526850
research-article2014
AORXXX10.1177/0003489414526850Annals of Otology, Rhinology & LaryngologyGuidi et al
Article
Risk of Otitis Externa Following Manual Cerumen Removal
Annals of Otology, Rhinology & Laryngology 2014, Vol. 123(7) 482–484 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0003489414526850 aor.sagepub.com
Jessica L. Guidi, BS1, Ralph F. Wetmore, MD1,2, and Steven E. Sobol, MD, MSc1,2
Abstract Objectives: Based on an interpretation of a recent Joint Commission protocol to sterilize instruments coming into contact with mucous membranes, there has been institutional interest in sterile packaging of cerumen curettes used for manual cerumen removal. To date, there are no studies that have assessed the risk of otitis externa (OE) following cerumen removal and the utility of sterile packaging is questionable. The objective of this study is to assess the incidence of OE following cerumen disimpaction prior to the implementation of sterile packaging at our institution. Methods: This was a retrospective chart review. Over a 1-year period, 1457 episodes of manual cerumen removal took place in the otolaryngology clinic. Charts were assessed for signs or symptoms of OE within 2 weeks of the procedure through follow-up phone calls and clinic visits in the otolaryngology division. Results: There were no patients who followed up with symptoms or signs suggestive of OE in the 2-week postprocedure period. Conclusion: There is no evidence that OE is a complication of manual cerumen removal when performed by otolaryngologists using clean technique. Unnecessary sterilization of tools leads to increased cost and time for this common outpatient procedure performed by the otolaryngologist. Keywords cerumen removal, otitis externa, sterilization Cerumen impaction is a common complaint in primary care and otolaryngology settings. While it can affect all age groups, it occurs at a higher frequency in children, geriatric, and cognitively impaired populations.1 Though often asymptomatic, cerumen impaction can lead to hearing loss, ear pain and fullness, itching, dizziness, tinnitus, and chronic cough.2 It can also prevent diagnostic assessment of the external auditory canal and tympanic membrane.3 There are several methods commonly used to manage cerumen impaction. Choice of method depends on experience, equipment, and patient factors including cooperation, otologic anatomy, and immune status.3 Manual removal is 1 such method and can be performed under direct visualization using curettes, spoons, forceps, right-angled hooks, or suction.2,3 This method is quick, is effective, and does not introduce moisture into the ear canal, a known risk factor for otitis externa. Though generally safe, there are complications associated with manual cerumen removal including ear canal laceration, tympanic membrane perforation, and pain during the procedure.1,3 Otitis externa is often cited as a potential complication of cerumen removal. However, in our literature search, sources linking infection to cerumen removal referred to cases in which irrigation was performed or the methodology was not specified.1,3-7
At our institution, cerumen removal has traditionally been performed in the outpatient setting using clean, but not sterile technique. There is a recent Joint Commission protocol mandating sterilization of instruments that come into contact with mucous membranes. Based on an institutional interpretation of this guideline, there has recently been interest at our hospital in sterile packaging of the instruments used for manual cerumen removal to limit the risk of infection. The utility and cost of sterilization has not been previously studied. The objective of this study is to assess the incidence of OE following cerumen disimpaction prior to the implementation of sterile packaging at our institution. We hypothesize
1
Division of Otolaryngology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA 2 Department of Otorhinolaryngology–Head and Neck Surgery, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA Corresponding Author: Steven E. Sobol, MD, MSc, Division of Otolaryngology, The Children’s Hospital of Philadelphia, 34th St & Civic Center Blvd, 1 Wood Center, Philadelphia, PA 19104, USA. Email: [email protected]
Downloaded from aor.sagepub.com at FRESNO PACIFIC UNIV on January 18, 2015
483
Guidi et al that cerumen removal using clean technique does not put the patient at a clinically significant risk of OE.
