Infection control and product evaluation

How does product evaluation impact infection control?

Product evaluation is a fundamental component of the infection control activities that help promotes a culture of patient safety.

Major United States initiatives to eliminate health care-associated infections (HAI) impact the product evaluation process in health care settings:

Since 2009, The Joint Commission’s National Patient Safety Goals (NPSG) for hospitals includes infection control practices, such as:

Improved compliance with hand hygiene
The use of contact precautions
Strategies for reducing transmission of health care-associated infections, including multi-drug resistant organisms

Beginning in 2008, the US Centers for Medicare and Medicaid Services (CMS) ruled that reimbursement to hospitals for certain health care associated infections would cease:

Surgical site infections
Catheter-associated urinary tract infections
Catheter associated bloodstream infections

As pressures for cost containment continue to impact health care delivery in all settings, infection control professionals (ICP) play a pivotal role in facilitating decisions regarding cost centers.

These efforts will expand the ICPs role beyond offering guidance related to traditional purchases, such as hand washing products and disinfectants including:

Major product and equipment purchases
Activities that affect infection prevention activities and, ultimately, patient safety
Advances in technology that impact infection control practice

What elements of product evaluation are necessary for infection prevention and control?

Evaluating infection control products and procedures requires a structured, multidisciplinary approach.

Infection control professionals (ICP) should take the lead when evaluating infection control-related products or processes that impact infection control activities.

The starting point is active participation in a multidisciplinary Product Evaluation Committee. The ICP’s contributions include the following:

An understanding of best practices and current guidelines
Helping to set priorities based on the facility’s rates of:

Certain categories of infection

Antibiotic-resistant infections

Sharps injuries, or other pertinent data

Developing criteria regarding product design and performance
Assessment of published data regarding the product or similar products
Gathering of information regarding the experiences of similar facilities
Reviewing Health Device Alerts from the US Food and Drug Administration (FDA) and other independent organizations (e.g., the non-profit ECRI Institute, formerly Emergency Care Research Institute).
Planning and assessing the results of a trial period for products in appropriate clinical settings to determine:

How well the product functions

Its acceptance by primary users

Analysis of the cost benefit or cost-effectiveness of the product
Looking beyond low tech products for opportunities to assess processes and procedures that impact infection control activities

What are the consequences of ignoring product evaluation?

A structured approach to product evaluation is a key driver of successful decision-making.

Attention to infection control fundamentals helps manage the costs of care, avoids the perception that a product or device is a substitute for the infection control fundamentals (e.g., hand hygiene, housekeeping, device maintenance), and, helps to maintain or improve patient safety.

Ignoring these key concepts can result in:

Faulty decision-making
Wasted time, money, and other resources
A compromise in patient safety
Accreditation citations
Having reimbursement withheld

What information supports product evaluation?

Cost effectiveness analysis (CEA)

CEA is an essential component when making a business case during the product evaluation process.

In infection control terms, the most logical CEA is an assessment of the benefits to be gained by a new product or intervention compared with the cost of the existing product or intervention, and the costs of any infections that might be prevented as a result.

The end result for infection control product evaluation should be a calculation of the costs of the new intervention for each infection averted.

Formula for simple infection control cost-effectiveness analysis:

Incremental costs of new product or intervention

(number of events without product) – ( number of events with product)

Other considerations for CEA:

The methodology for cost calculations may use actual cost experience in the facility or can be derived or estimated from the experience of others.

The methodology should always be noted in any CEA analysis, so that there is a clear understanding of how the results were derived.

CEA should include, in addition to the cost of the product in question, the cost of personnel time for education and implementation.

Adequate and well-controlled outcomes studies demonstrating an impact on infection rates can be the basis for a valid cost-benefit analysis.

Product manufacturers may have resources such as full-text articles or bibliographies of published evidence to help expedite the review process.

However, the ICP should review the data to ensure that studies were adequate in size, well designed and controlled, and reached statistical significance, and are not merely anecdotal reviews or promotional pieces.

