Guidelines Regarding HIV and Other Bloodborne Pathogens in Vascular/Interventional Radiology
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Policy and Position Statements Guidelines Regarding HIV and Other Bloodborne Pathogens in Vascular/Interventional Radiology Margaret E. Hansen, MD, Subcommittee Chair, Curtis W. Bakal, MD, MPH, G. David Dixon, MD, David J. Eschelman, MD, Keith M. Horton, MD, Michael Katz, MD, Eric W. Olcott, MD, David Sacks, MD, and the Members of the Society of Interventional Radiology Technology Assessment Committee1 J Vasc Interv Radiol 2003; 14:S375–S384 CONCERN about human immunode- LEVEL OF RISK IN tal procedures. Stool is included only ficiency virus (HIV) and other blood- INTERVENTIONAL if visible blood is present. Urine is gen- borne pathogens is rising throughout RADIOLOGY erally not included either, but it society as infection becomes more should be considered potentially in- prevalent. Many members of the So- Information about the risk of blood- fectious if the urinary tract has sus- ciety of Interventional Radiology borne pathogen transmission during tained trauma or been instrumented. procedures in interventional radiology All such materials other than blood (SIR) have expressed the need for an is limited. Transmission of HIV from are grouped under the term “other po- official statement from the Society health care worker to patient during tentially infectious materials,” or that addresses practice issues unique an interventional radiology procedure OPIM. to interventional radiology. As a re- has not been reported to date, nor sult, the SIR Subcommittee on HIV have cases of transmission in the op- and Bloodborne Pathogens was posite direction been confirmed. Due formed to review current knowledge Patient-to–Health Care Worker Risk to the extremely low level of risk, about risk of bloodborne pathogen however, it is possible that transmis- Transmission of bloodborne patho- transmission during interventional sion has not been reported because the gens in the health care setting has been radiology procedures, to summarize number of procedures done is rela- documented to occur through percu- exposure control regulations and tively small. This document will re- taneous exposure, mucous membrane recommendations as they pertain to view what is currently known about exposure, or contact with nonintact the practice of interventional radiol- the level of risk in interventional radi- skin (1–7). Such exposures, to blood or ogy and review ways that risk can be ology, and compare that to what is to other fluids, can occur during inter- reduced, and to formulate a policy known for surgery, which is probably ventional radiology procedures for the Society to assist its members the medical specialty with the greatest (8 –11). Infection through contact with in dealing with this complicated sub- risk. intact skin has not been documented ject. Many pathogens are of concern in (2,7). medical practice today, including My- The risk of bloodborne pathogen cobacterium tuberculosis and others, but transmission during an interventional bloodborne agents pose a special risk radiology procedure depends on sev- in interventional radiology. Accord- eral things: the likelihood of a sharps This article first appeared in J Vasc Interv Radiol ingly, this document will focus on the injury or other parenteral exposure oc- 1997; 8:667– 676. bloodborne agents HIV, hepatitis B vi- curring during a procedure, the prev- From the HIV/Bloodborne Pathogens Subcommit- rus (HBV), and hepatitis C virus alence of infection in the population, tee of the SIR. Address correspondence to SIR, (HCV). and the likelihood of establishment of 10201 Lee Highway, Suite 500, Fairfax, VA 22030. Body fluids considered infectious infection after a parenteral exposure. 1 Gary J. Becker, MD, Dana R. Burke, MD, Patricia E. or potentially infectious include blood; The rate of needlestick and other Cole, MD, Michael D. Dake, MD, Richard J. Gray, semen; cerebrospinal, vaginal, syno- sharps injuries in interventional radi- MD, Ziv J. Haskal, MD, Robert W. Holden, MD, Lindsay S. Machan, MD, Nilesh H. Patel, MD, and vial, pleural, pericardial, peritoneal, or ology is low. In a national survey of Richard Shlansky-Goldberg, MD. amniotic fluid; any fluid that is either practicing interventional radiologists, contaminated with blood, mixed with the median number of injuries per © SIR, 2003 another potentially infectious fluid, or year of practice was 0.3 (95% confi- DOI: 10.1097/01.RVI.0000094608.61428.ed of uncertain origin; and saliva in den- dence interval [CI]: 0 –1.9) (8). The es- S375
S376 • Guidelines Regarding HIV and Other Bloodborne Pathogens September 2003 JVIR timated number of injuries per 100 HCV infection was found in 5% and tion in the patient population served. procedures ranged from 0 to 2.2, with 18%, respectively, of patients in the Gynecologic surgeons and oral sur- a median of 0.06 and a mean of 0.12 same emergency department (22). In geons are at the greatest risk because (95% CI: 0 – 0.42). In a prospective certain subgroups, the rates were their work frequently involves manip- study of interventional radiology pro- much higher: HCV was found in 83% ulation of sharp instruments inside a cedures, sharps injuries occurred in of injecting drug users, 21% of trans- body cavity where visual control is only 0.6% of cases (9). In contrast, the fusion recipients, and 51% of black limited or nonexistent. The fact that no frequency of sharps injuries in surgery men aged 35– 44 years old (22). In an- surgeons without behavioral risk fac- ranges from 1.7% to 15.4% of proce- other center, 19% of hemodialysis pa- tors have tested positive in studies to dures (12–16), whereas surgeons re- tients were HCV-positive (23). Evi- date (32) casts doubt on the accuracy ported a median of two injuries per dence of HBV and HCV exposure in of these