IMPLEMENTING A TEAM APPROACH TO PREVENTING TASS. Understanding implications and following best practices. by Cynthia Hubbard, RN, BS

Size: px
Start display at page:

Download "IMPLEMENTING A TEAM APPROACH TO PREVENTING TASS. Understanding implications and following best practices. by Cynthia Hubbard, RN, BS"

Transcription

1 IMPLEMENTING A TEAM APPROACH TO PREVENTING TASS Understanding implications and following best practices by Cynthia Hubbard, RN, BS Objectives 1. Identify the causes of Toxic Anterior Segment Syndrome (TASS). 2. Identify recommended practices for reprocessing intraocular instruments. 3. Develop an interdepartmental strategy to prevent TASS. 4. List the quality monitoring documentation that can help prevent TASS. Test Questions True or False. Circle the correct answer. 1. Toxic Anterior Segment Syndrome (TASS) is an early postoperative complication of cataract surgery caused by an infection. 2. Due to the multiple potential sources of toxins it is often time-consuming, expensive, frustrating and difficult to isolate a particular cause directly after a TASS outbreak. 68 MANAGING INFECTION CONTROL

2 3. Ophthalmic viscosurgical device solutions (OVDs) should not be allowed to dry on the instruments in the OR. 4. All materials used in intraocular surgery or instrument management must be chemical, residue and lint-free. 5. AAMI suggests designating an individual to be responsible for collecting and documenting current recommendations for processing intraocular instruments. 6. All ophthalmic instrument manufacturers recommend use of a detergent for cleaning their products. 7. Bacterial endotoxin contamination of ultrasonic cleaners is highly probable if they are not properly emptied, cleaned, disinfected, rinsed, and dried at least daily and preferably after each use. 8. If tap water is approved by the detergent and instrument manufacturers for rinsing, always use sterile distilled or sterile deionized water for the final rinse to prevent TASS. 9. Exotoxins, released as a result of cell destruction during the cleaning and sterilizing, have not been linked to TASS. 10. Preventive maintenance of equipment like sterilizers, ultrasonic cleaners, water filtration systems, and boilers is not useful to help prevent TASS. Introduction Toxic Anterior Segment Syndrome (TASS), a.k.a. toxic endothelial cell destruction, is a non-infectious inflammation after an uncomplicated and uneventful eye surgery. TASS is an early postoperative complication of anterior chamber surgery. The anterior segment is located between the lens and the cornea the area targeted in cataract surgeries. 1 A cataract is a clouding of the eye s lens that affects vision. Most cataracts are related to aging and by age 80, more than half of all Americans either have a cataract or have had cataract surgery. 2 Archaeological findings attest to primitive operations performed by the early Chinese, Romans and Greeks. Deliberate blows to the head or insertion of metal needles into the eye were used to dislodge cataracts so that light could again penetrate into the eye. 3 Many thanks to the team at 3M Health Care for working with Managing Infection Control to provide the following accredited course. IAHCSMM has awarded one (1) contact point for completion of this continuing education lesson toward IAHCSMM recertification. The CBSPD has preapproved this inservice for one (1) contact hour for a period of five (5) years from the date of publication, and to be used only once in a recertification period. This inservice is 3M Health Care Provider approved by the California Board of Registered Nurses, CEP 5770 for one (1) contact hour. This form is valid up to five (5) years from the date of publication. Instructions for submitting results are on page 84. Managing Infection Control and 3M Health Care will be working collaboratively to provide continuing education courses in monthly editions of Managing Infection Control. 70 MANAGING INFECTION CONTROL

3 While these methods were crude by today s standards, the ancients were on the right track. The only effective treatment for cataracts is surgery to remove the clouded lens. Today s surgeons can also replace it with a clear lens implant. Surgery is recommended when cataracts begin to interfere with a person s ability to perform normal daily activities. The frequency of cataract surgery is expected to increase as baby boomers age. 4 The Centers for Disease Control and Prevention (CDC) reports that more than 3.1 million cataract procedures were performed in the United States during outpatient surgery in Cataract surgery is successful in 90 percent to 95 percent of all cases. How often, then, does TASS occur? Data on the incidence of TASS are lacking, but a North American database collects voluntary data to track outbreaks that appear to be more widespread since The Association of perioperative Nurses (AORN s) 2009 edition of Perioperative Standards and Recommended Practices notes that in 2005 more than 300 cases of TASS associated with endotoxin-contaminated balanced salt solutions were reported to the U.S. FDA, leading to recall of the product. 6 More than 100 North American clinics reported TASS over a 4-month period in In 2008 it was reported that clusters ranging from a few cases to up to 20 cases occur several times each year in the United States. 1 Sometimes surgery centers must close until the cause(s) are identified and appropriate changes are made. This has happened in both the United States and Canada. 8.9 Table 1: Categories and Examples of Substances Implicated in TASS Outbreaks1 Categories Extraocular Substances inadvertently entering the anterior chamber during or after surgery: Products introduced into the anterior chamber during the surgical procedure: Irritants on the surfaces or inside lumens of surgical instruments used for anterior chamber procedures: Examples Topical antiseptics; Talc from surgical gloves; Ophthalmic ointments. Anesthetics like lidocaine 2%; Preservatives like benzalkonium chloride; Inappropriately reconstituted intraocular preparations; Mitomycin-C; Intraocular lenses (IOLs); Contaminated irrigating solutions. Denatured viscosurgical devices; Enzymatic detergents; Bacterial endotoxin residue from ultrasonic cleaners; Impurities of autoclave steam; Oxidized metal deposits and residues. The most effective way to prevent TASS is to increase awareness of its multi-faceted causes in all members of the healthcare team. Causes of TASS Investigations have shown that TASS is caused by substances that are foreign to the anterior chamber and cause toxic, rather than infectious, reactions. Three general categories of substances show up in the literature review of TASS cases. They include extraocular substances that inadvertently get into the anterior chamber during or after surgery, products introduced into the anterior chamber during the surgical procedure, and irritants on the surfaces of surgical instruments used for the procedure. Table 1 provides examples of these toxins. 1 Developing TASS Awareness and Implementing a Facility-wide Prevention Strategy The most effective way to prevent TASS is to increase awareness of its multi-faceted causes in all members of the healthcare team. Recommended practices, guidelines, and notifications related to reprocessing and preventing TASS outbreaks exist and are published by these professional associations and U.S. Government agencies: American Society for Cataract Refractive Surgery ( American Society of Ophthalmic Registered Nurses ( Association for the Advancement of Medical Instrumentation ( Association of perioperative Registered Nurses ( International Association of Healthcare Central Service Materiel Management ( Centers for Disease Control and Prevention ( Food and Drug Administration ( 72 MANAGING INFECTION CONTROL

