EarlySense

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EarlySense
Private
Industry Medical Technology
Founded 2004
Headquarters Waltham, Massachusetts, United States
Ramat Gan, Israel
Area served
Worldwide
Key people
Avner Halperin (CEO)
Website earlysense.com

EarlySense is a medical-device company that develops contact-free and continuous monitoring solutions to identify early signs of patient deterioration and motion in hospitals, elderly care facilities and homes.[1][2][3][4] The company’s US headquarters are located in Waltham, Massachusetts.[5] The CEO of the company is Avner Halperin,[6][7][8] and Tim O’Malley is the president of EarlySense Inc.

EarlySense system[edit]

The Joint Commission National Patient Safety Goals 9, 14, and standard of care PC.02.01.19 require hospitals to reduce patient falls, pressure ulcers and have a process for early recognition of patient deterioration.[9]

EarlySense contact-free sensing technology monitors heart rate, respiratory rate and motion by measuring key parameters with a sensor placed underneath the patient’s mattress. The EarlySense System empowers the medical staff in unmonitored wards to early detect patients’ deterioration by following and analyzing the patients' vital signs and motion. This enables the nursing staff to improve clinical outcomes and proactively reduce length of stay in the hospital’s general wards and in ICU, and also reduce adverse events such as pressure ulcers and falls.[2][3][10][11][12]

The EarlySense system is cleared by the US Food and Drug Administration and has a CE mark.[2][3][4][11][12][13][14]

Pressure ulcers are one of the most costly patient safety risks in hospitals. The EarlySense system alerts medical staff about the motion level of a patient and verifies patient turns by nurses. By identifying low patient movement, patients methodically can prevent pressure ulcers.[2][3][3][4][4][11][12] Pressure ulcers are one of the most costly patient safety risks in hospitals.[3]

Another patient safety risk is falls. The EarlySense system notifies the medical staff when the patient gets in and out of bed.[10] Patient falls occur in approximately 1.9% to 3% of all acute care hospitalizations; The bedside is the most common place for falls to occur.

Clinical research[edit]

Study results reported in the Journal of General Medicine (JGM) in 2003 noted that slow transfer to the ICU of a medical or surgical ward patient who has shown deterioration increases the risk of death in the hospital.[15] The study, cited in the JGM in 2003, surveyed 285 US hospitals including teaching and nonteaching institutions. Its authors observed an aggregate in-hospital mortality of 12% for ICU patients.[15][16] Patients transferred from the ward to the ICU were noted to have a 20% to 65% in-hospital mortality rate.[15][17][18] The authors also stated that patients transferred from the ward to the ICU are also much more costly to treat.[15][17] The authors of the article concluded: Slow transfer to the ICU of physiologically defined high-risk hospitalized patients was associated with increased risk of death.[15] Conversely, intensive care patients discharged too early are also at risk of deterioration because of complex care needs.[19]

A study was conducted by Chaboyer, Thalib, Foster, Ball and Richards to identify the types, frequency, and predictors of adverse events that occur in the 72 hours after discharge from an intensive care unit when no evidence of adverse events was apparent before discharge.[19] Adverse events are defined as injuries or events that are due to health care management rather than to underlying disease and that result in prolonged hospitalization or some disability.[19] A total of 147 adverse events, 17 (11.6%) of which were defined as major, were incurred by 92 patients (30.7%).[19] Two predictors, respiratory rate less than 10/min or greater than or equal to 25/min and pulse rate exceeding 110/min, were significant independent predictors.[19] The study investigators concluded in a report published by the American Journal of Critical Care in 2008 that taking, recording, and reporting vital signs are important.[19]

A clinical study was conducted at a Dignity Health Hospital. The study outline and results were reported in the American Journal of Respiratory and Critical Care Medicine and presented at the ATS International Conference in San Francisco on May 21, 2012.[20][21][22] The objective of the study was to determine the effects of continuous patient monitoring, using the EarlySense contact-free monitor, on the length of stay in a medical-surgical unit, ICU transfers and ICU length of stay for patients initially admitted to non-ICU units.[20][21][22] The study was conducted in a 316-bed acute care hospital as a pre-post evaluation study.[20][21][22] The EarlySense system was positioned in a 33-bed medical-surgical unit including bed side monitors, a central nursing station display and integration with the mobile phones of the nurses.[20][21][22] Just over 7,600 patient charts, 2,314 in the intervention arm and the rest from three separate control arms were reviewed.[20][21][22] Comparing the intervention unit to the control unit, which did not go through with the intervention, outcome results showed a reduction in the average stay in the ICU of just over 2 days (a 45.9% reduction) comparing the pre-intervention to the post-intervention, with a trend of a decline in the number of transfers.[20][21][22] This resulted in a 47.2% decrease in the rate of total ICU days for transfers between the pre-intervention and the post-interventions periods. The length of stay of patients in the medical-surgical units was reduced following the intervention by a mean of 0.4 days, a reduction of almost 10%.[20][21][22]