models, suggesting that the year in a New York City survey (17). the general population is less common actual lifetime risk of occupational in- In another recent study, the sharps in- (3%–14% and 0.6%, respectively fection may be much lower (33). Cer- jury rate was 3.1 per 100 surgical pro- [7,24,25]), but up to 1% of hospitalized tainly, the lifetime risk of occupational cedures, and the total exposure rate, patients may be chronic carriers of HIV infection should be lower still for including both skin contact and sharps HBV (7), most of whom are asymp- interventional radiologists because injuries, was 10.4 per 100 operations tomatic. It is estimated that 0.1%– 0.7% blood contacts and parenteral expo- (18). of the general population are HBV car- sures are much less frequent in this There are several important differ- riers, although the prevalence of field than in surgery (8 –18). In a study ences between interventional radiol- HBsAg in certain high-risk groups based on computer models similar to ogy and surgery that could account for may be as high as 15% (6,7). those used for surgery, the lifetime oc- lower rates of sharps injury during in- For a given exposure, the risk of cupational risk for interventional radi- terventional radiology procedures. subsequent infection or seroconver- ologists was estimated to be between First, interventional radiology proce- sion is likely to depend, in turn, on .009% and 16% for a 30-year career dures are less invasive than most sur- several factors. These include the type (34). Recent studies have found that gical procedures because they are of exposure (cutaneous, mucous mem- the prevalence of HCV infection done through very small incisions. As brane, or percutaneous) and its sever- among health care workers is also a result, there is less blood loss in most ity (depth of penetration), the type very low, in the range of 1% (25). Oc- cases. Second, many interventional ra- (blood or OPIM) and amount of fluid cupational infection with HBV, how- diology procedures are shorter in du- in the inoculum, the viral titer in the ever, remains common: 3%–10% of un- ration than surgical ones, and require source individual’s blood at the time, vaccinated health care workers who use of fewer sharp instruments. When his/her stage of illness, whether or not do not have frequent blood contacts such instruments are used in interven- he/she is receiving antiviral medica- show evidence of HBV infection (24), tional radiology, both of the operator’s tion, and the number and concentra- as do 10%–30% of those with frequent hands are almost always in full view, tion of infected cells circulating in his/ blood contacts (6). The Centers for Dis- and work in confined body cavities is her blood at the time (26 –29). For ease Control and Prevention (CDC) es- very rare. Both of these factors reduce sharps injuries, the type of instrument timates that 12,000 health care workers the likelihood of inadvertent injury to is also important: hollow-bore needles acquire HBV infection on the job each the nondominant hand, a common site pose a higher risk than other sharp year (6). of injury during surgery. Lastly, the instruments; this is thought to be be- use of suturing techniques (such as cause they introduce a larger amount Health Care Worker–to-Patient Risk palpating for the tip of a needle with of blood or OPIM into the injured tis- the index finger of the nondominant sue. Given all this, the risk of serocon- The risk of bloodborne pathogen hand) and suturing materials (such as version after a single percutaneous or transmission from health care worker wire) that increase the risk of puncture mucous membrane exposure to HIV to patient during an interventional ra- injury is rare in interventional radiol- has been estimated at 0.3%– 0.4% (2– diology procedure depends on the ogy. 4). HBV is much more easily transmit- likelihood of a sharps injury or other The prevalence of HIV infection in ted: the risk of infection after a single parenteral exposure occurring during the general population of the United parenteral exposure can be as high as a procedure, the prevalence of infec- States is estimated to be less than 1% 30% (6). HCV is not as infectious as tion in the population of health care (19). Among hospitalized patients, HBV, but is more so than HIV: the risk workers, and the likelihood of estab- however, the prevalence may be high- of infection after a single parenteral lishment of infection after an expo- er: in one study, from 0.2% to 14.2% of exposure was 2.7% in one report (5). sure. Because all of these events are inpatients had evidence of HIV infec- The cumulative career or lifetime uncommon, the level of risk during an tion (20). Infection may also be more risk that an interventional radiologist interventional radiology procedure is prevalent among patients seen in the will become occupationally infected probably extremely low. emergency department: in one urban with HIV or another bloodborne As we have seen in the previous hospital, 19% of young adults admit- pathogen is unknown. Attempts have section, the likelihood of parenteral ted with penetrating trauma were been made to estimate this risk for exposure occurring during an inter- HIV-positive, as were 6% of all emer- surgeons, ranging from 1% (30) to 20% ventional radiology procedure is very gency department patients (21). In a (31) during a 30- or 40-year career, small: sharps injuries occur in only related study, evidence of HBV and depending on the prevalence of infec- 0.6% of cases (9). For transmission
