Ask The EXPERT

Dr. William A. Rutala.Agosto 22 -23. Irvine, CA.US

Disinfection

a. According to Spaulding's classification, semi-critical devices must be disinfected.When they are not used immediately, how do you recommend storing them and keeping them disinfected?

a. De acuerdo a la clasificaciónde Spaulding, los dispositivos semicríticosdeben ser desinfectados.Cuando no son utilizados de forma inmediata, ¿cómo recomienda almacenarlos y conservar su desinfección?

Examples of compliant storage include, but not limited to, a peel pouch or a closedplastic bag. Examples of non-compliant storage would include unwrapped blades inan anesthesia drawer as well as an unwrapped blade on top of or within a code cart.The packaging not only prevents recontamination but also distinguishes a processedfrom a non-processed semi-critical item. Ideally, hospitals and ambulatory carefacilities should develop a strategy that prevents patient exposures to contaminateddevices.

Disinfectionb. Considering the evidence that exists of Infections associated with the bad reprocessing of Duodenoscopy, you think that the classification of Spaulding should change? What are these reasons?

b. Considerando la evidencia que existe de infecciones asociadas al malreprocesamiento de Duodenoscopios, Usted considera que la clasificación deSpaulding debe cambiar? Cúales serían esta razones?

c. Do you believe that taking cultures on flexible endoscopes should be a standard? Applies to all endoscopes?

c. Usted cree que la toma de cultivos en los endosocpios flexibles debe ser unestándar ? Aplica a todos los endoscopios ?

Tomar muestras microbiológicas de endoscopios es una opción, pero muchoshospitales de US no hacen cultivos

d. What do you think the future of reprocessing of flexible endoscopes will be? In the future (estimate 5 years), I believe endoscopes will be sterilized?

d. Qué piensa Usted del futuro del reprocesamiento de EndoscopiosFlexibles?

En el futuro (un estimado a 5 años), cree que los endoscopios deberán ser esterilizados?

e. What is your recommendation for the reprocessing of medical devices used in patients with CJD (Creutzfeldt-Jakob)?

e. Cuál es su recomendación para el reprocesamiento de dispositivosmédicos usados en pacientes con CJD (Creutzfeldt-Jakob)?

f. For cleaning, medical devices, we have available in the market Detergents alkaline, neutral, enzymatic. In terms of effectiveness, what kind of detergent you recommend?

f. Para la limpieza de dispositivos médicos, encontramos en el mercadoDetergentes alkalinos, neutros, enzimáticos. En términos de eficiencia, que clase de Detergente recomienda Usted?

Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. For instrument cleaning, a neutral or near-neutral pH detergent solution commonly is used because such solutions generally provide the best material compatibility profile and good soil removal. Enzymes, usually proteases, sometimes are added to neutral pH solutions to assist in removing organic material. Enzymes in these formulations attack proteins that make up a large portion of common soil (e.g., blood, pus).

g. For video surgery instruments that come in contact with natural orifices, do you recommend the high-level disinfection process?

g. Para Instrumental de Video-Cirugía que entra en contacto con orificiosnaturales, usted recomienda el reprocesamiento con Desinfección de Alto Nivel?

h. How is the process of cleaning a medical device validated? What is your recommendation?

h. Cómo se valida el proceso de Limpieza de un dispositivo médico? Cuáles su recomendación ?

i. What is your recommendation for the reprocessing of medical devices contaminated with HIV?

i. Cuál es su recomendación para el reprocesamiento de dispositivosmédicos contaminados con HIV?

Endoscopes and other semicritical devices should be managed the same

way regardless of whether the patient is known to be infected with HBV, HCV, HIV or M. tuberculosis.

J. What is your recommendation for processing a Transvaginal Ultrasound?

J. Cuál es su recomendación para reprocesar las sondas de ultrasonidotransvaginal?

CDC guideline for disinfection and sterilization proposes that a new condom/probe cover should be used to cover the probe for each patient and since condoms/probe covers may fail, high-level disinfection of the probe also should be performed.

Rooks and co-workers found that condoms were superior to commercially available probe covers for covering the ultrasound probe (1.7% for condoms versus 8.3% leakage for probe covers).

