Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority Bioburden on Surgical Instruments P ennsylvania hospitals have submitted a number of reports to PA-PSRS describing cases in which sterilized surgical instruments have been contami- Suture remained on tunneler. Particles of tissue were found in cannulated nated with organic material from a prior procedure— instrumentation. something healthcare workers call “bioburden.” While These cases indicate problems of quality control in most of these cases are recognized before the de- the form of failure to adequately clean and inspect vices reach the patient, in some instances these instruments before sterilization.4-7 soiled instruments have contaminated the sterile field. Adequate cleaning requires removal of all residue These occurrences put patients at risk of surgical site remaining on the instrument from previous use. Fail- infection (SSI), even if the instrument never touches ure to remove debris interferes with disinfection and the patient, because of the potential for contaminating prevents sterilization.8-11 Even sterilized foreign mate- the surgical field. Additionally, when contaminated rial left behind from a previous surgery becomes a equipment is recognized after a procedure has be- foreign body inside the patient and will stimulate the gun, precious operating time is lost, and the patient patient’s defense mechanisms to reject or wall off this experiences prolonged anesthesia while properly alien substance. Additionally, damage to instruments, sterilized equipment is obtained.1 such as corrosion, rust, or pitting, can occur from pro- Background longed contact with organic material when cleaning is Despite modern infection control practices, the inci- not thorough.1,12,13 dence of SSIs remains high. SSIs have been esti- mated as the third most frequently reported type of The level of disinfection or sterilization depends on healthcare-associated infection.2 Despite advances the intended use of the instruments. The accepted in asepsis, environmental controls, and antimicrobial gold standard is the Spaulding method (see Exhibit prophylaxis, SSIs continue to cause morbidity and 1), by which medical instruments are categorized as mortality among surgical patients. Various explana- critical, semicritical, or noncritical according to their tions include an increase in the number of frail pa- intended use. This method has been in use for more tients with chronic debilitating diseases who undergo than 35 years and guides decisions related to levels surgery, increased utilization of implants and organ of disinfection and sterilization.9,11 However, all instru- transplants, and the presence of antibiotic-resistant ments, regardless of the category of use, require ap- organisms.2 propriate cleaning. In July 2005, the Pennsylvania Health Care Cost Surgical Instrument Preparation Containment Council (PHC4) reported on hospital- Surgical instruments are processed in a multistep, acquired infections in the state, estimating that pa- prescriptive fashion.1 Initially, instruments are cleaned tients with SSIs had a mortality rate of 3.1%.3 either manually or with equipment, depending on the manufacturer’s recommendations. Instruments then Reports to PA-PSRS undergo disinfection, removing most disease-causing Following are excerpts from reports submitted to PA- organisms. Sterilization is the final step to kill all or- PSRS in which sutures, bone, or tissue have been discovered when instruments were unwrapped in the This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 3, No. surgical field: 1—March 2006. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI & ISMP under contract to the Authority as When placing the tissue protector on the drill, part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). old dried blood and tissue came out. Copyright 2006 by the Patient Safety Authority. This publication may be re- Triple trocar was full of dried blood and printed and distributed without restriction, provided it is printed or distributed in smelled foul. Removed from sterile field. its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. Bone found in reamer prior to using it on pa- To see other articles or issues of the Advisory, visit our web site at tient. Bone was removed and reamer auto- www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. claved. Equipment was not used on patient. ©2006 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Bioburden on Surgical Instruments (Continued) ganisms, including pathogens. Sterilization is effective Exhibit 1. Rational Approach to Disinfection and only if all