Patients today are between a rock and a hard place because when they get sick a hospital may be the last place they want to go. Hospital Acquired Infections, also known as Healthcare-associated infections (HAI) are the 4th leading cause of patient deaths, killing 270 people per day in the USA. Recently the Federal Government and Payers are implementing incentives and penalties on hospitals that are not doing all they can to reduce HAIs.
HAIs are defined as infections not present and without evidence of incubation at the time of admission to a health care setting. Within hours after admission, a patient’s flora begins to acquire characteristics of the surrounding bacterial pool. Most infections that become clinically evident after 48 hours of hospitalization are considered hospital-acquired. Infections that occur after the patient is discharged from the hospital can be considered healthcare-associated if the organisms were acquired during the hospital stay. There have been several cases of patients going into the hospital for minor surgeries and coming out in coffins, yet limited media coverage has been devoted to this area of concern.
Healthcare-associated infections can be localized or systemic, can involve any system of the body, be associated with medical devices or blood product transfusions. Three major sites of healthcare-associated infections are bloodstream infection, pneumonia, and urinary tract infection. HAIs result in excess length of stay, mortality and healthcare costs. In 2002, an estimated 1.7 million healthcare-associated infections occurred in the United States, resulting in 99,000 deaths. In March 2009, the CDC released a report estimating overall annual direct medical costs of healthcare-associated infections that ranged from $28-45 billion.
Hand hygiene has long been regarded as one of the most effective methods to prevent healthcare associated infections. Xhale Innovations is an interesting early stage company that is just beginning full commercialization. Their target market is HAIs. Xhale can assist hospitals in improving hand hygiene by documenting adherence and providing feedback to clinical professionals about their behavior.
Guidelines from the CDC have repeatedly emphasized that hand washing is the single most important procedure for preventing infections, yet reports continue to indicate that health care worker adherence to hand washing guidelines is low. The most significant action healthcare professionals can take is to improve their compliance to hand hygiene standards.
A product of Xhale, HyGreen is designed to provide the first line of defense in the control of HAIs. The system actively reminds busy healthcare workers to wash their hands and records all hand washing events and patient-staff interactions in the hospital environment giving hospitals the first comprehensive and definitive tool to effectively monitor adherence to hand hygiene protocols. The HyGreen Hand Hygiene System has recently been installed at The University of Illinois Medical Center at Chicago and Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, the first installation of HyGreen into the VA system nationally.
Similarly, BioVigil, LLC has developed a proprietary system to increase the compliance for hand hygiene. The BioVigil system monitors the precise location of healthcare workers and tests their hand-washing compliance upon entry and exit of every patient room. The data is collected in a WEB based central database for hospital administrators to track the improvement in hand-washing compliance.
HAIs are estimated to occur in 5% of all hospitalizations in the United States. In 1999, national point-prevalence surveys in pediatric intensive care units (PICU) and neonatal intensive care units (NICU) showed 11.9% of 512 patients had PICU-acquired infections, whereas 11.4% of 827 patients had NICU-acquired infections.
Internationally, both developed and resource-poor countries are faced with the burden of healthcare-associated infections. In a World Health Organization (WHO) cooperative study (55 hospitals in 14 countries from four WHO regions), about 8.7% of hospitalized patients had hospital acquired infections.
With increasing recognition of burden from healthcare-associated infections, national surveillance systems have been developed in various countries; these have shown that nationwide healthcare-associated infection surveillance systems are effective in reducing healthcare-associated infections.
In addition to the presence of systemic signs and symptoms of infection (eg, fever, tachycardia, tachypnea, skin rash, general malaise), the source of healthcare-associated infections may be suggested by the instrumentation used in various procedures. For example, an endotracheal tube may be associated with sinusitis, tracheitis, and pneumonia; an intravascular catheter may be the source of phlebitis or line infection; and a Foley catheter may be associated with a urinary tract infection.
The biofilms that form on indwelling urinary catheters are widely theorized to be the most common breeding ground for resistant bacteria and all the hand washing in the world will not be effective here – it will require new technology like that from Enox BioPharma or the SRS Medical In-Flow device.