4 This article organizes and summarizes recommended practices and suggestions to facilitate interdepartmental discussions and assist in updating policies and procedures. TASS cases can be reduced through facility-wide awareness and education. Infection Control Early recognition of the symptoms of TASS is directly tied to the prognosis and recovery. Delays in treatment can result in vision loss or the need for additional surgery. Symptoms of TASS that differentiate it from an infectious process include: 1. A reduction in visual acuity due to corneal edema and accumulation of white cells in the anterior chamber of the eye occurring within hours after surgery. 2. By contrast, symptoms of an infectious process generally appear hours post-operatively. 3. TASS is not bacterial and cultures will be negative. 4. Patients with TASS may be pain-free or have only mild pain. 5. Pupils are dilated and intraocular pressure may increase suddenly. 6. If initially treated as an infection, the symptoms of TASS do not respond to antibiotics. 1 The most common treatment for TASS is use of topical steroids to decrease inflammation, given in an intense hourly regime, for several days. Sometimes oral steroids are also prescribed. 10 Milder cases resolve within a few days to one to three weeks, but after five weeks, more dire consequences are likely. Recovery prognosis ranges from good to very poor as the inflammatory response to the toxins has the potential to cause serious damage to intraocular tissues. In severe cases TASS leads to a torn or detached retina, a form of glaucoma, a permanently dilated pupil and vision loss. 11,15 Surgery What are the responsibilities of surgery personnel to prevent TASS? Verify expiration dates and product packaging integrity for all irrigating solutions, drugs and intraocular devices prior to their use for surgical procedures. Several references cite an increased risk of TASS when instruments (including cannulas) are reused quickly between cases and the proper time is not available for thorough cleaning and rinsing prior to sterilization. 8,9,12,15 Develop a plan to provide adequate instruments so that flash sterilization is not routinely practiced. Both AORN and American Society for Cataract Refractive Sugery (ASCRS) caution against flash sterilization, as it shouldn t be used to save time or be a substitute for having sufficient inventory to handle the day s caseload. 6,13 During the surgical procedure intraocular instruments should be managed with these best practices: 1. Do not allow ophthalmic viscosurgical device solutions (OVDs) to dry on instruments; these solutions harden within minutes, making cleaning extremely difficult. 6,12 2. Wipe instruments in use with a damp, lint-free cloth and flush and/or immerse them in sterile water in the operating room (OR) immediately after use. 6,12 3. Keep the organic material on instruments moist to prevent biofilm formation. Biofilm adheres to the surfaces of instruments and is very difficult to remove Flush phacoemulsifier handpieces, irrigators, aspirators, and their accessories before disconnecting the handpiece from the unit to prevent occluded tips that have been implicated as a potential cause of TASS. 6,12 5. Use disposable cannulas and tubing whenever possible. 6,12 6. Devices labeled single use should be used only once or reprocessed in accordance with FDAvalidated methods. 6,12 7. Use only preservative-free epinephrine. 6,12 Monitor all materials placed into the eye during surgery (anesthetics, OVDs, antibiotics or other medications) as they have been associated with TASS ASCRS recommended practice states that all instruments opened for the procedure should be transported from the OR in a closed container to the decontamination area where immediate cleaning (separate from other nonophthalmologic instruments) must take place. 12 Sterile Processing The Association for the Advancement of Medical Instrumentation Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities, ANSI/ AAMI ST79:2006/A1:2008 notes in Annex N that many of the reprocessing issues related to TASS outbreaks have occurred due to improper processing methods and 74 MANAGING INFECTION CONTROL

5 procedures that are not in alignment with recommended practices. Intraocular instruments are complex, delicate, and many can not be processed by automated methods. This means that manual cleaning is the preferred processing method Receiving Intraocular Instruments in Decontamination: a. Once dedicated closed containers of intraocular instruments are received in the decontamination area do not co-mingle them with other types Cleaning and Rinsing Recommendations: a. Always consult the instrument manufacturers for written cleaning procedures and acceptable cleaning products. 12 b. Immediate cleaning, separate from other nonophthalmologic instruments, must take place so that viscoelastic solutions do not harden on or in the lumens of instruments. 6,12 c, Clean intraocular lens injectors/inserters carefully as residues in the injector can be inserted into the next patient s eye chamber and cause TASS. 6 d. Single-use syringes and brushes are recommended to clean ophthalmic instruments; they should be discarded after each use. 12 e. If you use reusable cleaning tools, understand that they may harbor various contaminants that can be reintroduced during cleaning of subsequent instruments. All reusable cleaning tools must, themselves, be cleaned and high-level disinfected or sterilized, preferably after each use or, at a minimum, daily. 12 f. Some ophthalmic instrument manufacturers may not recommend use of any detergent for cleaning their products; do not assume that the products you use for other instruments are recommended for ophthalmic instruments. 6,15 g. Use enzyme-formula cleaners only in accordance with the instrument and chemical manufacturers directions. Some enzymatic detergents contain subtilisin, an exotoxin that is not inactivated by autoclaving and causes inflammation, edema and potential corneal damage. 11 h. Following cleaning, instruments must be thoroughly rinsed with copious volumes of water to remove all chemicals from all surfaces. CDC notes that failure to adequately clean instruments results in higher bioburden, protein load, and salt concentration that interferes with sterilization. 16 Consider any rinse volumes recommended by the detergent or instrument manufacturers to be minimum rinse volumes. 12 i. Rinsing procedures should flow/flush water over/ through the instruments and discard it into a sink or separate basin so that the fluid is never reused during the rinsing process. 6 j. If tap water is approved for rinsing by the detergent and instrument manufacturers always use sterile distilled or sterile deionized water for the final rinse. 12 In 2008 a Spanish hospital implicated tap water final rinses as the cause of their five-patient TASS outbreak. 17 k. Agitation in a basin of water is not adequate for a final rinse. 12 l. Instruments with lumens should be fully flushed with sterile water and dried with filtered forced or compressed air that is free of oil and water. 6,12 m. AORN recommends that manually-cleaned instruments be wiped with alcohol to disinfect and render them safe to handle Using an Ultrasonic Cleaner: Concerns with using ultrasonic cleaners for intraocular instruments stem from the high probability of bacterial endotoxin contamination discovered in some TASS outbreaks. 6,8 If you decide to continue to use an ultrasonic cleaner follow these best practices: a. Use only ultrasonic cleaners designated for cleaning medical instruments. 12 b. Use only EPA-registered disinfectants, facilityapproved for instruments, and suitable for use in ultrasonic cleaners; their use must also be approved by the instrument manufacturer. 12 c. Properly empty, clean, disinfect, rinse, and dry the ultrasonic with a lint-free cloth, preferably after each use or at least daily. If not contraindicated by the manufacturer, an alcohol rinse is also recommended. 12 d. Check the manufacturer s reprocessing instructions before putting intraocular instruments into an ultrasonic cleaner, as some may not be compatible with the process. 12 e. Remove gross soil from instruments prior to using an ultrasonic cleaner. 12 f. Refill the ultrasonic just prior to use so that the water does not sit for long periods of time; do not put nonophthalmologic instruments into the ultrasonic at the same time it is used for eye instruments. 12 g, Endotoxins, released by certain gram negative bacteria when these cells are destroyed, must be thoroughly removed by rinsing after the cleaning cycle. 6,12 h. Instruments with lumens should be fully flushed with sterile water and dried with filtered forced or compressed air that is free of oil and water. 2 i. AORN recommends that instruments should be wiped with alcohol after ultrasonic cleaning to disinfect and render them safe to reassemble MANAGING INFECTION CONTROL

