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Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 [PDF - 948 KB]

Laparoscopes and Arthroscopes

Although high-level disinfection appears to be the minimum standard for processing laparoscopes and arthroscopes between patients 28, 86, 174, 175, this practice continues to be debated 89, 90, 176.  However, neither side in the high-level disinfection versus sterilization debate has sufficient data on which to base its conclusions. Proponents of high-level disinfection refer to membership surveys 29 or institutional experiences 87 involving more than 117,000 and 10,000 laparoscopic procedures, respectively, that cite a low risk for infection (<0.3%) when high-level disinfection is used for gynecologic laparoscopic equipment. Only one infection in the membership survey was linked to spores. In addition, growth of common skin microorganisms (e.g., Staphylococcus epidermidis, diphtheroids) has been documented from the umbilical area even after skin preparation with povidone-iodine and ethyl alcohol. Similar organisms were recovered in some instances from the pelvic serosal surfaces or from the laparoscopic telescopes, suggesting that the microorganisms probably were carried from the skin into the peritoneal cavity 177, 178.  Proponents of sterilization focus on the possibility of transmitting infection by spore-forming organisms.  Researchers have proposed several reasons why sterility was not necessary for all laparoscopic equipment: only a limited number of organisms (usually <10) are introduced into the peritoneal cavity during laparoscopy; minimal damage is done to inner abdominal structures with little devitalized tissue; the peritoneal cavity tolerates small numbers of spore-forming bacteria; equipment is simple to clean and disinfect; surgical sterility is relative; the natural bioburden on rigid lumened devices is low179; and no evidence exists that high-level disinfection instead of sterilization increases the risk for infection 87, 89, 90.  With the advent of laparoscopic cholecystectomy, concern about high-level disinfection is justifiable because the degree of tissue damage and bacterial contamination is greater than with laparoscopic procedures in gynecology. Failure to completely dissemble, clean, and high-level disinfect laparoscope parts has led to infections in patients180.   Data from one study suggested that disassembly, cleaning, and proper reassembly of laparoscopic equipment used in gynecologic procedures before steam sterilization presents no risk for infection181.

As with laparoscopes and other equipment that enter sterile body sites, arthroscopes ideally should be sterilized before used.  Older studies demonstrated that these instruments were commonly (57%) only high-level disinfected in the United States 28, 86.  A later survey (with a response rate of only 5%) reported that high-level disinfection was used by 31% and a sterilization process in the remainder of the health-care facilities30 High-level disinfection rather than sterilization presumably has been used because the incidence of infection is low and the few infections identified probably are unrelated to the use of high-level disinfection rather than sterilization. A retrospective study of 12,505 arthroscopic procedures found an infection rate of 0.04% (five infections) when arthroscopes were soaked in 2% glutaraldehyde for 15–20 minutes. Four infections were caused by S. aureus; the fifth was an anaerobic streptococcal infection 88.  Because these organisms are very susceptible to high-level disinfectants, such as 2% glutaraldehyde, the infections most likely originated from the patient's skin. Two cases of Clostridium perfringens arthritis have been reported when the arthroscope was disinfected with glutaraldehyde for an exposure time that is not effective against spores 182, 183.

Although only limited data are available, the evidence does not demonstrate that high-level disinfection of arthroscopes and laparoscopes poses an infection risk to the patient. For example, a prospective study that compared the reprocessing of arthroscopes and laparoscopes (per 1,000 procedures) with EtO sterilization to high-level disinfection with glutaraldehyde found no statistically significant difference in infection risk between the two methods (i.e., EtO, 7.5/1,000 procedures; glutaraldehyde, 2.5/1,000 procedures)89.  Although the debate for high-level disinfection versus sterilization of laparoscopes and arthroscopes will go unsettled until well-designed, randomized clinical trials are published, this guideline should be followed 1, 17.  That is, laparoscopes, arthroscopes, and other scopes that enter normally sterile tissue should be sterilized before each use; if this is not feasible, they should receive at least high-level disinfection.

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Tonometers, Cervical Diaphragm Fitting Rings, Cryosurgical Instruments, and Endocavitary Probes