The use of 2% glutaraldehyde for high-level disinfection of contaminated transvaginal transducers, has been questioned because it may shorten the life of the transducer and may have toxic effects on the gametes and embryos.

Ultrasound probes that are used during surgical procedures and have contact with sterile body sites may be covered with a sterile sheath to reduce the level of contamination on the probe and reduce the risk of infection. However, the probes should be sterilized between each patient use as with other critical items. If this is not possible, minimally high-level disinfect the probe and cover it with a sterile probe cover.

Human Papilloma Virus (HPV) A recent paper demonstrated that the FDA-cleared high disinfectants (i.e., glutaraldehyde, OPA) tested did not inactivate the human papilloma virus, a non-enveloped virus. These findings are inconsistent with many papers in the peer-reviewed literature which demonstrates that HLD such as OPA and glutaraldehyde inactivate non-enveloped viruses such as HAV, polio, adenovirus, norovirus, etc. In a conversation with CDC staff regarding this issue, it was determined hospitals should continue to use the FDA-cleared high-level disinfectants consistent with the manufacturers’ instructions until the data can be corroborated. Data have demonstrated the activity of a hydrogen peroxide mist device to inactivate the human papilloma virus.

k. When there is insufficient availability of laryngoscopes, nasolaryngoscopy and it is not possible high-level disinfection or sterilization, using Isopropyl Alcohol can be a safe option?

k.Cuando no hay suficiente disponobilidad de Laringoscopios y naso-laringoscopios y no es posible hacer desinfección de alto nivel ni esesterilizar, usar Alcohol Isopropílico es una opción segura?

Three techniques are available to reprocess nasopharyngoscopes: manual high-level disinfection; use of an automated endoscope reprocessor; and use of adisposable sheath.Ethyl alcohol, at concentrations of 60%–80%, is a potent virucidal agent inactivating all of the lipophilic viruses (e.g., herpes, vaccinia, and influenza virus) and many hydrophilic viruses (e.g., adenovirus, enterovirus, rhinovirus, and rotaviruses but not hepatitis A virus (HAV) or poliovirus). Isopropyl alcohol is not active against the nonlipid enteroviruses but is fully active against the lipid viruses.

l. What is the effectiveness of high-level disinfection of a Colonoscopeusing CIDEX-OPA in patients with Clostridium difficile infection?

i. Cuál es la efectividad de la desinfección de alto nivel de unColonoscopio, usando CIDEX-OPA en pacientes infectados con Clostridiumdifficile ?

m. How Ammonium Quaternary from the fifth (5a) generation caninactivate Mycobacterium? Could be classified as intermediate leveldisinfectants?

m. Cómo el Amonio Cuaternario de quinta generación puede inactivar elMicobacterium ? Podría ser clasificao como un desinfectante de NivelIntermedio?

I have no information/data on fifth generation QUATs and activity against M.tuberculous. The paragraphs below discuss QUATs (to include fourth generation)and their antimicrobial activity.

Sterilization

a. In some Institutions, it is frequent to find wet loads after the sterilization process, do you consider safe the use of this instrument?

a. En algunas Instituciones es frecuente que se encuentren paquetes mojados después del proceso de esterilización. Usted considera seguro el uso de este intrumental?

Reference: Seavey R. 2013. Am J Infect Control 41: S111-S117A package is considered a wet pack if moisture in the form of dampness,droplets, or puddles of water is found on or within a textile pack,instrument, basin set, or rigid container or containment devices after thesterilization and cool-down process. If packs are found to be wet aftersterilization, they should not be released for use. ANSI and AAMI ST79recommends any set containing moisture inside the container systemshould be considered contaminated because there are no scientific studiesto prove otherwise.

Sterilization

2. In some sterilization services, the same cleaning area is used for medicaldevices and patient urinals. What is your recommendation? Is it a safepractice?

En algunos servicios de esterilización, la misma área de limpieza es usadapara dispositivos médicos y orinales de pacientes. Cuál és surecomendación? Esta es una práctica segura?

