Product Evaluation and Purchasing: Advice from Clinical Experts

By Kelly M. Pyrek

In an era of value-based purchasing, product evaluation and purchasing has been impacted by the continued cutbacks in healthcare spending and by the quest for improved quality and cost containment. As hospital administrators target various budget line items for reduction or eradication, they are looking closely at new products/technologies and existing supplies to see if they can be replaced with those that still perform well but are less costly.

Infection Control Today spoke with Frank Myers, MA, CIC, infection preventionist III/Infection Prevention Clinical EPI for UC San Diego Health System, about how infection preventionists can play a more significant role in the products and technologies being evaluated and purchased. We also present the results of an ICT reader survey looking at the product evaluation and purchasing experiences of infection preventionists.

Infection Preventionists' Role in Product Evaluation and Purchasing: Q&A with Frank Myers, MA, CIC

Q: Do you believe infection preventionists should take a greater interest in participating in their institutions product evaluation and purchasing activities? 
A: Infection preventionists must be involved in product evaluation and purchasing activities. Besides products that reduce a patients risk for infection, even products that may not appear relevant to infection prevention can have an impact on infection rates.  Infection preventionists must make sure products are being evaluated for at least two questions: Is this product cleanable? and  Does the list of materials used to clean this item compatible with what the institution uses. 

Q: What are some ways they can get more involved in influencing the infection control product purchasing process? 
A: Being involved on your product committee is crucial.  If you put in the time evaluating and supporting other peoples products or offering valuable critiques, the products you bring to the committee are more likely to garner serious consideration.  If you show you know how to evaluate products outside the infection prevention realm, the organization is more likely to trust your judgment on products you support.      

Q: Many IPs wait on CDC recommendations or published outcome studies before proceeding with using certain products/technologies what are the advantages/disadvantages to doing so? 
A: The advantage of waiting for a guideline to recommend a type of product is that you are not likely to squander your organizations resources.  A lot of products look to be beneficial with secondary markers (i.e. bacterial load reductions) for infection prevention but never achieve infection reductions in the clinical.  But you have to remember that even in a guideline-recommended type of product, your rates of an event (i.e., CLABSI) may already be so low that you are not likely to see a benefit by using the product. But with a guideline recommendation to use this type of product, you know you have a whole body of literature on why to use a product, not just one isolated study. The advantage of waiting until the product is shown to reduce infections in the scientific literature is that you are not likely to be squandering your organization's resources. Someone has shown that in some situation, this product is associated with lower infection rates. However, you really have to read the study and think about how the practices described in the study reflect your organization's practices. You also have to think about what other things described in the study may have been partially or fully responsible for the reduction in infection rates. The disadvantages of waiting for a guideline to endorse a type of product being looked at is lost time and potentially lost patient lives. Guidelines can sometimes take a decade to get revised, so much literature is pointing in the direction of doing something that it can become community standard to use something and still not have a guideline endorsement. If your rates are not coming down and a product can engineer out a process issue you are having, you really need to seriously look at the product even without a guideline endorsement. The disadvantages of waiting for a guideline to endorse a type of product being looked at is lost time and potentially lost patient lives. Some products on their face appear to solve a staff behavior issue that you cant educate or discipline your way around. If you have a high rate of infections and staff have been educated and disciplined to do a task like scrubbing a hub, cleaning the room, doing subglottic suctioning and a product appears to do the task without depending on the staff, you may need to seriously consider trialing the product even without the outcome data by the manufacturer. This is true if the product is relatively new, as it may not yet have had time to publish the improved outcome study. If the product has been on the market for five years and still doesnt have an outcome study -- one that shows a reduction in infection rates -- it probably doesnt solve that problem.  

Q: What are a few considerations to keep in mind when IPs are walking exhibit hall floors at shows to evaluate products? What should they be asking manufacturers?
A: Generally my first recommendation is to be a little skeptical about what you are told. The FDA or EPA, depending on the product, have very clear rules as to what can be said in the written marketing information for a product. So if I hear a claim that a product reduces infections I ask them where it says that in their literature, please point to it. If they cant, or they point to something doesnt quite say that, like reduces bacterial loads, I will point that out. If a company says their product is the type recommended in a guideline, I ask which of the citations used in the guideline used their product. If none of the citations used their product, the claim is concerning. Ask where the product is being used and who stopped using it. Even great products will lose accounts, so they should be willing to share.  And then call those facilities' IPs and ask them what their experience is with the product.  A few times I have been told that the product was in use at an institution I was working at!  I had no idea, nor would I have approved it, but it was there, in very, very small volumes. And if a concern is obvious with a product, i.e., subglottic trauma from a continuous subglottic suctioning device, dont just stop looking at the product, know that the company and the FDA will have looked at that issue. Ask to see data around your concern.