Planning and preparedness for unanticipated events is an important, but often overlooked, component of the product evaluation process.

Gaps in our preparedness planning provide examples of the importance of both product evaluation and product procurement.

Unantipated events include:

Product recalls or shortages
Budget modifications, such as directives to reduce expenses due to financial or other constraints
Outbreaks of infection within the facility or the community
Public health emergencies, such as the recent H1N1 influenza pandemic or bioterrorism events

Various guidance statements for health care facilities for seasonal influenza and H1N1 pandemic influenza planning cite product shortages (e.g., personal protective equipment, especially masks; influenza vaccine; antivirals, pharmaceuticals) as a result of increased demand.

Other CDC guidance includes software to assist in planning for a surge in hospital-based services that may prove useful in the planning process to avoid shortages of essential products.

While advance planning for product evaluation is ideal, the nature of infection prevention and control also requires a response to unanticipated events (e.g., outbreaks of HAI, and the emergence of infectious diseases, such as H1N1 influenza and multi-drug resistant microorganisms).

In times of a health emergency, the fundamentals of infection control still apply.

The difference is that the decision-making process will need to be expedited – but not ignored completely.

To maintain clinical operations, the product evaluation team should plan for these events and, as a minimum

maintain a list of alternative critical equipment and products, and supply chain information to maintain an essential inventory for important patient care items
evaluate purchases regarding their reusability in the event of product shortages

Finally, the product evaluation team should be on the alert for bogus product infiltration into the supply chain.

The recent emergence of the H1N1 strain of influenza offers an example of the simultaneous emergence of unproven products to “manage” H1N1.

A major problem involved internet sales of unapproved products with bogus claims and of fake products with real names (e.g., bogus oseltamivir).

A summary of current controversies regarding infection control and product evaluation.

This discussion includes two areas of controversy related to infection control product evaluation: (1) low technology and (2) high technology products.

Low-technology controversies

One example of this is the use of copper-based products as an infection control strategy.

In general, copper’s antimicrobial properties have been used as evidence to support copper-based hardware or paint’s role in reducing infection rates.

The consensus of experts is that these marketing claims have no scientific basis.

The fallacy of adopting copper for infection control purposes, beyond the incremental costs, is that strategies like this create the impression that they are a substitute for the infection control fundamentals, especially hand hygiene, environmental maintenance, and isolation precautions.

High technology controversies

Management and prevention of transmission of antibiotic-resistant pathogens is the best example.

In this case, guidelines and expert consensus support the strategy of implementing a program of active surveillance cultures linked to contact precautions to control the spread of epidemiologically significant antibiotic-resistant pathogens in health care, in particular methicillin-resistant Staphylococcus aureus (MRSA).

The controversy lies in how this guidance is implemented, beyond traditional low-tech, and often retrospective, traditional surveillance.

Programs for MRSA prevention will vary with:

Type of surveillance
Population screened
Frequency of surveillance
Subsequent interventions

With MRSA, there is enough latitude to develop a prevention program suitable for the institution instead of a “one size fits all” approach.

In the end, this flexibility to develop an individualized program underscores the importance of the ICPs role in product evaluation, program development and implementation.

What is the impact of product evaluation relative to the impact of other aspects of infection control?

The product evaluation process impacts all areas of health care delivery and infection control. Evaluation of low-tech products such as hand hygiene products and disinfectants are fairly straightforward.

High tech products are receiving more attention in health care lately. Some of these high technology products, such as molecular-based, rapid tests for MRSA screening, are linked directly to infection control activities, such as isolation and surveillance of infection.

These newer technologies, and their associated impact on infection prevention activities, highlight the infection prevention program’s overall importance in the product evaluation process.

Overview of important clinical trials, meta-analyses, case control studies, case series, and individual case reports related to infection control and product evaluation.

There are no clinical trials or meta-analyses directly related to the product evaluation process.

In most cases, the decision to evaluate standard infection control items such as disinfectants and hand hygiene products requires a simple value analysis and common sense that avoids decision-making based on marketing claims.