Volume 14 Number 9 Part 2 Hansen et al • S377 from health care worker to patient to health care workers who do not have niques similar to those used for sur- occur, an infected health care worker frequent blood contact, but the preva- gery and the injury (8,9) and sero- must sustain an injury that causes lence of the carrier state (as manifested prevalence (19) data given previously, bleeding and there must be subse- by chronic HBsAg positivity) is only we estimate the risk of HIV transmis- quent additional parenteral contact 0.3% (24). sion from an infected interventional between the patient and the blood of Quantitation of the risk to patients radiologist to a patient to be 7.5 per the injured health care worker. In in- from HIV-infected health care workers million procedures (95% CI: 0 –15.3 terventional radiology, this could oc- has been attempted with use of com- per million procedures) (34). If the cur if an injured health care worker’s puter modeling techniques and prob- HIV status of the interventional radi- blood contacts the patient directly, or ability theory. Their practical utility is ologist is unknown, the risk is esti- indirectly via a needle, guide wire, or uncertain, but all such estimates have mated to be .03 per million procedures other instrument. In surgery, such “re- been very low. The CDC estimated the (95% CI: 0 –3.8 per million procedures) contact” can occur if a needle is reused risk of an infected surgeon transmit- (34). To put this risk in perspective, it after an injury, or if the injured sur- ting HIV to a patient during surgery to would be helpful to know the total geon bleeds into the wound. Recontact range from one in 420,000 procedures number of interventional radiology is rare during interventional radiology to one in 42,000 procedures (0.00024% procedures performed annually in the procedures: in the aforementioned to 0.0024%) (36). Lowenfels and United States. Unfortunately, this survey, contaminated instruments Wormser estimated that one incident number is difficult to determine from were reused in only 1% of cases after of HIV transmission would occur per available data. We have used data injury, and direct contact between a 83,000 hours of surgery (37). Rhame, in from a survey of SIR members (8) to patient and the injured health care an editorial in JAMA, estimated the estimate the total number of proce- worker’s blood occurred in only one risk at one in 1,000,000 operations dures they perform in 1 year; the re- case, or 0.2% of injuries (8). In the pro- (0.0001%) to one in 100,000 operations sult is 1,017,450 ⫾ 726,750 (range, spective study of interventional radi- (0.001%) (38). More recently, Schul- 290,700 –1,744,200; Hansen ME, McIn- ology procedures, no contaminated in- man et al have estimated the risk of tire DD, unpublished data, 1993). This struments were reused, and no contact transmission of HIV from surgeon to is an underestimate of the actual num- between patients and health care patient to be less than one in 1,000,000 ber because non-SIR members and workers’ blood occurred (9). In com- procedures (39). All of these numbers nonradiologists were not included in parison, recontact rates in surgery are based on the estimated risk of se- the original survey. It is not known vary considerably, with reuse of con- roconversion after a single percutane- what proportion of interventional ra- taminated instruments in up to 29% of ous or mucous membrane exposure to diology procedures are done by non- cases in a recent study (15). Gyneco- blood containing HIV, which is ap- SIR members or nonradiologists. logic procedures, especially vaginal proximately 0.3%– 0.4% (2– 4), com- The risk of HBV transmission is hysterectomy, were associated with bined with various estimates of how more of a concern. HBV is many times the highest rates of sharps injury and often such exposures may occur, and more infectious than HIV, and has recontact in this study. estimates of the prevalence of HIV in- been transmitted to patients despite The prevalence of HIV infection fection among surgeons. The actual adherence to universal precautions among health care workers is not risk of transmission of HIV from an and lack of recognized injury during known, but probably resembles that of infected health care worker to a pa- procedures (40 – 43). In several early the general population. A study of tient is probably lower than 0.3% for a cases, transmission was attributed to dental professionals found that only single exposure because the infectivity the failure to wear gloves. The use of one of 1,309 (0.07%; 95% CI: 0%– 0.4%) of a person’s blood is related to his/ gloves, which is now routine during individuals without behavioral risk her viral titer. Higher titers, which are invasive procedures, has dramatically factors for HIV infection was seropos- believed to confer greater risk of dis- reduced the number of cases of HBV itive, despite frequent puncture inju- ease transmission, are associated with transmission. However, there have ries and occupational exposure to more severe clinical disease, which been at least three such cases that oc- bloody fluid (35). Voluntary testing of may be incompatible with the de- curred despite the use of gloves and surgeons attending the 1991 Annual mands of interventional radiology lack of recognized sharps injury dur- Meeting of the American Academy of practice. It is, therefore, likely that in- ing a procedure (43). In all cases in Orthopaedic Surgeons found that fected physicians still well enough to which HBV was transmitted from a none of the 3,267 (95% CI: 0%– 0.09%) practice interventional radiology chronically infected health care participants without behavioral risk would have much lower titers. For the worker to a patient, the source was factors were HIV-positive, despite fre- reasons previously discussed, inter- HBeAg-positive (41). quent blood exposure and sharps inju- ventional radiology procedures are ries (32). Of the 108 participants with likely to pose significantly lower risk TESTING FOR HIV reported behavioral risk factors, two of HIV transmission to patients than (1.9%; 95% CI: upper limit ⫽ 5.7%) surgical procedures. The risk of such Some have argued that all patients, were HIV-positive (32). As mentioned transmission is certainly much lower and all health care workers, should be previously, evidence of exposure to than many other risks associated with tested for evidence of HIV infection on HCV is found in only 1% of health care medical care, which are accepted with- the theory that identifying all infected workers (25). Evidence of exposure to out question by patients and providers individuals would reduce the risk of HBV can be found in up to 10% of alike. With use of modeling tech- accidental transmission of the virus
