MRSA / Hospital Acquired Infection Litigation

The Deficit Reduction Act (DRA) of 2005 as well as the Affordable Care Act of 2010 have both channeled additional financial pressure onto a system in which the hospitals and surgeons are already experiencing drastic decreases in reimbursement and profits. To complicate the situation further, penalties and hold-backs from Medicare and other insurers will go into effect this October. The trial lawyers’ community has taken significant notice in regards to these changing circumstances along with the issue of Hospital Acquired Infection (HAI’s) – often referred to as “The Next Asbestos” due to HAI related litigation increasing tenfold in the last five years. Thus, not only will reimbursement penalties and hold-backs have impact in the millions on your average hospital, but hospital administrations will see such costs increase even further with increased litigation. 

Date	Publication	Title
Current	spine-health	Staph infection after surgery – blog
2012	San Francisco Chronicle	Parkland health department reach settlement
2012	ESPN Boston	Bobby Jenks had serious back issue
2000	Infection Control Today	Infection Control Today – Surgical Site Infections

Antibiotic Resistant Bacteria

Currently, almost two-thirds of all healthcare associated infections (HAIs) are caused by just six multidrug-resistant organisms that can be remembered using the acronym ESKAPE: Enterococcus species, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter species. These pathogens have been able to “ESKAPE” from many antibiotics by developing alarming rates of antibiotic resistance (tabulated below).

Amp- Ampicillin, Meth-Methicillin, Vanc-Vancomycin, 3GC- third generation cephalosporins, Cbpms- Carbapenems, N.A-not available.
Table recreated from: Hindron et al. 2008.Infection Control and Hospital Epidemiology, 29: 996-1011.

Date	Publication	Title
2013	DiFUSION Abstract	Antimicrobial Efficacy of a novel Orthobiologic PEEK in treating Surgical Site Spine Infections
2012	Medscape Today	Methicillin-Resistant Staphylococcus aureus (MRSA) News
2012	Medscape Today	Methicillin-Resistant Staphylococcus aureus (MRSA) Perspectives
2011	Medscape Today	Methicillin-Resistant Staphylococcus aureus (MRSA) Perspectives

Sterile Packaging

In the United States, approximately 46.5 million surgical procedures more invasive medical procedures are performed each year — including more invasive procedures like the 5 million gastrointestinal endoscopies and 400,000 spinal fusion surgeries. Each of these procedures involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membrane. A major risk of all such procedures is the introduction of pathogens that can lead to infection. Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g. hepatitis B virus) and transmission of environmental pathogens (e.g. S.aureus and Pseudomonas aeruginosa). Because sterilization of all patient-care items is not necessary, healthcare policies must identify whether cleaning, disinfection, or sterilization is indicated – primarily on the basis of the items’ intended use. Multiple studies done in a variety of countries have documented a lack of compliance with established guidelines for disinfection and sterilization, leading to numerous infection outbreaks.

Adequate cleaning requires removal of all residue remaining on the instrument from previous use. Failure to remove debris interferes with disinfection and prevents sterilization. Even sterilized foreign material left behind from a previous surgery becomes a foreign body inside the patient and will stimulate the patient’s defense mechanisms to reject or wall off this alien substance. Additionally, damage to instruments (i.e. corrosion, rust, or pitting) can occur from prolonged contact with organic material when cleaning is not thorough. The level of disinfection or sterilization depends on the intended use of the instruments. The accepted gold standard is the Spaulding method by which medical instruments are categorized as critical, semi critical, or noncritical according to their intended use. This method has been in use for more than 35 years and guides decisions related to levels of disinfection and sterilization.

However, since hospitals are under increasing pressure to complete more surgeries, they may try to make changes to processes without new validations and without talking to the OEMs. For example, they might not take into account the positioning of an instrument, the weight of a kit, or the contact/drying time required for effective sterilization of these implants/instruments. Additionally, orthopedic and spinal systems can be far more difficult to clean effectively than other types of surgical instrumentation since bone matter is unlike other forms of bioburden and can be harder to thoroughly remove from instrumentation. Interestingly enough, very few studies have documented the exact hospital borne costs associated with sterilization of devices/instrumentation – largely due to the difficulty in determining the variables and standardizing them for a sterilization procedure. Hence, there is a prerogative for medical device companies to address these concerns by helping to overcome the hospital’s lack of expertise in sterilization and packaging – in addition to offsetting the hidden yet significant cost of sterilization.