As new technologies become a part of routine patient care, the ICP’s role takes on new importance. One important advance involves the use of new diagnostic technologies that impact isolation utilization for emerging infections, such as methicillin-resistant Staphylococcus aureus (MRSA).

While there is universal agreement that some kind of surveillance for MRSA prevention is necessary, there is no agreement regarding the nature of the prevention program.

Table I summarizes some of the options outlined in key studies of MRSA prevention.

Table I.

Type of surveillance	Population to be screened	Frequency of surveillance	Interventions
Traditional surveillance	All hospital admissions	On admission	Antibacterial nasal ointment for all patients
Culture-based screening	Intensive care unit patients	On admission and periodically thereafter	Nasal antibacterial ointments for MRSA carriers
Rapid molecular-based screening	Cardiothoracic surgery patients		More appropriate and timely use of isolation for MRSA carriers

Table II summarizes representative studies of healthcare-associated MRSA.

Table II.

Author	Assumptions/endpoints	Costs of Intervention	Outcomes
Chaix	Compared costs of care in patients with ICU- acquired MRSA vs. ICU controls hospitalized at same time without MRSA.	NA	Mea costs of MRSA: $9,275.00/patient.Excess isolation, screening costs $705/patient.
Clancy	Culture-based MRSA screening on ICU admission decreases unnecessary isolation and reduces MRSA infection compared with experience during 15 months prior to screening.	$3,475/month	MRSA infection rates: – Pre-intervention:6.1/1,000 census days – Post-intervention:4.1/1000census days (p<01) Averted 2.5 infections/month Net costs avoided: $19,714/patient/month using Chaix’s cost data.
			On admission MRSA prevalence: 6.7% (ICUs combined) Median time from ICU admission to notification of results decreased from – 87 to 21 hours in the SICU (P <0.001) – 106 to 23 hours in the MICU (P < 0.001). In SICU, 1,227 pre-emptive isolation days for 245MRSA-negative patients saved by using rmMRSA MRSA cross-infection reduced in MICU but not SICU In SICU, 1,227 pre-emptive isolation days avoided for 245 MRSA-negative patients
Walsh	Intervention targeted to MRSA screening using culture-based methods would reduce MRSA infections in cardiothoracic surgery patients	No cost data reported	Post-operative MRSA wound infections decreased by 93% during intervention period vs. baseline period of observation.
Harbath	On admission screening using mrMRSA in two ICUs decreases notification time for test results and drives more appropriate use of isolation	No cost data reported	On admission MRSA prevalence: 6.7% (ICUs combined) Median time from ICU admission to notification of results decreased from – 87 to 21 hours in the SICU (P <0.001) – 106 to 23 hours in the MICU (P < 0.001). In SICU, 1,227 pre-emptive isolation days for 245MRSA-negative patients were saved by using rmMRSA MRSA cross-infection reduced in MICU but not SICU In SICU, 1,227 pre-emptive isolation days avoided for 245 MRSA-negative patients

Abbreviations: ICU, intensive care unit; MICU, medical intensive care unit; MRSA, methicillin-resistant Staphylococcus aureus; NA, not applicable; SICU, surgical intensive care unit; rmMRSA, rapid molecular MRSA screening test.

While these studies are not directly comparable, they build on each other, and some authors think provide evidence to support a more pro-active approach to MRSA prevention.

In the study by Chaix et al., the investigators present their experience with those excess health care costs associated with MRSA infections acquired in their intensive care units (ICU).

The second study, by Clancy et al., is helpful for two reasons:

It quantifies their experience with culture-based methodology for screening patients to determine the need for contact precautions, and
It uses the excess cost data from Chaix to drive their own assumptions for the excess costs of screening.

Walsh et al., use a culture-based approach to drive their interventions to prevent MRSA wound infections in cardiothoracic surgery patients. While the results are impressive (e.g., 93% reduction in MRSA infections), there is no accompanying CEA.

