ImpAct sAFe INstrUmeNt
processING
Regulations
Learning oBjeCtiveS
1. Discuss the role of federal agencies in the regulation of processing procedures 2. explain the role of professional
associations in improving the safety of instrument processing
3. Describe key concerns of regulatory agency and professional association personnel as they inspect/survey healthcare facilities
4. Indicate the impact that regulatory agencies and professional associations have on reprocessing medical devices
this series of self-study lessons on cs topics was developed by the International Association of Healthcare central service materiel management (IAHcsmm), and can be used toward crcst re-certification or toward nursing credits. pfeidler enterprises and IAHcsmm both offer grading opportunities.
earn continuing education credits online: nursing credit: pfiedler enterprises will award nursing credit for this self-study Lesson plan. pfiedler enterprises is a provider approved by the california board of registered Nursing, provid-er Numbprovid-er cep 14944, for 1 contact hour. obtaining full credit for this offering depends upon attendance, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes.
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I
NFECTION PREVENTION IS THE RESPONSIBILITY OF EVERYhealthcare worker. There is no more important obligation to patient safety than to ensure that instruments and other reusable devices are consistently processed according to evidence-based standards. Reprocessing personnel have some important allies in their campaign of processing excellence: governmental agencies that issue and administer regulations, and professional associations that develop and promote guidelines for best reprocessing practices that impact processing standards and protocols.
Regulations and regulatory and voluntary standards are issued by federal, state and local governing agencies. Professional organizations also issue voluntary standards. These voluntary standards are built on sound principles, evidence backed up by re-search and opinions of experts in the field, and, therefore, are considered best practices.
obJectIve 1: dIscUss tHe Role oF FedeRal aGencIes In tHe ReGUlatIon oF PRocessInG PRocedURes
Federal agencies administer enforceable regulations that impact reprocessing in healthcare facilities. Regulations are mandatory laws or rules issued by a gov-erning body. A regulatory standard is a comparison benchmark that is mandated by a governing agency and, if not com-plied with, may cause a facility to be in violation and liable for legal penalty.1 Not
following regulations and standards set forth by federal agencies can also affect a healthcare organization’s reimbursement, and that could make or break healthcare facilities that function with tight budgets.2
The Department of Health & Human Services (HHS) houses three agencies that directly impact healthcare facilities: U.s. Food and dRUG adMInIstRatIon (Fda). The FDA has issued numerous regulations that apply to reprocessing, including those related to:
• Medical device classification. This system determines the level of regula- tion placed on medical devices and
places instruments in three categories: • Class I devices (low risk and least
regulated), such as most hand-held surgical instruments and ultrasonic cleaners,
• Class II devices (potential risk and moderate regulation), such as most type of sterilization equipment, and biological or chemical indicators, and • Class III devices (high risk and most
stringent regulation), such as heart valves, pacemakers, and other life-sustaining devices.1
• Pre- and post-market requirements. These regulations specify what medical device manufacturers must do to ensure that new devices will be safe and effective for their intended use.
• Before a device can come to market, the FDA requires manufactures to apply for a 510(k) submission for Class I and Class II devices, unless the device is listed as exempt from regulations. Class II devices are usually subject to performance standards, post-market surveillance studies, and specific guidelines or special labeling.
• Manufactures of new Class III de- vices must obtain a pre-market
approval (PMA) from the FDA to demonstrate the safety and effective- ness of these products. A PMA is
more complicated to complete and must be based on valid scientific evidence, which may include clinical studies in healthcare facilities. • Post-market device requirements
Nursing Lesson Plan 601
reprocessors, and include FDA mandates applicable to: • Registration and listing;
• Medical device reporting, tracking, corrections, and removals;
• Quality system regulations; and • Labeling.1
• Medical device reporting requirements. The Safe Medical Device Act of 1990 requires healthcare facilities to become subject to user reporting requirements, including suspected medical device- related deaths and injuries. The Med
Watch Program is the safety information and adverse events reporting system that serves healthcare professionals and the public by reporting serious problems suspected to be associated with the drugs and medical devices they prescribe, dispense and use. MedWatch encourages the voluntary reporting of device-related problems. It is conceiv- able that certain sterilization failures
may have to be reported if they can be linked to patient illness.1 For more
information on the FDA’s MedWatch program, visit http://www.fda.gov/ Safety/MedWatch/default.htm. • Reuse of single use devices (SUDs).
