ANZ J. Surg.

2007; 77: 8083

doi: 10.1111/j.1445-2197.2006.03560.x

SURGICAL RESEARCH

EFFECT OF RE-STERILIZATION OF SURGICAL SUTURES BY ETHYLENE OXIDE

PREM ANAND NAGARAJA AND DEVI SHETTY
Narayana Hrudayalaya, Bommasandra Industrial Area, Anekal Taluk, Bangalore, Karnataka, India
Background: Surgical suture packs are opened (and external packaging removed) on the operating table prior to surgery. Some of these suture packs may not be used in the surgery for reasons of inappropriateness or change in the surgical technique or following accidental contact with a non-sterile surface. These unused sutures with their foil packs still unopened are sometimes re-sterilized using ethylene oxide to allow for reuse. This re-sterilization of unopened suture packs can be contentious, due to legislation and health regulations in developed countries. The purpose of the present paper was to measure the effect of such repeated gas sterilization on sutures. Methods: The knot tensile strength was measured for new sterile sutures and ethylene oxide re-sterilized sutures. The tests were conducted on two available brands of sutures, including both absorbable and non-absorbable synthetic sutures. Results: No statistically significant difference was observed in the tensile strengths between the two sets of sutures, before and after re-sterilization. Some foil packs showed slight crimping after re-sterilization, but remained intact. No humidity was observed inside the foil packs. Conclusions: Re-sterilization of unused suture foil packs can be carried out without loss of tensile strength. Key words: knot tensile strength, re-sterilization, surgical sutures.

INTRODUCTION
Surgical sutures are available with two layers of packaging: an outer paperplastic layer that maintains sterility and an inner foil pack that acts as a moisture barrier. Surgical suture packs are labelled for single use only. However, more often than not, the outer packaging is removed but the foil pack is not opened for various reasons. It may happen that the surgical procedure planned may be changed in the course of the surgery, which may require a different suture material or an altogether different size. Unused suture foil packs may accidentally contact a nonsterile area in the surgical field or may be dropped on the floor, rendering it unsuitable for use. These sutures are re-sterilized for reuse, using activated glutaraldehyde or ethylene oxide. Absorbable sutures are made of polyglactin or polyglycolic acid while non-absorbable sutures are made of polyester or polypropylene. We have attempted to study the effect of ethylene oxide re-sterilization on the mechanical properties of these polymers. Knot tensile strength was determined for all these types of sutures. The re-use of re-sterilized sutures is not an accepted practice in developed countries following strict health regulations. Ethical issues and extensive monitoring for dependable quality of resterilization make it contentious to implement such methodology. However, in the developing countries it remains an accepted practice to re-sterilize unopened suture packs. This could be the

fallout of financial and managerial issues connected with material management.

METHODS
Twenty non-absorbable and 15 absorbable suture types being used at Narayana Hrudayalaya, Bangalore, were chosen for testing. Two commercial brands of sutures were tested. Ten of the nonabsorbable suture types were from Johnson & Johnson (brand A; Ethicon, Johnson & Johnson, Mumbai, India) while the remaining 10 were from Centenial (brand B; Centenial Surgical Suture, Murbad, Mumbai). Eight of the absorbable sutures were from Centenial (brand B) and the remaining seven from Johnson & Johnson (brand A). The details of the sutures chosen for testing are given in Table 1. Two numbers of each suture type were procured for the testing. The outer packaging of one of each suture type was opened to simulate an in-use situation, and the sealed inner foil pouch was repacked in paper-plastic packaging. These repacked sutures were sterilized using 100% ethylene oxide in a Sterivac 8XL (3M, USA). The process of re-sterilization was carried out in the institutes own Central Sterile Supplies Department. The sutures were subjected to a 3-h exposure and 12-h aeration at 37C. All the suture packs, including the original and re-sterilized, were inspected for intactness of the packaging and integrity of the foil packs. The tensile strength testing of the re-sterilized sutures was out-sourced. The knot tensile strength testing was performed at a laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories, New Delhi. The testing was performed according to American Society for Testing and Materials D 412 standard test procedure.1 The rate of loading used was 60 mm/min. The end-point considered was a break in the suture. Two readings of ultimate load were taken for