residual debris has been removed in the Sterilization preceding steps.5,8-10 More than 35 years ago, Earl Spaulding developed a method Cleaning instruments, like cleaning dishes, is more to categorize medical instruments according to the amount of difficult when material has dried. The objective is to contact the instrument has with the body to determine the level remove debris before it has a chance to dry. Pre- or degree of disinfection and sterilization required.1 There are cleaning may be done during the surgery or as soon three categories: critical, semicritical, and noncritical. as possible after the procedure.6,10,12,13 Methods in- clude: • Critical objects are items that penetrate soft tissue, bone, or the vascular system or through which blood • Wiping the instrument with a lap or gauze flows, such as implanted medical devices, and sponge wet with sterile water during or after should be sterile when used. the procedure. • Semicritical items are objects that touch mucous • Soaking the instrument in an enzymatic solu- membranes or nonintact skin, such as endoscopes tion according to manufacturer recommenda- and respiratory therapy equipment, and require high- tions after the procedure.8 level disinfection (elimination of all microorganisms • Flushing the instrument lumens with sterile except high numbers of bacterial spores). water during or after the procedure. • Noncritical items are objects that contact intact • Using a nonfibrous sponge to wipe delicate skin, such as bedpans, blood pressure cuffs, and microsurgical and ophthalmic instrument bedside tables. Low-level disinfection is required.2,3 tips.13 Notes 1. Rutala WA, Weber DJ. Disinfection and sterilization in health care facilities: The Association of periOperative Registered Nurses what clinicians need to know. Clin Infect Dis 2004 Sep 1;39(5):702-9. (AORN) suggests that sterile water be maintained in a 2. Rutala WA, Weber DJ. New disinfection and sterilization methods [online]. sterile ring stand to separate it from sterile saline on Emerg Infect Dis 2001 Dec [cited 2005 Jul 7]. Available from Internet: http:// the operating room back table. Sterile saline should www.cdc.gov/ncidod/eid/vol7no2/pdfs/rutala.pdf. 3. Association for Professionals in Infection Control and Epidemiology. APIC not be used to clean instruments, as saline causes guideline for selection and use of disinfectants. Am J Infect Control 1996 pitting and damage.1,12 Aug;24(4):313-42. Instruments should be prepared for cleaning by sepa- trays. Hard-to-clean equipment may be soaked in an rating all detachable parts. Complete disassembly is enzymatic solution or covered with spray, gel, or foam necessary to expose all surfaces during the mechani- to initiate the decontamination process. cal action of cleaning, whether automated or manual. All movable parts should be disassembled. Instru- Various methods exist to ensure that instruments are ment box locks, hinges, and joints should be decontaminated in readiness for sterilization.1 Auto- opened.7,10 The lumens of cannulated instruments mated methods include washer/sterilizers, ultrasonic must be flushed with the cleaning solution and cleaners, and washer/decontaminators; as a last re- checked for soilage. sort, devices may be cleaned manually. Manual cleaning using brushes is effective for instruments Manual and Mechanical Cleaning/ with lumens. The amount of friction or the number of Decontamination brush strokes used during cleaning affects consis- The goal of cleaning is threefold: remove visible de- tency of instrument cleanliness.8 In manual washing, bris, remove invisible soilage, and eliminate as many the instruments are cleaned underwater to reduce the microorganisms as possible.10 These tasks are com- risk of employee exposure to potentially contaminated pleted in central supply by technicians who are often aerosols. Advantages of automated cleaning include trained by the institution. Education is important to decontamination consistency and protection of staff help ensure that the technician recognizes the signifi- from exposure to organisms. cance of his/her contribution to an infection-free surgi- cal outcome.8,14 Mechanical cleaning is performed using several differ- Meticulous cleaning is a prerequisite for disinfection ent types of equipment. Washer-sterilizers use me- and is essential to the integrity of sterilization.4-7 chanical action and detergent to remove residue. If Cleaning begins with decontamination and removal of instruments have crevices or are cannulated, prelimi- obvious debris. Typically, instruments are arranged in nary irrigation and cleaning are