6 j. Validation of the functioning, degassing and preventive maintenance of ultrasonic cleaners is required Instrument Inspection and Assembly: a. Review use of water-soluble instrument lubrication as it may not be appropriate for intraocular instruments. Any milk bath residuals in the cannula lumens may be toxic when injected into the anterior chamber. Milk bath can grow gram-negative bacteria when left unchanged for an extended time. Upon sterilization the heat-stable endotoxins may cause TASS. 10 b. After cleaning and disinfection, instruments that have contacted viscoelastic material should be inspected under good lighting and magnification. 6 OVDs remaining in reusable cannulas may become denatured during sterilization and may be injected into the next patient s eye. 10 c. Instruments that have oxidized metal deposits and residues have been implicated in TASS outbreaks. 8 Inspection with magnification can assist in identifying instruments with rust or corrosion; remove them from inventory as they cannot be safely sterilized or used in this condition. d. All materials used in intraocular surgery or instrument management must be chemical, residue and lint-free. 6,12 5. Sterilization concerns: When it comes to anterior chamber surgery it s not enough to merely kill bacteria. The endotoxins released when the bacteria are lysed must be broken down or they can cause irritation. Residues from sterilization processes have been implicated in TASS. 1,15,18 When quick turn-around of sub-optimal instrument inventories occurs, inadequate time for proper cleaning and sterilization may result. 6,15 a. Glutaraldehyde is not recommended for sterilizing intraocular instruments due to highly toxic residues that can result from inadequate rinsing. 12 In 2006 a Turkish hospital reported a TASS outbreak related to cold sterilization with 2% glutaraldehyde in the OR. The affected corneas did not heal and subsequent surgical procedures were required for six patients. 19 b, Low temperature sterilization must be approved by the ophthalmic instrument manufacturer. 12,13 In 2000, gas plasma sterilization degraded brass-containing instruments implicated in a TASS outbreak. 12 c. Monitoring of sterilizer function should be completed in accordance with the sterilizer manufacturer s instructions and published recommended practice guidelines, and be appropriately documented. 6,12,13,16 d, Flash sterilization is not recommended 6,12,15 but still occurs as a substitute for maintaining sufficient inventories; budget for appropriate instruments so that flashing or short cycle sterilization is not required for turnaround of eye cases. 12,15 Supply Chain (Purchasing/Value Analysis/ Materials Management) As previously mentioned, contaminated ophthalmic solutions have been linked to TASS. Even brand-name suppliers are outsourcing production these days and do not have direct control over manufacturing processes. The root of a contaminated solution may be several steps down the industrial supply chain. 15 The Federal Register of announced enforcement action starting in Nov against unapproved ophthalmic balanced salt solutions due to increasing numbers of adverse events reported to the FDA. 20 Check this notice to ensure that the products you are using are FDA approved. If current products have yielded good results, there may be reluctance to substitute new brands. A new product evaluation checklist for ophthalmic products/ solutions and drugs might include a note to check proposed manufacturers recall/product alert histories. Purchase quality products from quality companies; be alert to recalls; and check the solution specifications with OR prior to changing brands. Ophthalmic pharmaceuticals deserve special attention. Generic medications must be scrutinized for different preservatives or other chemicals from the brandname counterparts, because any dissimilar compounds could cause inflammation. 10 Expiration dates must be verified on all incoming ophthalmic products, per quality control procedures. 78 MANAGING INFECTION CONTROL

7 By investigating suspected TASS cases Risk Managers help the organization uncover mitigating circumstances by reviewing all aspects of the issue. They work with the team to identify deviations from recommended practices; implement procedural changes; document them, and monitor the results of procedural changes. Risk managers also may provide training to hospital staff to help reduce future incidents. Voluntary reporting of any TASS cases to the database on helps to track this complex phenomenon. Commercial products implicated in a TASS outbreak are reported to the FDA; go to TASS also may be a reportable incident to your state health department. Facilities Engineering Awareness of TASS by the healthcare engineers is important. TASS is linked to foreign materials like heavy metals, chemical contaminates and impurities in the water and steam which can be deposited on instruments during processing in automated equipment. ANSI/AAMI ST79:2006/A1:2008, Annex N, provides a summary of the approach to preventive maintenance that may be helpful in preventing TASS: 1. Complete proper maintenance of equipment like sterilizers, ultrasonic cleaners, water filtration systems, and boilers. 2. Consult equipment manufacturers operations manuals for maintenance activities and monitoring frequency. 3. Use only qualified personnel to complete preventive maintenance. 4. Document all maintenance activities. 13 Engineering can greatly assist areas which have sterilizers by providing notification of boiler chemical treatment. This allows them to run several empty cycles to flush out chemicals and contaminants from steam lines prior to sterilizing medical devices. Risk Management Risk Management seeks to prevent liability through a process of education, feedback, and early response. 21 Risk Managers investigate incidents to determine if there is any liability exposure on the part of the hospital/organization. Their role in monitoring manufacturer s recalls and FDA communications via public health alerts is helpful to other team members. Risk Managers help increase awareness by disseminating information received on products and devices associated with TASS outbreaks. Education Education, competency validation and periodic performance reviews are required for anyone handling intraocular instruments; document this as you would for other training. 12,13,16 When new devices/procedures are introduced, educate and document competency. The ASCRS recommends that all staff involved with handling eye instrumentation be educated about TASS upon hiring and included in updates. 12 The Recommended practices for cleaning and sterilizing intraocular surgical instruments, developed by the ASCRS/ASORN task force on TASS is available at no cost at upload/tass_guidelines.pdf. Quality Monitoring A continuous quality monitoring program has long been recommended by AAMI. 13 While specifics are left up to the organization, all phases of instrument reprocessing must be monitored. Cases of TASS should prompt immediate re-evaluation of cleaning and sterilizing procedures. 12 Facilities that have not experienced the intensity and expense of investigating suspected TASS usually lack a surveillance system for it. Don t be caught in this dilemma; once procedures are up-to-date for all departments consider developing a TASS surveillance tool for your organization. Documentation of policies/procedures related to surgical instrument reprocessing is already required or recommended by many agencies. 6,12,13,16 Here are a few key points that can help prevent TASS: 1. Since a variety of eye instruments require cleaning based on the manufacturers recommendations keep updated documentation readily accessible. 12,13,16 2. AAMI suggests designating an individual to be responsible for collecting and documenting current recommendations for processing intraocular instruments Reprocessing staff should understand the specifics of intraocular instrument processing; document competency and annual skills reviews. 12,13,16 80 MANAGING INFECTION CONTROL

8 4. Document sterilizer monitoring in accordance with recommended practices. 6,12,13,16 A Korean hospital concluded that ineffective sterilization of eye instruments caused 15 patients to develop TASS in Monitor steam quality; the sterile processing department (SPD) and OR must be aware of annual boiler maintenance chemical treatment so that steam lines can be properly flushed prior to re-using the sterilizers. 12 A Florida hospital implicated steam impurities (sulfates, copper, zinc, nickel and silica) in their improperly maintained autoclaves in the outpatient surgical center as the cause of a TASS outbreak in AORN recommends that records should be maintained of all cleaning methods, detergent solutions and lot numbers of cleaning solutions. These records can be used to help investigate any suspected or confirmed cases of TASS. 6 Summary Because so many different factors are implicated in TASS it is vital that each person understand the implications of their role and follow best practices. The experience gained by investigators in TASS outbreaks challenges some previously accepted cleaning practices. Identifying toxins as a cause for patient injury during cataract surgery brings new focus to the need for meticulous removal of organics, cleaning products and other potential toxins. Obtain the manufacturers latest recommendations for intraocular instrument re-processing, and then develop best practices. Everyone responsible for handling ophthalmic instruments must be aware of TASS-related issues. It is not enough for the surgeon and OR team to be informed about TASS; all associated personnel must be aware of this emerging issue to help prevent it. Documenting training and skills competency annually reinforces the importance of each person s role in preventing TASS outbreaks. Glossary of Terms Balanced salt solution: A sterile isotonic irrigating solution made to a physiological ph and salt concentration, used during intraocular surgery to temporarily replace intraocular fluids. 20 Bioburden: The degree of microbial load; the number of viable organisms contaminating an object. 6 Biofilm: A thin coating containing biologically active organisms with the ability to grow in water and water solutions. They coat the surface of structures such as cannulas and instruments and, by becoming entrapped with the organic matter, protect themselves from destruction by antimicrobial agents. 6 Cataract: A clouding of the lens in the eye that affects vision. A cataract can occur in either or both eyes, but cannot spread from one eye to the other. 2 Endotoxin: A toxin produced by certain bacteria and released upon destruction of the bacterial cell. 6 Exotoxin: A soluble protein excreted by microorganisms like bacteria, fungi, algae and protozoa. Both gram negative and gram positive bacteria produce exotoxins. They are highly potent and can cause major damage to the host. Exotoxins may be released during lysis of the cell. 23 Phacoemulsification or phaco: The preferred method of performing cataract surgery, it s also called small incision cataract surgery. It uses a machine with an ultrasonic hand piece equipped with a titanium or steel tip. A small incision is made on the side of the cornea. A tiny probe is inserted into the eye that emits ultrasound waves to soften and break up the lens so that it can be removed by suction. 2 Viscoelastic: gels injected into the anterior chamber during ophthalmic surgery to maintain the depth of the chamber, protect the corneal endothelium, and stabilize the vitreous. 6 References 1. Al-Ghoul AR, Charukamnoetkanok P, Dhaliwal DK. Toxic Anterior Segment Syndrome updated Feb.14, medscape.com/article/ overview Elliott, J. The Romans carried out cataract ops. co.uk/mpapps /pagetools/print/news.bbc.co.uk/2/hi/health/ stm 4. treatments-and-drugs 5. CDC Online Newsroom Press Release January 28, Perioperative Standards and Recommended Practices, 2009 edition. Denver, CO: AORN, Inc; 2009: Holland SP, Morck, DW, Lee TL. Update on toxic anterior segment syndrome. ttp://unboundmedicine.com/medline/ebm/record/ MMWR Morb Mortal Wkly Rep. 2007:56(25): Davis B, Mamalis, N. Averting TASS. com/03_archive/0203/041.html 11. Parikh CH, Edelhauser HF. Ocular surgical pharmacology: corneal endothelial safety and toxicity. Current Opinion in Ophthalmology 2003; 14: American Society of Cataract and Refractory Surgery. Recommended practices for cleaning and sterilizing intraocular surgical instruments. J Cataract Refract Surg 2007; 33: Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities, Association for the Advancement of Medical Instrumentation, ANSI/AAMI ST79:2006/A1: American Society of Cataract and Refractive Surgery & American Society of Ophthalmic Administrators, Memorandum to: ASCRS Members URGENT COMMUNICATION, April Amorphousanatomyof.pdf 16. Centers for Disease Control. Guideline for Disinfection and Sterilization in Healthcare Facilities, Sarobe Carricas M, Segrelles Bellmunt G, Jimenez Lasanta L. Toxic anterior segment syndrome (TASS) studying an outbreak. unboundmedicine.com/medline/ ebm/ record/ Hellinger WC, Hasan SA, Bacalis LP, et al. Outbreak of toxic anterior segment syndrome following cataract surgery associated with impurities 82 MANAGING INFECTION CONTROL