P. A. Nagaraja MD; D. Shetty MS. Correspondence: Prem Anand Nagaraja, Narayana Hrudayalaya, no. 258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road, Bangalore 560099, Karnataka, India. Email: [email protected] Accepted for publication 5 May 2005. 2007 Royal Australasian College of Surgeons

RE-STERILIZATION OF SURGICAL SUTURES

81

Table 1. Type of sutures, sizes and the manufacturer No 1 2 3 4 5 6 7 Suture Size 20, 30, 40, 50 20, 40, 50, 60, 70, 80 20, 40, 50, 60, 70, 80 20, 30, 40 10, 20, 30 10, 20, 30 00, 10, 20, 30, 50, 60 Material PO, silicone coated PP, monofilament PP, monofilament PO, green PGA PGA, undyed PG Nature Non-absorbable Non-absorbable Non-absorbable Non-absorbable Absorbable Absorbable Absorbable Company Centenial Centenial Johnson & Johnson Johnson & Johnson Centenial Centenial Johnson & Johnson

PG, polyglactin; PGA, polyglycolic acid; PO, polyester; PP, polypropylene.

Table 2. Results of tensile strength testing No. 1 2 3 4 5 6 7 8 9 10 11 12 Nature Absorbable, PG Absorbable, PGA Non-absorbable, PO Non-absorbable, PO Non-absorbable, PP Non-absorbable, PP Absorbable, PG Absorbable, PGA Non-absorbable, PO Non-absorbable, PO Non-absorbable, PP Non-absorbable, PP Brand A B A B A B A B A B A B Situation Original sutures Original sutures Original sutures Original sutures Original sutures Original sutures Re-sterilized sutures Re-sterilized sutures Re-sterilized sutures Re-sterilized sutures Re-sterilized sutures Re-sterilized sutures Range of tensile strength (kg) 1.348.8 2.87.8 1.724.6 1.23.2 0.193.8 0.173.6 1.38.8 2.68.4 1.725.0 1.043.6 0.163.8 0.163.0 Mean ultimate load (kg) 5.32 4.86 2.95 2.08 1.09 1.08 5.33 4.85 3.13 2.15 1.08 1.0

A, brand A (Johnson & Johnson); B, brand B (Centenial); O, original; PG, polyglactin; PGA, polyglycolic acid; PO, polyester; PP, polypropylene; R, re-sterilized. Methods: ASTM D 412.1 Rate of loading: 60 mm/min.

each suture. The Students t-test and Wilcoxon signed ranks tests were used to calculate statistical differences in the measured knot tensile strengths before and after re-sterilization.

DISCUSSION
Reuse of single-use devices is documented widely. The first recycled device in the USA was the haemodialysis filter, which remains the most commonly reused disposable medical device.3 The practice of recycling these filters was that patients used only their own filters and therefore, patient-to-patient transmitted infections were not an issue. This practice has become accepted worldwide, but it is not risk free. Although studies have not found death rates to be increased related to haemodialysis filter reuse, the Centers for Disease Control and Prevention has investigated 12 outbreaks of pyrogenic reactions or bacterial infections, primarily as a result of inadequate reprocessing.4 Sutures with their outer packages opened but inner packaging intact are often labelled as opened but unused devices.5 These are sometimes re-sterilized for reuse, although they are labelled for single use only. The mechanical properties of the polymers used in sutures are known to be affected by sterilization methods. The effectiveness of reprocessing procedures requires constant surveillance and validation. Tests must be performed for pyrogens, sterility, and ethylene oxide residues. Quality assurance is a key factor to ensure that the system is controlled and product integrity and safety are not compromised. Product sampling on a routine basis, as well as periodic review of the external variables (e.g. employee education, physical facility remodeling) that may affect reuse products, also must occur.6 The most obvious benefit of reprocessing is the potential for saving money. The greatest opportunity for cost savings is found in reprocessing critical devices, such as diagnostic cardiac

