An environmental science response to eliminate hospital acquired infections

According to the latest figures from the U.S. Centers for Disease Control (CDC), there were over two million incidences of hospital acquired infections and twenty-three thousand fatalities from these during 2014.

Although this represents a considerable improvement in treating such illnesses from which over 75,000 died during 2011, there has not been a reduction in the number of cases, for which the Center for Medicare and Medicaid Services ostensibly since 2008 refuses payment. Recently, in a nationally broadcast webinar organized by the National Patient Safety Foundation (Boston, MA), spokespersons from the CDC, from the Agency for Health Research and Quality, and from the Center for Medicare and Medicaid Services together have asked for help in combating what is now recognized as a serious public health problem. Specifically it was mentioned that current measures incorporating hand hygiene and other existing cleansing procedures still result in an unacceptable level of occurrences of HAIs and that more is needed. There is also increased concern that illnesses caused by antibiotic-resistant bacteria may, through the discharge of still-infected patients, get out into the general public.

It has recently been shown by the Antimicrobial Copper Group Division of the Copper Development Association that use of antimicrobial copper alloy surfaces for bed rails, IV-poles and other touch-surfaces reduces incidences of hospital acquired infections by 58% (1). This can likely be augmented to even higher levels by use of coatings containing silver or the use of such coatings in combination with antimicrobial copper. In laboratory studies it has been found that silver and copper break down the cell walls of bacteria and also interfere fatally with respiration and reproduction processes.

Although these metals would provide surface environments free from pathogenic organisms, such surfaces would have to be periodically cleansed to remove biofilms. Such films form on surfaces covered with dust, sweat, or even dead cells and microorganisms. There are a number of commercial cleansing formulations that are well known to members of the infection control community. There is also concern that the use of such surfaces would increase antibiotic resistance to silver and copper. However these metals have been used for thousands of years without such resistance being developed It has also been shown in peer reviewed literature that exposure to metallic silver does not induce resistance in pathogenic microorganisms. (2) (3).

Efforts over the last decade at direct sales and participation at health-care expositions made from purveyors of silver based coating formulations and from members of the Antimicrobial Copper Group have not led to widespread adoption by the health care community. It will require pressure from the Centers for Disease Control or from insurance companies or from both. Efforts have been made and are continuing to obtain acceptance from the CDC; but despite the fact that meetings have been held within the Agency on this issue, the Centers has not issued or advocated even experimentation on such uses. The CDC though has issued a five-step protocol for evaluation of such surface materials and recognizes that it must form partnerships and collaborations with organizations offering likely prevention and cure methods. The CDC also has frequent opportunities for vendors to introduce their products to the Agency.

One particular difficulty is that creating greatly reduced pathogen environments is a preventative measure and thus becomes a public health issue. Money will have to be spent to create such environments. For hospital administrators, it is generally far easier and there is far less budgetary strain just to administer pills. Unfortunately, for many microorganisms (the SuperBugs), there are no effective medications available. Such antibiotic resistant microorganisms are now another major concern of the Health and Human Services Cabinet Department. Although there are many new drugs being developed by pharmaceutical companies, the time from conception to commercialization is extremely long. The price of such newly developed pharmaceuticals also tends to be extremely high (for example, a newly developed medication for treatment of hepatitis C is estimated to cost $84,000.00 annually, well beyond the budget of most individual patients). In addition, the cost may not even be covered for insured patients.

The CDC and other HHS agencies including the Office of the U.S. Surgeon General and the Agency for Healthcare Research and Quality (AHRQ) recognize that in combating diseases, prevention is preferable to cure. Programs have already been instituted for reduction of surgical site infections; for example, reduction in catheter associated urinary tract infections. For much greater reduction both in HAIs and in problems caused by antibiotic resistant microorganisms, the technology already exists to implement economical preventive measures. Further research does however need to be done. Studies need be done on copper alloys to supplement the work sponsored by the Antimicrobial Copper® group, on coatings containing silver (generally in the parts per million of the metal by weight range), and on coatings containing organic biocides. There may well be other methods to reduce HAIs in hospitals, in off-campus patient treatment centers, and in nursing homes. Such studies may also include research on reducing pathogen transmission, and in looking at the effectiveness in preventing HAI development in specific groups of patients that may be more susceptible to pathogenic organisms such as those that are neonatal, and those who are elderly, and those who have compromised immune systems. Burn victims and bone marrow treatment patients are also likely to incur far less risk from procedures and recovery taking place in ultra-low bioburden environments.

Discussions with physicians and clinician nurses generally leads to the conclusion that adopting permanently antimicrobial surfaces has considerable merit. In medical practice, physicians have reasonable control over medical devices and instrumentation to mitigate risk from surgical site infections. Examples are the use of coatings containing silver on patient touch surfaces of stethoscopes and on the contact surfaces of urinary catheters. However, when suggestions to create low bioburden environments are passed on to hospital administrators, it has been found that no action is taken, or the comeback answer is that "HAIs are under control." Administrators must be reminded that such surfaces are only likely to be needed where patients are most susceptible to acquiring HAIs. These would be primarily in operating or other surgical theaters, and in recovery rooms and in intensive care units. Also, only certain objects likely to be touched by the patient or by hospital personnel such as bed rails, IV poles, trays, tables and perhaps flooring need to be permanently biocidal. Existing measures known to be effective in infection control must also continue to be implemented. These include diligent hand hygiene, the use of antimicrobial gowns and bed linens, and constant monitoring of surfaces for biofilm formation. Such films need to be scrubbed away. Where proven effective the use of UV-radiation treatment of the room can also be implemented.