9 in autoclave steam moisture. Infect. Control Hosp Epidemiol 2006:27: Unal M, Yucel I, Oner A. Outbreak of toxic anterior segment syndrome associated with glutaraldehyde after cataract surgery. unboundmedicine. com/medline/ebm/record/ Federal Register. Tuesday, September 23, 2008/Notices.73:185: Choi JS, Shyn KH. Development of toxic anterior segment syndrome immediately after uneventful phaco surgery. unboundmedicine.com/medline/ebm/ record/ Wikipedia. health/article.asp Sterile Process and Distribution CEU Information CEU Applicant Name Address City State Zip Code The CBSPD (Certification Board for Sterile Processing and Distribution) has pre-approved this inservice for one (1) contact hour for a period of five (5) years from the date of publication. Successful completion of the lesson and post test must be documented by facility management and those records maintained by the individuals until recertification is required. DO NOT SEND LESSON OR TEST TO CBSPD. For additional information regarding Certification contact: CBSPD, Inc. 148 Main St., Lebanon, NJ or call or visit the Web site at www. sterileprocessing.org. IAHCSMM has awarded one (1) Contact Point for completion of this continuing education lesson toward IAHCSMM recertification. Cynthia Hubbard, RN, BS, is a published author and independent nurse consultant. She has worked in the healthcare industry for more than 30 years, including positions in ER nursing, occupational health nursing, materials management, and sterile processing management at Saint Mary Hospital, Mayo Clinic in Rochester, Minn. Ms. Hubbard was a design consultant on national and international construction projects related to sterile processing, materials and waste management for 14 years with the Lerch Bates Hospital Group of Littleton, Colo. After moving to Washington State in 2003 Cynthia served as the sterile processing manager at Sacred Heart Medical Center in Spokane during their surgical building addition. She is a fellow member and served on the ASHCSP Board of Directors and received their Educator of the Year Award. Nursing CE Application Form This inservice is approved by the California Board of Registered Nurses, CEP 5770 for one (1) contact hour. This form is valid up to five years from the date of publication. 1. Make a photocopy of this form. 2. Print your name, address and daytime phone number and position/title. 3. Add the last 4 digits of your social security number or your nursing license number. 4. Date the application and sign. 5. Answer the true/false CE questions. KEEP A COPY FOR YOUR RECORDS. 6. Submit this form and the answer sheet to: Workhorse Publishing Managing Infection Control PO Box 25310, Scottsdale, AZ For questions or follow-up, contact craig@manageinfection.com. 8. Participants who score at least 70% will receive a certificate of completion within 30 days of Managing Infection Control s receipt of the application. Application Please print or type. Name Mailing Address City, State, Country, Zip Daytime phone ( ) Position/Title Social Security or Nursing License Number Date application submitted ANSWERS 1. B 2. A 3. A 4. A 5. A 6. B 7. A 8. A 9. B 10. B Signature Offer expires July 2014 On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this program for the following: 1) Overall content 2) Met written objectives 3) Usability of content Reprint with permission from Workhorse Publishing L.L.C. Copyright 2009/Workhorse Publishing L.L.C./All Rights Reseved. <07/09> MANAGING INFECTION CONTROL

Water for Instrument Processing

Water for Instrument Processing Water for Instrument Processing by Marcia Frieze, Case Medical Water, the universal solvent Water can dissolve more substances than any other liquid. It is essentially nonionic or neutral. While alkaline

More information

Review Article. Toxic anterior segment syndrome Moudgil T 1, Bansal Y 2

Review Article. Toxic anterior segment syndrome Moudgil T 1, Bansal Y 2 Toxic anterior segment syndrome Moudgil T 1, Bansal Y 2 Review Article 1 Dr Tania Moudgil Associate Professor vishalmoudgil1980@gmail.com 2 Dr Yashi Bansal Assistant Professor dryashibansal@gmail.com 1,2

More information

Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes Webinar FAQ

Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes Webinar FAQ Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes Webinar FAQ Disclaimer: The Society of Gastroenterology Nurses and Associates, Inc. assume no responsibility for the

More information

Best Practices for High Level Disinfection Part I

Best Practices for High Level Disinfection Part I Best Practices for High Level Disinfection Part I Nancy Chobin, RN, AAS, ACSP, CSPM, CFER 2017 Sterile Processing University, LLC. **This in-service has been Approved by the CBSPD for 1.5 CEUs. The Bible

More information

Best Practices for Reprocessing Endoscopes

Best Practices for Reprocessing Endoscopes Best Practices for Reprocessing Endoscopes Reprocessing of Endoscopes Reprocessing Room Standards The resources referenced include: Canadian Standards Association Provincial Infectious Disease Advisory

More information

Choose a category. You will be given the answer. You must give the correct question. Click to begin. Instructions for using this template.

Choose a category. You will be given the answer. You must give the correct question. Click to begin. Instructions for using this template. Instructions for using this template. Remember this is Jeopardy, so where I have written Answer this is the prompt the players will see, and where I have Question should be the player s response. To enter

More information

Christina Bradley Endoscope Decontamination A Webber Training Teleclass. Christina Bradley

Christina Bradley Endoscope Decontamination A Webber Training Teleclass. Christina Bradley ENDOSCOPE DECONTAMINATION Christina Bradley Hospital Infection Research Laboratory City Hospital NHS Trust Dudley Road, Birmingham B18 7QH Hosted by Paul Webber paul@webbertraining.com www.webbertraining.com

More information

Competency Guide: Care and Handling of Rigid Endoscopes

Competency Guide: Care and Handling of Rigid Endoscopes Competency Guide: Care and Handling of Rigid Endoscopes This document details the basic steps to correctly process and maintain a rigid endoscope. This document can be used to perform a competency review

More information

Guide for Cleaning, Sterilization and Storage of Introducers for Caldera Medical Implants

Guide for Cleaning, Sterilization and Storage of Introducers for Caldera Medical Implants Guide for Cleaning, Sterilization and Storage of Introducers for Caldera Medical Implants M Manufactured by: Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 U.S. Toll Free: 866-4-CALDERA

More information

One such problem is blood residual inside the channels of a robotic arm.