Survey Reveals Infection Preventionists' Experiences With Product Evaluation and Purchasing

Infection Control Today asked infection preventionists about involvement in their healthcare institutions' product evaluation and purchasing processes, as well as for their thoughts on how they research new products and technologies.

Do you provide input on the evaluation and purchasing of infection control-related products at your institution?

Yes  96%
No  4%

Are you a member of your institution's product evaluation and purchasing committee?

Yes  73%
No  27%

Is your institution a member of a GPO?

Yes 92%
No 8%

If YES, can your facility purchase products not approved by your GPO(s)?

Yes 77%
No 23%

Who has the final say in terms of purchasing decisions at your institution?

C-suite leadership    34%
Purchasing director/manager   32%
Other      25%
Department head    9%

Do you wait for a product/technology to be discussed in the medical literature or mentioned in scientific guidelines before you recommend its introduction at your institution?

Sometimes  52%
Yes   40%
No   9%

Where do you, as an infection preventionist, get involved in the product evaluation/purchasing cycle?

Early in the evaluation and decision-making process       67%
Before the final decision is made         26%
After the decision-making process is made and product implementation/training is required   7%

Should frontline clinicians be more involved in the product evaluation/purchasing process?

Yes   89%
Uncertain  9%
No   2%

How do you primarily gather information about a product/technology?

From the manufacturer's website      5%
From a company representative visiting at the institution    3%
From a trade publication       2%
From a company representative at a trade show    2%
All of the above        89%

How satisfied are you with the quality/amount of information available from manufacturers on their products?

Satisfied   82%
Not satisfied   10%
Very satisfied   8%

Do you think manufacturers' reps provide a satisfactory amount of information/demonstrations of their products/technology?

Yes    59%
Uncertain   21%
No    19%

Are you skeptical of manufacturers' claims?

Sometimes   61%
Frequently   16%
Usually   15%
Not usually   7%
Uncertain   0%

 

Product Evaluation and Purchasing Industry Roundtable

What is the most important consideration that infection preventionists should keep in mind when evaluating your product/service category and why?
 
DebMed: Infection preventionists, patient safety and quality leaders need reliable, accurate tools that they can depend on to help them decrease healthcare-associated infections (HAIs). As such, the most important consideration for hand hygiene monitoring should be the accuracy of the data. Its only with reliable, credible data that real change can be made to positively staff impact behavior and reduce these unnecessary and life-taking events. IPs should choose a system that electronically monitors the WHO Five Moments for Hand Hygiene, as it is a higher clinical standard than simply cleaning hands before and after patient care.  Studies show only cleaning hands when entering and exiting patient rooms misses up to 50 percent of hand hygiene opportunities. It is also important to implement a system that doesnt interfere with staff workflow and is not viewed by staff as punitive.  This can be an issue with the systems that require staff to wear badges. A comprehensive solution should also include an effective yet gentle line of skin care products designed for healthcare, the ability to monitor compliance at the critical point-of-care, and supporting tools such as training, educational and reminder materials to help create a culture of safety.