necessary to ensure Page 2 ©2006 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Bioburden on Surgical Instruments (Continued) that all residue is removed before decontamination in 2. Instruments should be kept free of gross soil- the washer-sterilizer. age during surgical procedures. Automated cleaning with heat will bake any residual a) Instruments should be wiped with gross organic material onto the instruments, render- sponges moistened with sterile water to ing them a challenge to sterilize.10 A washer- prevent corrosion, rusting, and pitting decontaminator can remove excess debris and elimi- from dried blood and debris. nate the need for manual cleaning of instruments, but b) Lumened or cannulated instruments automation does not eliminate the need for inspection should be irrigated with sterile water. Sa- after they have been cleaned. line causes instrument deterioration and should not be used. Ultrasonic cleaning uses high-frequency sound waves to penetrate and remove debris after the visible or 3. Effective and timely decontamination of in- gross residue has been rinsed off the instrument.10 It struments should be performed in a manner is most effective once the overt residue is removed, that minimizes risk to those performing the and it is effective on instruments with lumens or task. joints.8 4. Surgical instruments with moving parts Vigilance in verifying the removal of bioburden is of should be checked for function after cleaning. utmost importance to ensure sterilization. The term Lubrication may be indicated. “bioburden” is often used to describe organic material 5. Instruments that have come in contact with on instruments15,16 but actually refers to the number prions (resilient protein substances) should of microorganisms contaminating an object.17 Prop- be treated according to a specific prion- erly cleaned nonlumen instruments have been dem- deactivation protocol. When changing policies onstrated to contain a minimal number of organisms, the most recent updates related to prion de- which are not pathogenic.18 activation should be obtained from the Cen- ters for Disease Control and Prevention Inspection (CDC), the World Health Organization, and Inspection is important to ensure that instruments are experts publishing new findings. Creutzfeldt- clean and disinfected, with no residue. Whenever any Jakob disease (CJD) is caused by a prion resistance or stiffness is noted in the movement of a (see Exhibit 2). The following is a condensed part, the presence of residual debris should be sus- version of the recommended practices for pected, and the instrument should be inspected ac- cleaning instruments when prion exposure is cordingly.1,7 During inspection, staff should verify that suspected: teeth mesh, that equipment demonstrates proper ten- sion, that ratchets work correctly, and that parts de- a) Keep instruments moist before treating. signed to move freely do so.7 b) Clean instruments as soon as possible. In January 2002, AORN revised its “Recommended c) Keep instruments of similar tissue infectiv- Practices for Cleaning and Caring for Surgical Instru- ity levels together. ments and Powered Equipment.” The goal of these d) Decontaminate instruments before proc- practices is “to assist perioperative nurses in decon- essing: taminating, cleaning, maintaining, handling, storing, and/or sterilizing surgical instruments and powered − Dispose of instruments that are im- equipment.”1 Acknowledgment is given in possible to clean or when cleaning is the guideline to the innumerable specialized instru- difficult and disposal is not cost- ments and powered equipment that necessitate prohibitive. manufacturers’ guidance for cleaning. − When indicated, soak instruments for AORN presents eight detailed recommended prac- one hour in normal sodium hydroxide tices, which provide generalized direction for cleaning before cleaning and sterilizing. instruments.1 The following is a synopsis of these practices: − Steam autoclave instruments at 132° to 134°C for 18 minutes in a prevac- 1. Surgical instruments and powered equipment uum sterilizer or at 121°C for 60 min- should be cleaned, handled, and used accord- utes in a gravity displacement steri- ing to manufacturers’ instructions. lizer. ©2006 Pennsylvania Patient Safety Authority Page 3 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Bioburden on Surgical Instruments (Continued) e) Avoid using power drills or saws on highly viewed at regular intervals, and made readily infective tissue. available in the practice setting. f) Note that disposable equipment is pre- See the published recommendations for details