S378 • Guidelines Regarding HIV and Other Bloodborne Pathogens September 2003 JVIR during medical procedures. Not only tential issues related to testing of ument, but its most important features would the cost of such testing be sub- health care workers include disability, are summarized below. More detailed stantial, the logic of the argument is liability, and other types of insurance, information can be found in a recent seriously flawed for several reasons. and confidentiality and reporting of review by Decker (53) or in the com- First, there is a certain error rate (both results, as well as questions about the plete text of the Standard and its sup- false positive and false negative) in- frequency of testing and whether to porting documents (7). herent in any test, including both the restrict the practice of a health care 1. Materials considered infectious/ ELISA and the Western blot methods worker who tests negative initially af- potentially infectious include of testing for HIV exposure (44). In ter an exposure. There are important blood and other fluids as listed addition, some people who are in- health care delivery issues at stake as in the first section of this docu- fected will not test positive for other well: if physicians know their careers ment. reasons. For example, they may be in will end should they become infected 2. Occupational exposure is defined the “window” period between expo- with HIV, they will be less willing to as parenteral, skin, or mucous sure and seroconversion, which is be- perform invasive procedures on in- membrane (including conjuncti- lieved to be 2 months or less (44) but fected patients, thereby reducing ac- val) contact with blood or may be as long as 6 months or more in cess of such patients to needed care OPIM that may be reasonably some cases (44 – 46). Others who are (39). Routine testing of physicians for anticipated to result from the not infected will test falsely positive, HIV infection also raises the issue of performance of a health care again for a variety of reasons (47). patient consent to having procedures worker’s duties. This includes Therefore, the reliability of test results done by HIV-positive doctors. contact that is prevented by use may not be adequate to achieve the For these reasons, the SIR joins the of protective equipment, such goal of preventing nosocomial trans- American Medical Association (AMA) as gloves, gowns, and face and mission. Second, testing of patients (49), the National Commission on eye protection (goggles, masks, cannot be done without their consent AIDS (50), the Association for Practi- and shields). in many states. What is to be done tioners in Infection Control and Epide- 3. An exposure control plan must be with patients who refuse? Who is to miology and the Society of Hospital developed by every employer have access to the results if testing is Epidemiologists of America (51), and of at least one worker whose done? Who decides which procedures the CDC (52) in opposing mandatory duties put him/her at risk for pose sufficient risk to the health care HIV testing of physicians and other occupational exposure. This worker to justify testing of patients? health care workers. Testing should plan must be reviewed with Third, although some physicians be- not be a condition of employment or employees and contain a sched- lieve they can take additional precau- for granting of hospital privileges, li- ule for meeting the various re- tions and be more careful during pro- censure, or liability insurance cover- quirements of the Standard re- cedures if they know a patient is HIV- age (49 –51). garding hepatitis B vaccination, positive, study has shown this to be The 1992 Bloodborne Pathogen training, record-keeping, post- fallacy: knowledge of the patient’s Standard requires that vaccination for exposure treatment, and so on. HIV status made no difference in the HBV be offered free of charge to all The plan must detail measures incidence of injuries or other blood ex- workers who may be at risk for occu- that the employer will take to posures among surgeons at San Fran- pational exposure to blood or OPIM, reduce exposure risks. cisco General Hospital (12,48). Fourth, and prevaccination testing for evi- 4. The Standard mandates adher- test results will not always be avail- dence of previous infection may be in- ence to universal precautions, as able before treatment must be given, dicated in some cases. However, man- well as certain specific engi- especially in the emergency setting. Fi- datory testing of all health care neering and work practice con- nally, and perhaps most importantly, workers for HBV and HCV would be trols. Two-handed recapping of testing for HIV will not identify pa- subject to many of the limitations and contaminated sharps instru- tients who pose other hazards to concerns discussed previously, and ments is strictly prohibited, as health care workers: in one study, test- the SIR is opposed to it as well. is bending or breaking of con- ing for HIV alone would have failed to taminated needles. Contami- identify 87% of patients infected with nated sharps must be placed in HBV and 80% of those infected with PROCEDURE SAFETY: appropriate containers immedi- HCV (22). The only logical course, RECOMMENDATIONS AND ately after use. Handwashing then, is to treat every patient as a