Healthcare facilities that reprocess or reuses an SUD must comply with FDA’s pre- and post-market requirements. This includes being able to demonstrate that (a) the item can be adequately cleaned and sterilized, (b) the quality of the device will not be adversely affected, and (c) the device will remain safe and effective for its intended use. More information on SUD reprocessing can be found at http://www.fda.gov/ MedicalDevices/DeviceRegulationand-
gle-UseDevices/ucm121487.htm.1
centeRs FoR MedIcaRe & MedIcaId seRvIces (cMs).This agency administers the Medicare program (hospital and
medical insurance and prescription drug coverage for seniors), Medicaid (medical expense coverage for low income persons under the age of 65) and the Children’s Health Insurance Program (CHIP) for low-income children.
In 1965, President Johnson made the Medicare and Medicaid programs law. The mission of CMS is “to ensure effec-tive, up-to-date healthcare coverage and to promote quality care for beneficiaries.” If a healthcare facility wishes to participate in Medicare, it must meet the standards specified in Title 42, Parts 416, 418, 482, 484, or 485 (as applicable) of the Code of Federal Regulations (CFR) and receive accreditation from an accreditation or-ganization (AO) that CMS has approved as a “deeming authority.” As of Novem-ber 2010, the CMS-approved AOs are as follows:
• Accreditation Association for Ambulatory Health Care (AAAHC) • Accreditation Commission for Health
Care (ACHC)
• American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF)
• American Osteopathic Association/ Healthcare Facilities Accreditation Program (AOA/HFAP)
• Community Health Accreditation Program (CHAP)
• DNV Healthcare (DNV) • The Joint Commission (TJC)2
centeRs FoR dIsease contRol and PReventIon (cdc). The CDC is a government agency that develops evi-dence-based guidelines on many health-care-related topics, including cleaning, sterilization and disinfection. Although CDC guidelines are not considered regu-latory, other agencies rely heavily on them and review healthcare facilities for com-pliance with them. Many CDC guidelines are incorporated into the policies and
pro-cedures of healthcare facilities, including their protocols for instrument processing following exposure to prions.1
The CDC Guideline for disinfection and sterilization in healthcare facilities provides recommendations on the pre-ferred methods for cleaning, disinfection and sterilization of patient-care medical devices, and for cleaning and disinfect-ing the healthcare environment. The last update on this document was 2008 and it can be downloaded for free at http:// www.cdc.gov/hicpac/pdf/guidelines/Dis-infection_Nov_2008.pdf.
In July 2011, the CDC released its Infection Prevention Guide for Outpa-tient Settings: Minimum Expectations for Safe Care, and the companion “Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care. The documents can be download-ed for free at http://www.cdc.gov/HAI/ pdfs/guidelines/standatds-of-ambula-tory-care-7-2011.pdf , and http://www. cdc.gov/HAI/pdfs/guidelines/ambulato-ry-care-checklist-07-2011.pdf .
occUPatIonal saFetY and HealtH adMInIstRatIon (osHa). The primary role and responsibility of OSHA is to pro-tect workers from occupationally-caused illnesses and injuries. Violation of its regulations and standards can create se-vere fines and also endanger accreditation by The Joint Commission. Two OSHA regulations are of critical importance to reprocessing personnel. The Occupation-al Exposure to Bloodborne Pathogens Standard outlines employee safety in all areas of the healthcare facility as they relate to potential exposure from blood-borne pathogens. OSHA has also issued guidelines for the safe use of Ethylene Oxide Sterilization (EtO).1,3,4 Current
penalties and citations can be viewed at: www.osha.gov.
aGencY (ePa). This agency is respon-sible for minimizing greenhouse gases and toxic emissions, regulating the reuse of solid wastes, controlling indoor air pollution, and developing and enforcing pesticide regulations. The EPA adminis-ters two acts that are very important to reprocessing personnel. The Federal Insecticide, Fungicide, and Rodenti-cide Act (FIFRA) regulates pestiRodenti-cide safety and effectiveness, and it impacts all antimicrobial products, including disinfectants and sanitizers. Reprocessing professionals must always read and consistently follow the information provided on all chemical labels. The 1990 Clean Air Act Amendments created a regulatory program to protect the earth’s ozone layer, and healthcare facilities must use an approved ethylene oxide (EtO) sterilant mixture. Another regulation affects the use of medical waste incin-erators. Because the cost of retrofitting existing incinerators is usually very high, some facilities are returning to reusable items, and this can create an increased workload in these CS departments.1 For
more information about the EPA, visit: www.epa.gov.