Disinfection strategies vary widely for other semicritical items (e.g., applanation tonometers, rectal/vaginal probes, cryosurgical instruments, and diaphragm fitting rings). FDA requests that device manufacturers include at least one validated cleaning and disinfection/sterilization protocol in the labeling for their devices. As with all medications and devices, users should be familiar with the label instructions. One study revealed that no uniform technique was in use for disinfection of applanation tonometers, with disinfectant contact times varying from <15 sec to 20 minutes 28.  In view of the potential for transmission of viruses (e.g., herpes simplex virus [HSV], adenovirus 8, or HIV) 184 by tonometer tips, CDC recommended that the tonometer tips be wiped clean and disinfected for 5-10 minutes with either 3% hydrogen peroxide, 5000 ppm chlorine, 70% ethyl alcohol, or 70% isopropyl alcohol 95.  However, more recent data suggest that 3% hydrogen peroxide and 70% isopropyl alcohol are not effective against adenovirus capable of causing epidemic keratoconjunctivitis and similar viruses and should not be used for disinfecting applanation tonometers 49, 185, 186.  Structural damage to Schiotz tonometers has been observed with a 1:10 sodium hypochlorite (5,000 ppm chlorine) and 3% hydrogen peroxide187.  After disinfection, the tonometer should be thoroughly rinsed in tapwater and air dried before use.  Although these disinfectants and exposure times should kill pathogens that can infect the eyes, no studies directly support this 188, 189.  The guidelines of the American Academy of Ophthalmology for preventing infections in ophthalmology focus on only one potential pathogen: HIV. 190  Because a short and simple decontamination procedure is desirable in the clinical setting, swabbing the tonometer tip with a 70% isopropyl alcohol wipe sometimes is practiced. 189  Preliminary reports suggest that wiping the tonometer tip with an alcohol swab and then allowing the alcohol to evaporate might be effective in eliminating HSV, HIV, and adenovirus189, 191, 192.  However, because these studies involved only a few replicates and were conducted in a controlled laboratory setting, further studies are needed before this technique can be recommended.  In addition, two reports have found that disinfection of pneumotonometer tips between uses with a 70% isopropyl alcohol wipe contributed to outbreaks of epidemic keratoconjunctivitis caused by adenovirus type 8193, 194.

Limited studies have evaluated disinfection techniques for other items that contact mucous membranes, such as diaphragm fitting rings, cryosurgical probes, transesophageal echocardiography probes 195, flexible cystoscopes 196 or vaginal/rectal probes used in sonographic scanning.  Lettau, Bond, and McDougal of CDC supported the recommendation of a diaphragm fitting ring manufacturer that involved using a soap-and-water wash followed by a 15-minute immersion in 70% alcohol96.  This disinfection method should be adequate to inactivate HIV, HBV, and HSV even though alcohols are not classified as high-level disinfectants because their activity against picornaviruses is somewhat limited72.  No data are available regarding inactivation of human papillomavirus (HPV) by alcohol or other disinfectants because in vitro replication of complete virions has not been achieved. Thus, even though alcohol for 15 minutes should kill pathogens of relevance in gynecology, no clinical studies directly support this practice.

Vaginal probes are used in sonographic scanning. A vaginal probe and all endocavitary probes without a probe cover are semicritical devices because they have direct contact with mucous membranes (e.g., vagina, rectum, pharynx). While use of the probe cover could be considered as changing the category, this guideline proposes use of a new condom/probe cover for the probe for each patient, and because condoms/probe covers can fail 195, 197-199, the probe also should be high-level disinfected. The relevance of this recommendation is reinforced with the findings that sterile transvaginal ultrasound probe covers have a very high rate of perforations even before use (0%, 25%, and 65% perforations from three suppliers). 199  One study found, after oocyte retrieval use, a very high rate of perforations in used endovaginal probe covers from two suppliers (75% and 81%) 199, other studies demonstrated a lower rate of perforations after use of condoms (2.0% and 0.9%) 197 200.  Condoms have been found superior to commercially available probe covers for covering the ultrasound probe (1.7% for condoms versus 8.3% leakage for probe covers)201.  These studies underscore the need for routine probe disinfection between examinations. Although most ultrasound manufacturers recommend use of 2% glutaraldehyde for high-level disinfection of contaminated transvaginal transducers, the this agent has been questioned 202 because it might shorten the life of the transducer and might have toxic effects on the gametes and embryos 203.  An alternative procedure for disinfecting the vaginal transducer involves the mechanical removal of the gel from the transducer, cleaning the transducer in soap and water, wiping the transducer with 70% alcohol or soaking it for 2 minutes in 500 ppm chlorine, and rinsing with tap water and air drying204.  The effectiveness of this and other methods 200 has not been validated in either rigorous laboratory experiments or in clinical use.  High-level disinfection with a product (e.g., hydrogen peroxide) that is not toxic to staff, patients, probes, and retrieved cells should be used until the effectiveness of alternative procedures against microbes of importance at the cavitary site is demonstrated by well-designed experimental scientific studies. Other probes such as rectal, cryosurgical, and transesophageal probes or devices also should be high-level disinfected between patients.

Ultrasound probes used during surgical procedures also can contact sterile body sites. These probes can be covered with a sterile sheath to reduce the level of contamination on the probe and reduce the risk for infection. However, because the sheath does not completely protect the probe, the probes should be sterilized between each patient use as with other critical items. If this is not possible, at a minimum the probe should be high-level disinfected and covered with a sterile probe cover.