Although an initial substantial cost may be involved, such cost will be over a fairly long period of time as the hospital will still have to provide services while conversion to microbe resistant environments takes place. Bond issues, or less preferably, raising taxes can be considered for financing. Fund drives within the hospital served community can be held. Insurance companies that will likely indirectly benefit can be solicited. There may also be money available from local and state government budget surpluses and from federal programs.

In the meantime, there are funds available for the necessary research from the CDC, from AHRQ, from state budget surpluses and, possibly even from agencies such as the Departments of Defense and Veterans Affairs. In almost all cases, research funding would largely be directed to major academic medical school institutions. Very often, state Departments of Health and on occasion, municipal health departments serve as intermediaries. The CDC, in addition, has registered a number of medical schools for direct funding of epidemiology studies and is looking to register more.

Additional measures taken by the CDC are to improve exchanges of data with other agencies and to assign key personnel for the necessary time to develop strategies to combat HAIs and antibiotic resistant pathogenic organisms. In the past, the CDC has often had to assign infection control personnel to handle emergency outbreaks such as ebola and respiratory virus epidemics on a long term basis. This has often led to discontinuities in HAI incidence reduction research.

The Way Forward: Searches are already being made of academic medical institutions and hospital complexes to see if any such would undertake the responsibilities of the research program. The funding agencies also need to establish their own criteria as to how many studies are needed to provide the necessary cachet to a disease prevention policy that would gain public acceptance. It is also recommended that to save the costs and mortalities of HAI incidences, initial research should be on total antimicrobial environments in health care settings. At a later stage, research can be done on selected components of the antimicrobial surface environment to determine, for example, if use of specially antimicrobial treated walls have any significant effect on reduction of HAI occurrences.

Another concern for the funding agencies, especially the CDC, is how clinical performance criteria for such surfaces and the total hospital environment in the proposed major target areas are to be established, and how products containing permanently antimicrobial surfaces are to be registered. (4). Antimicrobial compositions and claims to efficacy fall under the jurisdiction of the Environmental Protection Agency (EPA). The agency requires such compositions to be registered. There is however, a major exemption from registration for objects treated with an antimicrobial coating or otherwise having the antimicrobial composition incorporated within the body of the object (the "treated article exemption"). There may also be useful precedents from the food processing industries. Food processors have long used permanently antimicrobial surfaces in the processing and packaging of food and beverages to increase shelf life by retarding spoilage.

Whether other federal and state health monitoring agencies will cede jurisdiction to the CDC also needs to be addressed. Adoption of permanently antimicrobial surfaces or a totally antimicrobial environment provides extremely low levels of risk to both patients and health care workers and can have very high levels of benefits. There does not seem to be a major need for agencies such as the FDA and EPA to become deeply involved, and it is hoped that the CDC will continue its effectiveness such that its influence will be paramount.

It is very likely that judicious use of permanently antimicrobial surfaces to create a low bioburden environment can greatly reduce incidences of hospital acquired infections at a very reasonable cost. The research that needs to be done to complete an "evidentiary hierarchy" for the satisfaction of the CDC is readily doable. Funding is readily available from the health care agencies and possibly from other sources. A commitment to implementation from the CDC and from other concerned divisions of HHS if research results are satisfactory will also be necessary to interest suppliers of such surfaces in participation in the research programs. Physicians and nursing professionals contacted are generally supportive of the technology. Use of permanently antimicrobial surfaces is of no risk to patients and to health care personnel. In the end, it is hospital management that has to be convinced to spend the necessary funds to engineer the environment in the areas of hospitals where both patients and health-care personnel are exposed to harmful pathogens. The old proverb that "an ounce of prevention is worth a pound of cure" still applies.

Biography of Dr. Ellis: Dr. Ellis is an independent consulting scientist who over a long career has focused on the development and sterilization processing of medical devices, and has worked for over fifteen years on the development of commercial antimicrobial markets for silver. He is a 50+ year member of the American Chemical Society and is an associate member of the Association of Professionals in Infection Control and Epidemiology. He has also taught environmental science at Florida International University (Miami, FL).

(1) H.T. Michels, PhD, PE, C. William Keevil, PhD, Cassandra D. Salgado, MD and Michael G. Schmidt, PhD, From Laboratory Research to a Clinical Trial: Copper Alloy Surfaces Kill Bacteria and Reduce Hospital Acquired Infections, Health Environment Research and Design Journal, Vol: 9 (1) (2015) 64-79.

(2) Jose Ruben Morones-Ramirez, Johnathan A. Winkler, Catherine S. Spina, and James J. Collins, Silver Enhances Antibiotic Activity Against Gram Negative Bacteria, Sci. Transl. Med. 5 (2013), 190ra81

(3) Jose Ruben Morones, Jose Luis Elechiguerra, Alejandra Camacho, Katherine Holt, Juan B. Kouri, Jose Tapia Ramirez, and Miguel Jose Yacaman, The Bacterial Effect of Silver Nanoparticles, Nanotechnology 16 (2005) 2346-2353.

(4) Evelyn Alvarez, MPH, Daniel Z. Uslan, MD, Timothy Malloy, JD, Peter Sinsheimer, PhD, and Hilary Godwin, PhD, It is time to revise our approach to registering antimicrobial agents in health care settings, American Journal of Infection Control, 44 (2016) 228-232.

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