po- REGULATIONS facilities must be readily acces- tential source of infection, and observe Current Exposure Control sible; hands must be washed universal precautions scrupulously in Regulations every time gloves are removed all cases. or changed. Eating, drinking, Testing of health care workers for In 1992, the Bloodborne Pathogens handling of contact lenses, and HIV poses other problematic ques- Standard developed by the Occupa- use of cosmetics are prohibited tions. Since the passage of the Ameri- tional Safety and Health Administra- in work areas where exposure cans with Disabilities Act, which en- tion (OSHA) was enacted into law (7). may occur. Specimens must be compasses AIDS and HIV infection, Failure to comply is a federal offense. placed in sealed, leakproof con- job discrimination issues have been A comprehensive review of the Stan- tainers that are red or bear the raised in several lawsuits. Other po- dard is beyond the scope of this doc- label “biohazard.” Appropriate
Volume 14 Number 9 Part 2 Hansen et al • S379 personal protective equipment must be kept for the duration catheter at the end of a procedure, eye must be provided for employ- of employment, plus 30 years. and face protection should be worn, as ees at risk, and cleaned, re- Although not discussed explic- well as gloves. Wearing a gown is also paired, or replaced as needed. itly in the standard, chemopro- recommended if there are breaks in 5. Employers must provide em- phylaxis is warranted after the skin of the arms. ployees who are at risk for oc- high-risk exposure to HIV; When there is a reasonable risk of cupational exposure with hepati- more information and recom- exposure to blood or bloody fluid dur- tis B vaccine free of charge. Vac- mended regimens may be ing any vascular or interventional pro- cination may be refused, but found in a recent report from cedure, the following additional pro- the employee must sign a form the U.S. Public Health Service tective clothing are recommended in indicating that it was offered (54). addition to the items listed previously: and declined. Training in infec- surgical “scrub” attire; shoes worn tion control must be provided only for performing procedures; fluid- within 10 days of an employee Minimizing the Risk of Bloodborne impermeable gown; shoe covers or Pathogen Transmission in gaiters to cover lower legs and feet; being hired and at least once Interventional Radiology and hair covering. annually thereafter, and must be documented. The Standard Generally, simple peripheral intra- We endorse the precautions delin- details certain elements that venous access procedures (such as eated by OSHA (7) and the CDC (52) must be included. Records of starting intravenous lines or phlebot- and urge members of the SIR to ad- this training must be kept for 3 omy) would not fall into this category. here to these guidelines. These general years. Records relating to hepa- Gloves and a face shield are adequate recommendations, which include ad- titis vaccination and postexpo- for these procedures in most cases. herence to universal precautions, use sure follow-up must be kept for Whenever transfusion equipment or of appropriate protective equipment, the duration of employment, blood products are handled, eye pro- and safe handling practices for sharps, plus 30 years. Records must be tection and gloves should be worn. can be expanded to yield techniques made available to OSHA and to Contaminated work surfaces must be that more specifically address the the employee. cleansed and disinfected promptly af- practice of interventional radiology ter contamination is noted, and at the 6. Employers must provide postex- (55), as has been done for surgical end of each procedure whether visibly posure prophylaxis and counseling. practice (56 –58). Accordingly, we pro- soiled or not. Blood from the source of the pose four categories of specific precau- exposure must be obtained and tions: 1) barrier devices and personal tested for HIV and HBV unless protective equipment; 2) performance Procedural Precautions the person is already known to of procedures; 3) equipment; and 4) 1. Recapping of needles or be infected or consent, if re- handling of specimens. resheathing of scalpel blades quired, is refused, in conjunc- by hand is to be avoided tion with individual state law. whenever possible. If this is Although HCV is not specifi- Barrier Devices and Personal Protective Equipment not possible, one of the follow- cally mentioned in the OSHA ing methods must be used: a Standard, testing for infection Standard precautions for all inter- one-handed technique wherein with this virus may also be in- ventional radiology procedures the cap is “scooped up” with dicated. Refusal must be docu- should include (a) handwashing with the point of the exposed sharp mented. Results of testing must a germicidal and virucidal agent be- instrument, or a two-handed be provided to the exposed em- fore and after each case (immediately technique wherein the cap is ployee, who is to be informed after removing gloves); and (b) wear- held with a clamp or other of applicable laws concerning ing appropriate protective clothing, mechanical device, not the op- disclosure of the source’s iden- including gloves, transparent face erator’s fingers. tity. The employee also may shield or a mask plus goggles with When needles must be re- have blood collected for testing, side protectors, and coverage of all ar- moved from syringes or ex- or to be stored for at least 90 eas of nonintact skin with a fluid-im- changed, this too should be days while the employee con- permeable material. done by using a clamp or siders whether to have testing Because occult perforations in sur- other mechanical device, done. The employer is to be gical gloves increase with time worn rather than one’s fingers. Use told only that the exposed (11), it may be prudent to change of disposable scalpels rather worker has been informed of gloves after 90 minutes of wear than reusable metal handles is the evaluation’s results and of whether a perforation is apparent or strongly recommended. any further evaluation or treat- not. Double-gloving is recommended 2. Immediately after being used, ment that is needed. The actual when breaks in the skin are noted, and all disposable sharp instru- results of the evaluation and all some individuals may elect to double- ments that may be reused dur- other findings are considered glove routinely. When there is a risk of ing a given procedure should confidential. All records per- splashing of blood or body fluids, be placed into stable plastic taining to an exposure incident such as when removing a vascular devices designed for use on
