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CRCST Self-Study Lesson Plan

Lesson No. CRCST 124 (Technical Continuing Education - TCE) by Susan Klacik, ACE, CHL, CRCST, FCS, CSS
Manager, St. Elizabeth Health Center
Sponsored by: Youngstown, Ohio

Regulations, Voluntary Standards
and Recommended Practices
Learning Objectives egulations are mandatory laws or rules, and many have
1. Discuss requirements of the U.S. a major impact on the daily activities of Central Sterile Supply Department
Food and Drug Administration (FDA) (CSSD) personnel. Several professional associations develop and promote
that affect Central Sterile Supply voluntary standards and recommended practices that provide a foundation
Departments. for the procedures and protocols used by CSSD personnel. These mandatory regula-
2. Review Occupational Safety and tions, voluntary standards and recommended practices are reviewed in this lesson.
Health Administration (OSHA)
regulations impacting Central Sterile Objective 1: Discuss require- formation about safe and effective use. It
Supply Departments. ments of the U.S. Food and must identify active ingredients and their
3. Discuss U.S. Environmental Protection Drug Administration (FDA) af- concentrations and provide information
Agency (EPA) regulations of concern to fecting Central Sterile Sup- about validating the in-use product for
Central Sterile Supply Departments. ply Departments. the minimum effective concentration
4. Review requirements of two other Medical devices require FDA clearance before use, which is typically performed
federal agencies impacting Central before they can be marketed. This clear- with a product- specific “test strip.” Ad-
Sterile Supply Departments. ance includes the instructions for use ditionally, information regarding the
5. Demonstrate how voluntary standards (IFU) that provide cleaning and disinfec- required contact time and temperature,
and recommended practices influence tion/sterilization instructions. reuse pattern, material and device com-
work practices in Central Sterile Supply All FDA-regulated products, including patibility, stability, and shelf life must also
Departments. liquid chemical sterilants and high-level be included on the product’s label. The
disinfectants (LCSs/HLDs), must be required personal protective equipment
labeled in accordance with FDA’s general (PPE) must also be specified, along with
labeling regulation – including specific any requirements for spill or leak clean-
requirements for directions for use. The up procedures.
labeling for LCSs/HLDS must provide in- Labeling includes a package insert

This series of self-study lessons on CSSD topics By mail or online: From January 1 to June 30 IAHCSMM provides online grading service for
was developed by the International Association of each year, Purdue Extended Campus offers an annual any of the Lesson Plan varieties. Purdue University
Healthcare Central Service Materiel Management mail-in or online, self-study lesson subscription for provides grading services solely for CRCST lessons.
(IAHCSMM). Purdue University’s Extended Campus $75 (6 specific lessons worth 2 points each). Call
and IAHCSMM both offer grading opportunities for 800.830.0629 for details. For grading of individual For more information:
Extended Campus points. lessons, send completed 20-question quiz and $15 Direct any questions about online grading to
to: PEC Business Office, Purdue University, Stewart IAHCSMM at 312.440.0078. Questions about writ-
Earn Extended Campus Points Center Room 110, 128 Memorial Mall, West Lafayette, ten grading are answered by Purdue University at
Online: You can use these lessons as an in-service IN 47907-2034. 800.830.0269. You can also print out any current
with your staff, or visit for online Each 20-question quiz with a passing score of valid lesson for grading at
grading at a nominal fee. 70% or higher is worth two points (contact hours) training/cssp/lessons/.