Methods After obtaining approval from the Committees for the Protection of Human Subjects, a retrospective chart review was performed on all children (0-18 years), with a diagnosis of “cerumen impaction” who were evaluated in the Otolaryngology Division at the Children’s Hospital of Philadelphia between January 2011 and January 2012. Indications for cerumen removal included hearing loss or inability to visualize the external auditory canal and/or tympanic membrane secondary to cerumen impaction. Charts were reviewed to ensure manual cerumen removal occurred in clinic. Manual cerumen removal was performed by otolaryngologists under direct visualization using an operating microscope or LumiView magnification (Welch Allyn, Skaneateles Falls, New York, USA). Cerumen was debrided with a curette using clean technique until the ear canal was clear or until the provider felt it was no longer safe to proceed due to lack of patient cooperation or a severe impaction. At our institution, all patient encounters, including phone calls, are tracked through the patient’s electronic medical record. Any follow-up phone calls or clinic visits within 2 weeks of the procedure were reviewed for symptoms or physical exam findings of OE. Patients were excluded from analysis if they did not undergo the manual cerumen removal procedure in clinic or if there was a diagnosis of active OE at the time of the original procedure.
Results Over the study period, there were 1536 outpatient manual cerumen removal procedures performed. Seventy-nine of these episodes were excluded from analysis due to active OE at the time of the procedure, leaving 1457 episodes of cerumen removal in 1253 patients. The number of procedures per patient ranged from 1 to 5 (mean 1.2 procedures per patient). Patients’ age ranged from 2 months to 18 years (median 5.5 years). There were 697 males (55.6%) and 556 females (44.4%). There were no episodes of otitis externa within the 2-week postprocedural period (0% incidence).
Discussion Otitis externa is cited as a possible complication following cerumen removal.1,3-7 A clinical practice guideline for cerumen impaction published by Roland et al3 notes that both cerumenolytics and irrigation carry risk of infection and should not be utilized in patients with active OE. The authors state that manual removal is rarely associated with infection. A survey of 289 general practitioners published
by Sharp et al4 revealed that OE was a common complication following cerumen removal. Within this survey population, 95% of responders utilized syringing and 4% used instrumentation. The article did not stratify cases of OE by which procedure was utilized, so it is unclear if infection occurred following manual cerumen removal. Malignant otitis externa has also been described following cerumen removal in rare, typically immunosuppressed, cases, but both articles specify irrigation, rather than manual cerumen removal, as a risk factor.5,6 In our study, there were no episodes (0% incidence) of otitis externa within 2 weeks of cerumen removal using clean technique in more than 1400 patients, suggesting that sterilization is unnecessary to prevent postprocedural infection. However, our study has several limitations that are worth noting. One limitation of our study is that the study group only included patients in whom a diagnosis code of “cerumen impaction” was used. In our practice, we see approximately 35 000 patients annually; based on the senior author’s experience in an average clinic, it is estimated that cerumen curettes are used for debridement in 25%, or 9000, of these cases to adequately evaluate the tympanic membrane. Therefore, our query using the ICD-9 code for “cerumen impaction” identified only a minority of our total patients who likely underwent this procedure during the study period. However, patients given this diagnosis code are typically the more technically challenging removals and would be the most likely to have otitis externa as a complication. An additional limitation of this study concerns instances of high-risk cerumen removals in which postprocedural OE may be more likely, for example immunosuppressed patients or cases of traumatic cerumen removal. In our chart review, we did not keep track of how many high-risk procedures took place over the study period. However, since we did not exclude patients from our study based on their risk of developing OE, we still feel that using clean technique in cases of high-risk cerumen removal is safe, but this may require future investigation. Another limitation of our study is that OE episodes were tracked only within