re- ferred and should be incinerated. lated to instrument and powered equipment cleaning 6. Surgical instruments should be visually in- and care when developing and/or revising policies.1 spected and prepared for storage or steriliza- tion after decontamination; specifically, staff Considerations for ensuring that surgical instruments should consider: remain free of debris include the following: a) cleanliness and proper functioning • Create an environment in which a team spirit is encouraged and infection prevention is a b) the presence of cracks, corrosion, pitting, shared duty and begins with the responsibility burs, and nicks of ongoing monitoring of the care of surgical c) sharpness of cutting edges equipment.7,8,10 d) loose pins • Implement routine proactive efforts during and immediately after surgery to prevent soilage e) wear and chipping of inserts and plated from drying on surgical instruments. surfaces f) any other defects. • Educate central supply staff on the principles of decontamination, disinfection, and steriliza- 7. Powered equipment and any attachments tion.8,14 should be disassembled, decontaminated after • Maintain quality control by reviewing instru- use, lubricated, assembled, tested, and steril- ment management practices and reinforcing ized according to manufacturer instructions. routine inspection of cleaned surgical instru- ments, especially those likely to have retained 8. Policies and procedures regarding the care soilage.4,16 and cleaning of surgical instruments and pow- ered equipment should be developed, re- To minimize the risk associated with a breakdown in Exhibit 2. Prion Concerns Effective reprocessing of surgical instruments is essential in • Use disposable instruments in known CJD cases or the prevention of Creutzfeldt-Jakob disease (CJD), a prion in brain biopsy procedures if possible.1,4 disease that is a transmissible spongiform encephalopa- thy.1,2 CJD is a fatal disorder that more commonly occurs in • Quarantine instruments used in neurosurgery until a older people, although vCJD (new variant Creutzfeldt-Jakob diagnosis is available.1 disease) occurs in younger people. Classic CJD is described as “insidious, taking up to 20 or more years for symptoms to • Incinerate instruments that cannot be cleaned.1 appear, with death occurring within 5 to 14 months after • Do not use flash sterilization.4 symptoms present.”1 • Keep instruments moist to prevent drying of organic While developing a test for assessing removal of protein material.4 from surgical instruments after cleaning, researchers in Eng- land discovered that alcohol strongly binds blood to stainless Notes steel. Reports related to transmission of CJD between hu- 1. Exposure to Creutzfeldt-Jakob disease. Jt Comm Perspect 2001 Aug;21 mans and chimpanzees indicate that the instruments were (8):10-1. 2. Lemmer K, Mielke M, Pauli G, et al. Decontamination of surgical instru- cleaned with alcohol-formaldehyde solutions.3 Therefore, ments from prion proteins: in vitro studies on the detachment, destabilization when CJD is suspected, alcohol and formaldehyde should and degradation of PrPSc bound to steel surfaces. J Gen Virol 2004 Dec;85 not be used to decontaminate surgical instruments used in (Pt 12):3805-16. neurosurgical cases. 3. Prior F, Fernie K, Renfrew A, et al. Alcoholic fixation of blood to surgical instruments—a possible factor in the surgical transmission of CJD? J Hosp The following strategies can help to reduce the risk of CJD Infect 2004 Sep;58(1):78-80. 4. Rutala WA, Weber DJ. Creutzfeldt-Jakob disease: Recommendations for transmission: disinfection and sterilization. Clin Infect Dis 2001 May 1;32(9):1348-56. Page 4 ©2006 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) Bioburden on Surgical Instruments (Continued) sterility, consider the following practices: http://www.infectioncontroltoday.com/articles/181instrument.html. 9. Association for Professionals in Infection Control and Epidemiol- • Open sterile instruments on a separate stand, ogy. APIC guideline for selection and use of disinfectants. Am J Infect Control 1996 Aug;24(4):313-42. such as the ring stand, and inspect the con- 10. Clayton JL. Decontamination, sterilization, and disinfection. tents to avoid the risk of contaminating other Minim Invasive Surg Nurs 1996 Spring;10(1):13-20. equipment or the surgical field. If contaminated 11. Rutala WA, Weber DJ. Disinfection and sterilization in health instruments are found, the scrub nurse’s gown care facilities: what clinicians need to know. Clin Infect Dis 2004 and gloves can be changed without contami- Sep 1;39(5):702-9. nating the supplies