One such problem is blood residual inside the channels of a robotic arm. SUBJECT: Robotic Arm Testing for residue blood DEPARTMENT: Central Service APPROVED BY: EFFECTIVE: REVISED: 07/2016 PURPOSE: To test for detection of blood residue inside and outside of a robotic arm and

More information

Unloading, Storage, Distribution, Transportation and Aseptic Presentation of Sterile Items

Unloading, Storage, Distribution, Transportation and Aseptic Presentation of Sterile Items Unloading, Storage, Distribution, Transportation and Aseptic Presentation of Sterile Items Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2006)

More information

Chemical Sterilants and High-Level Disinfectants: Managing Practical, Safe and Effective Use

Chemical Sterilants and High-Level Disinfectants: Managing Practical, Safe and Effective Use Chemical Sterilants and High-Level Disinfectants: Managing Practical, Safe and Effective Use by Donald P. Satchell, Ph.D. Objectives After completion of this self-study activity, the learner will be able

More information

If All Else Fails Read the Directions. Disclosure. Manufacturer s Instructions. Presenter: Sue Lafferty CHICA Canada Conference, May 2010

If All Else Fails Read the Directions. Disclosure. Manufacturer s Instructions. Presenter: Sue Lafferty CHICA Canada Conference, May 2010 If All Else Fails Read the Directions The Importance of Medical Device Manufacturer s Instructions Presenter: Sue Lafferty CHICA Canada Conference, May 2010 Disclosure Member of 3M Canada Speakers Bureau:

More information

Sterile Compounding elearning Course Curriculum 28 lessons with 33 hours of CE. Fundamentals of Sterile Compounding (8 lessons/8 hours CE)

Sterile Compounding elearning Course Curriculum 28 lessons with 33 hours of CE. Fundamentals of Sterile Compounding (8 lessons/8 hours CE) Sterile Compounding elearning Course Curriculum 28 lessons with 33 hours of CE CriticalPoint s Sterile Compounding elearning curriculum is written by industry experts and covers both Chapter and

More information

Is contamination of bronchoscopes really a problem?

Is contamination of bronchoscopes really a problem? Is contamination of bronchoscopes really a problem? 1 Is contamination of bronchoscopes really a problem? High Level Disinfection does not methodically clean bronchoscopes What we know 210 More than 210

More information

What Dentistry Can Learn from AAMI ST79. Best Practices for device and instrument reprocessing

What Dentistry Can Learn from AAMI ST79. Best Practices for device and instrument reprocessing What Dentistry Can Learn from AAMI ST79 Best Practices for device and instrument reprocessing Learning goals: Purpose and goals of AAMI organization. Overview of ST79. Review selected topics: IFUs, tools

More information

IT S A GLOBAL LEADER. IT S PROVEN.

IT S A GLOBAL LEADER. IT S PROVEN. isert Preloaded IOL System IT S A GLOBAL LEADER. IT S PROVEN. IT S isert. isert delivers the combination of simple operation, outstanding visual quality, and procedural efficiency. LEADERSHIP, WITH VISION

More information

3M s Sterilization Tech Line FAQs Sandra Velte, BA, CSPDT

3M s Sterilization Tech Line FAQs Sandra Velte, BA, CSPDT 3M Sterile U Sterilization Assurance Continuing Education 3M s Sterilization Tech Line FAQs Sandra Velte, BA, CSPDT May 2013 Objectives After completion of this self-study activity, the learner will be

More information

Updates to AAMI s ST79 Steam Sterilization Standard Tuesday, January 15, :00 noon 1:30 pm Eastern

Updates to AAMI s ST79 Steam Sterilization Standard Tuesday, January 15, :00 noon 1:30 pm Eastern Updates to AAMI s ST79 Steam Sterilization Standard Tuesday, January 15, 2013 12:00 noon 1:30 pm Eastern Martha Young, MS, BS, CSPDT Martha L. Young, LLC marthalyoung1@aol.com Updates to AAMI s ST79 Steam

More information

Packaging for Sterilization

Packaging for Sterilization Packaging for Sterilization IT S NOT JUST A BOX, A BAG OR GIFT WRAPPING! by Rose Seavey, RN, BS, MBA, CNOR, ACSP Objectives After completion of this self-study activity, the learner will be able to: 1.

More information

OPHTHALMOLOGY FIELD ADVISORY COMMITTEE MEETING Virtual Teleconference October 20, :00 PM 3:00 PM EST

OPHTHALMOLOGY FIELD ADVISORY COMMITTEE MEETING Virtual Teleconference October 20, :00 PM 3:00 PM EST OPHTHALMOLOGY FIELD ADVISORY COMMITTEE MEETING Virtual Teleconference October 20, 2017 12:00 PM 3:00 PM EST Reference/Issue 1:00 Pharmacy EST Dr. Linda Margulies Discussion Guests: Deb Khachikian, PharmD,

More information

USP <797> Compliance Common Challenges and Potential Solutions

USP <797> Compliance Common Challenges and Potential Solutions USP Compliance Common Challenges and Potential Solutions Angela Yaniv, Pharm.D Assistant Director - Sterile Products May 2, 2017 - OSHP Annual Meeting Angela Yaniv has no actual or potential conflict

More information

Sterilization & Disinfection

Sterilization & Disinfection Sterilization & Disinfection Prof. Hanan Habib College of Medicine-KSU Objectives 1- Define the terms sterilization, disinfectant and antiseptic. 2- Classify the different methods of sterilization (physical

More information

Sterilization and Disinfection: Getting It Right. Instructions

Sterilization and Disinfection: Getting It Right. Instructions Sterilization and Disinfection: Getting It Right Instructions 1. Print the document. Read the activity and record your answers to the post test questions on the answer sheet. 2. A score of 80 is required

More information

LABORATORY WASTE MANAGEMENT PROGRAMMES

LABORATORY WASTE MANAGEMENT PROGRAMMES LABORATORY WASTE MANAGEMENT PROGRAMMES Sylvia Wanjiru Kamau INTERNATIONAL LIVESTOCK RESEARCH INSTITUTE LABORATORY MANAGEMENT AND EQUIPMENT OPERATIONS WORKSHOP. 17 TH -21 ST JUNE 2012 TRAINING OBJECTIVES

More information

The Role of Cleaning and Sterilization in Infection Control:

The Role of Cleaning and Sterilization in Infection Control: CE ONLINE The Role of Cleaning and Sterilization in Infection Control: A Focus on Powered Surgical Instruments A Continuing Education Activity Sponsored By Grant Funds Provided By Welcome to The Role of

More information

Guidelines for the Cleaning and Sterilization of Intraocular Surgical Instruments. Ophthalmic Instrument Cleaning and Sterilization (OICS) Task Force

Guidelines for the Cleaning and Sterilization of Intraocular Surgical Instruments. Ophthalmic Instrument Cleaning and Sterilization (OICS) Task Force Guidelines for the Cleaning and Sterilization of Intraocular Surgical Instruments Ophthalmic Instrument Cleaning and Sterilization (OICS) Task Force Co-chairs: David F. Chang, MD, Nick Mamalis, MD OICS

More information

Sterilization Packaging Systems, Preparation and Loading for Steam Sterilization

Sterilization Packaging Systems, Preparation and Loading for Steam Sterilization Sterilization Packaging Systems, Preparation and Loading for Steam Sterilization by Rose Seavey, RN, MBA, CNOR, ACSP Many thanks to the team at 3M Health Care for working with Managing Infection Contro

More information

Quality is Our Promise.