aGencY FoR HealtHcaRe adMInIs-tRatIon (aHca). All healthcare facilities must be licensed by the government. While AHCA’s primary function is inspection of new and renovated facility constructions, annual facility inspections are also performed. This inspection process is in cooperation with OSHA to help ensure that facili-ties continue to be safe for workers and patients. For example, if a facility decides to install a new EtO sterilizer, permits, inspections and/or testing would be required by at least these agencies: AHCA, OSHA, EPA.
dePaRtMent oF tRansPoRtatIon (dot). Its laws relating to healthcare in-clude those concerning the transportation of minimally-processed instrumentation for repair/labeling, and the transportation “of hazardous and radioactive wastes. Note: State or local regulations may be more restrictive than federal regulations and, in all cases, regulations with the most strin-gent provisions apply. For more informa-tion about the DOT, visit: www.dot.gov.
obJectIve 2: exPlaIn tHe Role oF PRoFessIonal assocIatIons In IMPRovInG tHe saFetY oF InstRUMent PRocessInG.
Several professional associations develop and promote voluntary standards that provide a foundation for the procedures and protocols used by reprocessing professionals. A voluntary standard is a comparison benchmark that is strongly recommended by a governing agency or
professional organization that provides recommendations and guidelines to pro-vide better patient care.1
assocIatIon FoR tHe advanceMent oF MedIcal InstRUMentatIon (aaMI). AAMI is a voluntary consensus orga-nization whose membership includes healthcare professionals, manufacturers, regulators, scientists, academics, and oth-er intoth-erested parties. AAMI committees research and develop new (or revise exist-ing) Recommended Practices and Stan-dards that address the use, care and pro-cessing of devices and systems. Although AAMI standards are voluntary, they are considered by regulatory agencies to be a major resource for healthcare guidelines. Noncompliance with these standards may result in negative citing during accredi-tation surveys. Noncompliance with the standards is cited by regulatory organi-zations that inspect healthcare facilities.
reprocessing professionals must always read
and consistently follow the information
provid-ed on all chemical labels. the 1990 clean Air
Act Amendments created a regulatory program
to protect the earth’s ozone layer, and
health-care facilities must use an approved ethylene
oxide (eto) sterilant mixture.
AAMI also develops standards which are recommendations that provide guidance to device manufacturers about design, performance, labeling, and other factors applicable to their instruments. For more information on AAMI, visit: www.aami.org. • AAMI recommended practices for
reprocessing in healthcare facilities include:
• ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
• ANSI/AAMI ST41 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
• ANSI/AAMI ST58 Chemical ster- ilization and high-level disinfection
in health care facilities
• ANSI/AAMI ST65 Processing of reusable surgical textiles for use in health care facilities
• ANSI/AAMI ST40 Table-top dry heat (heated air) sterilization and sterility assurance
• AAMI standards for manufactures of sterilization equipment intended for use in healthcare facilities include: • ANSI/AAMI ST8 Hospital steam
sterilizers
• ANSI/AAMI ST55 Table-top steam sterilizers
• ANSI/AAMI ST24 Automatic, general-purpose ethylene oxide sterilizers and EtO sterilant sources intended for use in HC facilities • ANSI/AAMI ST50 Dry heat (heated
air) sterilizers
aMeRIcan natIonal standaRds InstItUte (ansI). While ANSI does not develop American standards, it provides a neutral arena for interested parties to work toward agreement. Its committee membership is similar to that of AAMI, and standards are submitted to ANSI for approval by other organizations.
Exam-ples of ANSI-approved standards include the Recommended Practices and Stan-dards developed by AAMI.
tHe assocIatIon oF PeRIoPeRatIve ReGIsteRed nURses (aoRn). This professional organization consists of perioperative nurses and others who are dedicated to providing optimal care to surgical patients. AORN’s mission is “to promote safety and optimal outcomes for patients undergoing operative and other invasive procedures by providing practice support and professional development opportunities to perioperative nurses. AORN will collaborate with professional and regulatory organizations, industry leaders, and other health care partners who support the mission.5
AORN committees develop nationally recognized Standards, Recommended Practices and Guidelines, and processing personnel must know about those that relate to instrument processing, which includes:
• Anesthesia Equipment – Cleaning and Disinfection
• Disinfection – High Level
• Flexible Endoscopes – Cleaning and Processing
• Instruments and Powered Equipment – Cleaning and Care of
• Packaging Systems – Selection and Use • Sterilization
tHe assocIatIon FoR PRoFessIon-als In InFectIon contRol and ePI-deMIoloGY Inc. (aPIc). APIC members work with other agencies, such as the CDC, to adopt standards for infection/ disease prevention. APIC’ s mission is to “Create a safer world through prevention of infection”.6 Reprocessing professionals
may interact with their facility’s Infection Prevention and Control professionals who conduct departmental surveys to ensure compliance with APIC Standards, Practices and Guidelines.