RESULTS
After re-sterilization no suture packs were found to be ruptured, bloated or deformed otherwise. However, some foil packs of brand A sutures showed some wrinkles, but no rupture or packaging disruption. All suture packs of brand B showed no visible changes after re-sterilization. No suture packs had de-lamination between the foil pack and the external polymer layer. All the foil packs after re-sterilization opened at the adhesive seal and did not tear across. All samples tested met the United States Pharmacopeia limits on average knot tensile strength.2 The out-of-pack mean knot tensile strengths of all the sutures increased, decreased or stayed the same after re-sterilization, in comparison to the values observed before resterilization. These changes were small and have not been observed to be significant. The overall results of tensile strength testing are depicted in Table 2. Statistical analysis was done using SPSS (version 10.0, SPSS Inc., Chicago, IL, USA) for significance of difference in tensile strength before and after re-sterilization and is depicted in Tables 3 and 4. As seen in Tables 3, 4, the difference in tensile strengths of both types of sutures from both brands before and after re-sterilization is not statistically significant. Analysis of the readings obtained from all the sutures of both the brands before and after resterilization found no statistically significant difference (Table 5).
2007 Royal Australasian College of Surgeons

82

NAGARAJA AND SHETTY

Table 3. Paired t-test analysis of tensile strengths of sutures before and after re-sterilization Paired suture samples PP_A_O vs PP_A_R PP_B_O vs PP_B_R PO_A_O vs PO_A_R PO_B_O vs PO_B_R PG_A_O vs PG_A_R PGA_B_O vs PGA_B_R d.f. 13 11 5 7 13 15 P (two-tailed) 0.835 0.249 0.140 0.307 0.845 0.906

less stringent than those used in industry and these may provide less consistent results.10

CONCLUSION
The most significant issue in evaluating a reuse programme is patient safety. The steps involved in reprocessing are numerous and complex. The process cannot be implemented casually, but must be controlled and vigorously monitored to ensure that clean and sterilized reprocessed items are used. Patient safety is paramount in all phases of reprocessing and any item that cannot be guaranteed to be free from blood, fluid, body tissues, bioburden, or other contaminants should not be included in a reprocessing programme. Health-care facilities are responsible for demonstrating that reprocessed devices continue to be safe, effective, and of a high quality.11 Loss of integrity of suture packs following re-sterilization is known to be associated with significant changes in the expected behaviour of the suture material. For some types of sutures the original expiration date is not listed on the inner suture package. If the expiration date is related to the mechanical characteristics of the suture or to the package that ensures its integrity rather than its sterility, the original date may be lost following repackaging. If the expiration date is related to an assurance of sterility, then a new expiration date should be applied. The most significant conclusion to be drawn from the present study is the observation that, as is true for other types of devices, it is not always possible to make general conclusions about the effects of re-sterilization on sutures. We, however, conclude that re-sterilization of nonabsorbable sutures may be carried out in select cases where the inner packaging is intact and the suture reused when the pack integrity is not breached after re-sterilization. The same, however, cannot be ensured in the case of absorbable sutures. It is well known that re-sterilization of items such as surgical sutures is not an accepted practice in developed countries, both by legislation and the process of hospital accreditation. However, developing countries would benefit from the present study in that valuable resources could be put to good use, lest they are wasted. Ethylene oxide is still a widely used sterilant for heat-sensitive surgical items and supplies used in patient care and are available in almost all the hospitals in developing countries. In the event that ethylene oxide may not be available, evaluation of plasma sterilization may have to be carried out on similar lines, subject to permissibility and legislation. Tensile strength is an important factor in deciding the role of sutures in maintaining good opposition of the edges of the surgical wound, thereby enabling them to heal rapidly. Loss of tensile strength in a suture would lead to premature wound dehiscence and failure to heal. Other factors such as rate of dissolution and altered chemical nature were not studied in the present project.

A, brand A (Johnson & Johnson); B, brand B (Centenial); O, original; PG, polyglactin; PGA, polyglycolic acid; PO, polyester; PP, polypropylene; R, re-sterilized.