Each 20 question, online quiz with a passing score toward your CRCST re-certification (12 points). Two
of 70% or higher is worth two points (2 contact hours) attempts to achieve a passing score are permitted
toward your CRCST re-certification (12 points). per examination. may / june 2012 Communiqué

Use of a third party reprocessor is terms based on the Spaulding classifica. and products with tors. the instrumentation. use and disposal of these products. intact skin of the patient. The FDA-required cal devices include including a 510(k) approval for each type labeling relies on broad disinfection of item. FDA’s Under the FDA medical device reporting age. sterilizers. The MedWatch DSs) for the chemicals they produce. sterilizers. ties for the employer. sure. Users should and outpatient treatment and diagnostic taking other OSHA-specified measures. The Occupational Safety and Health Ad- • Semi-critical devices – Instruments or processed daily in ministration (OSHA) protects employees objects that contact intact mucous by ensuring a safe work environment. (either into or in contact with the scopes.and post-market requirements. quality monitors. The MSDSs provide informa- (high risk and most stringent regulation). Reuse of single-use devices (SUDs) • Hazard(s) identification facturers and importers to inform FDA are also regulated by the FDA. State and local health agencies also regu- high-level disinfection. also acceptable (with 510(k) clearance). manufacturer deaths and serious injuries jected to certain labeling requirements. packaging. ambulatory care facilities. cal sterilants and disinfectants. be able to infer the microbiocidal efficacy facilities) to report to the FDA and device Product manufacturers might be sub- of a product by examining its FDA. FDA-regulated medi. sterile fluid pathways. system to determine the level of medical requirements. reprocessing SUDs must comply with tal information needed for the product’s FDA’s pre. membranes or non-intact skin of the CSSDs. nurs. if they do. by implementing engineering controls. serious injuries and defining procedures for safe employee FDA’s policy requires that labeling not device malfunctions that could result in work practices. tives visiting a facility for a specific reason • Non-critical devices – Instruments toring depends upon have the right and obligation to investi- or objects that usually contact only the gate any violation they find. tion system. the level of public. and ensure proper use of devices Healthcare personnel should know their regulation and monitoring depends upon and the health and safety of patients. Employers contact with patients or. which defines the following: • Critical devices – Instruments or objects packaging. the level of Any substantiated or proven violation of patient during use. and implants done to alert health professionals and the and they are sometimes more stringent. quality moni. These regulations must the instrumentation. er problems with medical devices. and effective by clinical . Class II (potential risk program is mandatory for death/perma. CRCST Self-Study Lesson Plan containing the above and any supplemen. establishing medical sur- contain references to specific diseases patient injury or death. only must ensure compliance with these limits with intact skin. but do not usually its regulations can yield fines and penal- penetrate the blood barrier or other regulation and moni. state and local obligations regarding stor- the medical device classification. and implants ile Supply Departments. Objective 2: Review Occupa- introduced directly into the human tional Safety and Health body. employing methods or specific microorganisms. Administration (OSHA) regula- bloodstream or other normally sterile tions impacting Central Ster- areas of the body). and least regulated). unless device user facilities (hospitals. providing worker protection. use and disposal. Hospitals • Ingredient composition Communiqué may / june 2012 www. This is be as stringent as federal requirements.iahcsmm. • Identification regulations require medical device manu. employers must make them available to and moderate regulation). healthcare facilities must OSHA mandates that manufacturers device regulation places each device into report suspected medical device-related provide material safety data sheets (MS- one of three categories: Class I (low risk and deaths and injuries. cleared claims for use in sterilization or resulting in permanent disability. scopes. safe and effective use. The FDA enacts product recalls and late certain aspects of chemical sterilant FDA-regulated medical devices include monitors reports of adverse events or oth. OSHA representa- normally sterile areas of the body. processed daily in CSSDs. the medical device OSHA has established occupational ex- • Environmental surfaces – A variety of posure limits for several agents in chemi- surfaces that usually do not come in classification. and Class III nent disability events and also encourages employees. They also require veillance programs. for monitoring for occupational expo- product lethality has been proven ing homes. voluntary reporting of any device-related tion about: Medical device reporting (MDR) problems or adverse events. about patient deaths.