GOJO Industries: With any aspect of Infection Control, the ultimate goal is to prevent patients and healthcare workers from acquiring infections while in the hospital. Hand hygiene is the single most important step a caregiver can take to prevent the spread of infections in the healthcare setting.1 With any hand hygiene product selection, the most important attribute is the products efficacy or ability to remove transient bacteria. Alcohol-based handrub (ABHR) products are tested for efficacy per the FDA Healthcare Personnel Handwash requirements. There should be a 2 log10 reduction of the transient marker organism at wash 1 and a 3 log10 reduction at wash 10. A log10 reduction is calculated by subtracting the quantity of bacteria recovered post product usage from the quantity recovered at baseline.2  Product literature should be examined to compare the quantity of product used in Healthcare Personal Hand Wash (HCPHW) tests to realistic in-use volumes. Total product formulation and product application volume, not alcohol concentration or product form, are key determinants of the in vivo antimicrobial efficacy of ABHR. Because formulation plays an important role in ABHR antimicrobial efficacy, critical examination of HCPHW data along with the quantity of product applied to hands in the test should be conducted when comparing antimicrobial efficacy of products. Finally, hand hygiene compliance is perhaps the most critical element to achieving clinical effectiveness. For this reason, the most effective ABHR are those that balance antimicrobial efficacy with skin performance and healthcare worker acceptability to ensure maximal compliance to hand hygiene practices.
1. Boyce JM and Pittet D. Guideline for Hand Hygiene in Health-Care Settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR Recomm. Rep. 51, 1-45, (2002).
2. Food and Drug Administration. (1994) Tentative Final Monograph for Healthcare Antiseptic Drug Products; Proposed rule. Federal Register 59, 31441-31450.

PDI Healthcare: When evaluating a product, its important to fully evaluate government approved or registered efficacy claims, specifically contact times, safety profile, and instructions for use. The Instructions for use portion of an EPA registered disinfectant's label must be in compliance with EPA regulations , so they can be easily understood and followed. In addition, the Infection Preventionist should carefully evaluate the efficacy and safety profile to ensure that the disinfectant has the relevant claims against gram positive and gram negative bacteria, enveloped and non-enveloped viruses, pathogenic fungi, and mycobacterium classes of microorganisms but also has a reasonable safety profile that ideally does not require the use of PPE for general handling. Accreditation agencies such as the Joint Commission, AAAHC, and DNV require that staff responsible for the cleaning and disinfection process receive formal training at the time of hire, and also on an annual basis. This training must include the indications for use, instructions for use, and also safety information to be compliant with OSHA recommendations. This inservice education can be delivered in partnership with the disinfectants manufacturer.

Rubbermaid Commercial Products: When evaluating a disposable microfiber cleaning product, infection preventionists should consider how the product will contribute to the healthcare facilitys need to manage infection rates, increase patient safety and satisfaction and improve productivity.  By evaluating product efficacy, cleaning performance and versatile use, the infection preventionist will have a better understanding of how effective the product will be once implemented as part of the cleaning process. Infection preventionists should first consider the evidence based science supporting the manufacturers microbe removal claims.  Microbe removal is critical in the fight against infection because it eliminates live pathogens and their food source.  The disposable microfiber product should incorporate technology that provides an optimal level of clean.  Features such as built-in scrubbers contribute to streak and smear free cleaning, which enhances environmental hygiene.  In addition, the coverage of the textile is a key indicator of cleaning performance and improved cost-in-use.  If the product is able to clean more surface area, with the ability to be used damp or dry, these features contribute to both productivity and ease-of- use.

WelchAllyn: There have been several studies conducted in the past twenty years to demonstrate blood pressure cuffs harbor pathogens such as MRSA and Clostridium difficile.  There are also studies that show reusing blood pressure cuffs on multiple patients can transfer these pathogens between patients.  In addition, a study at a community hospital revealed patients were 53 percent less likely to have Clostridium difficile infection when single patient use disposable blood pressure cuffs were used.  Cleaning and disinfection of blood pressure cuffs may seem like a viable solution to mitigate the cross contamination and infection risks.  However, there are inherent drawbacks to this approach that must be considered.  First, blood pressure cuffs are made of soft, porous materials.  Most disinfectants are validated for hard porous surfaces only and therefore effectiveness on blood pressure cuffs has not been established.  Second, clinicians do not have time to clean or disinfect blood pressure cuffs between patients.  Even if these methods were proven effective, the contact time required and the drying time would make the process very inefficient. 
For these reasons, many infection control conscious hospitals have adopted a single patient use model for blood pressure cuffs.  In this model, every patient gets his or her own blood pressure cuff upon admission to the hospital.  These blood pressure cuffs stay with the patients as they are transferred from department to department.  When the patient is discharged, the blood pressure cuff is discarded.   
 
What strategies can infection preventionists adopt to better evaluate and implement new products and technologies into practice?
 
