Infection Rates after Periocular Surgery Utilizing New versus Re-Processed Monopolar Electrocautery

Abstract

Background:

To determine if there is a difference in periocular post-operative infection rates when utilizing new versus re-processed monopolar electrocautery tips.

Methods:

Retrospective cohort study of 4,976 consecutive surgical cases involving 17,149 procedures. Post-operative infections were identified using chart review, facility infection surveillance records, and surgeon reporting. The main outcome measure was the presence or absence of infection within 30 post-operative days. The Fischer exact test was used to compare infection rates between cautery modalities. All statistical analysis was conducted at the 0.05 α level.

Results:

There was no statistically significant difference between new and re-processed monopolar cautery infection rates (p=0.3879).

Conclusions:

Post-operative infection rates are similar for periocular surgery using both new and re-processed monopolar cautery. These findings suggest that re-processed cautery is a viable option for periocular surgery to decrease cost and reduce material waste without affecting the quality of care.

The future of health care delivery will stress not only doing “more with less,” but also producing better outcomes. Periorbital surgery is performed commonly for functional and cosmetic defects. The majority of these procedures are performed on an outpatient basis in accredited surgical centers (ASCs). Unlike the hospital setting, this places the burden of materiel cost on the surgeon. Therefore, it is important to control this cost while not affecting the quality of care.

The periocular area has a robust, highly anastomotic vascular supply that allows for a reduced infection rate compared with other surgical sites [1]. The National Nosocomial Infections Surveillance system reported a post-operative infection rate of approximately 2% for all surgery types from 1990 to 2002 [2]. By contrast, studies examining specific, common periocular procedures place the infection rate between 0.04% and 0.4% [3,4]. Despite these favorable statistics, serious infections can occur involving atypical mycobacteria, Staphylococcus aureus, and group A beta-hemolytic Streptococcus necrotizing fasciitis [5 –11]. The previously cited studies detailing infection rates in blepharoplasty did not mention the type of cautery modality utilized.

In 2000, the U.S. Food and Drug Administration (FDA) released guidelines for regulation of single-use devices, such as electrocautery tips [12]. These regulations stated that hospitals and third-party re-processors would need to produce sterilized equipment that met the same standards as devices that are new from the manufacturer. Several studies have demonstrated the safety of re-processed single-use devices with the benefit of substantial cost savings [13 –15].

During periocular surgery, surgeons can choose multiple cautery modes, with electric monopolar and bipolar cautery being used most frequently. Monopolar cautery was introduced in the twentieth century, replacing the technique of applying heated rods to bleeding tissue to produce hemostasis. Typically, monopolar cautery hand pieces and tips are disposed of after each surgical case, but certain monopolar tips can be re-used with proper sterilization procedures. Re-processed tips can be obtained either through an outside vendor or sterilized with other surgical instruments in a facility's autoclave. Although the utilization of re-processed tips can lead to cost savings, no studies have evaluated their safety profile.

Patients and Methods

A retrospective, chart review of consecutive periocular surgical cases was performed with exempt Institutional Review Board approval according to Title 45 of the Code of Federal Regulations (45 CFR 46.101[b][4]). Cases were performed at hospitals, ASCs, office treatment rooms, and emergency departments at 19 different sites. Intra-operative antibiotics were used only for trauma cases treated in a hospital setting. All patients in this study were given topical antibiotic ointment for 1 to 4 wks after surgery. There were 2,284 cases in which post-operative oral antibiotics were utilized, consisting of cephalexin 250 mg orally four times a day for 1 wk or erythromycin 250 mg four times a day for 1 wk for patients with a penicillin allergy.

The practice database was queried for 46 unique Current Procedural Terminology (CPT) codes, resulting in 17,149 periocular procedures in which cautery was used (Table 1). Because multiple procedures (CPT codes) were often performed in a single case, patient identifiers were used to filter the output to 4,976 unique cases, with 42% of the cases involving a bilateral component. One of two cautery modalities were used by all surgeons in this study: monopolar cautery with a new Colorado needle tip (Stryker, Kalamazoo, MI) or a reprocessed Colorado needle tip. The needle tips were sterilized using Steris pre-vacuum steam autoclaves (Steris, Mentor, OH). The standardized sterilization protocol consisted of a pre-vacuum cycle of 5 min exposure and 30 min dry time at 270°F and 30 pounds per square inch steam pressure.

Table 1.

Current Procedural Terminology Codes Utilized for Data Collection

15820-15821: Blepharoplasty, lower eyelid	364
15822-15823: Blepharoplasty, upper eyelid	4,156
21172: Reconstruction superior-lateral orbital rim and lower forehead	7
21280,21282: Medial or lateral canthopexy	82
21390: Open treatment of orbital floor blowout fracture	58
67400,67445: Orbitotomy	157
67710: Severing of tarsorrhaphy	13
67715: Canthotomy	2
67810: Biopsy of eyelid	176
67830: Correction of trichiasis; incision of lid margin	9
67840: Excision of lesion of eyelid (except chalazion)	2,648
67875: Temporary closure of eyelids by suture (e.g., Frost suture)	601
67880,67882: Construction of intermarginal adhesions, median tarsorrhaphy, or canthorrhaphy	75
67900: Repair of brow ptosis (includes endoscopic approach–15824)	746
67901,67903,67904,67908: Repair of blepharoptosis	3,679
67909: Reduction of overcorrection of ptosis	87
67911,67912: Correction of lid retraction	501
67917: Repair of ectropion	626
67921,67923,67924: Repair of entropion	473
67930,67935: Suture of recent eyelid wound	74
67950: Canthoplasty	984
67961,67966: Excision and repair of eyelid	418
67971,67973,67974,67975: Reconstruction of eyelid	212
68320,68325,68326,68328: Conjunctivoplasty	990
68330,68340: Repair of symblepharon	11
Total	17,149