Quality is Our Promise. Quality is Our Promise. Our goal at KRS Global Biotechnology is to provide the highest quality pharmaceutical preparations. We accomplish this with an unrivaled quality assurance and quality control program

More information

Instructions for Use Reprocessed Balloon Inflation Devices

Instructions for Use Reprocessed Balloon Inflation Devices Reprocessed by Instructions for Use Reprocessed Balloon Inflation Devices Reprocessed Device for Single Use Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

More information

Sterilization of Schweickhardt Instruments

Sterilization of Schweickhardt Instruments Sterilization of Schweickhardt Instruments INTRODUCTION l Most dental instruments are made of corrosion-resistant highgrade steels. The requirements for grades of steel are defined in national and international

More information

Policies Concerning Survival Surgery of Mice

Policies Concerning Survival Surgery of Mice Policies Concerning Survival Surgery of Mice Date approved: October 25, 2016 Purpose This document details the minimum standards for survival (recovery) surgery in all laboratory rodent species. Responsibility

More information

2016. All rights reserved.

2016. All rights reserved. DOCUMENT: Future AAMI/ISO 17664, 12 May 2017 Final Draft Standard Sterilization of health care products Information to be provided by the device manufacturer for the processing of medical devices Public

More information

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed physician.

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed physician. TM CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed physician. TABLE OF CONTENTS Section Port Styles 4 Description 5 Indications 5 Contraindications 5-6 Information

More information

ISO INTERNATIONAL STANDARD

ISO INTERNATIONAL STANDARD INTERNATIONAL STANDARD ISO 14161 First edition 2000-10-01 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results Stérilisation des produits

More information

Chapter 8 Control of Microorganisms by Physical and Chemical Agents

Chapter 8 Control of Microorganisms by Physical and Chemical Agents Chapter 8 Control of Microorganisms by Physical and Chemical Agents Why control the microbial activity? Prevention from : Food spoilage and Contamination Pathogen and their transmission Longer preservation

More information

Chapter 7: Control of Microbial Growth

Chapter 7: Control of Microbial Growth Chapter 7: Control of Microbial Growth 1. Physical Methods 2. Chemical methods Important Terminology sterilization > commercial sterilization > disinfection = antisepsis > degerming > sanitization Also,

More information

Important Terminology

Important Terminology Chapter 7: Control of Microbial Growth 1. Physical Methods 2. Chemical methods Important Terminology sterilization > commercial sterilization > disinfection = antisepsis > degerming > sanitization Also,

More information

مادة االدوية املرحلة الثالثة أ.م.د. حسام الدين سامل

مادة االدوية املرحلة الثالثة أ.م.د. حسام الدين سامل مادة االدوية املرحلة الثالثة أ.م.د. حسام الدين سامل 2017-2016 ANTISEPTICS AND DISINFECTANTS Dr. Husam Aldeen Salim General information They have specific use and their selectivity is very low. Disinfectants

More information

ISO Ophthalmic optics Contact lenses and contact lens care products Guidance for clinical investigations

ISO Ophthalmic optics Contact lenses and contact lens care products Guidance for clinical investigations INTERNATIONAL STANDARD ISO 11980 Third edition 2012-11-15 Ophthalmic optics Contact lenses and contact lens care products Guidance for clinical investigations Optique ophtalmique Lentilles de contact et

More information

01.48 Receiving and Processing Vendor Owned Surgical Instrumentation in the Sterile Processing Department

01.48 Receiving and Processing Vendor Owned Surgical Instrumentation in the Sterile Processing Department 01.48 Receiving and Processing Vendor Owned Surgical Instrumentation in the Purpose To provide effective management of and ensure standardization of processing for all reusable surgical instruments that

More information

RIGID ENDOSCOPE OPERATING INSTRUCTIONS

RIGID ENDOSCOPE OPERATING INSTRUCTIONS RIGID ENDOSCOPE OPERATING INSTRUCTIONS Note: Read this manual first. It contains important instructions and warnings concerning the proper assembly, use, and service of your new rigid endoscopy product(s).

More information

2. Describe correct actions to take to address sterilization process failures. 3. List possible causes of sterilization process failures.

2. Describe correct actions to take to address sterilization process failures. 3. List possible causes of sterilization process failures. Objectives 1. Discuss the importance of sterilization process monitoring. 2. Describe correct actions to take to address sterilization process failures. 3. List possible causes of sterilization process

More information

Designing an effective cleaning procedure for medical devices through laboratory studies

Designing an effective cleaning procedure for medical devices through laboratory studies Designing an effective cleaning procedure for medical devices through laboratory studies Elizabeth Rivera Technical Service Specialist STERIS Corporation elizabeth_rivera@steris.com October 2012 Agenda

More information

Products made in Switzerland

Products made in Switzerland Products made in Switzerland HYGIENIC AND MEDICALLY CLEAR DIFFERENT PRODUCTS BUT THE SAME QUALITY LABEL HYGIENIC AND MEDICALLY CLEAR 2 MDD TECHNOLOGIES FOR: 1. Cleaning 2. Disinfection 3. High Level Disinfection

More information

Instructions for use. Reusable surgical instruments. Hersteller:

Instructions for use. Reusable surgical instruments. Hersteller: Hersteller: ROLAN Instruments GmbH Ernst-Thälmann-Str. 50 15859 Storkow / Germany Tel.: 0049 33678 449433 E-Mail: info@rolan-instruments.de Item codes 01-02- 03-04- 05-06- 07-08- 09-10- 11-12- 13-14- 15-16-

More information

GUIDE TO INSPECTIONS OF STERILE DRUG SUBSTANCE MANUFACTURERS

GUIDE TO INSPECTIONS OF STERILE DRUG SUBSTANCE MANUFACTURERS GUIDE TO INSPECTIONS OF STERILE DRUG SUBSTANCE MANUFACTURERS Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any

More information

Technicians & Nurses Program

Technicians & Nurses Program ASCRS ASOA Symposium & Congress Technicians & Nurses Program April 17-21, 2015 San Diego, California Instrument Care and Handling Lori Pacheco, RN, CRNO Clinical Director Cape Cod Eye Surgery and Laser

More information

BIP Central Venous Catheter

BIP Central Venous Catheter Bactiguard Infection Protection BIP Central Venous Catheter For prevention of healthcare associated infections Bactiguard benefits Reduced healthcare costs Reduced use of antibiotics Save lives Bloodstream

More information

The heyelight in ophthalmic surgery MEGATRON

The heyelight in ophthalmic surgery MEGATRON The heyelight in ophthalmic surgery S3 MEGATRON GEUDER Precision made in Germany GEUDER AG is one of the leading manufacturers of ophthalmic surgical instruments and systems in Germany and in the international

More information

Lab Exercise #4 Microbial Control Lab Exercise #4 Control of Microorganisms: Physical, Chemical and Chemotherapeutic

Lab Exercise #4 Microbial Control Lab Exercise #4 Control of Microorganisms: Physical, Chemical and Chemotherapeutic Lab Exercise #4 Control of Microorganisms: Physical, Chemical and Chemotherapeutic I. OBJECTIVES: Investigate the effectiveness various agents of control. Assess the effectiveness of heat in killing vegetative

More information

Biosafety Protocol. Biodesign Swette Center for Environmental Biotechnology Standard Operating Procedures

Biosafety Protocol. Biodesign Swette Center for Environmental Biotechnology Standard Operating Procedures Biosafety Protocol Written by: Diane Hagner 11-4-15 Updated: Sarah Arrowsmith 2-28-17 1 P a g e Purpose The Biodesign Institute Center for Environmental Biotechnology Biosafety Protocol is intended to

