Research on infection control in the broader context of health care delivery is extensive. It is, among other things, well established that health care workers can easily spread infections and diseases from one patient to another.1 In fact, almost 2 million hospitalized patients in the United States develop infections during their hospital stay every year and approximately 90,000 of them die because of those infections.2 This can also be the result of contact with an unclean item, but generally occurs due to the transference of disease from patient to patient via the health care worker’s hands. Despite this knowledge, some health care workers such as nurses and doctors have been found to fail to comply with protocols on hand hygiene to prevent disease transmission.1 According to the Centers for Disease Control and Prevention (CDC), “Clean hands are the single most important factor in preventing the spread of pathogens and antibiotic resistance in health care settings,” and the minimum recommended length of time for a health care worker to wash his or her hands is 15 seconds.2 However, research suggests that this recommendation is not always heeded, much as noncompliance with most any regime is an issue, no matter the simplicity or importance.3 Moreover, even if all patients are treated with universal precautions, recommended hand-washing protocols, and use of only sterile equipment, that same care may not extend to the potentially contaminated orthotic or prosthetic devices of those patients.
A challenge to research into the topic of infection control as it pertains to orthotics and prosthetics (O&P) is that, because there is very little information regarding the spread of infectious disease in the field, it has not been established that infection is even an issue, for example, as a common cause for amputation. Although complications of diabetes are very common reasons for amputation, diabetes itself does not automatically result in amputation. Simply recording “diabetes” as the cause for an amputation, as is often done, ignores the specific cause that may have been infection or other issues. This gap in documentation implies that real infection rates among patients may be greater than indicated in the existing outcome data. Accordingly, reducing the risk of acquiring disease from O&P facilities should be a priority.
Unfortunately, published information about infection control specific to O&P is scarce. To the authors’ knowledge, only one scholarly publication mentioned an infection control protocol specifically for O&P. The article that was published in the 1980s in wake of the acquired immune deficiency syndrome (AIDS) hysteria, while not citing any sources and seemingly being fueled by some contemporary misconceptions about AIDS, does suggest that the practitioners wear “vinyl or latex gloves” when treating infected patients, even “double-gloving” when removing casts.4 Even non-refereed publications on infection control in O&P are few. One pertinent trade article contains the recommendation to wipe down tables and patient contact areas after each patient to prevent methicillin-resistant Staphylococcus aureus (MRSA).5 However, specific products to use to prevent MRSA are not discussed in this article, and neither is the patient device’s potential to transmit infectious materials to surfaces in the laboratory when the practitioner makes modifications to it.
Regulatory provisions that pertain to O&P infection control exist but are not very far-reaching. The Occupational Safety and Health Administration (OSHA) “…has no standards specific to orthotics and prosthetics [and] its safety and health standards for health care facilities apply to the O&P profession.”5 This very coarse approach may not sufficiently take into account that O&P is different from other health care professions in that there is normally a laboratory within the facility to which devices are taken for repairs and adjustments without the patient. Health and safety standards that apply to other health care facilities may be followed completely in all areas of O&P facilities where patients are seen, but this may not be enough without respective protocols that account for the typical uses of O&P laboratory and storage areas.