Some cryosurgical probes are not fully immersible. During reprocessing, the tip of the probe should be immersed in a high-level disinfectant for the appropriate time; any other portion of the probe that could have mucous membrane contact can be disinfected by immersion or by wrapping with a cloth soaked in a high-level disinfectant to allow the recommended contact time. After disinfection, the probe should be rinsed with tap water and dried before use. Health-care facilities that use nonimmersible probes should replace them as soon as possible with fully immersible probes.

As with other high-level disinfection procedures, proper cleaning of probes is necessary to ensure the success of the subsequent disinfection 205. One study demonstrated that vegetative bacteria inoculated on vaginal ultrasound probes decreased when the probes were cleaned with a towel 206.  No information is available about either the level of contamination of such probes by potential viral pathogens such as HBV and HPV or their removal by cleaning (such as with a towel). Because these pathogens might be present in vaginal and rectal secretions and contaminate probes during use, high-level disinfection of the probes after such use is recommended.

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Dental Instruments

Scientific articles and increased publicity about the potential for transmitting infectious agents in dentistry have focused attention on dental instruments as possible agents for pathogen transmission207, 208. The American Dental Association recommends that surgical and other instruments that normally penetrate soft tissue or bone (e.g., extraction forceps, scalpel blades, bone chisels, periodontal scalers, and surgical burs) be classified as critical devices that should be sterilized after each use or discarded.  Instruments not intended to penetrate oral soft tissues or bone (e.g., amalgam condensers, and air/water syringes) but that could contact oral tissues are classified as semicritical, but sterilization after each use is recommended if the instruments are heat-tolerant 43, 209.  If a semicritical item is heat–sensitive, it should, at a minimum, be processed with high-level disinfection 43, 210.  Handpieces can be contaminated internally with patient material and should be heat sterilized after each patient.  Handpieces that cannot be heat sterilized should not be used. 211   Methods of sterilization that can be used for critical or semicritical dental instruments and materials that are heat-stable include steam under pressure (autoclave), chemical (formaldehyde) vapor, and dry heat (e.g., 320ºF for 2 hours). Dental professionals most commonly use the steam sterilizer 212.  All three sterilization procedures can damage some dental instruments, including steam-sterilized hand pieces 213. Heat-tolerant alternatives are available for most clinical dental applications and are preferred43

CDC has divided noncritical surfaces in dental offices into clinical contact and housekeeping surfaces43.   Clinical contact surfaces are surfaces that might be touched frequently with gloved hands during patient care or that might become contaminated with blood or other potentially infectious material and subsequently contact instruments, hands, gloves, or devices (e.g., light handles, switches, dental X-ray equipment, chair-side computers). Barrier protective coverings (e.g., clear plastic wraps) can be used for these surfaces, particularly those that are difficult to clean (e.g., light handles, chair switches). The coverings should be changed when visibly soiled or damaged and routinely (e.g., between patients). Protected surfaces should be disinfected at the end of each day or if contamination is evident. If not barrier-protected, these surfaces should be disinfected between patients with an intermediate-disinfectant (i.e., EPA-registered hospital disinfectant with tuberculocidal claim) or low-level disinfectant (i.e., EPA-registered hospital disinfectant with an HBV and HIV label claim) 43, 214, 215.

Most housekeeping surfaces need to be cleaned only with a detergent and water or an EPA-registered hospital disinfectant, depending of the nature of the surface and the type and degree of contamination.  When housekeeping surfaces are visibly contaminated by blood or body substances, however, prompt removal and surface disinfection is a sound infection control practice and required by the Occupational Safety and Health Administration (OSHA) 43, 214.

Several studies have demonstrated variability among dental practices while trying to meet these recommendations216, 217.  For example, 68% of respondents believed they were sterilizing their instruments but did not use appropriate chemical sterilants or exposure times and 49% of respondents did not challenge autoclaves with biological indicators216.  Other investigators using biologic indicators have found a high proportion (15%–65%) of positive spore tests after assessing the efficacy of sterilizers used in dental offices.  In one study of Minnesota dental offices, operator error, rather than mechanical malfunction218, caused 87% of sterilization failures.  Common factors in the improper use of sterilizers include chamber overload, low temperature setting, inadequate exposure time, failure to preheat the sterilizer, and interruption of the cycle.

Mail-return sterilization monitoring services use spore strips to test sterilizers in dental clinics, but delay caused by mailing to the test laboratory could potentially cause false-negatives results.  Studies revealed, however, that the post-sterilization time and temperature after a 7-day delay had no influence on the test results219.  Delays (7 days at 27ºC and 37ºC, 3-day mail delay) did not cause any predictable pattern of inaccurate spore tests 220.

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