Enox Biopharma embeds nitric oxide (NO) into polymer based medical devices. NO is the work horse of the body’s respiratory immune system and is a broad spectrum antimicrobial that does not create microbe resistance like antibiotics do. NO remains stable while embedded in the device until clinical use. Contact of the device with moisture or humidity releases NO over a period of time to block biofilm formation and kill microbes. Enox’s technology is applicable to any indwelling polymer medical device including, but not limited to catheters, endotracheal tubes, tympanostomy tubes and cosmetic implants.
HAIs can be caused by viral, bacterial, and fungal pathogens. Most patients who have healthcare-associated infections caused by bacterial and fungal pathogens have a predisposition to infection caused by invasive supportive measures such as endotracheal intubation and the placement of intravascular lines and urinary catheters. Ninety-one percent of bloodstream infections were in patients with central intravenous lines (CVL), 95% of pneumonia cases were in patients under going mechanical ventilation, and 77% of urinary tract infections were in patients with urinary tract catheters.
The SRS Medical In-Flow Device employs a new approach to bladder drainage. Unlike all urinary catheters, which rely on gravity to passively drain the bladder, the In-Flow has an internal pump that spins at 10,000 RPM and actively empties urine. As a result, voiding is more natural. The In-Flow is a replaceable urinary prosthesis that is designed to normalize toileting in women. The device simulates normal physio-logic function in two ways: 1) its internal pump simulates normal bladder function by fully evacuating urine even in patients with hypotonic/acontractile (atonic) bladder, and 2) its valve simulates normal sphincter function by closing at the control of the patient in order to block the flow of urine for patients with refractory urinary incontinence.
While prevention is the most effective tactic in battling HAIs, proper treatment of an HAI once it occurs is equally important. To this end, NovaBay Pharmaceuticals, a clinical stage biotechnology company, focuses on developing its proprietary and patented topical Aganocide compounds. NovaBay’s Aganocide compounds are novel, broad-spectrum, fast-acting, synthetic antimicrobial molecules designed to mimic the body’s defense against infection. These compounds are being developed to treat and prevent a wide range of local, non-systemic infections with a low likelihood of developing bacterial resistance. NovaBay is focusing its technology on four distinct therapeutic areas: dermatology, ophthalmology, urology and hospital infections. The company’s most advanced programs are focused on chronic non-healing wounds and urinary tract infections associated with Foley catheters. Approximately 6,000,000 patients suffer from chronic wounds such as diabetic ulcers, bed sores and venous stasis ulcers. These wounds frequently act as a reservoir for many resistant bacteria and fungi in the hospital setting. NovaBay’s NeutroPhase has the potency to eradicate bacteria and biofilm in patients’ wounds without damaging the sensitive epithelial tissues necessary for the wound closure. The cost of treating chronic wounds is estimated at $5-7 billion in the U.S., and the occurrence of these wounds is increasing at a rate of 10% per year. NeutroPhase has been cleared for marketing by the US-FDA device division. Expect to see NeutroPhase on the market in 2012.
The new federal health care reform law may bring health insurance to millions of Americans, but one if its lesser-known features, according to a national consumers group, is the law’s attempt to reduce the number of costly—and deadly—HAIs. The new act, signed into law by President Obama last year, will require more public reporting of medical errors, such as infections, at hospitals. The federal law attempts to encourage better patient outcomes through various incentives and restrictions, according to Consumers Union.
Beginning in October 2012 non-rural acute care hospitals that beat federal performance standards for at least five measures, including certain hospital-acquired infections, will receive higher Medicare payments. The federal government pays hospitals and other medical providers for delivering services to Medicare recipients.
Two years later in 2014, the federal government will reduce Medicare payments by one percent for those hospitals with the highest rates of medical harm as measured by “hospital-acquired conditions,” the Consumers Union reports. Those include certain preventable infections and medical errors, such as serious bedsores, catheter-associated urinary tract infections and certain types of falls and trauma, the organization reports. Meanwhile, the federal government will expand to Medicaid a policy of restricting payments to hospitals for extra care due to “certain preventable infections and medical errors.” Hospitals and other medical providers are financially reimbursed for Medicaid and Medicare services.
“They respond to reimbursement,” said Sen. Dede Feldman, D-Albuquerque, who has pushed for greater reporting of medical error and infection rates from New Mexico hospitals. “If they are awarded for improving, they will pay attention to that too. That is very good news. That will force change, more than any requirement.” With improved care, improved outcome can be anticipated.
Other companies making advancements in the field of Hospital Acquired Infections include Kenta Biotech AG, and Advaxis Incorporated.