Some O&P facilities have documentation in the exposure control plan of their OSHA binders regarding the roles and responsibilities of an infection control coordinator (ICC), an individual who has been designated by the company to develop the written procedures set in place to prevent and control infections in the workplace.6 It is not mandatory that a facility have an ICC, and the role of the ICC can vary from company to company. In addition, to become an American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC)–accredited facility, certain documentation must be in place to be reviewed by ABC surveyors who will approve or deny the request for accreditation. This documentation must address the prevention of cross-contamination, the use of universal precautions, an explanation of how items will be properly stored for later use (to prevent cross-contamination), and a policy to investigate reports of an infection potentially acquired from the patient’s device.7 However, despite the fact that infection control is one of the few things that should not vary between O&P offices, there is no standard language to be followed by all ABC-accredited facilities regarding infection control, and it is up to each individual facility to self-govern regarding this issue.7 The most applicable risk of the spread of infection generally exists in the form of bloodborne pathogens and fungal infections. Yet, due to the nature of some of the comorbidities O&P patients may present with, contaminants on devices may include biofilm,8 fecal matter, urine,9 vomit, and even pet excrement. This may prompt practitioners to wash their hands after merely touching the device of a given patient, but little else may be done regarding the sanitation of tools used to tend to that patient’s orthotic or prosthetic needs. Although the significance of bloodborne pathogens may be lower in O&P than in other health professions, the associated risk must not be discounted. Any O&P professional can accidentally incur skin damage when working on a device, posing an entry (or exit) point for bloodborne pathogens. Patients may present with any manner of open wounds, from diabetic ulcerations to bleeding sports injuries. Even dried blood, which can be difficult to distinguish from the everyday dirt and grime found on patient devices, may still be infectious. The hepatitis C virus can survive in dried blood for up to 4 days, and the hepatitis B virus can survive in dried blood for up to 1 week.10
Fungal and yeast infections are other contagious diseases that may be spread through contact with a contaminated device, and they are very prevalent among diabetic patients.11 Those with diabetes represent a large population of O&P patients, either as users of prostheses (diabetes is a common risk factor of lower-limb amputation12) or of orthopedic shoes and inserts provided by O&P professionals. The most frequently diagnosed fungal infection among diabetic patients is tinea pedis (aka athlete’s foot),11 a “highly contagious”13 condition that “may lead to the development of foot ulcers.”14 Tinea pedis affects more than 20% of the population, and the prevalence increases with the individual’s age.15 It can be spread through contact with a contaminated surface, which may include shoe inserts, ankle foot orthoses, or anything with a footplate.
“Contaminated inanimate objects” are known as fomites.16 The term “fomite” is common to discussions about infection control, and hospital rules have been established in response to fomites posing a risk to patient health. Examples of such intervention include disallowing long sleeves and neckties on professionals who interact with patients. Items that may come in contact with more than one patient, such as stethoscopes, have been found to have a high contamination rate for MRSA.16 Like stethoscopes in hospitals, in O&P, many items that are used every day and stored for later use can be classified as fomites. Goniometers, measuring tapes, Brannock devices, M/L sticks, casting liners, and restocked orthotic devices are only a few of the items that are commonly used on more than one patient but may not be properly cleaned in between uses and before being returned to storage. Each of these fomites can pose a threat to the health of patients seeking O&P care.
Especially in the case of tools, conventional preconceptions (such as that tools belong in a garage and should be “dirty” to some degree) may obscure the fact that the tools of practitioners in the field of O&P are ultimately used to provide a medical service to patients. In that, those tools resemble a dental hygienist’s equipment, which is sterilized between each use.17 Although the risk of infection via instrument is certainly not as immediate in O&P as it is in dental medicine, it must not be assumed that current infection control practices in the field are sufficient. For example, practitioners commonly wear gloves in the examination room18 to protect them and their patients from transmitting disease to each other. However, O&P care does not stop in the examination room but regularly extends to the fabrication laboratory and/or storage areas where tools, devices, and ancillary items may become contaminated before they are being used with another patient.
The aim of this study was to investigate current O&P infection control methods outside of patient examination rooms, to assess general knowledge of terms regarding infection control among O&P professionals, and to evaluate perception of risk of infection in the O&P industry. Thus being able to compare the infection control practices of the O&P industry to those implemented in other fields may provide the basis for future research that can lead to a standard protocol to protect patients and professionals from infectious disease.
Participants were recruited from OANDP-L, an online discussion list consisting of members of the O&P community. An email containing study information, background, and appeal for participation with a hyperlink to the Qualtrics survey Web site was sent to this list for recruitment. The survey (provided as supplemental material, see Supplemental Digital Content 1, http://links.lww.com/JPO/A15) was open for approximately 2 weeks. This study was exempted from ethics approval, as determined by the University of Pittsburgh Institutional Review Board (IRB).
A statistical analysis of closed-ended survey results included descriptive statistics and was designed to include a post hoc analysis as appropriate. SPSS (IBM Corp, Armonk, NY, USA) was used to perform the nonparametric Mann-Whitney U test during this post hoc analysis with a significant α set to 0.05.
A total of 123 of the roughly 4,000 subscribers to the OANDP-L participated in the study. For convenience of reference, a list of survey questions can be found in Table 1. Background information regarding the roles of the participants and years of experience in the O&P industry can be found in Tables 2 and 3.