S380 • Guidelines Regarding HIV and Other Bloodborne Pathogens September 2003 JVIR procedure trays. These holding sharp instrument is in use, the tions should be done with use devices should be placed in an operator should remove his/ of closed drainage sets. area of the tray where they her nondominant hand from 3. Self-sheathing or needleless in- will not be in the way and the field unless patient safety travenous systems should be will not be readily knocked or would be compromised by used whenever possible. tipped over. All members of doing so. 4. Glass syringes should not be the operating team must be 7. Disposal containers for sharp used unless plastic syringes are aware of the nature and loca- instruments must be readily not suitable. tion of the designated con- available, conveniently lo- 5. Luer-lock fittings are preferred tainer. Disposable sharp in- cated, and labeled according over the Luer-slip type for all struments that will not be re- to OSHA regulations. Contain- syringes, connecting tubing, used during a given procedure ers must be replaced before drainage systems, and the like. should be disposed of in ap- they are three-quarters full, or 6. “Bloodless” puncture systems propriate containers immedi- whenever items protrude from ately after use. Sharps contain- for arterial and/or venous ac- the opening (see section 2 re- ers must be of adequate di- cess are widely available and garding appropriate size of mensions to contain all sharp may be used at the discretion these containers). instruments used in a proce- 8. Adequate lighting in proce- of the operator. dure completely, with no por- dure rooms is essential. For 7. Resuscitation bag/mask sets tion of the instrument protrud- dedicated angiointerventional should be available in all pa- ing from the opening of the rooms, tableside control of tient care areas, including pro- container. Sharp instruments room lighting is recom- cedure rooms. should not be bent to force mended. This may be accom- 8. Plastic containers or other sta- them to fit into a container plished via a light switch or ble devices designed to contain that is not large enough to ac- by interconnection of the fluo- sharp instruments on procedure commodate them. roscopy controls and the room trays while maintaining their 3. All nondisposable sharp in- lighting. sterility should be used when- struments must be placed into 9. Technologists or other person- ever possible. designated containers immedi- nel who clean procedure trays 9. Glass containers (such as con- ately after use. These contain- should use long-handled for- trast media bottles) should be ers must be of adequate di- ceps or clamps to remove disposed of in sharps contain- mensions to contain the instru- sharp instruments. Gloves ers, rather than in waste bags, ments completely, as de- should be worn in all cases, to reduce the risk of injury to scribed under section 2 (dis- and splash protection (gown, housekeeping personnel from cussed previously). All mem- face shield, or mask plus gog- breakable materials in infec- bers of the operating team gles) may be needed also. tious waste bags. Removal of must be aware of the nature 10. If a member of the operating the metal caps from contrast or and location of the designated team sustains a sharps injury, container. medication vials should be the instrument responsible done with a hemostat or other 4. Members of the operating must be removed from the team should communicate ver- instrument to avoid injury, and procedure field immediately, the metal tops should then be bally regarding the use and without being reused on the location of all sharp instru- placed in a sharps disposal con- patient. Any additional pieces ments. tainer. of equipment that have come 5. Sharp instruments should not in contact with the injured be handed directly from one health care worker’s blood, team member to another. Specimen Handling Precautions such as guide wires, catheters, Rather, the “no touch” method gauze pads, and so on, must 1. Gloves must be worn at all should be used, in which the be discarded immediately as times when handling speci- instrument is set down onto a well. The exposed individual mens. stable surface by one team shall follow the procedure for member, who then withdraws 2. Specimens must be placed in reporting and treatment of ex- clearly marked, sealed contain- his/her hand before the in- posure incidents that has been strument is picked up by a ers, which are then transported established at that facility. inside a second sealed container second team member. 6. Suturing should be performed (such as a bag) that is labeled only by using needle holders, “biohazard.” Equipment Precautions never by holding or grasping 3. Facial splash protection (face the needle in one’s fingers. 1. Closed flush and waste contain- shield, or mask and goggles) Palpation to locate or guide ment systems should be used must be worn when fluid sam- the needle tip should never be for angiography. ples are injected into containers done. Similarly, whenever a 2. Drainage of large fluid collec- or poured from containers.