disposal. persons who are involved in the shipping tion is also provided on the MSDS. information and against exposure to infectious materials. United States. It permits the continued use of EtO. and it specifies record measures indicated on EtO labels. OSHA Bloodborne Pathogen Standard.” This means and effectively. The product not-for-profit organization that accredits establishes national standards that states is considered to be misused if specified and certifies more than 19. how voluntary standards significant risks to human health and tion number. ber process is required for EtO treatment health and quality of life by prevent- ity. dilutions. and Rodenticide Act. at which time (DOT) requires formal training of all transport. must also adhere to the be performed only in vacuum or gas tight is subject to significant penalties. The manufacturer may then and recommended practices the environment where they live. The Bloodborne Pathogen Standard (sterilization and aeration are to occur ing and controlling may / june 2012 Communiqué . sell and distribute the product in the influence work practices and work. regulatory. The U. process. OSHA In 2008. The Joint Commission The EPA implements environmental tions and use directions on the labeling The Joint Commission is an independent. pares shipping documents. environment. and other informa. EtO. and Prevention (CDC) promotes the safety in all areas of a healthcare facil. in Central Sterile Supply • national efforts to reduce environmental The following statement appears on all Departments. If train- Healthcare professionals. ecological. that users must follow the safety precau. and other employee safety requirements. Two “general awareness” to “function-specific. • Handling and storage Fungicide. The EPA regulates disinfectants used tools required by people and communi- on environmental (housekeeping and ties to protect their health. including anyone who prepares requires environmental monitoring of istration Eligibility Decision (RED) for hazardous items for shipment or pre- Ethylene Oxide (EtO) and other chemi. can be The Department of Transportation Toxicological. Centers for Disease Control a comprehensive guideline for employee • After February 28. (EPA) regulations of concern methods for microbicidal activity.S. learn. Several levels cals.” keeping. protective clothing. and Directions for Use heading: “It is a viola. facility usage of EtO: issues and must be documented. Often. agencies that impact Central • Stability and reactivity out of Oxyfume 2002. and by responding to health decontamination room wear appropriate healthcare facilities. If and science. CDC per- Objective 3: Discuss U. One Objective 4: Review require- • Exposure controls/personal protection change. ranging from these chemicals. CRCST Self-Study Lesson Plan • First-aid measures CSSD professionals must be aware that plication. including • Sterilization/fumigation with EtO must ing records are not complete. signage. the EPA completed a Rereg. The agency’s goal is to EPA concludes a product does not cause ensure that: unreasonable adverse effects. 2010. The CDC collaborates to personal protective equipment to protect create the expertise. contact times. a single cham. laws by developing regulations. organizations and programs in the United www. and preparedness for new to Central Sterile Supply stability and toxicity to animals and health threats. injury.S. tions develop protocols that are used • federal laws protecting human health tion of federal law to use this product by CSSDs: and the environment are enforced fairly inconsistent with its labeling. an alternate mixture of Oxyfume. Oxyfume2000 . and these data must be submit. humans. the product Objective 5: Demonstrate • all Americans are protected from and its labeling receive an EPA registra. 2010. Sterile Supply Departments. first specific restrictions exist for healthcare The required training must include safety aid. Manufacturers sonnel accomplish this through health ronmental Protection Agency must test formulations with accepted promotion. injury and mandates that employees working in the in the same chamber) in hospitals and disability. the shipper those in the CSSD. Envi. used until January 1. The CDC develops non- Departments. it will also be phased-out (discontinued). 2015. risks are based on the best available EPA-registered product labels under the The following three voluntary organiza- scientific information. it of each registered product. clinical contact) surfaces. method of ap.”1 emergencies.000 healthcare then enforce with their own regulations. prevention of disease. and disability. effective January 1.iahcsmm. or any other conditions of use • Fire-fighting measures the EPA also regulates ethylene oxide are not followed. It sets permissible exposure levels for provided users adopt new risk mitigation of training are specified. • Accidental release measures (EtO) under the Federal Insecticide. that ments of two other federal • Physical and chemical properties affected CSSDs was the required phase. chambers designed for use with EtO. regulatory guidelines based on research The EPA protects human health and the ted to EPA with proposed labeling.