A total of 75% of participants indicated that they left their home office to treat patients in other settings (e.g., hospitals, patient homes, skilled nursing facilities, or other similar locations) on at least 1 day per week.
Overall, 63% of the survey participants believed to some extent that patients who receive prosthetic or orthotic care are at risk of disease cross-contamination from their device. This number was 68% among individuals with 0 to 20 years of experience in the O&P industry and only 57% for those respondents with 21 or more years in the O&P industry, but the difference was not deemed statistically significant. In fact, the only statistically significant difference in responses between those two groups was with regard to the frequency of hand washing between devices. Individuals with more than 20 years of experience wash their hands more frequently between devices than do individuals with less than 20 years of experience (P = 0.01).
Less than half of the participants (47%) correctly identified the definition of a fomite from the other choices made available in the survey, and only 43% of participants reported that their place of work had an ICC. The presence of an ICC significantly improved the frequency of hand washing between devices (P = 0.02), time spent washing hands (P = 0.02), frequency of cleaning devices (P < 0.01), and frequency of cleaning tools (P < 0.01).
Based on the responses from survey questions 8 and 9, 49% of respondents reported that they do not wash their hands for as long as what they think is the recommended length of time. Only 14% of respondents chose the correct length of time to wash their hands as recommended by the CDC, and just 54% of participants reported washing their hands for more than the recommended 15 seconds.
A total of 44% of respondents reported cleaning patient devices brought into the fabrication laboratory about half the time or less frequently. Tools in the fabrication laboratory are reported to have been cleaned about half the time or less frequently by 76% of participants, but 63% of respondents report always cleaning casting liners, ill-fitting liners, or off-the-shelf orthotic devices before putting them back in the box to be fit on another patient.
Significant results of selected comparisons are listed in Table 4.
Our findings illustrate considerable differences between O&P practitioners’ attitudes toward and knowledge about infection control. Although overall a majority seems to be aware of the pertinent infection risks in this field, the responses also indicate substantial, yet addressable, shortcomings in how those risks are being managed.
Notably, three of the certified prosthetist/orthotists (CPOs) and two certified orthotists (COs) who responded reported that washing their hands between performing work on different devices does not apply to their role in the field. The availability of this response option was originally intended for students who may observe but are less likely to have hands-on experience and therefore would not be touching any device. It is possible that these practitioners misinterpreted the question to refer solely to workers in the fabrication laboratory. It is difficult, however, to imagine a job description under which these practitioners would go through their days without getting in contact with any devices, where washing their hands between devices would, in fact, apply to their role in the field. Of this group of practitioners, two responded to survey question 6 that they disagree that patients are at risk of cross-contamination from their device. Because of this information, it is possible that the practitioners chose the “does not apply” response with regard to washing their hands between devices because they genuinely do not believe that there is an application for it.
Individuals who selected “other” as their role in O&P included, in addition to other variations of practitioners in O&P, an office administrator and an office manager. Neither of these individuals selected the “This does not apply to my role in the field of prosthetics and orthotics” option on questions 7 or 10, and only one chose that answer on questions 11 and 12. These responses suggest that the individuals in the roles of office personnel in O&P either have additional credentials in which they would be working on patient devices, or they have duties which extend beyond office work and include cleaning devices before forwarding them to a practitioner. This brings to light another issue in O&P in the case of the patient who drops off a device for repair. Should office personnel have to handle the devices, they face the same risks of cross-contamination as other workers in the office and the same precautions should be taken regardless of role in the field.
A high percentage of participants (75%) reported leaving their home office to treat patients in other locations at least once per week. Such practice not only increases the number of treatment locations where disease may spread, but also adds another storage area of concern with the O&P professional’s vehicle.
The self-reported responses of cleaning agents used in specific situations were alarming. Although many of the responses included disinfectant or some type of antibacterial agent, responses of compressed air and Windex were also reported. Alcohol was reported as a cleaning agent a great number of times, yet the Food and Drug Administration (FDA) “…has not cleared any liquid chemical sterilant or high-level disinfectant with alcohol as the main active ingredient” because it fails to eliminate bacterial spores.19 Based on the survey responses, patient devices, tools, and restocked items are not always cleaned by O&P professionals. These are items that are at risk of cross-contamination, and even when they are reported to have been cleaned, the cleaning agents used are often not adequate in eliminating all contaminants.