More information

FDA Update on Compounding

FDA Update on Compounding FDA Update on Compounding Julie Dohm, JD, PhD Senior Science Advisor for Compounding, Center for Drug Evaluation and Research; Agency Lead on Compounding, FDA Compounding A Snapshot Compounded drugs: Are

More information

ISO/TC 198. Secretariat: ANSI

ISO/TC 198. Secretariat: ANSI DRAFT INTERNATIONAL STANDARD ISO/DIS 17664 ISO/TC 198 Secretariat: ANSI Voting begins on: Voting terminates on: 2016-04-28 2016-07-27 Processing of health care products Information to be provided by the

More information

CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Manufacturer Silony Medical GmbH Leinfelder Strasse 60 70771 Leinfelden-Echterdingen Germany US Representative: Silony Medical Corp. 8200 NW 27TH STR, STE#104, DORAL, FL 33122 USA Phone: +1 305 916 0016

More information

Prevention of Transmission of the Superbug Carbapenem-Resistant Enterobacteriaceae (CRE) during Gastrointestinal Endoscopy

Prevention of Transmission of the Superbug Carbapenem-Resistant Enterobacteriaceae (CRE) during Gastrointestinal Endoscopy Prevention of Transmission of the Superbug Carbapenem-Resistant Enterobacteriaceae (CRE) during Gastrointestinal Endoscopy Sponsored by: Presentation by: Lawrence F. Muscarella, Ph.D. President LFM Healthcare

More information

FREQUENTLY ASKED QUESTIONS IPAC Lapses

FREQUENTLY ASKED QUESTIONS IPAC Lapses FREQUENTLY ASKED QUESTIONS IPAC Lapses Updated: December 15, 2017 Reprocessing in Community Health Care Settings Medication Administration Laboratory Office design/facilities Reprocessing in Community

More information

CMS, FDA and AAMI Requirements for Bicarbonate Systems Made Simple. Compiled January 2012 by AmeriWater Incorporated

CMS, FDA and AAMI Requirements for Bicarbonate Systems Made Simple. Compiled January 2012 by AmeriWater Incorporated CMS, FDA and AAMI Requirements for Bicarbonate Systems Made Simple Compiled January 2012 by AmeriWater Incorporated Background on the Standards FDA, 21 CFR Sec. 876.5820(a) states that hemodialysis systems

More information

AUTOMATED ENDOSCOPE REPROCESSOR. OER-Pro Easy. Fast. Reliable.

AUTOMATED ENDOSCOPE REPROCESSOR. OER-Pro Easy. Fast. Reliable. AUTOMATED ENDOSCOPE REPROCESSOR OER-Pro Easy. Fast. Reliable. Olympus Endoscope Reprocessor The only reprocessor designed by an endoscope manufacturer. The OER-Pro provides high-level disinfection of Olympus

More information

St Boniface Research Centre Winnipeg, Manitoba Canada

St Boniface Research Centre Winnipeg, Manitoba Canada Medical Device Reprocessing: Can we Ban the Biofilm?! St Boniface Research Centre Winnipeg, Manitoba Canada Nancy Olson & Michelle Alfa Dr. Michelle J. Alfa, Ph.D., FCCM Professor, University of Manitoba,

More information

In the Know about.appropriate Use of 3M Attest Rapid Readout Biological Indicators

In the Know about.appropriate Use of 3M Attest Rapid Readout Biological Indicators 3M Attest Sterile U Web Meeting Jan 22, 2009 In the Know about.appropriate Use of 3M Attest Rapid Readout Biological Indicators ww.3m.com/atteststerileuonline 7/15 Modified per Inma s input. SDF Prepared

More information

MINIMUM REQUIREMENTS FOR A VENDOR

MINIMUM REQUIREMENTS FOR A VENDOR MINIMUM REQUIREMENTS FOR A VENDOR When outsourcing the production of sterile products the first step in vendor evaluation is to see if they meet the minimum requirements. We ve developed a group of questions

More information

Your Sterile Processing Partner. Duraholder IPS

Your Sterile Processing Partner. Duraholder IPS Your Sterile Processing Partner Table of Contents Item Page Duraholder Case Study 17 AAMI ST79 Reference 20 Steam Sterilization Efficacy Testing 21 PRODUCT INDEX Product Page Standard Pouches DURA050/100

More information

Comparison of ANSI/AAMI ST-91 Standards, SGNA Standards and AORN Guidelines on Processing Endoscopes March 9, 2017

Comparison of ANSI/AAMI ST-91 Standards, SGNA Standards and AORN Guidelines on Processing Endoscopes March 9, 2017 New guidelines for processing endoscopes, published May 2015 Precleaning AORN 2017 Endoscopy Guideline N/A Review N/A 1. Precleaning; 2. Leak testing; 3. Manual cleaning; 4. Rinse after cleaning; 5. Visual

More information

Cleaning Procedures. These guidelines are intended for Bulk Pharmaceutical Chemicals but almost every word applies to Drug Products

Cleaning Procedures. These guidelines are intended for Bulk Pharmaceutical Chemicals but almost every word applies to Drug Products CLEANING DEVELOPMENT Cleaning Procedures as the FDA See It These guidelines are intended for Bulk Pharmaceutical Chemicals but almost every word applies to Drug Products BPC CLEANING (& Drug Products)

More information

Best Practices for Reprocessing Robotic Instruments

Best Practices for Reprocessing Robotic Instruments Best Practices for Reprocessing Robotic Instruments Nupur Jain Manager, Validation Engineering Services Intuitive Surgical, US Agenda 1. Background on robotic instruments 2. Reprocessing procedure for

More information

Flexible Endoscopes: The A,B,C s of Monitoring Manual Cleaning Efficacy!

Flexible Endoscopes: The A,B,C s of Monitoring Manual Cleaning Efficacy! Flexible Endoscopes: The A,B,C s of Monitoring Manual Cleaning Efficacy! Dr. Michelle J. Alfa, Ph.D., FCCM Medical Director, Clinical Microbiology, Diagnostic Services of Manitoba, Winnipeg, Canada Disclaimers:

More information

Packaging Systems for Central Service Operations

Packaging Systems for Central Service Operations Lesson No. CRCST 132 (Technical Continuing Education - TCE) Sponsored by: by Carol Petro, RN, CRCST, CIS, CNOR OR Educator and Sterile Processing Educator Indiana University Health North Hospital Carmel,

More information

INFECTION PREVENTION PROCESSES 1

INFECTION PREVENTION PROCESSES 1 INFECTION PREVENTION PROCESSES 1 PROCESSING INSTRUMENTS, GLOVES, AND OTHER ITEMS As shown in Figure 1, decontamination is the first step in processing soiled (contaminated) instruments, gloves, and other

More information

Your instruments are a significant investment! Contact us (800) , FAX (314) or for assistance.