catheters, forceps, and orthopaedic burrs.7 However, expensive disposables such as sutures also contribute to effective utilization of financial resources, more so in developing countries. An article published in 2002 documented breaches in the integrity of packs, puffier or wrinkled packs, de-lamination and some instances of tearing across packs while being opened after resterilization.8 In the present study some of the foil packs of a particular brand were observed to be lightly crimped, but with no damage to the overall integrity or any change in behavioural characters of the suture packs. A key mechanical assessment is the tensile test, which measures the force required to stretch a device for a range of extensions. Other tests for reprocessed single-use items include measures of hardness, torsional rigidity and flexibility, fatigue, electrical conductivity, and leaks (for balloons). Subjective measurements include visual inspection and observation with a low-power microscope. Health-care workers should keep in mind that it may be difficult to simulate in an experimental situation the various stresses that a device is exposed to in a clinical environment.6 No statistically significant difference was observed in the mean knot tensile strengths of all the sutures before and after resterilization. Woods et al. documented differences in tensile strength concurrent with changes in the pack integrity, but these differences were not statistically significant.8 Loss of seal integrity might not cause an initial strength loss. However, in the case of all absorbable sutures having the inner seal destroyed during repackaging, exposure to increased humidity for an extended time will cause suture degradation. This can lead to a loss of strength after shelf ageing, and a loss of strength and possible changes in the degradation behaviour after clinical use. These changes in the suture material could result in wound dehiscence or other complications. Changes in suture strengths are associated with hydrolysis of the suture polymer following exposure to moisture.9 This happens following loss of integrity of absorbable sutures, as reported by Woods et al.8 The concept of reprocessing and related protocols in standard health-care facilities and third-party reprocessors are generally

Table 4. Wilcoxon signed ranks test PP_A_R vs PP_A_O Z Asymp. P (two tailed) 1.783 0.075 PP_B_R vs PP_B_O 0.153 0.878 PO_A_R vs PO_A_O 1.604 0.109 PO_B_R vs PO_B_O 1.185 0.236 PG_A_R vs PG_A_O 0.788 0.431 PGA_B_R vs PGA_B_O 0.000 1.000

A, brand A (Johnson & Johnson); B, brand B (Centenial); O, original; PG, polyglactin; PGA, polyglycolic acid; PO, polyester; PP, polypropylene; R, re-sterilized. Based on positive ranks; based on negative ranks; sum of negative ranks equals sum of positive ranks. 2007 Royal Australasian College of Surgeons

RE-STERILIZATION OF SURGICAL SUTURES

83

Table 5. Analysis of tensile strengths of all sutures before and after re-sterilization Original vs re-sterilized Paired d.f. 69 P (two-tailed) 0.782 sample test Wilcoxon Z 0.802 Asymptotic P (two-tailed) 0.422 signed ranks test
Based on negative ranks.

ACKNOWLEDGEMENTS
We wish to thank Cosmic Industrial Laboratories, Electronics City, Bangalore for their help in testing the tensile strength of suture materials.

REFERENCES
1. American National Standards Institute. Standard Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension. Document Number: ASTM D41298a(2002)e1. ANSI: ASTM International, 2002. 2. The United States Pharmacopeial Convention. USP 24-Nf 19 Supplement 2. Rockville, MD: The United States Pharmacopeial Convention, July 1, 2000; 2859.

3. Gibson NK. The Reuse of Single-Use Medical Devices. Guidelines for Healthcare Facilities, Canadian Healthcare Association. Debate on reuse of disposable medical equipment fueled by FDA. J. Clin. Monit. 1998; 14: 75. 4. Schultz JK. Reservations are voiced about the reuse of single-use items. OR Manager 1997; 13: 17. 5. Spears LD. Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals. Guidance for Industry and for FDA Staff. US Department of Health and Human Services, US Food and Drug Administration, Center for Devices and Radiological Health, Division of Enforcement III, Office of Compliance, 2000. 6. Reichert M. Reuse of disposables: choice to reuse disposables requires factual assessment. OR Manager 1996; 12: 89. 7. Radford R. Reprocessing single-use devices: choosing a thirdparty reprocessor for a given single-use device. Infect. Control Today 2001; 5: 279. 8. Woods TO, Brown SA, Merritt K, McNamee S, Hitchins V. Effects of repeated ethylene oxide sterilization on synthetic absorbable sutures. User Facility Reporting Bulletin. US Food and Drug Administration, Center for Devices and Radiological Health, Division of Enforcement III, Office of Compliance, 2002. 9. Middleton JC, Tipton AJ. Synthetic biodegradable polymers as medical devices. Med. Plast. Biomaterials 1998; 5: 309. 10. ECRI. Special Report. Reuse of Single-Use Medical Devices: Making Informed Decisions. Plymouth Meeting, Pa: ECRI. 1997. 11. Dunn D. Reprocessing single-use devices: equipment connection. AORN J. 2002; 75: 114358.

2007 Royal Australasian College of Surgeons