DebMed: When evaluating and implementing new technologies, you have to think of the people using them. The best options today are those offering group monitoring. Studies show that in order to best change behavior and maintain the change for a sustainable period of time, it should be done in a positive manner.  Find a system that monitors the hand hygiene compliance rates of groups of people in units, rather than by tracking individuals compliance, which can be seen as punitive. This type of monitoring drives individual accountability through group collaboration, and tends to result in higher compliance for a longer period of time, as evidenced in the hand hygiene improvement study done at Memorial Sloane-Kettering Hospital.  Working at the group level can also ease communications with staff as a whole as to why new solutions are being installed in the facility. Plus it could make for some fun and productive healthy competition between units.

GOJO Industries: Strategies include:
Providing products that healthcare personnel will want to use. Testing products to ensure staff acceptance is important. Some of the characteristics of hand hygiene products that are assessed as an indicator of staff satisfaction include dermal tolerance, skin reactions, fragrance, consistency and color.1 Involving the people who will be using the products in the selection of products is imperative.
Placing products so that they are readily accessible and easy to use. Many studies have shown that the level of accessibility of hand hygiene materials impacts the frequency of hand hygiene events.2 Consideration should be given not just to dispensers on the wall but also to products available at the point of care.
Education for staff, patients and visitors. The best products in the world might not be utilized as intended without staff education. Staff could possibly not know the moments when to clean their hands in a healthcare setting, the why and the how, and be afraid to ask the questions.
Measuring hand hygiene compliance. With staff accepted products, dispensers readily accessible to staff and hand hygiene education programs for staff, patients, and visitors, the hand hygiene program is complete with accurate methods to measure hand hygiene compliance. Although direct observation has a role in providing opportunities for coaching and teaching hand hygiene compliance, a hand hygiene program owner might want to consider the technology available with electronic compliance monitoring. With electronic compliance monitoring, thousands of data points are captured. Reporting mechanisms can free up time spent creating reports and yield more time for educating staff, patients and visitors.
1,-2  Larson E, et al. (2006). Skin reactions related to hand hygiene and selection of hand hygiene product. Am J Infect Control. 34(10) 627-635.

PDI Healthcare: Infection prevention touches all aspects of the healthcare delivery system, in both inpatient and outpatient settings. Disinfectants, in particular, are used by a variety of healthcare professionals to maintain a clean and sanitary environment. The product evaluation process should involve all affected disciplines that will be involved in the disinfection process. This is typically accomplished through a multi-disciplinary value-analysis committee. Staff members in the clinical units that will be utilizing the product should also be solicited for their input in the evaluation process. The role of the healthcare environment is becoming an increasingly important concern in the transmission of healthcare-associated infections. Given the recent cuts in reimbursement for preventable HAIs, facilities should carefully implement environmental disinfectants to ensure that staff is consistently and appropriately utilizing them, with a focus on high-touch surfaces. Because of the potential impact on patients, disinfectants should be thoroughly evaluated for their use around sensitive patients. Lastly, the infection preventionist should ensure that the disinfectant meets all evidence-based clinical guidelines and recommendations from the Centers for Disease Control and Prevention (CDC). This will assist the facility in meeting the stringent regulatory and accreditation requirements for the environment of care and infection prevention standards. Implementation of the disinfectant must be fully integrated into the facilitys environment of care program with both clinical nursing personnel, and also environmental services. Careful environmental monitoring such as ATP monitoring is recommended by the CDC to ensure that the established facility protocol is being executed successfully. Each of these measures potentially impacts patient satisfaction and other outcome measures that are included in the reimbursement to the facility.

Rubbermaid Commercial Products: In order to evaluate the cleaning efficacy and performance of disposable microfiber products, infection preventionists should review the data that demonstrates proven microbe removal.  Disposable microfiber cleaning textiles with the ability to remove microbes reduces the risk of infection while contributing to patient safety.  In addition, one of the most effective ways to understand if a disposable microfiber cleaning product is the right cleaning product for the specific cleaning application is to trial the product in the facility.  This process allows the users of the product to provide feedback on cleaning performance, increased productivity and ease of use.

WelchAllyn: In order to implement a single patient use blood pressure cuff model, it is critical to standardize all of the blood pressure devices within the hospital to a common connection method. This helps to ensure that every patient receives a cuff that is compatible with the equipment in all departments. Most major blood pressure cuff manufactures offer complementary services to help hospitals during this process. While there are different methods available to achieve standardization, infection preventionists should select a connection method that is reliable and easy to use. They are also some new single patient use blood pressure cuffs on the market that are designed to reduce environmental impact.