This ultimately results in easy and reliable management of spinal implants which are delivered to the hospital individually packaged, thereby dispelling the need to sterilize a multitude of implants or question the sterility of a product – a typical concern as biofilms can persist on the surface of products even after autoclaving. Furthermore, sterile packaged implants assist in simplifying the inventory management process since right-off-the-shelf usage helps surgeons implant the correct sized implant while preventing the sets from getting jumbled and disorganized.

Date	Publication	Title
2012	DiFUSION Inc.	XIPHOS™ – Sterile Packaged Spine Implants
2012	The Journal of Hospital Infection	Surgical site infections linked to contaminated surgical instruments.
2011	Joint Diseases and Related Surgery	Hidden sterilization cost of consignment orthopedic implants
2008	CDC	Guideline for Disinfection and Sterilization in Healthcare Facilities 2008
2008	Infection Control Resource	Sterilization processes:What every infection control practitioner needs to know
2006	Pennsylvania Patient Safety Authority	Bioburden on Surgical Instruments
2004	Healthcare Epidemiology	Disinfection and Sterilization in Health Care Facilities:What Clinicians Need to Know
2000	The Annals of Thoracic Surgery	Spread of Coagulase-Negative Staphylococci During Cardiac Operations in a Modern Operating Room

MediCare Reimbursement Penalties for Hospital Infection

On February 8, 2006, the President signed the Deficit Reduction Act (DRA) of 2005 which mandates
non-payment for all costs associated for Hospital Acquired Infection in an effort to curtail the
booming epidemic. The unintended consequences for hosptals and surgeons are monumental.
As the new legislation phases in Pay for Performance aspects of the bill will actually hold-back
payments for the worst offending hospitals even if there is not an infection in a given procedure.
Hence, if a hospital has a high infection incidence – they will receive less of the reimbursement
code and suffer additional potential holdbacks.

“The average hospital which admits 10,000 patients could lose between $5 to $15 million
per year in non reimbursed cots and penalties not counting litigation costs”

 

Date	Publication	Title
Current	Premier Inc.	CMS Hospital-Acquired Conditions (HAC) and Present on Admission (POA) Indicators
Current	Premier Inc.	CMS CoP infection control interpretive guidelines – 2008
2012	Associated Press	Medicare fines over hospitals’ readmitted patients
2010	APIC	Guide to the Elimination of Orthopedic Surgical Site Infections
2008	Nashville Medical News	CMS Reimbursement Changes Increase Hospital Focus on Infection

Comparative Effectiveness and Pay for Performance

Change is coming to the US Healthcare system regardless of the permanence of the new Healthcare Act. Under the new bill, priority will be given to procedures and devices which are non-experimental and have superior outcomes while reducing costs – leaving unproven and expensive products with no cost reduction benefits in the dust. With such changes on the horizon, new standards will inevitably begin to emerge.

 

Date	Publication	Title

A Self Sterilizing BioMaterial that Fights Infection and Promotes Bone Growth – The New Standard of Care

What if all existing surgical implants could be comprised of materials that are impregnable to infection and biofilm formation? DiFUSION believes in taking existing, proven procedures and making them better in an effort to reduce costs on a variety of fronts while ever-improving the outcomes (all without increasing the cost of the actual device). Its the right thing do for the patient, surgeon, hospitals and even for the healthcare
system as a whole – Which is why we have developed CleanFUZE™. CleanFUZE™ can be applied to any metal or polymer medical device and is proven 99.9999% effective in eradicating MRSA.

*CleanFUZE™ is not FDA approved for sale in the U.S.*

 

Date	Publication	Title
2012	Materials Letters	Bioactivity assessment of ZSM-5 type zeolite functionalized with silver or zinc
2011	Acta biomaterialia.	Bioinorganics and biomaterials: bone repair.
2007	Journal of Material Science. Materials in Medicine	In vitro evaluation of the use of zeolites as biomaterials: effects on simulated body fluid and two types of cells.
2003	Marcel Dekker Inc.	Medical Applications of Zeolites
1992	Journal of Bone and Mineral Research	Zeolite A increases proliferation and differentiation and transforming growth factor beta production in normal adult human osteoblast-like cells in vitro.