The Journal of Hospital Medicine published - online in August 2012 and in the October 2012 print edition - the results of a post regulatory approval clinical and non-interventional prospective study conducted to determine if the EarlySense system accurately predicts patient deterioration.[23][24] This clinical study was performed in two different medical departments at two separate academic medical centers.[23][24] Sensitivity and specificity in predicting deterioration was found to be 82% and 67%, respectively, for HR and 64% and 81%, respectively, for RR. For trend alerts, sensitivity and specificity were 78% and 90% for HR, and 100% and 64% for RR, respectively.[23][24] The conclusion of the researchers: “When tracking adverse clinical events for patients monitored by the EarlySense device, we found the monitor was able to identify hours ahead of time most of these events.[23][24] The current study provides data supporting the ability of this system to accurately predict patient deterioration.”[23][24]

Clinical results were presented at the 2013 Annual Scientific Meeting of the American Geriatrics Society in a poster titled "The Effect of a Continuous Patient Monitoring System on Reducing Hospitalization and Falls in Skilled Nursing Facilities" was presented. It reported research conducted by the Hebrew Home at Riverdale, NY and Derot Medical Center in Israel. The research showed that the EarlySense system helped to reduce falls and in turn lower hospitalizations for residents in skilled nursing facilities.

A clinical research team at California Hospital in Los Angeles won "Best Novel Idea" Prize at the Rapid Response Systems and Medical Emergency Teams 2013 8th International Conference. The award was for research done on the implementation of the EarlySense system at California Hospital. The scientific poster that won the prize is titled "Contact-Free Under the Mattress Monitoring for Early Recognition of End-of-Life in Med/Surg Units". According to the poster, EarlySense monitors were implemented in a 33-bed medical-surgical unit. Performance was compared between a baseline 9-month period and an intervention 9-month period as well as against a different "sister" unit. During intervention more than 2300 patients were monitored by the EarlySense system and more than 7000 patients records were viewed in all study arms. An automated algorithm for end-of-life detection was tested on an additional data set of more than 4000 records. The automated detection indicator for end-of-life was tested and resulted in 58% sensitivity and 99% specificity.[25][26][27]

Study results published in the Critical Care Med.[28] 2014 by Dr. Slight et al. showed that the implementation of EarlySense monitoring system was associated with a highly positive return on investment. The magnitude and timing of these expected gains to the investment costs may justify the accelerated adoption of this system across remaining inpatient non-ICU wards of the community hospital. The study objective was to evaluate the cost savings attributable to the implementation of a continuous monitoring system in a total 316 beds in the medical-surgical unit and to determine the return on investment associated with its implementation. Two models were constructed: a base case model (A) in which we estimated the total cost savings of intervention effects and a conservative model (B) in which we only included the direct variable cost component for the final day of length of stay and treatment of pressure ulcers. In the 5-year return on investment model, the monitoring system saved between $3,268,000 (conservative model B) and $9,089,000 (base model A), given an 80% prospective reimbursement rate. A net benefit of between $2,687,000 ($658,000 annualized) and $8,508,000 ($2,085,000 annualized) was reported, with the hospital breaking even on the investment after 0.5 and 0.75 of a year, respectively. The average net benefit of implementing the system ranged from $224 per patient (model B) to $710 per patient (model A) per year. A multi-way sensitivity analyses was performed using the most and least favorable conditions for all variables. In the case of the most favorable conditions, the analysis yielded a net benefit of $3,823,000 (model B) and $10,599,000 (model A), and for the least favorable conditions, a net benefit of $715,000 (model B) and $3,386,000 (model A). The return on investment for the sensitivity analysis ranged from 127.1% (25.4% annualized) (model B) to 601.7% (120.3% annualized) (model A) for the least favorable conditions and from 627.5% (125.5% annualized) (model B) to 1739.7% (347.9% annualized) (model A) for the most favorable conditions.