socIetY oF GastRoenteRoloGY nURses and assocIates (sGna). This non-profit organization collects information and establishes standards and guidelines related to the processing of flexible endoscopes. SGNA’s mission is “advancing the science and practice of
Nursing Lesson Plan 601
the Joint commission’s surveys emphasize
continuous improvement in the quality of
patient care, and its standards may be
incorporated by reference into federal, state
and/or local statutes, and then become binding
on healthcare facilities.
and collaboration, and by promoting the professional development of its members in an atmosphere of mutual support”. 7
SGNA has two publications important to those that reprocess flexible endo-scopes they are:
• Guideline for Use of High Level Disin- fectants & Sterilants for Reprocessing
of Flexible Gastrointestinal Endoscopes • Standards of Infection Control in
Reprocessing of Flexible Gastrointesti- nal Endoscopes
tHe JoInt coMMIssIon. This private, independent not-for-profit organiza-tion develops standards for healthcare facilities. Its representatives evaluate healthcare organizations and programs in the U.S. by conducting on-site surveys at least every three years. Failure to comply with its standards can result in the loss of accreditation by the federal and state governments. This, in turn, may cause the loss of millions of dollars in Medicare and Medicaid program payments. TJC’s Trac-er Methodology of unannounced surveys and direct observation and personal contact with everyone involved in patient care has brought the surveyors directly into the operating room and other pro-cedure locations. The Joint Commission’s surveys emphasize continuous improve-ment in the quality of patient care, and its standards may be incorporated by reference into federal, state and/or local statutes, and then become binding on healthcare facilities.
natIonal FIRe PRotectIon asso-cIatIon (nFPa). This association is important to reprocessing staff members because of the fire safety standards used for the buildings in which they work. As well, NFPA standards address the fire burden of all disposable packaged items stored and used within the facility, the fire
the processing areas.1 For more
informa-tion about NFPA, visit: www.nfpa.org. UnIted states PHaRMacoPoeIa – natIonal FoRMUlaRY (UsP-nF). The USP-NF creates and revises standards for medicines, dosages, forms, drug sub-stances, and dietary supplements. The USP-NF is important to reprocessing em-ployees who work with purified water or sterilized water for irrigation.1 For more
information, visit: www.usp.org/uspnf.
obJectIve 3: descRIbe KeY con-ceRns oF ReGUlatoRY aGencY and PRoFessIonal assocIatIon PeRsonnel as tHeY InsPect/ sURveY HealtHcaRe FacIlItIes.
Representatives of regulatory and vol-untary organizations look for quality, regulatory and standards compliance, verification of the operation, and evi-dence of self-monitoring. Signs of quality include well-defined operating parame-ters and services, and a statement about the mission and goals reprocessing areas.
The surveyor/inspector will determine if the department is clean, neat and in good physical repair because this reflects the quality of patient care that is provided.
Record-keeping is paramount for regulatory and standards compliance and must demonstrate consistent adherence to all relevant statutes and departmental policies. For example, OSHA requires fa-cilities using EtO sterilization to maintain extensive utilization records, employee education, area leak testing, employee exposure monitoring, and health screen-ing. These records must be maintained for 30 years beyond termination of em-ployee service.3 Note: Other sterilization
methods do not require such complex monitoring and, depending on state and facility requirements, records may only need to be retained for three, five or seven
All employees who have contact with, or work in the vicinity of EtO, peracetic acid, glutaraldehyde, and hydrogen per-oxide products must receive an OSHA-re-quired annual review of the hazards and safety procedures associated with each product.8 Records to support this will be
reviewed by OSHA inspectors.
One point of standard compliance that will be emphasized relates to the docu-mentation of education and proficiency. Appropriate education must be provided for each type of equipment processed. A documented return demonstration of successfully completing the processing steps validates the proficiency. Documen-tation of new hire orienDocumen-tation, education for new products, devices and processes, and mandatory annual reviews can keep a manager very busy.