Finally, Harbeth et al., discuss the use of a rapid, molecular diagnostic test that decreased notification time for identification of MRSA carriers, resulting in more appropriate use of isolation.

Studies such as these have direct impact on infection control practices in health care; in this case the more appropriate use of isolation activities. While the ICP will not necessarily take the lead here, evaluations such as these advance the importance of the ICP’s role beyond traditional surveillance.

Controversies in detail.

The role of cost effective analysis

One important unsettled issue relates to cost-effective analysis (CEA). While experts agree that some kind of CEA is needed, there is no agreement as to the extent of the analysis, other than to keep it simple. In the case of purchases that represent cost savings or are cost-neutral, the analysis can be brief. For product evaluations that are linked to program changes or interventions, CEA assessment in terms of cost per infection prevented is preferred, although costs avoided per patient per month with an intervention is equally acceptable, depending on the product and intervention being reviewed. In either case, a business case can be made using local cost figures combined with results from published studies.

Studies of complex purchases linked to infection control interventions that do not assess costs are probably the least desirable. Many studies of this type are important and relevant, but generally lack a strong business case to support widespread adoption.

Evidence to support product use

Beyond costs, infection control product evaluation can be classified into three major areas as shown below.

(1) Products for which there is no evidence or consensus in favor of their use. In general, the value of such products or practices come primarily from marketing claims that conflict with current infection control thinking, the mechanisms of infection transmission, common sense, and/ or logic. Products that claim to “kill viruses on contact,” or are “effective against methicillin-resistant Staphylococcus and H1N1 influenza” should be viewed with caution. In other words, the fundamentals of infection control should not be overlooked in favor of marketing claims without evidence to support them.

For example, the role of copper as an antimicrobial has received some attention over the years as an infection control product in hospitals. Clinical trials data are limited and show only that copper reduces bacterial burden. Obviously, this is an attractive concept. However, there are no trials to show its impact on reducing infection rates. Instead, the limited data on its bactericidal properties are marketed as “evidence” to support copper’s role as an agent against methicillin resistant Staphylococcus aureus and antibiotic-resistant bacteria. Many experts believe that these claims exaggerate copper’s role as an infection control tool. On the other hand, some facilities have taken the paucity of evidence for copper and replaced door hardware and other metal objects, or used copper-based paints as an infection control tool.

(2) Products with evidence or consensus for their use as adjuncts to standard infection control practices. There is general agreement that ultraviolet (UV) light kills M. tuberculosis. The use of this type of product needs to be put into context with the nature of the individual facility, the frequency with which tuberculosis patients are seen in the facility, and tuberculin (PPD) conversion rates of employees.

Also, the consensus among experts is that UV light alone is not an adequate control measure and the CDC’s guidelines state that UV lights cannot substitute for proper air handling units, but could be used as an adjunctive measure. In other words, despite recent data on the effectiveness of UV light in preventing transmission of M. tuberculosis in animal models, proper attention to the environment is still required. In this case, UV light is not a substitute for the infection control fundamental of adequate air handling systems.

(3) Controversial products or practices with an emerging body of evidence, including cost-effectiveness data, to support their use. This discussion moves beyond disinfectants and hand hygiene products and discusses an evaluation of new technologies and strategies for methicillin-resistant Staphylococcus aureus (MRSA) prevention. Advances in technology have replaced traditional surveillance activities for MRSA and have direct implications on the cost effectiveness of our activities.

In this case, the controversy involves moving beyond the traditional “low tech” approach (i.e., administrative support, staff education, judicious use of antimicrobial agents, and surveillance) to infection prevention. More recently, active screening programs to detect potential MRSA carriers have advanced the earlier approach to managing clusters of infection after MRSA transmission has been identified. Instead, screening selected patients with either culture-based techniques or with rapid screening technologies for MSRA are emerging components of MRSA control, particularly in intensive care units. While patient screening increases the direct costs of care, the emerging evidence suggests that MRSA screening can be cost-effective and is worthy of consideration.

