed a higher risk of peritonitis.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [23]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Interpretationown data
Excellent water/air selectivity is obtained using LEDs at 1450 and 1550 nm.
“An excellent water/air selectivity is obtained using LEDs at 1450 and 1550nm.”
Quote in the paperSubstantial claim - Premisecitation
Research showed that 80 to more than 90% of alarms are false positives in physiologic monitor devices like ECG.
“Research showed, notably in physiologic monitor devices like ECG, that 80 to more than 90% of alarms are false positives [20].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [20]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisecitation
The median occlusion detection time at 0.1 U/h ranged from 4 h to more than 40 h in commercial insulin pumps.
“Some data suggested that the median occlusion detection time (ODT) at 0.1 U/h ranged from 4h to more than 40h in commercial insulin pumps [26].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [26]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisereasoning
Bubble detection using the US technique or light reflection/refraction could lead to a false alarm if tiny bubbles remain stuck on the tubing wall, notably at a low or intermediate flow rate.
“Also, bubble detection using the US technique or light reflection/refraction could lead to a false alarm if tiny bubbles remain stuck on the tubing wall, notably at a low or intermediate flow rate.”
Quote in the paperSubstantial claim - Interpretationown data
The IR bubble sensor allows accurate determination of the cumulated air volume infused.
“Accurate determination of the cumulated air volume infused”
Quote in the paperSubstantial claim - Premisecitation
Many adverse events are directly related to alarms.
“Surprisingly, many adverse events are directly related to alarms [1,2].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [1]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- cites [2]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisecitation
Injection of small air bubbles (typically under 0.2 mL) is not dangerous.
“since there is evidence that injection in the circulation of small air bubbles (typically under 0.2 mL) is not dangerous [15].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [15]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisecitation
A MEMS-based micropump shows an occlusion detection time of about 12 minutes at 0.1 U/h.
“In patch or catheter-less devices, an important breakthrough was achieved with a MEMS-based micropump which shows an ODT of about 12 minutes at 0.1 U/h [30][31][32][33].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [30][31][32][33]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Premisereasoning
The ultrasonic signal is strongly weakened by any bubble present in the liquid.
“The US signal is strongly weakened by any bubble present in the liquid.”
Quote in the paperSubstantial claim - Premisecitation
The presence of free air in the peritoneal cavity (pneumoperitoneum) is balanced by air absorption up to 13.5 mL/day.
“The presence of free air in the peritoneal cavity, called pneumoperitoneum (PP), shall indeed be balanced by air absorption up to 13.5 mL/day [22].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [22]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Interpretationreasoning
Alarms are often turned off due to a high false alarm rate.
“Thus, alarms are often turned off due to a high false alarm rate.”
Quote in the paperSubstantial claim - Interpretationreasoning
Alarms in medical devices can be considered dangerous for patient safety.
“In other words, alarms in medical devices can be considered dangerous for patient safety.”
Quote in the paperSubstantial claim
- May combine two claims. 13
- Classified as probably not a substantial claim. 7
May combine two claims.
Findingnone givenThe IR bubble sensor is insensitive to small bubbles (typically a few microliters) but can detect reliably bubbles of a few tenths of microliters.
“This IR bubble sensor is insensitive to small bubbles (typically a few microliters) but can detect reliably bubbles of a few tenths of microliters.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingcitationThe percentage of transmitted optical power through 4 mm of water at 1300, 1450, and 1550 nm is 64%, 0.001%, and 1.5%, respectively.
“Table 1 Percentage of transmitted optical power through 4mm of water at 1300, 1450, and 1550 nm Wavelength (nm) Transmitted power / Incident power in % 1300 64 1450 0.001 1550 1.5”
Quote in the paperSubstantial claimMay combine two claims.
FindingreasoningIn case of total occlusion, no insulin flows and the outlet valve remains open until the next downward movement of the piezo.
“In case of total occlusion, no insulin flows and the valve remains open until the next downward movement of the piezo.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe FDA MAUDE database identifies 566 alarm-related patient deaths between January 2005 and June 2010.
“The U.S. Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database identifies 566 alarm-related patient deaths between January 2005 and June 2010, a figure that is further considered by industry experts to underrepresent the actual number of incidents [4].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [4]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisereasoningA US bubble sensor has high sensitivity and can detect bubbles of 1 microliter or less.
“Because the signal is greatly reduced when an air bubble in the tubing passes between the piezo transducer and the receiver, this sensor has a high sensitivity, and bubbles of 1 microliter or less can be detected.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationThe proportion of acoustic energy transmitted into air is about 0.12%, representing a 30 dB loss.
“The proportion of acoustic energy transmitted into the air, about 0.12%, represents a 30 dB loss [21].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [21]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
May combine two claims.
PremisecitationAir bubbles in an insulin pump can cause hypoglycemia due to expansion in the insulin reservoir or hyperglycemia if the air bubble in the catheter lowers the amount of insulin delivered.
“Bubbles in an insulin pump can either cause hypoglycemia (low blood sugar) due to its expansion in the insulin reservoir (e.g., during airplane depressurization) or hyperglycemia (high blood sugar) if the air bubble in the catheter lowers the amount of insulin delivered [14].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [14]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe literature suggests that the 1 mL/15 min limits may be generous for neonates or patients with right-to-left cardiac shunts.
“The literature suggests that these limits may be generous for neonates or patients with right-to-left cardiac shunts [17].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [17]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
May combine two claims.