The study published at The American Journal of Medicine on March 2014 validated that Continuous monitoring on a medical-surgical unit was associated with a significant decrease in total length of stay in the hospital and in intensive care unit days for transferred patients, as well as lower code blue rates. 7643 patient charts were reviewed: 2,314 that were continuously monitored in the intervention arm and 5,329 in the control arms. Comparing the average length of stay of patients hospitalized in the intervention unit following the implementation of the monitors to that before the implementation and to that in the control unit, a significant decrease was observed (from 4.0 to 3.6 and 3.6 days, respectively; P <.05). Total intensive care unit days were significantly lower in the intervention unit post-implementation (63.5 vs 120.1 and 85.36 days/1000 patients, respectively; P = .04). The rate of transfer to the intensive care unit did not change, comparing before and after implementation and to the control unit (P = .19). Rate of code blue events decreased following the intervention from 6.3 to 0.9 and 2.1, respectively, per 1000 patients (P = .02).[29]

Consumer technology[edit]

In September 2015 the company launched myEarlySense, a product geared toward sleep and wellness monitoring at privat homes.[30] Placed under the mattress, the sensor collects information on heartbeat, respiratory rate, sleep stages and movement, and then wirelessly transmits the data to a smartphone app.[31] The solution integrates with home automation systems like home security and smart bed, allowing users to adapt their home environment based on the information collected from the sensor.[32]

EarlySense made its technology available for OEM integration into consumer electronics, and Samsung Electronics was the first major player to incorporate the technology into its sleep tracking device, SleepSense.[33] The technology has also been integrated into Beurer’s Sleep Expert 80.[34]

Popular culture[edit]

EarlySense central nurses’ station monitor as seen at All Saints Hospital on season 5 of "Nurse Jackie"

The EarlySense system can be seen in the American TV series "Nurse Jackie" and in the American TV series "Royal Pains".[35]

See also[edit]

References[edit]