First, making the case for an intervention such as rapid molecular screening for MRSA requires a hierarchical approach to the problem and provides a good example of the importance of the multidisciplinary team approach to state the case. For this evaluation, infection control staff, ICU staff and administration, infectious diseases, laboratory, and hospital administration and finance staff are key team members.

The central question is how aggressive the approach should be to prevent MRSA. The first level of control would be some kind of surveillance of selected patients. Since patient surveillance has already been shown to be cost effective, a cost effectiveness study in the institution is not likely to add much new information to support the case.

Instead, the critical decision point for the patient surveillance case is which patients should be screened, and whether to use the traditional culture based method vs. adopting a rapid molecular testing method. If the goal of reducing unnecessary isolation time to improve patient care is a priority, a simple calculation will help make the case for rapid MRSA testing. As a minimum, a trial period of rapid MRSA testing might also support its value, assuming that the laboratory is suitably equipped to perform molecular testing and is willing to participate.

Using Laufler and Chiarello’s formula [5] with assumptions specific to the facility may be all that is necessary to support the case. Once the rapid testing intervention is in place, ongoing monitoring of the intervention’s impact should help sustain it as an ongoing component of MRSA control. However, if the decision is made to continue with either no patient surveillance or to use culture-based surveillance, the infection control team should continue its MRSA surveillance and the impact of the decision.

What national and international guidelines exist related to infection control and product evaluation?

Existing guidelines address product evaluation in general terms.

Centers for Disease Control and Prevention (CDC)

The CDC’s Healthcare Infection Control Practices Advisory Committee, in its 2007 guideline recommends:

Evaluation of new medical products that could be associated with increased infection risk. e.g., intravenous infusion materials; evaluation of products relative to hand hygiene with reference to management of antibiotic-resistant organisms (MRSA, vancomycin-resistant Enterococcus [VRE], disposable products,
Adequate supplies and equipment necessary for the consistent observance of Standard Precautions, including hand hygiene products and personal protective equipment (e.g., gloves, gowns, face and eye protection) in all areas where healthcare is delivered.
Inclusion of the infection control professional in the evaluation of new products or procedures on patient outcomes

World Health Organization (WHO)

The health organization should:

Facilitate access to materials and products essential for hygiene and safety
Review risks associated with new technologies
Monitor the risk of acquiring an infection from new devices and products, before their approval for use;
Ensure appropriate staff training in infection control and safety management
Provide adequate safety materials such as personal protective equipment and products; evaluation of material and products

National Institute of Occupational Safety and Health (CDC/NIOSH)

This initiative is limited to sharp medical devices to prevent blood borne pathogen transmission. The process uses five stepa and covers a variety of facilities (hospitals, nursing homes, home health agencies, and dental settings).

What other consensus group statements exist and what do key leaders advise?

Society for Healthcare Epidemiology (SHEA)

Guidelines for infection control infrastructure and essential activities include product evaluation as a component of providing cost-effective infection control.

While the guidelines do not offer formulas or specific examples of CEA, their key points note that:

Every intervention strategy used to prevent infections requires some kind of cost analysis
CEA should express costs in terms of infections prevented
A product evaluation committee is part of a systematic approach to product evaluation

The Association for Professionals in Infection Control and Epidemiology (APIC)

The APIC text of Infection Control and Epidemiology recommends that:

New products and devices be evaluated to ensure that healthcare personnel can be trained in its use and to circumvent any issues concomitant with a new, unfamiliar technology.
Products to be considered must be safe, effective and conducive to high-quality patient care
Product evaluation should been overseen by a committee with clearly defined responsibility and authority
Product evaluation should be based on objective criteria
A trial be conducted before selecting a product
An annual review should be done of the policies and procedures associated with product evaluation and selection

References

Joint Commission. Initiative for national patient safety goals 2011 (NPSG 2011). Accessed February 1, 2011 at: http://www.jointcommission.org/standards_information/npsgs.aspx

Center for Medicare and Medicaid Services. Medicare program: changes to the hospital inpatient prospective payment systems and fiscal year 2008 rates. 42 CFR Parts 411, 412, 413, and 489.