Chicago: of Medical Instrumentation and adoptability in all settings where IAHCSMM. the facility can lose sional responsibility for perioperative level disinfection in health care facilities. but can be of value to any CRCST technician who works with surgical instrumentation. These Susan Klacik. recommended facilities. BA. international speaker and widely certification of CRCST (12 points) or CIS (6 points).iahcsmm. rected to CSSDs include: 30 years experience managing Central Sterile You can use these lessons as an in-service with • ST79:2010 Comprehensive guide to Supply Departments. OH. Instrumentation. science cal Instrumentation (AAMI). The Joint Commission accreditation Association of periOperative Additional Reading and certification is recognized nationwide Registered Nurses (AORN) Association for the Advancement of Medical as a symbol of quality that reflects an The Perioperative Standards and Recom. and currently serves your staff. standards and recommended practices Practices 2011. 2003. and guidance voluntary. International Association of Healthcare Central They guide perioperative nursing Service Materiel Management. Central Service Association for the Advancement practices. These impact the leading source of essential information daily work practices in place to provide on medical devices and equipment. CSSD CSSD personnel refer to mandates is- personnel. While approved standards. These comprehensive Association for the Advancement of Medical Joint Commission survey show failure to documents reflect the scope of profes. Morbidity and Mortality Weekly Report. Instrument Continuing Education (ICE) lessons pro- vide members with ongoing education in the com- are based on current technology. Centers for Disease Con- ers interested in medical devices. The Association for the Advancement surgical and other invasive procedures of Medical Instrumentation (AAMI) is are performed. CRCST Self-Study Lesson Plan States. 72. ACE. . You can use these points toward either your re- in health care facilities: safety and consultant. critical forum for stakeholders. Sterile Process- practices” in terms of patient safety. CRCST. Klacik is also a hours). 2007. Mailed submissions to IAHCSMM will not be effectiveness published author on sterilization-related graded and will not be granted a point value (paper/ • ST58:2005 Chemical sterilization and subject matter. CIS. and by Perioperative Standards and Recommended government representatives. plex and ever-changing area of surgical instrument and forum consensus. Instrumentation. She has more than CIS technicians. IL tory and other requirements that enhance resentative to the Association technology to assist patients. Standards for the Advancement of Medi. 248. These lessons are designed for Recommended practices that are di.62-64 ing physicians. No. Environmental Protec- • ST 8 Steam Sterilizers tion Agency. IAHCSMM accepts only online submissions). ing Manager. and co-chairs the AAMI Process Challenge care and handling.  pencil grading of the ICE Lesson Plans is not high-level disinfection in health care available through IAHCSMM or Purdue University. this quiz: practices. includ. sued by governmental agencies. It provides a mendations and Reports. These issued by voluntary organizations when trol and Prevention.Comprehensive guide to steam organization’s commitment to meeting mended Practices contains the AORN. or visit www. which are the basis of “good Lisa Huber. Anderson Hospital. BS. ANSI/ accreditation by federal and state govern. facilities Reference • ST 77R Containment Devices for 1. IL Paula for online grad- steam sterilization and sterility as CSS Manager and CRCST Instructor ing at a nominal fee. Should a statements. www. nurses. In Conclusion 52(RR17). patient care and a safe work diverse groups have made AAMI the policies are developed. CRCST. ANSI/AAMI ST79: 2010 The Joint Commission’s standards are practices. They patients with safe and effective products IAHCSMM acknowledges the assistance of the following two CSSD professionals who reviewed develop standards and recommended used in their care. Device (PCD) committee. CS Technician.iahcsmm. educators. and this results in the forfeiture of information for the delivery of safe Medicare and Medicaid payments. serves as the IAHCSMM Rep. Maryville. Chemical sterilization and high- meet these standards. Each lesson plan graded online with a passing assurance in health care facilities and Course Director for St. FCS. they are substantial.cdc. Anderson Hospital. while allowing for flexibility Technical Manual. December 19. pedic Specialist. regula. registered nurses and provide essential AAMI ST58:2005 ments. Seventh Edition. manufacturers. U. 40 CFR Part 63: National Emission • ST24 Ethylene Oxide Sterilizers Standards for Hospital Ethylene Oxide Sterilizers. Ortho- practices harmonize marketplace. researchers.S. 2007/Rules and Regulations. Elizabeth Health score of 70% or higher is worth two points (2 contact • ST41:2008 Ethylene oxide sterilization Center in Youngstown. December 28. Communiqué may / june 2012 www. and oth. guidelines. CRCST. Recom- a nonprofit organization. Reusable Medical Device Sterilization.Federal Register / Vol. sterilization and sterility assurance in health care certain performance standards.