We do not reprocess urinals in the same area as medical/surgicalinstruments. Urinals at UNC Hospitals are disposal. Only medical/surgicalinstruments requiring reprocessing (generally sterilization) are sent to CentralProcessing for reprocessing/sterilization.

Sterilization

c. Control of temperature and humidity in the storage area sterile medical devices, is it important? What are the parameters set for these areas?c. El control de temperatura y humedad en la área de almacenamiento de los dispositivos médicos esterilizados es una práctica importante? Cuáles son los parámetros que debemos considerar para estas áreas?

Physical Facilities. The central processing area(s) ideally should be divided into at least three areas: decontamination, packaging, and sterilization and storage. Physical barriers should separate the decontamination area from the other sections to contain contamination on used items. In the decontamination area reusable contaminated supplies (and possibly disposable items that are reused) are received, sorted, and decontaminated. The recommended airflow pattern should contain contaminates within the decontamination area and minimize the flow of contaminates to the clean areas. The American Institute of Architects 1022 recommends negative pressure and no fewer than six air exchanges per hour in the decontamination area (AAMI recommends 10 air changes per hour) and 10 air changes per hour with positive pressure in the sterilizer equipment room. The packaging area is for inspecting, assembling, and packaging clean, but not sterile, material. The sterile storage area should be a limited access area with a controlled temperature (may be as high as 75oF) and relative humidity (30-60% in all works areas except sterile storage, where the relative humidity should not exceed 70%). 322 The floors and walls should be constructed of materials capable of withstanding chemical agents used for cleaning or disinfecting. Ceilings and wall surfaces should be constructed of non-shedding materials. Physical arrangements of processing areas are presented schematically in four references. 322, 876, 983, 1020

d. Most of the institutions receive material for orthopedic surgeries delivered by commercial houses to be sterilized for the next day. We have a case where the manufacturer of the steam sterilizer specifies the parameters with which the instruments must be sterilized. Can the sterilizer manufacturer do that?

d. Las instituciones reciben instrumental de terceros para cirugías de ortopedia para reprocesar para el día siguiente. Hay un caso en el que el fabricante del esterilizadorde vapor especifica los parámetros con los que se debe esterilizar dicho instrumental. Puede el fabricante del esterilizador de vapor hacer eso?

Reference: Seavey R. 2013. Am J Infect Control 41: S111-S117

Facilities frequently borrow surgical implants for specialty operative procedures. IAHCSMM states that health care facilities should have loaner trays at least 2 business days before the scheduled use (www.iahcsmm.org ). The borrowed surgical instruments must be processed as all reprocessed instruments (e.g., decontamination, packaging, sterilization). Sterilizer manufacturers can specify the parameters for sterilization.

e. At the end of the cycle, leaving the sterilized material in the autoclave chamberwith the door open is safe practice?

Al finalizar un ciclo de vapor, dejar el instrumental en la cámara con la puerta abierta

Se considera una práctica segura?

• Reference: Seavey R. 2013. Am J Infect Control 41: S111-S117

Yes, there is a cool-down period. The cool-down period begins within the sterilizerchamber. The door may be opened slightly at the end of the cycle and the items leftinside for a period of time in order to reduce the potential for condensationformation.

The time allowed for cooling should take into account the type of sterilizer being used,the design of the device being sterilized, the temperature and humidity of the ambientenvironment, and the type of packaging used. A minimum cooling time of 30 minutesis recommended. Sterilized packages should not be touched until after the cool-downperiod. Cooling packages is an important step in preventing wet packs.

Sterilization

f. When a sterile tray has a clamp with organic matter, is the whole box considered non-sterile? Are there studies to determine if the entire tray would be contaminated or just that clamp?

f. Cuando en una bandeja estéril se encuentra una pinza con materiaorgánica, toda la bandeja se considera contaminada? Hay estudios que determinen esto?

II am not aware of a national guideline or recommendation of this specific question of contamination of clamp with organic matter and the effect on the entire tray but AAMI would be a possible source. I think most hospitals would consider the entire tray contaminated if there is an instrument contaminated with organic matter as there are no studies to prove otherwise.

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