Agencies that inspect and/or survey healthcare facilities will also be looking for evidence of quality monitors in-cluding “measures of success” related to operation and services.9 Straight-forward
verification of sterilization cycles is com-mon. Load contents, cycles and parame-ters are everyday records of sterilization quality monitors. Biological and chemical monitoring of select cycles verifies correct operation of the equipment in use. It is also important to document the recall procedure associated with each specific sterilization process. Utilizing an actual event or staging an event indicates that the process is functional and adequate. Processes that require qualification testing include any major renovation or repair of sterilization equipment. Chang-ing packagChang-ing systems or products, such as rigid containers or wrapping materials, should also be verified as effective with utilization of your facility’s equipment. Changing products for cleaning, dis-infection or lubrication should also be evaluated. Even if your facility does not
experience frequent changes of this type, periodic documented monitoring of these processes will assure surveyors/inspec-tors of your level of commitment to high quality care.
obJectIve 4: IndIcate tHe IMPact tHat ReGUlatoRY aGen-cIes and PRoFessIonal assocI-atIons Have on RePRocessInG MedIcal devIces.
Regulatory agencies and professional associations have one common goal: the provision of safe, appropriate, high quality care. When violations of statutes or standards are observed, federal and state agencies can levy fines in amounts determined by severity of the infraction, number of like infractions found, and their level of concern for potential harm to workers or patients.10
CMS officials can reduce the amount of funding the facility receives for services rendered to Medicare and Medicaid patients if its standards of minimal ex-pectations of quality patient care are not maintained. No one wants less for their patients or to be paid less for their efforts, so ongoing procedures to ensure compli-ance with CMS expectations are always in order.
Extreme consequences, including the immediate closure of a facility or service, are possible. An action of this magni-tude reflects imminent life-threatening circumstances for the patients or staff. It is a rare, but not unheard of, occurrence that can be initiated by State or Federal agencies.11
sUMMaRY
The consistent provision of the highest quality disinfection and sterilization services can be a monumental task, and it is a vital link in efforts to provide safe healthcare. The standards and recom-mended practices of regulatory agencies
and professional associations provide a guide for the ongoing efforts needed to provide safe, evidence-based and high quality healthcare. Focusing on the primary goal of providing safe, high quality care will minimize concerns when interacting with inspection and survey personnel who partner with CS personnel in efforts to help all healthcare recipients and providers.
endnotes
1. IAHcsmm. chapter 5, regulations and standards. In: central service technical manual, seventh edition. chicago, IL: International Association of Healthcare central service materiel management; 2007:77-96.
2. seavey, r. Association for the Advancement of medical Instrumentation. sterile processing in Healthcare Facilities: preparing for Accreditation surveys. 2011. 3. ethylene oxide. osHA safety website. http://www.oshasafety.org/osha_ethylene_
oxide.asp 2003.
4. Introduction to osHA. princeton University web site. http://web.princeton.edu/sites/ehs/ healthsafetyguide/F1.htm
5. http://www.aorn.org/aboutaorn
6. http://apic.org/About-ApIc/Vision-and-mission 7. http://www.sgna.org/AboutUs.aspx
8 Introduction to osHA. princeton University website. http://web.princeton.edu/sites/ehs/ healthsafetyguide/F1.htm
9. Understand the Quality of care measures. the Joint commission. Website. http://www. jointcommissionreport.org/background/ qualityofcaremeasures.aspx 10. Federal, state, and osHA regulations,
statutes, Fines and penalties. American professional safety trainers Alliance. Website. http://www.apsta.org/laws-fines.html 11. Utah Administrative code: rule r432-3.
General Healthcare Facility rules Inspection and enforcement. http://www.rules.utah.gov/ publicat/code/r432/r432-003.htm
Nursing Lesson Plan 601
roSe SeaveY is president/ceo of seavey Healthcare consulting and formerly the Director of the sterile processing Department at the children’s Hospital of Den-ver. she served on the AorN board in 2008-2010. she received AorN’s award for mentorship in 2012 and outstanding Nurse education in 2001. seavey is a past president of AsHcsp. she was one of the Who’s Who in Infection prevention in 2006 by Infection control today, and received the IAHcsmm Award of Honor in 2013. seavey is the author of the book sterile processing In Healthcare Facili-ties: preparing for Accreditations surveys, published by AAmI, and she serves on several AAmI committees writing standards.