Volume 14 Number 9 Part 2 Hansen et al • S381 PRACTICE GUIDELINES FOR minimal, and thus we believe there is by a local panel, as described HIV-POSITIVE PHYSICIANS no reason to restrict the practice of below. infected individuals except in unusual 5. If a physician tests positive for Background cases. A policy that allows some flex- a bloodborne pathogen, he/ ibility is essential, both to ensure pa- she shall disclose that informa- Currently, there is no federal stan- tion, if required by hospital tient safety and to protect the rights of dard that defines how HIV-positive policy, to his/her local Medi- practitioners. Practice restrictions, if health care workers should be dealt cal Director or other physician needed, should be based on a case-by- with; rather, each state was directed in similar position of authority case review by a local review panel as by Congress to determine its own pol- on a confidential basis. If re- described below. icy and legal position on this issue. As quired by hospital policy, he/ a result, policies concerning HIV-pos- she shall also provide the itive health care workers, and poten- Policy Medical Director with releases tial legal restrictions on their practice, allowing medical information may vary considerably from state to 1. Physicians must adhere to the to be obtained from his/her state. Every practicing interventional principles of universal precau- personal physician. radiologist should be aware of the tions for blood and OPIM and 6. If required by state law, the laws in his/her own state. In addition, comply with the OSHA Blood- state Health Department must we encourage every interventional ra- borne Pathogen Standard (7) be notified of the infected phy- diologist to take an active role in shap- and local hospital policy. This sician’s status. Knowledge of ing policy at each institution in which includes vaccination against the physician’s status must be he/she practices. It is particularly im- HBV (unless a waiver declin- restricted to individuals with portant to do so before an exposure ing vaccination is signed), legitimate need to know, and incident occurs, so that a policy pro- with revaccination or booster must be held in strictest confi- tecting both patients’ and health care doses as needed. dence. All persons who are workers’ rights will already be in 2. Physicians who perform inva- informed of the infected phy- place, and a mechanism for handling sive procedures and have non- sician’s status must be explic- these difficult situations will be estab- occupational risk factors for itly instructed that no one else lished and available. infection with a bloodborne may be told without consent Despite the lack of a federal stan- pathogen should be aware of from the infected physician. dard, several national organizations their HIV, HBV, and HCV an- All records pertaining to the have promulgated their own policies tibody status through volun- infected physician’s condition concerning HIV-positive health care tary, confidential testing. must be kept confidential and workers, including the AMA (49), the 3. Physicians should be retested stored separately from routine CDC (52), the National Commission voluntarily whenever there hospital records, including the on AIDS (50), the Surgical Infection has been probable exposure to institutional computer system. Society (59), the Association for Prac- a bloodborne pathogen, or as 7. If there is concern that the in- titioners in Infection Control and Epi- determined by local institu- fected physician’s physical or demiology and the Society of Hospital tional policy. mental health is such that his/ Epidemiologists of America (51), the 4. Physicians who are HBsAg- her ability to practice is im- Association of Operating Room positive should know their paired, the case will be re- Nurses (60), and others. Numerous HBeAg status as well, because ferred to the local Impaired state and local medical societies have HBeAg-positivity is associated Physician Committee or simi- followed suit. with a higher risk of viral lar body. The SIR Subcommittee on HIV and transmission. In accordance 8. If the infected physician per- Bloodborne Pathogens has developed with CDC guidelines, persons forms, on a routine or emer- the following policy to assist members who are HBsAg-positive but gency basis, invasive proce- in addressing these complex concerns HBeAg-negative need not be dures that may constitute a with local hospital boards and other restricted from performing risk to patients, his/her case regulatory bodies should the need procedures unless they have will be referred to a local re- arise. The policy has been reviewed by been proven to be associated view panel formed to deal representatives of the Association of with HBV transmission (6) or with his/her particular situa- Vascular and Interventional Radiogra- they have exudative or weep- tion. The institution’s Medical phers and the American Radiologic ing skin lesions that could Director, or other person in Nurses Association, and incorporates come in contact with patients similar position of authority, some features of the AMA policy (49), or equipment used on pa- shall be responsible for form- as well as some from other sources. It tients. Whether physicians ing the review panel. As rec- must be stressed that all available ev- who are HBeAg-positive ommended by the CDC (52) idence suggests that the risk of blood- should be restricted from per- and AMA (49), members of borne pathogen transmission from forming invasive procedures this panel might include an health care workers to patients during should be determined on a infectious disease specialist interventional radiology procedures is case-by-case basis after review with expertise in the epidemi-