  1. ^ "Avigayil Kadesh, "Sensing patients' needs 24/7," Ministry of Foreign Affairs, December, 2010". 
  2. ^ a b c d "Daniel, Robert, "Israel stocks up; FDA moves on 2 medical-tech firms," Marketwatch, June 21, 2010". 
  3. ^ a b c d e f "Vanac, Mary, "EarlySense gets FDA nod for improved patient-monitoring system," MedCity News, June 21, 2010.". 
  4. ^ a b c d ""EarlySense raises $13m in third round," Israel21C, June 17, 2010". 
  5. ^ Lee, Jaimy. "Jaimy Lee, "EarlySense names O'Malley president," ModernHealthcare.com, September 12, 2012". 
  6. ^ "David E. Williams, "EarlySense contact-free medical monitor. Discussion with CEO Avner Halperin," Health business blog, April 4th, 2012.". 
  7. ^ "Omar Ford, "EarlySense gives clinicians heads up in deteriorating vitals", Medical Device Daily,September 24, 2012.". 
  8. ^ "EarlySense CEO Says Seeking More Funding for Growth". Bloomberg. 
  9. ^ "Joint Commission National Patient Safety Goals, 2010." (PDF). 
  10. ^ a b "Feldman, Batya, "Patient monitor co EarlySense raises $13m," Globes, 3 June 10.". 
  11. ^ a b c "Krieger, Sari, "EarlySense Finds $13M To Expand Sales Of Patient Monitoring Machines," Dow Jones, VentureWire, Lifescience, June 04, 2010.". 
  12. ^ a b c ""Fresh Off Funding Round, EarlySense Gains FDA Approval," Dow Jones Venture Wire, Lifescience, June 22, 2010". 
  13. ^ "Gali Weinreb, "Patient monitor co EarlySense raises $7m", Globes, 20 October 10 16:7". 
  14. ^ ""EverOn Central Display Station for Contact Free Monitoring of Multiple Patients," Medgadget, October 13, 2010". 
  15. ^ a b c d e Young, Michael P.; Gooder, Valerie J.; Mc Bride, Karen; James, Brent; Fisher, Elliott S. (2003). "Inpatient Transfers to the Intensive Care Unit: Delays Are Associated With Increased Mortality and Morbidity". Journal of General Internal Medicine. 18 (2): 77–83. doi:10.1046/j.1525-1497.2003.20441.x. PMC 1494814Freely accessible. PMID 12542581. 
  16. ^ Zimmerman, JE; Wagner, DP; Draper, EA; Wright, L; Alzola, C; Knaus, WA (1998). "Evaluation of acute physiology and chronic health evaluation III predictions of hospital mortality in an independent database". Critical Care Medicine. 26 (8): 1317–26. doi:10.1097/00003246-199808000-00012. PMID 9710088. 
  17. ^ a b Rapoport, J; Teres, D; Lemeshow, S; Harris, D (1990). "Timing of intensive care unit admission in relation to ICU outcome". Critical Care Medicine. 18 (11): 1231–5. doi:10.1097/00003246-199011000-00009. PMID 2225891. 
  18. ^ Lundberg, JS; Perl, TM; Wiblin, T; Costigan, MD; Dawson, J; Nettleman, MD; Wenzel, RP (1998). "Septic shock: an analysis of outcomes for patients with onset on hospital wards versus intensive care units". Critical Care Medicine. 26 (6): 1020–4. doi:10.1097/00003246-199806000-00019. PMID 9635649. 
  19. ^ a b c d e f Chaboyer, W; Thalib, L; Foster, M; Ball, C; Richards, B (2008). "Predictors of adverse events in patients after discharge from the intensive care unit". American Journal of Critical Care. 17 (3): 255–63; quiz 264. PMID 18450682. 
  20. ^ a b c d e f g "Eyal Zimlichman, MD, Jamie Terrence, RN, Dalia Argaman, MSc, Zvika Shinar, PhD and Harvey Brown, MD, Effect Of Contactless Continuous Patient Monitoring In A Medical-Surgical Unit On Intensive Care Unit Transfers: A Controlled Clinical Trial, American Journal of Respiratory and Critical Care Medicine Vol 185. pp. A3793, (2012)". 
  21. ^ a b c d e f g "Anthony Vecchione, "Wireless Sensors Reduce ICU Days", Description: Description: Description: Description: Description: Description: Description: http://twimgs.com/infoweek/iwk_refresh/icon_email_10.gifInformationWeek, June 11, 2012".  External link in |title= (help)
  22. ^ a b c d e f g "Deborah Hirsch, "EarlySense Continuous Monitoring Sends Patients Home From ICUs More Quickly", HealthTechZone Contributor, May 22, 2012". 
  23. ^ a b c d e "Eyal Zimlichman MD, MSc, Martine Szyper-Kravitz MD, Zvika Shinar PhD, Tal Klap, Shiraz Levkovich, Avraham Unterman MD, Ronen Rozenblum PhD, MPH, Jeffrey M. Rothschild MD, MPH, Howard Amital MD, MHA, Yehuda Shoenfeld MD, "Early recognition of acutely deteriorating patients in non-intensive care units: Assessment of an innovative monitoring technology", Journal of Hospital Medicine, article first published online: 3 AUG 2012". 
  24. ^ a b c d e "Omar Ford, "EarlySense gives clinicians heads up in deteriorating vitals", Medical Device Daily, September 24, 2012". 
  25. ^ Terrence, Jamie. "Contact-Free Under-the-Mattress Monitoring for Early Recognition of End-of-Life in Med/Surg Units" (PDF). 
  26. ^ "Rapid response systems and medical emergency teams 8th international conference" (PDF). 
  27. ^ Terrence, Jamie. "Contact-Free Under-the-Mattress Monitoring for Early Recognition of and Response to Clinical Deterioration in Medical/Surgical Units" (PDF). 
  28. ^ Slight. "The return on investment of implementing a continuous monitoring system in general medical-surgical units". Crit Care Med. 42 (8): 1862–8. doi:10.1097/CCM.0000000000000340. PMID 24717454. 
  29. ^ Terrence. "Continuous Monitoring in an Inpatient Medical-Surgical Unit: A Controlled Clinical Trial". 
  30. ^ "EarlySense moves patient monitoring tech to at-home setting". 
  31. ^ "EarlySense, Samsung unveil direct to consumer, contact free sleep monitor". 
  32. ^ "EarlySense releases myEarlySense for digital health consumer market". 
  33. ^ "Samsung's Sleep Sense Monitor with Contact-Free Heart and Breathing Rate Monitoring". 
  34. ^ "beurer SE 80 SleepExpert with Contact-Free Heart and Breath Monitoring". 
  35. ^ "Earlysense debuts on prime time". 

External links[edit]