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DoubleLock Healthcare, Inc.™
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  • Advantage
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  • About Us
  • Contact Us

The Problem

 Intravenous ports and syringe tips are exposed, easily contaminated, and implicated in contributing to a healthcare-associated infection (HAI) according to published research. Per a 2022 study by the World Health Organization and pending the country where care is provided, 7-15% of patients in acute care hospitals acquire an HAI while in the facility’s care; 10% of these patients die each year from such HAIs. The Centers for Disease Control states that catheter-related bloodstream, surgical site, and antibiotic-resistant HAIs cost the U.S. Healthcare system $13 billion and cause 99,000 preventable deaths annually.  


Global Volume of Surgery and Incidence of Post-Operative Infectious Complications

“Globally, a staggering 310 million major surgeries are performed each year, around 40 to 50 million in USA and 20 million in Europe. It is estimated that 1-4% of these patients will die, up to 15% will have serious post-operative morbidity, and 5-15% will be readmitted within 30 days.” 

“Global estimates indicate that on average 8 million patients die every year from major surgery, and up to twice this number experience postoperative complications.”

7% of patients develop infectious complications as a result of surgically-induced stress. 

“If surgical complications were classified as a pandemic, like HIV/AIDS or coronavirus (COVID-19), developed countries would work together and devise an immediate action plan and allocate resources to address it.”

Trauma of major surgery: A global problem that is not going away. Dobson GP. Int J Surg. 2020. PMID: 32738546  DOI: 10.1016/j.ijsu.2020.07.017  


Definition, Types of Healthcare-Associated Infection (HAI) and Key Solutions

A healthcare-associated infection is defined as “an infection occurring in a patient during the process of care in a hospital or other healthcare facility which was not present or incubating at the time of admission. This includes infections acquired in the hospital, but appearing after discharge, and also occupational infections among staff or the facility.” 

CR-BSI - catheter-related bloodstream infections CR-UTI catheter-related urinary tract infection  HAP - healthcare-associated pneumonia  SSI - surgical site infection VAP - ventilator-associated pneumonia

Key Solutions
1. Identifying local determinants of the HAI burden  2. Improving reporting and surveillance systems at the national level 3. Ensuring minimum requirements in terms of facilities and dedicated resources available for HAI surveillance at the institutional level including microbiology laboratories’ capacity 4. Ensuring that core components for infection control are in place at the national and healthcare setting levels  5. Implementing standard precautions, particularly best hand hygiene practices at the bedside  6. Improving staff education and accountability 7. Conducting research to adapt and validate surveillance protocols based on the reality of developing countries  8. Conducting research on the potential involvement of patients and their families in HAI reporting and control  

Report on the Burden of Endemic Health Care-Associated Infection Worldwide: Clean Care is Safer Care. A Patient Safety Initiative from WHO.org 


Incidence of CR-BSI Catheter-Related Blood Stream Infections

“Point Incidence rates of intravascular device (IVD)-related BSI were lowest with peripheral intravenous catheters (0.1%, 0.5 per 1000 IVD days) and midline catheters (0.4%, 0.2 per 1000 catheter-days). Far higher rates were seen with short-term noncuffed and nonmedicated central venous catheters (CVCs) (4.%, 2.7 per 1000 catheter-days). Arterial catheters used for hemodynamic monitoring (0.8%, 1.7 per 1000 catheter-days) and peripherally inserted central catheters used in hospitalized patients (2.4%, 2.1 per 1000 catheter-days) posed risks approaching those seen with short term conventional CVCs used in the intensive care unit.”

The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006 Sep;81(9):1159-71. doi: 10.4065/81.9.1159. Maki DG, Kluger DM, Crnich CJ. PMID: 16970212  DOI: 10.4065/81.9.1159 


Contaminated IV Ports

“Microorganisms causing vascular catheter-related sepsis gain access to the bloodstream through either the skin at the catheter insertion site or through the catheter hub.” 

Relevance of the catheter hub as a portal for microorganisms causing catheter-related bloodstream infections. Nutrition. 1997 Apr;13(4 Suppl):15S-17S. M B Salzman, L G Rubin. PMID: 9178305  DOI: 10.1016/s0899-9007(97)00217-7


“The predominant source of intravascular catheter-related bloodstream infections has been a research and clinical question for more than 30 years. During that time, we’ve moved from the position of a single source predominating in all clinical scenarios to a more realistic appraisal that both skin at the insertion site and the catheter hub / connector (i.e., an extraluminal and an intraluminal source of infection, respectively) are important and that maximally effective prevention programs must address both sources of infection.” 

What is the predominant source of intravascular catheter infections?. Mermel LA. Clin Infect Dis. 2011. PMID: 21288845  DOI: 10.1093/cid/ciq108


“Potentially pathogenic multi drug resistant bacterial organisms are transmitted during the practice of general anesthesia to both the anesthesia work area and intravenous stopcock sets.” 