Halvorson CK and Chinnes LF. Collaborative leadership in product evaluation. AORN Journal 2007; 85: 342-352.

ECRI Institute.

Laufer FN and Chiarello LA. Application of cost-effectiveness methodology to the consideration of needle stick prevention technology. Am J Infect Control. 1994;22:75-82. Discusses a simple approach to cost effectiveness for infection control.

Scheckler WE, Brimhall D. Buck AS, Farr BM et a. Requirements for infrastructure and essential activities of infection control and epidemiology in hospitals: a consensus panel report. Infection Control and Hospital Epidemiology 1998; 19: 119-124.

Effective Clinical Practice Series (no author). Primer on cost-effectiveness analysis. September/ October 2000. American College of Physicians Online.

(A more complex discussion of cost effectiveness, this paper offers an in depth discussion of the relevance of CEA in health care with examples.)

Product evaluation for infection prevention. Infection Control Today. May 24, 2010.

Braun BI, Wineman NV, Finn NL et al. Integrating hospitals into community emergency preparedness planning. Ann Int Med 2006; 144:799-811.

Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee, 2007 Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings.

Centers for Disease Control and Prevention. Prevention strategies for seasonal influenza in healthcare settings 2010.

Centers for Disease Control and Prevention. Pandemic influenza preparedness tools for professionals.

Food and Drug Administration. FDA Warns of Unapproved and illegal H1N1 drug products purchased over the internet. Press Release. October 15, 2009.

Cooney TE. Bactericidal activity of copper and noncopper paints. Infect Control Hosp Epidemiol. 1995;16:444-446.

Muto CA, Jernigan JA, Ostrowsky BE, et al. SHEA guideline for preventing nosocomial transmission of multidrug-resistant strains of Staphylococcus aureus and Enterococcus. Infect Control Hosp Epidemiol 2003;24: 362-386.

Chaix C, Durand-Zaleski I, Alberti C et al. Control of endemic methicillin-resistant Staphylococcus aureus: a cost-benefit analysis in an intensive care unit. JAMA. 1999; 282: 1745-1751.

Clancy M, Graepler A, Wilson M et al. Active screening in high-risk units Is an effective and cost-avoidant method to reduce the rate of methicillin-resistant Staphylococcus aureus infection in the hospital. Infect Control Hosp Epidemiol 2006;27:1009–1017.

Walsh EE, Green L and Kirschner R. Sustained reduction in methicillin-resistant Staphylococcus aureus wound infections after cardiothoracic surgery. Arch Int Med 2011; 171: 68-73.

Harbarth S, Masuet-Aumatell C, Schrenze J et al. Evaluation of rapid screening and pre-emptive contact isolation for detecting and controlling methicillin-resistant Staphylococcus aureus in critical care: an interventional cohort study. Critical Care 2006; Critical Care 2006, 10:R25.

Sepkowitz K. Tuberculosis control in the 21st century. Emerging Infect Dis 2001;7:259-262.

Centers for Disease Control and Prevention. Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005. MMWR. 2005; 5417): 1-141.

Escobe AR, Moore DAJ, Gilman RH et al. Upper-room ultraviolet light and negative air ionization to prevent tuberculosis transmission. Public Library of Science (PLoS) Medicine. March 2009.

World Health Organization, Regional Office for South-East Asia and Regional Office for Western Pacific. Practical guidelines for infection control in health care facilities. World Health Organization. 2003.

National Institute for Occupational Safety and Health/ Centers for Disease Control and Prevention. Safer medical device implementation in health care facilities. Undated.

(Limited to management of sharps injuries, but a very user friendly orientation to cost analysis.)

The Association for Professionals in Infection Control and Epidemiology (APIC). APIC text of infection control and epidemiology, Charrico, R, ed,3rd edition. APIC,Washington DC. 2009, Chapter 33. ISBN: 1-933013-44-3.

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