and other items in the ster- 12. Petersen C. Compressed medical gases; preparing IV fluids in advance; Clostridium difficile; sterile water on back tables; closing ile field.4 OR doors [online]. AORN J 2004 Dec [cited 2005 Jul 7]. Available from Internet: http://www.aorn.org/journal/2004/decci.htm. • If a soiled instrument is noted during the pro- 13. LeTexier R. Optimum cleaning and disinfection of surgical in- cedure, pass the instrument off the table and struments [online]. Infect Control Today 2002 Apr 1 [cited 2005 Jul inform the surgeon so that prophylaxis can be 7]. Available from Internet: http://www.infectioncontroltoday.com/ provided.4 articles/241clean.html. 14. Cantrell S. “When all else fails, read the directions.” Safely using disinfectants and sterilants [online]. Healthc Purch News Look for new guidelines on processing practices to be 2005 Jul [cited 2005 Jul 7]. Available from Internet: http:// released some time in the future. This will be the first www.hponline.com/inside/July05/0507InfectionConnection.html. revision since the 1985 release of CDC’s “Guideline 15. Petersen C. Leaving OR doors open; sterilizing wood; national for Handwashing and Hospital Environmental Con- patient safety goals; bioburden; mercury thermometers [online]. trol.” The new guidelines, which are in draft form as of AORN J 2003 Mar [cited 2006 Jan 12]. Available from Internet: http://www.aorn.org/journal/2003/marci.htm. February 2006, are intended to replace the section on 16. Conner R. Washing and restringing instruments; bone debris; sterilization and disinfection in the original guideline. preparing setups; patient restraints; Group A Streptococcus The June 2002 issue of OR Manager contains high- [online]. AORN J 2001 Apr [cited 2006 Jan 12]. Available from lights of the draft, which covers inactivation of patho- Internet: http://www.aorn.org/journal/2001/aprci.htm. gens such as those causing CJD, disinfection of 17. American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI). Steam sterili- equipment, decontamination of bone, endoscope dis- zation and sterility assurance in health care facilities infection, and new sterilization processes.19 The draft [recommended practice]. ANSI/AAMI ST46:2002. 2002. is no longer available on CDC’s Web site and is in the 18. Rutala WA, Gergen MF, Jones JF, et al. Levels of microbial process of comment review.20 contamination on surgical instruments. Am J Infect Control 1998 Apr;26(2):143-5. Notes 19. Mathias JM. Draft guideline on processing practices. OR Man- 1. Conner R, ed. Standards, recommended practices, and guide- ager 2002 Jun;18(6):7-9. lines. Denver: Association of periOperative Registered Nurses; 20. Rutala WA, Weber DJ. Draft guideline for disinfection and ster- 2005:309. ilization in healthcare facilities [online]. 2002 [cited 2006 Jan 31]. Available from Internet: http://www.premierinc.com. 2. Mangram AJ, Horan TC, Pearson ML, et al. Guideline for pre- vention of surgical site infection, 1999 [online]. 1999 [cited 2005 Jul 7]. Available from Internet: http://www.cdc.gov/ncidod/dhqp/gl_surgicalsite.html. 3. Pennsylvania Health Care Cost Containment Council. Hospital acquired infections in Pennsylvania [online]. Research Briefs. 2005 Jul [cited 2006 Jan 30]. Available from Internet: http:// www.phc4.org. 4. Petersen C. Surgical-grade stainless steel; when to administer antibiotics; medication labels; mixing medications; bioburden [online]. AORN J 2002 Dec [cited 2005 May 20]. Available from Internet: http://www.aorn.org/journal/2002/decci.htm. 5. Centers for Disease Control and Prevention. Guidelines for in- fection control in dental health-care settings—2003. MMWR Re- comm Rep 2003 Dec 19;52(RR-17):1-61. 6. McLachlan E. Proper sterilization of instruments is essential to patient safety [online]. [cited 2005 Jul 6]. Available from Internet: http://www.apic.org/Content/NavigationMenu/Publications/ InfectionConnection/Proper_Sterilization.htm. 7. Murphy M. Handheld instrument maintenance is both an art and a science [online]. Healthc Purch News 2003 Jul [cited 2006 Jan 30]. Available from Internet: http://www.findarticles.com. 8. Chu N, Favero M. Cleaning: an important prerequisite for instru- ment sterilization and disinfection [online]. Infect Control Today 2001 Aug 1 [cited 2005 Jul 8]. Available from Internet: ©2006 Pennsylvania Patient Safety Authority Page 5 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 3, No. 1 (March 2006) An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP's efforts are built on a non-punitive approach and systems-based solutions. Page 6 ©2006 Pennsylvania Patient Safety Authority