our division. Therefore, it is possible that we missed cases of postprocedural OE that presented to an outside emergency room or to the primary care physician. Patients seen in our clinic are strongly encouraged to follow up directly with our division if they have any earrelated complaints following a procedure and our nursing and house staff are available at all hours. Given this easy accessibility, we believe that this limitation is not likely to be significant. Sterilization of the tools used for manual cerumen removal comes at an additional expense, both in money and in time, for the patient and provider. Sterile processing requires that instruments are marked in a way to identify otolaryngology division ownership ($4.00/curette), transportation to and from the sterilization site (unknown cost),
Downloaded from aor.sagepub.com at FRESNO PACIFIC UNIV on January 18, 2015
484
Annals of Otology, Rhinology & Laryngology 123(7)
and packaging following sterilization ($7.00/curette). Based on our prediction that 25% of the annual 35 000 patients seen in clinic require cerumen removal using a curette, we estimate that the annual cost of the sterilization process for wax curettes in our division is approximately $70 000 to $80 000. The cost of sanitizing curettes to achieve clean technique is negligible as this task was previously performed by existing technical staff in the division. Given the current national push for cost containment and evidence-based protocols, we conclude that the cost of sterilization of cerumen curettes for outpatient use is not justified and that clean technique is a safe and cost-effective means of cerumen removal. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References 1. Guest JF, Greener MJ, Robinson AC, Smith AF. Impacted cerumen: composition, production, epidemiology and management. Q J Med. 2004;97:477-488. 2. McCarter DF, Courtney AU, Pollart SM. Cerumen impaction. Am Fam Physician. 2007;75:1523-1528. 3. Roland PS, Smith TL, Schwartz SR, et al. Clinical practice guideline: cerumen impaction. Otolaryngol Head Neck Surg. 2008;139:S1-S21. 4. Sharp JF, Wilson JA, Ross L, Barr-Hamilton RM. Ear wax removal: a survey of current practice. BMJ. 1990;301:12511253. 5. Zikk D, Rapoport Y, Himelfarb MZ. Invasive external otitis after removal of impacted cerumen by irrigation. N Engl J Med. 1991;325:969-970. 6. Grandis JR, Branstetter BF, Yu VL. The changing face of malignant (necrotising) external otitis: clinical, radiological, and anatomic correlations. Lancet Infect Dis. 2004;4:34-39. 7. Nussinovitch M, Rimon A, Volovitz B, Raveh E, Prais D, Amir J. Cotton-tip applicators as a leading cause of otitis externa. Int J Pediatr Otorhinolaryngol. 2004;68:433-435.
Downloaded from aor.sagepub.com at FRESNO PACIFIC UNIV on January 18, 2015
research-article2014
AORXXX10.1177/0003489414526850Annals of Otology, Rhinology & LaryngologyGuidi et al
Article
Risk of Otitis Externa Following Manual Cerumen Removal
Annals of Otology, Rhinology & Laryngology 2014, Vol. 123(7) 482–484 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0003489414526850 aor.sagepub.com
Jessica L. Guidi, BS1, Ralph F. Wetmore, MD1,2, and Steven E. Sobol, MD, MSc1,2
Abstract Objectives: Based on an interpretation of a recent Joint Commission protocol to sterilize instruments coming into contact with mucous membranes, there has been institutional interest in sterile packaging of cerumen curettes used for manual cerumen removal. To date, there are no studies that have assessed the risk of otitis externa (OE) following cerumen removal and the utility of sterile packaging is questionable. The objective of this study is to assess the incidence of OE following cerumen disimpaction prior to the implementation of sterile packaging at our institution. Methods: This was a retrospective chart review. Over a 1-year period, 1457 episodes of manual cerumen removal took place in the otolaryngology clinic. Charts were assessed for signs or symptoms of OE within 2 weeks of the procedure through follow-up phone calls and clinic visits in the otolaryngology division. Results: There were no patients who followed up with symptoms or signs suggestive of OE in the 2-week postprocedure period. Conclusion: There is no evidence that OE is a complication of manual cerumen removal when performed by otolaryngologists using clean technique. Unnecessary sterilization of tools leads to increased cost and time for this common outpatient procedure performed by the otolaryngologist. Keywords cerumen removal, otitis externa, sterilization Cerumen impaction is a common complaint in primary care and