EPA approval 10.0269 If your name has changed in the last 12 months. regulatory requirements b. licensure regulations a. a license with approval code tion and sterility assurance in health care a. OSHA guidance a. Disinfectants for environmental surfaces d. Non. a sales tax code a. information and tools d. AAMI a. Very-critical b.TCE) • Lesson expires May 2015 1. FDA clearance from blood borne pathogens c. IN 47907-2034 Email Address 800. don’t matter government agencies? failure to meet standards. Ethylene oxide is regulated by which 15. Supply forecasts based on standard exposure limits for to protect public health and planned reimbursements a. political decisions 5. please provide your former name Purdue University is an equal access/equal opportunity institution may / june 2012 Communiqué . in the sterilizer’s external room or using either online check or credit card) m I have enclosed the scoring fee of $15. none of the above d. the hospital can c. fold. mandatory 9. Semi-critical c. operating instructions for medical devices patient costs between facility departments c. information about chemicals used by surgical procedures in the United States employees c. PPE a.830. employees Objective 4 disinfection in health care facilities d. nursing staffing patterns for normal a. Disposable packaging 18. The FDA regulates b. respirators b. AORN and DOT b. EPA and OSHA a. in the sterilizer’s chamber c. The EPA regulates which of the following? c. AORN approved standards. provide data to meet The Joint Commis. The Perioperative Standards and Recom- c. AAMI and FDA lose accreditation by federal and state d. at an elevated temperature practices include: d. increases in facility operating costs before being marketed. science and b. High-level disinfectants for endoscopes a. costs and technology a. OSHA requires ______to protect employees d. Comprehensive guide to steam steriliza- 6. regulate operating procedures for CSSDs care facilities: safety and effectiveness 7. (please make checks _______________________________________________________________________________ payable to Purdue University. failure to receive required state licenses 2. set standard levels for sterilization of b. budgetary concerns c. loss of Medicare and Medicaid payments a. OSHA and AORN governments resulting in c. employee safety given___ before they can be sold. cleaning instructions for medical devices d. expense reports 4. guidelines.critical a. sterilization temperatures medical instrumentation 20. DOT 11. revocation of physicians’ surgery licenses b. the environment 14. current technology. set assembly instructions for endoscopes surgical instrumentation Request for paper/pencil scoring (please print or type information below) Request for online scoring (payment and scoring made directly online at www. AORN expense practices for allocating b. patients d. Which government agency regulates high- d. The AAMI standards and recommended d. The purpose of material safety data sheets statements (MSDS) is to provide: b. AORN b. Which term is not a Spaulding classification? b.iahcsmm. low-level disinfectants without causing unreasonable adverse consensus c. Regulations are laws or rules that are Objective 3 Objective 5 a. sterile storage temperatures sion requirements a. medical licenses effects. instrumentation 13. Voluntary Standards and Recommended Practices Lesson No. We regret that no refunds can Name be given) m Check here if you have a change of address _______________________________________________________________________________ Mailing Address (be sure to include apartment numbers or post office boxes) m Check here if you wish to have your results emailed to you _______________________________________________________________________________ Detach quiz. OSHA has established occupational b. The purpose of OSHA is to protect c. and return to: City State Zip Code Purdue University PEC Business Office _______________________________________________________________________________ ( ) Stewart Center. CRCST Self-Study Lesson Plan Quiz - Regulations. CRCST 124 (Technical Continuing Education . and guidance 8. Chemical sterilization and high-level c. inconsequential b. CDC approval b. mended Practices contains d. two-year testing approval facilities b. AORN guidelines for manufacture of d. Critical 12. FDA c. c. Medical devices require ____________ d. Ethylene oxide sterilization in health a. An EPA registration number 19. a. lead aprons practices which are the basis of c. AAMI develops standards and recommended d. AAMI standards are based on d. not enforced a. If EPA concludes a product may be used c. agents used in sterilants and disinfectants c. implant tracking a. Room 110 Daytime telephone IAHCSMM Membership Number 128 Memorial Mall _______________________________________________________________________________ West Lafayette. surgical procedures b. Instrumentation sterilization d. scrub attire 16. The CDC’s role is to c. Should a Joint Commission survey show b. good practices 3. at a lower temperature a. Which is not an AAMI document for CSSD? Objective 2 b. recommended practices. revenue enhancements level disinfectants? c. the product and its labeling are d. The EPA requires EtO aeration to occur d. employee exposure to stress d. visitors b. create expertise.