Post-operative infections were identified by querying the patient database using the International Classification of Diseases, 9th revision, (ICD-9 Clinical Modification CM) [16] diagnosis codes for eyelid and periorbital cellulitis, abscess, and infection (codes 373.13 and 376.01). The query was conducted independent of CPT codes to ensure no infections were missed because of code linking. Hospital and ASC infection surveillance records and physician reporting were also used to detect any additional cases not captured by the database search. In total, 155 potential post-operative infections were identified. Manual chart review was performed for these cases to determine if an infection occurred within a 30-d post-operative period and that monopolar cautery was utilized. Fisher exact test was utilized to determine if there was any statistically significant difference in the occurrence of post-operative infections between new versus re-processed cautery tips. The study power level was calculated using G*Power version 3.1.7 (Heinrich Heine Universität Düsseldorf, Düsseldorf, Germany). Statistical analysis was done with Prism 5 (GraphPad Software, San Diego, CA). Statistical testing was conducted at the 0.05 α level, with two-tailed p values. Post-hoc power analysis showed a power level of 100%.

Results

There were 155 potential cases of post-operative infection identified. After manual chart review, only one patient had a post-operative infection after monopolar cautery was used. The remaining 154 cases did not have an infection within 30 d post-operatively, were misidentified because of a coding error, or had an operation in which bipolar cautery was used instead of monopolar. The confirmed case of post-operative infection resulted in pre-septal cellulitis approximately 2 wks after an anterior orbitotomy with bony window.

Table 2 illustrates the distribution of surgical cases among the cautery groups. The results demonstrate that there was no statistically significant difference between infection rates of new and re-processed cautery tips (p=0.3879). Table 2 also illustrates the low overall post-operative infection rate (0.02%) in this data set, ranging from zero with re-processed monopolar cautery tips to 0.05% with new monopolar cautery tips. The cases comprising the re-processed monopolar group involved post-operative oral antibiotic use in a majority of the cases (75%). When adjusting for this variable there was still no significant clinical or statistical difference (Table 3, p=1.0).

Table 2.

Total Number of Surgical Cases and Infection Rate by Cautery Type Used

	Number of cases	Infection rate	p
New	1,930	0.05%
Re-processed	3,046	0%	0.3879
Total	4,976	0.02%

Fisher exact test p value is shown for the comparison of new versus reprocessed.

Table 3.

Comparison of Cases not Involving the Use of Post-Operative Oral Antibiotic Therapy

	Number of cases	Infection rate	p
New	1,930	0.05%
Re-processed	762	0%	1.0
Total	2,692	0.03%

Fisher exact test p value is shown for the comparison of new versus reprocessed.

Discussion

This study shows a low overall infection rate (0.02%) for all periocular procedures independent of cautery type. It further confirms prior reports of low infection rates after specific periocular procedures, such as blepharoplasty. The post-operative infection rate for monopolar re-processed cautery (zero) in this study was lower than infection rates reported previously and involved a larger sample size of patients (Tables 2 and 3). However, because previous studies did not differentiate between new and re-processed tips when reporting infection rates, comparisons can only be made on the overall infection rate.

Cautery use in general increases the occurrence of post-operative infections [17]. The intriguing result in this study was that re-processed monopolar cautery had a lower infection rate than new monopolar cautery. An explanation for this finding—other than a lower infection rate for this body area—is elusive because the large sample size and 100% study power lends credance to the results. The use of post-operative oral antibiotics in the majority of reprocessed cases (75%) could potentially account for the reduced infection rate, but no infections occurred either in the 754 cases in which antibiotics were not used.

The small number of post-operative infections in periocular procedures presents an inherent limitation to this study. This limitation is offset by the large sample size, diversity of facilities, and multiple surgeons. The post-operative infection identified in this series may have been influenced by surgeon technique, surgical setting, or procedure type.

The utilization of electrocautery can provide substantial cost savings without affecting the quality of care. Reprocessed monopolar cautery tips can be “manufactured” in-house via a facility's autoclave, or purchased from outside vendors. Cost estimates for Colorado needle tips are $50 for a new tip and $25 for a re-processed tip from a certified vendor. Alternatively, tips can be re-processed in-house for approximately $3 via a surgical facility's autoclave. The utilization of reprocessed tips in this study saved approximately $143,350.

Periocular surgery has a low post-operative infection rate that is independent of utilizing new or re-processed monopolar cautery tips. The study demonstrated no statistically significant difference in post-operative infection rates of new and re-processed monopolar cautery tips. The results support the safe use of re-processed Colorado needle tips for periocular surgery to aid in cost savings for patients, providers, and facilities. The cost and refuse reduction did not affect the quality of care delivery as evidence by post-operative infection rate. This study further adds to the growing body of evidence that certain single-use medical devices are safe and cost effective to reuse when sterilized and monitored properly.

Footnotes

Author Disclosure Statement

No competing financial interests exist.

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