otolaryngology settings. While it can affect all age groups, it occurs at a higher frequency in children, geriatric, and cognitively impaired populations.1 Though often asymptomatic, cerumen impaction can lead to hearing loss, ear pain and fullness, itching, dizziness, tinnitus, and chronic cough.2 It can also prevent diagnostic assessment of the external auditory canal and tympanic membrane.3 There are several methods commonly used to manage cerumen impaction. Choice of method depends on experience, equipment, and patient factors including cooperation, otologic anatomy, and immune status.3 Manual removal is 1 such method and can be performed under direct visualization using curettes, spoons, forceps, right-angled hooks, or suction.2,3 This method is quick, is effective, and does not introduce moisture into the ear canal, a known risk factor for otitis externa. Though generally safe, there are complications associated with manual cerumen removal including ear canal laceration, tympanic membrane perforation, and pain during the procedure.1,3 Otitis externa is often cited as a potential complication of cerumen removal. However, in our literature search, sources linking infection to cerumen removal referred to cases in which irrigation was performed or the methodology was not specified.1,3-7
At our institution, cerumen removal has traditionally been performed in the outpatient setting using clean, but not sterile technique. There is a recent Joint Commission protocol mandating sterilization of instruments that come into contact with mucous membranes. Based on an institutional interpretation of this guideline, there has recently been interest at our hospital in sterile packaging of the instruments used for manual cerumen removal to limit the risk of infection. The utility and cost of sterilization has not been previously studied. The objective of this study is to assess the incidence of OE following cerumen disimpaction prior to the implementation of sterile packaging at our institution. We hypothesize
1
Division of Otolaryngology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA 2 Department of Otorhinolaryngology–Head and Neck Surgery, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA Corresponding Author: Steven E. Sobol, MD, MSc, Division of Otolaryngology, The Children’s Hospital of Philadelphia, 34th St & Civic Center Blvd, 1 Wood Center, Philadelphia, PA 19104, USA. Email: [email protected]
Downloaded from aor.sagepub.com at FRESNO PACIFIC UNIV on January 18, 2015
483
Guidi et al that cerumen removal using clean technique does not put the patient at a clinically significant risk of OE.
Methods After obtaining approval from the Committees for the Protection of Human Subjects, a retrospective chart review was performed on all children (0-18 years), with a diagnosis of “cerumen impaction” who were evaluated in the Otolaryngology Division at the Children’s Hospital of Philadelphia between January 2011 and January 2012. Indications for cerumen removal included hearing loss or inability to visualize the external auditory canal and/or tympanic membrane secondary to cerumen impaction. Charts were reviewed to ensure manual cerumen removal occurred in clinic. Manual cerumen removal was performed by otolaryngologists under direct visualization using an operating microscope or LumiView magnification (Welch Allyn, Skaneateles Falls, New York, USA). Cerumen was debrided with a curette using clean technique until the ear canal was clear or until the provider felt it was no longer safe to proceed due to lack of patient cooperation or a severe impaction. At our institution, all patient encounters, including phone calls, are tracked through the patient’s electronic medical record. Any follow-up phone calls or clinic visits within 2 weeks of the procedure were reviewed for symptoms or physical exam findings of OE. Patients were excluded from analysis if they did not undergo the manual cerumen removal procedure in clinic or if there was a diagnosis of active OE at the time of the original procedure.
Results Over the study period, there were 1536 outpatient manual cerumen removal procedures performed. Seventy-nine of these episodes were excluded from analysis due to active OE at the time of the procedure, leaving 1457 episodes of cerumen removal in 1253 patients. The number of procedures per patient ranged from 1 to 5 (mean 1.2 procedures per patient). Patients’ age ranged from 2 months to 18 years (median 5.5 years). There were 697 males (55.6%) and 556 females (44.4%). There were no episodes of otitis externa within the 2-week postprocedural period (0% incidence).