Your instruments are a significant investment! Contact us (800) , FAX (314) or  for assistance. Changes in surgical techniques require increased use of intricate instruments/accessories that need routine inspection. Microsurgical instruments for ophthalmology have miniaturized from 10-50% in working

More information

ISO INTERNATIONAL STANDARD

ISO INTERNATIONAL STANDARD INTERNATIONAL STANDARD ISO 14161 Second edition 2009-09-15 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results Stérilisation des produits

More information

Important Terminology (pg )

Important Terminology (pg ) Number of living microbes 10/18/2016 Chapter 9: Control of Microbial Growth 1. Physical Methods 2. Chemical methods Important Terminology (pg. 263-264) sterilization > commercial sterilization > disinfection

More information

CSA Z314 Series Standards Understanding the Standards

CSA Z314 Series Standards Understanding the Standards CSA Z314 Series Standards Understanding the Standards September 10,2013 Ian Pequegnat Where do standards come from? What influences their development The International Organization for Standardization

More information

Instructions for Use Reprocessed Ethicon ENDOPATH XCEL TM Dilating Tip Trocar with OPTIVIEW Technology

Instructions for Use Reprocessed Ethicon ENDOPATH XCEL TM Dilating Tip Trocar with OPTIVIEW Technology Reprocessed by Instructions for Use Reprocessed Ethicon ENDOPATH XCEL TM Dilating Tip Trocar with OPTIVIEW Technology Reprocessed Device for Single Use Caution: Federal (U.S.A.) law restricts this device

More information

Getinge da Vinci Solution

Getinge da Vinci Solution Getinge da Vinci Solution A comprehensive cleaning solution for da Vinci EndoWrist instruments This document is intended to provide information to an international audience outside of the US. Validated,

More information

USP Chapter 823 USP 32 (old) vs. USP 35 (new)

USP Chapter 823 USP 32 (old) vs. USP 35 (new) USP Chapter 823 USP 32 (old) vs. USP 35 (new) Sally W. Schwarz, MS, BCNP Research Associate Professor of Radiology Washington University School of Medicine St. Louis, MO Why USP Chapter ? FDA has

More information

FREQUENTLY ASKED QUESTIONS FOR THE ADVANTAGE

FREQUENTLY ASKED QUESTIONS FOR THE ADVANTAGE FREQUENTLY ASKED QUESTIONS FOR THE ADVANTAGE What is an Automated Endoscope Reprocessor? An Automated Endoscopes Reprocessor (AER) performs all the cycle steps (fresh water preflush, rinsing, disinfection,

More information

PREVENTING WOUND INFECTION BEGINS BEFORE THE PATIENT

PREVENTING WOUND INFECTION BEGINS BEFORE THE PATIENT Lesson No. CRCST 132 (Technical Continuing Education - TCE) Sponsored by: by Carol Petro, RN, CRCST, CIS, CNOR OR Educator and Sterile Processing Educator Indiana University Health North Hospital Carmel,

More information

Health Science Career Cluster Surgical Technician I Course Number:

Health Science Career Cluster Surgical Technician I Course Number: Health Science Career Cluster Surgical Technician I Course Number: 25.44700 Course Description: The goal of this course is to provide fundamental surgical technician skills and knowledge to include the

More information

Cranio-caudal Fixation Unit CC-GE MR10063-CC-GE

Cranio-caudal Fixation Unit CC-GE MR10063-CC-GE Cranio-caudal Fixation Unit CC-GE MR10063-CC-GE Cranio caudal Fixation Unit CC-GE for Immobilization with the GE 8 channel breast coil Operator s Manual Revision 04 Issued Date: August 2016 Technichal

More information

PHYSICIAN OFFICE BILLING INFORMATION SHEET FOR IMLYGIC (talimogene laherparepvec)

PHYSICIAN OFFICE BILLING INFORMATION SHEET FOR IMLYGIC (talimogene laherparepvec) PHYSICIAN OFFICE BILLING INFORMATION SHEET FOR IMLYGIC (talimogene laherparepvec) INDICATION IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable

More information

CDC Natural Disasters Healthcare Water System Repair Following Disruption of Water...

CDC Natural Disasters Healthcare Water System Repair Following Disruption of Water... CDC Natural Disasters Healthcare Water System Repair Following Disruption of Water... ATTACHMENT F Page 1 of 5 DISASTER RECOVERY INFORMATION Emergency Preparedness and Response Healthcare Water System

More information

Medical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS

Medical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS Medical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS Key Topics Definitions Essential Principles Classification Conformity Assessment Framework License to Manufacture, Import,

More information

Controlling Microbial Growth

Controlling Microbial Growth Controlling Microbial Growth What factors limit microbial growth? In what situations are large microbial numbers undesirable? Concept of Microbial Control Factors Which Affect Control Temp., species type

More information

Laboratory Research Ethics, Conduct and Safety

Laboratory Research Ethics, Conduct and Safety Laboratory Research Ethics, Conduct and Safety Biohazards and Biosafety Guidelines & Standards Human Pathogens Public Health Agency of Canada Canadian Food Inspection Agency Animal Pathogens Definition:

More information

RapidPort EZ Port Applier DIRECTIONS FOR USE (DFU)

RapidPort EZ Port Applier DIRECTIONS FOR USE (DFU) RapidPort EZ Port Applier DIRECTIONS FOR USE (DFU) RapidPort EZ Port Applier Ref. No. C-20390 RapidPort EZ Port Applier INTRODUCTION The RapidPort EZ Port Applier is an optional accessory for the LAP-BAND

More information

Sterilization Service Revolution Service Enhancement in HA Hospitals

Sterilization Service Revolution Service Enhancement in HA Hospitals Sterilization Service Revolution Service Enhancement in HA Hospitals Hong Kong Hospital Authority Convention 2014 7 May 2014 LAW Tat Hong Samuel Cluster Operations Manager Central Sterile Supplies Department,

More information

Volume 13, Issue 5/ Medtech

Volume 13, Issue 5/ Medtech Volume 13, Issue 5/2011 - Medtech The New Central Sterile Supply Department of University Hospital Authority St. Orsola- Malpighi Polyclinic The new Central Sterile Supply Department (CSSD) of the University

More information

Clostridium difficile Update Dr. Michelle Alfa, Winnipeg Sponsored by ARJO

Clostridium difficile Update Dr. Michelle Alfa, Winnipeg Sponsored by ARJO Clostridium difficile: Update Dr. Michelle Alfa Ph.D, FCCM Diagnostic Services of Manitoba St. Boniface General Hospital Site Hosted by Paul Webber paul@webbertraining.com Sponsored by www.arjo.com www.webbertraining.com

More information

Central Service Equipment and Product Testing Procedures

Central Service Equipment and Product Testing Procedures Lesson No. CRCST 131 (Technical Continuing Education - TCE) Sponsored by: by Carla McDermott, RN, CRCST Clinical Nurse III South Florida Baptist Hospital Plant City, FL Central Service Equipment and Product

More information

Therapeutic Goods Administration (TGA) Medical Devices Safety Update, Vol 5, No 3, May 2017

Therapeutic Goods Administration (TGA) Medical Devices Safety Update, Vol 5, No 3, May 2017 Disclosures GAMA Healthcare Board Member of the Infection Prevention Society (UK) I m a nurse! With personal experience of Trying to clean equipment that can t be cleaned Seeing equipment being destroyed

More information

Biomedical Waste Handling and Disposal

Biomedical Waste Handling and Disposal Approved by: Biomedical Waste Handling and Disposal Corporate Director, Environmental Supports Environmental Services Operating Standards Manual Number: Date Approved Next Review May 3, 2018 Purpose Applicability

More information

Microbiological Cleaning Method Validation

Microbiological Cleaning Method Validation Microbiological Cleaning Method Validation The purpose of cleaning procedures should never be to reduce bioburden to an acceptable level! Fergus O Connell QA Manager Eurofins ams Laboratories www.eurofins.com

More information

Urine DNA Isolation Maxi Kit (Slurry Format) Product # 50100

Urine DNA Isolation Maxi Kit (Slurry Format) Product # 50100 3430 Schmon Parkway Thorold, ON, Canada L2V 4Y6 Phone: 866-667-4362 (905) 227-8848 Fax: (905) 227-1061 Email: techsupport@norgenbiotek.com Urine DNA Isolation Maxi Kit (Slurry Format) Product # 50100 Product

More information

Instructions for Use Reprocessed Ethicon ENDOPATH XCEL TM Universal Trocar Stability Sleeve. Reprocessed Device for Single Use.

Instructions for Use Reprocessed Ethicon ENDOPATH XCEL TM Universal Trocar Stability Sleeve. Reprocessed Device for Single Use. Reprocessed by Instructions for Use Reprocessed Ethicon ENDOPATH XCEL TM Universal Trocar Stability Sleeve Reprocessed Device for Single Use Caution: Federal (U.S.A.) law restricts this device to sale

More information