A list of evidence-based guidelines for safe injection practices that were established by the CDC in 2007 and reaffirmed in 2012 is presented in
Table 2.
24,26,27 These guidelines have been promoted by the Safe Injection Practices Coalition,
2,27,28 started in 2009, with the associated One & Only Campaign, which recommends using 1 needle and 1 syringe for only 1 patient.
29
Physicians can evaluate their procedures using the CDC injection safety checklist at
https://www.cdc.gov/injectionsafety/pdf/sipc_checklist.pdf.
30 These guidelines have an accord with the World Health Organization's (WHO) guidelines for safe injection practice published in 2010.
11 The WHO guidelines place particular emphasis on the use of an aseptic technique, including hand hygiene, disinfecting the skin at the site of venipuncture, and glove use (1 pair of gloves per procedure or patient). The WHO guidelines also reinforce the CDC's injection safety guidelines in the following areas: the advisement of 1 sharp
31 used per procedure, with immediate disposal of the used sharp in a designated sharps container with a tamperproof lid; encouragement to assume that damaged or opened medical equipment has been used and cannot be used again; and recommendation to avoid the use of multiuse vials and, if used, to discard contaminated vials immediately.
11 Some notable additions in the WHO guidelines are the recommendation to use 1-handed methods whenever possible, to avoid unneeded injections, such as oral or rectal routes of medication administration, and to report accidents immediately.
11 For most bloodborne pathogens, it is recommended to start postexposure prophylaxis within 72 hours. However, HCV is unique because, as the WHO guidelines point out, there is no postexposure prophylaxis or vaccine for HCV; the only response to exposure is to perform baseline testing for antibodies to HCV and alanine aminotransferase levels so that appropriate treatment can begin.
11
Analysis of a 2014 iatrogenic HCV outbreak in Tennessee showed how the Tennessee Department of Health properly used the CDC guidelines to evaluate the dialysis facility where the suspected source patient was identified.
32 The facility was found to have no visible blood; sinks were available for hand hygiene, glove use was observed; dialysis stations were properly disinfected between patients; medications were observed to be prepared for specific patients away from patient areas; and multidose vials were not allowed in treatment areas and were only used in a separate clean room to maintain sterility. Although 2 cases of iatrogenic HCV spread were identified as linked to treatment at this dialysis center, no violation of the CDC's injection safety guidelines was detected.
32
During a 2007 New York State HCV infection outbreak investigation, 2 distinct groups of iatrogenic HCV-infected patients were identified.
33 This investigation was initiated after a patient from the first group reported having acute symptoms, which started the process of notification and screening for bloodborne pathogens.
20,33 Most patients with chronic HCV infection are asymptomatic, as were all of the patients in the second group discovered during this investigation.
6,19 This second group of patients would likely not have been identified if a concurrent local investigation had not been initiated.
20,33 Therefore, a reasonable medical professional cannot rely solely on using injection safety guidelines for documented HCV infection.
4,5,19
Step 3 in the
Figure shows that replacement of just the needle does not remove the HCV infection risk from the contaminated syringe.
20,24,28 This concept also applies to the use of IV bags, tubing, and connectors, which must also be changed between every patient in addition to replacement of the needle that punctured the skin.
5 Research has shown that check valves and needle exchanges do not reduce the risk of contamination back to IV bags and tubing.
5 Single-dose vials also cannot be used more than once, as shown in step 4 in the
Figure.
24,28 These vials lack preservatives and are an environment in which bacteria or viruses have a high potential to multiply and compromise the vial,
2,26 leading to iatrogenic infection if that vile is used for another patient.
24,28
Patient-to-patient transmission in the health care environment is the major concern of the CDC guidelines, the One & Only Campaign, and the WHO guidelines, but preventing transmission to patients from clinicians is another way to reduce the iatrogenic spread of HCV. The Society for Health Care Epidemiology of America (SHEA) compiled a list of evidence-based guidelines to reduce the risk of clinician-to-patient transmission of bloodborne pathogens.
3,35 Although SHEA states that infected clinicians pose almost no risk to patients, it also states that this low risk applies to noninvasive procedures or an infected clinician whose infection is well controlled.
3,35 The SHEA guidelines recommend that if a clinician's viral load is greater than or equal to ×10
4 GE/mL, he or she should wear 2 pairs of gloves and should not perform category-3 procedures, during which there is a high transmission risk.
3,35 Category-3 procedures include general surgery, general oral surgery, cardiothoracic surgery, open extensive head and neck surgery, neurosurgery, emergency surgery, obstetrics and gynecology, orthopedic surgery, transplantation, plastic surgery, trauma intervention, and any open surgical procedure longer than 3 hours, as well as situations in which there is a risk of a patient biting a clinician.
3,35
Clinicians who know that they have a bloodborne pathogen such as HCV are ethically obligated to monitor their own viral load and submit to twice-per-year testing.
3,35 It is also recommended that infected clinicians have the results analyzed by a physician who can initiate proper viral load-reducing treatment and report the results to a review panel to regulate the infected clinician's practice scope.
3,35 A lookback study can be initiated if proactive reporting identifies a clinician who may have a viral load that could put patients at risk,
3,35 if there is a suspected or recorded clinician-to-patient transmission event, if a clinician's viral infection is linked to a viral burden beyond the stated limits, or if recommended screening determines that a clinician was involved in category-3 procedures while having a viral load beyond the stated limits.
3,35 Prevention of iatrogenic clinician-to-patient HCV transmission additionally involves identifying clinicians who are impaired owing to the use of injectable drugs in or outside the workplace.
18,20 A total of 13,162 patients were notified of bloodborne pathogen risk in notification events associated with clinician drug diversion of fentanyl in 2004, 2009, and 2010.
18,20 Policies that prevent diversion include locking medications in schedule II through V categories securely in accordance with the Comprehensive Drug Abuse Prevention and Control Act of 1970,
18 using tamper-resistant syringes, testing wasted drugs to confirm whether they are narcotics, and labeling prefilled syringes with patient identification.
18 Drug diversion by clinicians must be reported to regulatory agencies, and the clinicians need to be referred to the State Medical Licensing Board's physician health program for rehabilitation.
18,20