InterpretationreasoningThis pump technology offers improved occlusion detection, but the downside is a potentially high false alarm rate.
“This pump technology offers improved occlusion detection, but the downside is a potentially high false alarm rate.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Premisenone givenAir-in-line sensors are usually very sensitive to the presence of small bubbles stuck on tubing and may therefore deliver false alarms.
“Airin-line sensors are usually very sensitive to the presence of small bubbles stuck on tubing and may therefore deliver false alarms.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
PremisecitationThe 1998 version of IEC60601-2-24 stated that infusion of 1 mL of air within 15 min is not considered a safety hazard, and bubbles of less than 0.05 mL each are omitted in summing up to the 1 mL.
“The version of the IEC60601-2-24 standard released in 1998 mentioned that”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [16]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationAlarm fatigue occurs because people usually respond to alarms in the same proportion as the perceived reliability of the alarm system.
“It was suggested that alarm fatigue occurs because people usually respond to alarms in the same proportion as the perceived reliability of the alarm system [5].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [5]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
May combine two claims.
InterpretationreasoningThe relative increase of the IR sensor signal in the presence of air is limited because of the parasitic signal transmitted by the transparent tubing itself and the limited collimation of the light which does not completely prevent crosstalk.
“The relative increase of the signal in the presence of air is limited here because of the parasitic signal transmitted by the transparent tubing itself and the limited collimation of the light which does not completely prevent crosstalk.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
InterpretationreasoningBecause the fluid path between the delivery site and the micropump outlet has low compliance, the pressure sensor can monitor any pressure change due to tissue compression or any other sources of partial occlusion.
“Because the fluid path between the delivery site and the micropump outlet has low compliance (i.e., low compressibility), the pressure sensor can monitor any pressure change due to tissue compression or any other sources of partial occlusion.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationHealthcare professionals may be exposed to over 1000 alarms per shift, and most of these alarms are nonactionable.
“Ruskin et al. reported that healthcare professionals may be exposed to over 1000 alarms per shift, and most of these alarms are nonactionable and require neither technical nor clinical action [3].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [3]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
May combine two claims.
InterpretationreasoningThere is plenty of time to maintain the piezo actuator at high voltage and thus sufficient pressure to allow insulin to flow toward the delivery site in the presence of partial obstruction of the fluid path.
“There is therefore plenty of time to maintain the piezo actuator at high voltage and thus sufficient pressure to allow insulin to flow toward the delivery site in the presence of partial obstruction of the fluid path.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningTwo case studies illustrate how technical factors can reduce false alarm rates, improve patient well-being, and prevent alarm-related adverse events.
“Two case studies were used to illustrate how technical factors, in addition to human and organizational factors not discussed here, can reduce false alarm rates, improve patient well-being, and prevent alarm-related adverse events.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningThe greater the fluid restriction, the larger the generated pressure and the longer the piezo remains activated, and the occlusion alarm should no longer be triggered since insulin is delivered at the intended rate.
“The greater the fluid restriction, the larger the generated pressure and the longer the piezo remains activated, and the occlusion alarm should no longer be triggered since insulin is delivered at the intended rate.”
Quote in the paperSubstantial claim
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
IR sensor's stated bubble sensitivity conflicts with its measured threshold
MinorThe sensor is said to reliably detect bubbles of a few tenths of a microliter, yet its reported signal transition occurs only for bubbles greater than 40 microliters. The first statement also conflicts with the claim that the sensor is insensitive to bubbles of a few microliters.
“This IR bubble sensor is insensitive to small bubbles (typically a few microliters) but can detect reliably bubbles of a few tenths of microliters.”
“Through an infusion line in PVC (internal and external diameters of ID=4 mm and OD=6 mm respectively), this all-or-nothing air sensor shows a steep increase in the monitored signal and thus a transition between low and high state for air bubbles greater than 40 microliters (see Fig. 4).”
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Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Chappel, E. (2024) · Encyclopedia · doi:10.3390/encyclopedia4020052
Self-citation
- Authors
- Chappel, E.
- Affiliations
- Debiotech (Switzerland) (CH)
- Corresponding author
- Eric Chappel
- ORCID
- Eric Chappel
- Venue
- Global Journal of Engineering and Technology Advances
- Publisher
- GSC Online Press
- Published
- 2023-09-30
- Volume
- 16
- Issue
- 3
- Pages
- 030-040
- ISSN
- 2582-5003 (ISSN-L)
- OpenAlex
- W4386504793
- Semantic Scholar
- 81470e86ae38f2120d7eb8cb284dfb3f128d17e6
- Cited by
- 1
- References
- 33
- Citations by year
- 2024: 1
- FWCI
- 0.24
- Type
- journal article
- Language
- en
- Open access
- hybrid
- dx.doi.org
- Licence
- cc-by
- Locations
- Global Journal of Engineering and Technology Advances (publishedVersion, cc-by)
- Topics
- Health Sciences › Medicine › Surgery › Healthcare Technology and Patient Monitoring
- Physical Sciences › Engineering › Biomedical Engineering › Intravenous Infusion Technology and Safety
- Health Sciences › Health Professions › Medical Laboratory Technology › Quality and Safety in Healthcare
- Keywords
- alarm fatigue, alarm management, medical devices, peritoneal dialysis, false alarm reduction, infrared sensors, bubble detection, piezoelectric micropump, servo control, adaptive threshold, pressure sensors
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-13.
Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-13.
Statistics and arithmetic are recomputed, not judged.
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