Transmission of pathogenic bacterial organisms in the anesthesia work area. Randy W Loftus, Matthew D Koff, Corey C Burchman, Joseph D Schwartzman, Valerie Thorum, Megan E Read, Tammara A Wood, Michael L Beach. Anesthesiology. 2008 Sep;109(3):399-407. PMID: 18719437 DOI: 10.1097/ALN.0b013e318182c855


Contaminated Syringe Tips

“This single-center study prospectively assessed the microbial contamination of anesthetic syringes handled preoperatively under different conditions. We documented high rates of bacterial contamination, with strong but statistically nonsignificant differences between handling groups. Our results identify skin contact as the main source of contamination, and thus we emphasize the impact of proper hand hygiene.”

Microbial contamination of anesthetic syringes in relation to different handling habits. Florian Heid, Carolin Bender, Hendrik Gervais, Joachim Schmeck, Wolfgang Kohnen, Rüdiger Noppens. Am J Infect Control. 2016 Mar 1;44(3):e15-7. Epub 2015 Nov 7. PMID: 26559736  DOI: 10.1016/j.ajic.2015.09.029


“High contamination rates were measured when the hub of syringes touched non sterile environmental surfaces and fingers.”

Microbial contamination of syringes during preparation: the direct influence of environmental cleanliness and risk manipulations on end-product quality. Stucki C, et al. Am J Health Syst Pharm. 2009. PMID: 19890087  DOI: 10.2146/ajhp070681


“Organisms were isolated from five of 38 (13%) bags from five of 20 simulated cases anesthetized by four of 10 anaesthetists, 10 of 197 (5%) syringes and 6 of 17 (35%) needles.”

Anaesthetic drug administration as a potential contributor to healthcare-associated infections: a prospective simulation-based evaluation of aseptic techniques in the administration of anaesthetic drugs. Gargiulo DA, et al. BMJ Qual Saf. 2012. PMID: 22706928  DOI: 10.1136/bmjqs-2012-000814


Cost of CR-BSI Catheter-Related Blood Stream Infections 

“The cost of CRBSIs is between $33,000 and $44,000 in the general adult ICU, between $54,000 and $75,000 in the adult surgical ICU, and approximately $49,000 in the pediatric ICU. Finally, CRBSIs are associated with reimbursement that is more than $26,000 less than costs. Hospital and clinical decision makers should be aware of the high cost of CRBSIs in the ICU, the relatively poor reimbursement, and the implied high value of prevention efforts.”

The cost of catheter-related bloodstream infections: implications for the value of prevention. Hollenbeak CS. J Infus Nurs. 2011. PMID: 21915004 DOI: 10.1097/NAN.0b013e3182285e43


Compliance with IV Port Decontamination

“The greatest risk for contamination of the catheter after insertion is the needleless connector with 33-45% contaminated and compliance with disinfection as low as 10%.” 

Disinfection of Needleless Connector Hubs: Clinical Evidence Systematic Review. Moureau NL, Flynn J.Nurs Res Pract. 2015;2015:796762. Epub 2015 May 14. Review. PMID: 26075093 DOI: 10.1155/2015/796762 



Solution / Doublelock advantage

The Solution

The DoubleLock Advantage

The DoubleLock Advantage

DoubleLock Healthcare, Inc. has completed the proof-of-concept and is developing the patented DoubleLock Sterile Entry Intravenous Port and Syringe System™ which aims to become the new standard-of-care in IV drug delivery by preventing bacterial infection to address this costly HAI issue, delivering 100% compliance with IV port and syring

DoubleLock Healthcare, Inc. has completed the proof-of-concept and is developing the patented DoubleLock Sterile Entry Intravenous Port and Syringe System™ which aims to become the new standard-of-care in IV drug delivery by preventing bacterial infection to address this costly HAI issue, delivering 100% compliance with IV port and syringe tip asepsis and preventing Luer-lock misconnections and wrong-route infusion or injection drug errors. 


Prototype #11 is shown in the images. 


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Laboratory Results

The DoubleLock Advantage

The DoubleLock Advantage

The DoubleLock Advantage

Protective cover - No Bacteria; Increased Safety - No Needles; Reduced Legal and Care Costs; Time Savings;  Ease of Use; Decreased Toxic Drug Vapors and Leakage; Ensures Compliance with IV Port Asepsis - No Alcohol Swabs or Alcohol Impregnated Caps Needed.

Unique connector to prevent tubing misconnections. 


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The Solution

 DoubleLock Healthcare, Inc. is developing the patented DoubleLock Sterile Entry Intravenous Port and Syringe System™ to address this costly HAI issue, delivering 100% IV port and syringe tip asepsis. 


This Product Has Not Yet Been Approved by the fda

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