Individuals with more than 20 years of experience in O&P washed their hands more frequently between devices than those individuals with less than 20 years of experience. Education about the impact of hand washing in health care settings has been made more prevalent in recent years, yet growing up with more information about hand washing does not seem to make younger O&P professionals more likely to implement it in practice than their more experienced counterparts.
The presence of a designated ICC in the workplace had a positive impact on the awareness of infection control practices, opinion, and the behaviors exhibited by O&P professionals. When an ICC was known to be present in the workplace, participants had in general more correct responses to survey questions regarding fomite definition and expressed stronger agreement that O&P patients are at risk of cross-contamination from their device than those participants whose workplace either did not have an ICC or who did not know whether their workplace had an ICC. In addition, participants whose workplace implemented the use of an ICC also reported a significantly greater frequency of hand washing, significantly more time spent washing hands, and a significantly higher frequency of cleaning tools.
One of the previously reported reasons for noncompliance with hand washing procedures is that health care workers feel there is not enough time in the day to properly wash one’s hands every time it is warranted.2 If simple hand washing procedures are overlooked due to a lack of time, it is likely that O&P professionals will feel that same strain when it comes to properly cleaning their patients’ devices should that become a future standard in the field. In describing products used to clean patient devices, one survey participant reported that time is already a problem: “Our schedule doesn’t allow much room to clean a heavily soiled device.”
In further addressing infection control in O&P, there is potential for financial ramifications for companies because no revenue is generated when performing tasks like cleaning a device or other item in the laboratory. The costs of infection control pose a challenge for other health care industries as well. To mitigate this issue in the dental field where “infection-control costs are expensive,”20 charging a sterilization fee of $5 to $20 or more is allowable for the proper sanitation of instruments used during dental procedures. For those purposes, a dentistry-specific D9999-“Unspecified Adjunctive Procedure” code20 is used, which is similar to the unspecified L—99 codes in O&P. If O&P professionals lobby to gain compensation from insurance companies for device and tool cleaning, reducing the risk of cross-contamination from patient devices would not have to come at the expense of profitability.
Our study is not without limitations. The survey response rate was approximately 3%, and it is possible that individuals who responded to the survey did so because they are either more knowledgeable about or more interested in infection control practices in O&P than those people who chose not to respond. This response bias could have caused the results to be skewed toward what may be perceived as a more favorable outcome. In addition, the very nature of self-reported data can be cause for deviations from actual practice. For example, without a timer present at every sink, the self-reported length of time that a participant washes his or her hands is merely an estimate and may not be accurate. Sincerity of responses may have been limited as well, considering that the nature of some questions may have carried the notion of self-accusation. A larger sample size would have been desirable to mitigate some of the potential error sources and to generally be more representative of the target population.
Future research may generate more conclusive evidence on the effectiveness of infection control policies in O&P such as the installation of an ICC or the reimbursement schedule for cleaning tasks. The development of designated disinfecting equipment may help increase the efficiency and thus promote adoption of implementing infection control routines into clinical work.
Like doctors and nurses, many professionals in the O&P industry fail to comply with the most basic recommended hand hygiene procedures aimed to reduce infection rates. A lack of knowledge contributes to this notion, as indicated by the low percentage of correct responses with regard to fomite definition and recommended hand-washing time. In addition, although the majority of O&P professionals who responded to the survey believe to some extent that patients are at risk of cross-contamination from their devices, not enough is being done to prevent it. Patient devices, tools, and restocked items are not always cleaned and the agents used to clean them are not necessarily adequate in reducing risk of infection. The implementation of an ICC in every office could improve awareness and compliance with regard to the frequency of cleaning specific items.
The contamination of surfaces is not always visible. Just as one would assume all patients have disease as per universal precautions, it may be best practice to extend the same precaution to the devices of those patients. A standard procedure for all professionals to follow has potential to better protect both patients and practitioners from unnecessary infection, yet is currently missing from the O&P industry. Such a standard should adequately address the nuances of every aspect of daily life as an O&P professional, specifically with regard to the indirect contact with patients in the fabrication laboratory and storage areas.
Our final recommendation beyond establishing standard procedures and installing ICCs is the implementation of a dedicated billing code that allows reimbursement for infection control measures.
The authors thank David Crish for his help revising the manuscript.
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