Discussion Otitis externa is cited as a possible complication following cerumen removal.1,3-7 A clinical practice guideline for cerumen impaction published by Roland et al3 notes that both cerumenolytics and irrigation carry risk of infection and should not be utilized in patients with active OE. The authors state that manual removal is rarely associated with infection. A survey of 289 general practitioners published
by Sharp et al4 revealed that OE was a common complication following cerumen removal. Within this survey population, 95% of responders utilized syringing and 4% used instrumentation. The article did not stratify cases of OE by which procedure was utilized, so it is unclear if infection occurred following manual cerumen removal. Malignant otitis externa has also been described following cerumen removal in rare, typically immunosuppressed, cases, but both articles specify irrigation, rather than manual cerumen removal, as a risk factor.5,6 In our study, there were no episodes (0% incidence) of otitis externa within 2 weeks of cerumen removal using clean technique in more than 1400 patients, suggesting that sterilization is unnecessary to prevent postprocedural infection. However, our study has several limitations that are worth noting. One limitation of our study is that the study group only included patients in whom a diagnosis code of “cerumen impaction” was used. In our practice, we see approximately 35 000 patients annually; based on the senior author’s experience in an average clinic, it is estimated that cerumen curettes are used for debridement in 25%, or 9000, of these cases to adequately evaluate the tympanic membrane. Therefore, our query using the ICD-9 code for “cerumen impaction” identified only a minority of our total patients who likely underwent this procedure during the study period. However, patients given this diagnosis code are typically the more technically challenging removals and would be the most likely to have otitis externa as a complication. An additional limitation of this study concerns instances of high-risk cerumen removals in which postprocedural OE may be more likely, for example immunosuppressed patients or cases of traumatic cerumen removal. In our chart review, we did not keep track of how many high-risk procedures took place over the study period. However, since we did not exclude patients from our study based on their risk of developing OE, we still feel that using clean technique in cases of high-risk cerumen removal is safe, but this may require future investigation. Another limitation of our study is that OE episodes were tracked only within our division. Therefore, it is possible that we missed cases of postprocedural OE that presented to an outside emergency room or to the primary care physician. Patients seen in our clinic are strongly encouraged to follow up directly with our division if they have any earrelated complaints following a procedure and our nursing and house staff are available at all hours. Given this easy accessibility, we believe that this limitation is not likely to be significant. Sterilization of the tools used for manual cerumen removal comes at an additional expense, both in money and in time, for the patient and provider. Sterile processing requires that instruments are marked in a way to identify otolaryngology division ownership ($4.00/curette), transportation to and from the sterilization site (unknown cost),
Downloaded from aor.sagepub.com at FRESNO PACIFIC UNIV on January 18, 2015
484
Annals of Otology, Rhinology & Laryngology 123(7)
and packaging following sterilization ($7.00/curette). Based on our prediction that 25% of the annual 35 000 patients seen in clinic require cerumen removal using a curette, we estimate that the annual cost of the sterilization process for wax curettes in our division is approximately $70 000 to $80 000. The cost of sanitizing curettes to achieve clean technique is negligible as this task was previously performed by existing technical staff in the division. Given the current national push for cost containment and evidence-based protocols, we conclude that the cost of sterilization of cerumen curettes for outpatient use is not justified and that clean technique is a safe and cost-effective means of cerumen removal. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References 1. Guest JF, Greener MJ, Robinson AC, Smith AF. Impacted cerumen: composition, production, epidemiology and management. Q J Med. 2004;97:477-488. 2. McCarter DF, Courtney AU, Pollart SM. Cerumen impaction. Am Fam Physician. 2007;75:1523-1528. 3. Roland PS, Smith TL, Schwartz SR, et al. Clinical practice guideline: cerumen impaction. Otolaryngol Head Neck Surg. 2008;139:S1-S21. 4. Sharp JF, Wilson JA, Ross L, Barr-Hamilton RM. Ear wax removal: a survey of current practice. BMJ. 1990;301:12511253. 5. Zikk D, Rapoport Y, Himelfarb MZ. Invasive external otitis after removal of impacted cerumen by irrigation. N Engl J Med. 1991;325:969-970. 6. Grandis JR, Branstetter BF, Yu VL. The changing face of malignant (necrotising) external otitis: clinical, radiological, and anatomic correlations. Lancet Infect Dis. 2004;4:34-39. 7. Nussinovitch M, Rimon A, Volovitz B, Raveh E, Prais D, Amir J. Cotton-tip applicators as a leading cause of otitis externa. Int J Pediatr Otorhinolaryngol. 2004;68:433-435.
Downloaded from aor.sagepub.com at FRESNO PACIFIC UNIV on January 18, 2015