S382 • Guidelines Regarding HIV and Other Bloodborne Pathogens September 2003 JVIR ology of bloodborne pathogen a health care worker’s HIV appropriate review and oppor- transmission, a state or local serostatus does little, if any- tunity for appeal. health department representa- thing, to enhance the patient’s tive, the infected physician’s safety. It inflates the risk of CONCLUSIONS personal physician, another HIV transmission out of pro- physician from the infected portion to other risks and is From the presented material, it can individual’s department who inconsistent with the princi- readily be seen that our knowledge performs the same type of ples and practice of informed about transmission of bloodborne procedures, if the infected consent” (50). pathogens is incomplete, and that physician consents to this per- 11. The infected physician may some risk is unavoidable in the prac- son being informed of his/her appeal the review panel’s de- tice of interventional radiology. Given condition, the infected physi- cisions within 7 days, and the currently available information, how- cian, the chair or director of review panel will meet again ever, we believe that this risk is very the infected physician’s de- within 4 business days of such low indeed, both from health care partment, or a hospital admin- appeal. worker to patient and vice versa. Cur- istrator. 12. Institutions should establish rent data indicate that the risk of 9. Except under unusual circum- policies on how to deal with pathogen transmission from patient to stances, to be determined by incidents in which patients health care worker is very low, and the institution’s Medical Direc- may have been exposed to that the risk from health care worker tor, the infected physician blood or OPIM from physi- to patient is extremely low. With use shall cease performing inva- cians. Such policies should of appropriate precautions and protec- sive procedures until the re- include notification of the pa- tive equipment and compliance with view panel meets, which must tient’s primary care provider exposure control regulations, these occur within 4 business days and self-reporting of the inci- risks can be reduced even further. It is after the Medical Director has dent to the infection control or most appropriate for each case of an been notified that the physi- occupational health program infected health care worker to be eval- cian is infected. (or the review panel if the uated individually, by people familiar 10. The review panel will consider physician is known to be in- with the skills, experience, and medi- what is known about risk to fected with a bloodborne cal condition of the infected practitio- patients for the procedures pathogen). If the source physi- ner and with the nature of the invasive performed by the infected cian is not known to be so in- procedures he or she performs. We do physician, as well as his/her fected, he/she is ethically obli- not believe that mandatory HIV test- individual experience, ability, gated to undergo testing for ing of all health care workers and/or and health status. The review HIV, HBV, and HCV. The ex- patients would achieve the goal of pre- panel may prohibit him/her posed patient should be told venting transmission of the virus in from performing those proce- promptly that he/she may the health care setting, nor is it feasible dures deemed to pose unac- have been exposed, but should in the current financial, legal, and so- ceptably high risk to patients. not be given the source physi- cial climate. The committee may allow cian’s name or told the precise We hope the policy set out in this him/her to continue perform- circumstances of the possible document provides guidance to SIR ing procedures that are be- exposure. He/she should be members and others who practice in lieved to not pose substantial notified of the source’s blood related fields. It is not meant to be risk to patients. If required by test results, and should receive immutable, but will be reviewed and state law, the physician must counseling and postexposure updated as more information becomes inform patients of his/her in- prophylaxis as indicated. The known, and therefore should remain a fection with HIV, HBV, or patient should be asked to useful tool for members of the SIR and HCV, and the fact that the consent to baseline blood test- all practitioners of interventional radi- procedure may pose a risk of ing, or storage of baseline se- ology well into the future. transmission. Written in- rum if testing is refused, and formed consent to such risk his/her primary care provider shall be obtained. Otherwise, should be informed. If both APPENDIX disclosure is not required. As testing and serum storage are Document Development and stated by the National Com- refused, the patient should Approval Process mission on AIDS in 1992, sign a written statement docu- “. . . a blanket policy of disclo- menting this. This document was developed by sure of health care providers’ 13. Refusal to abide by the recom- the Bloodborne Pathogen Subcommit- HIV status to patients not only mendations of the review tee of the SIR with assistance from the would fail to make the health panel may result in suspen- Technology Assessment Committee. care workplace any safer, it sion of medical staff privi- Consensus on its major provisions was would also have a deleterious leges, as mandated by the in- obtained by using a modified Delphi impact on access to health stitutional Medical Director or polling method (61); three rounds of care. Mandatory disclosure of Credentials Committee, after polling were conducted and consen-
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