by Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT President/CEO of Seavey Healthcare Consulting LEGAL ISSUES: Regulations That Protect the Healthcare Worker and Their Patients LEARNING OBJECTIVES 1. Identify the three major federal regulatory agencies governing work in Central Service 2. Outline major provisions of the Clean Air Act Amendments, Safe Medical Devices Act (including medical device reporting), MedWatch program and Labeling Document 3. Address the U.S. Food and Drug Administration Enforcement Priorities Document applicable for reprocessing single-use devices CENTRAL SERVICE (CS) TECHNICIANS PERFORM MANY IMPORTANT tasks on a daily basis. These tasks may be very simple, such as recording the area temperature and humidity levels, or very challenging, such as processing complex instrumentation. Several government agencies have issued regulations to protect the healthcare worker while they perform important tasks like processing or using the instrumentation. Patients are also protected by these regulations because the guidance provided allows the healthcare worker to process and use the devices correctly. This lesson plan will address a few of the key government agencies and the regulations they enforce for the protection of healthcare workers and their patients. OBJECTIVE 1: IDENTIFY THE THREE MAJOR FEDERAL REGULATORY AGENCIES GOVERNING WORK IN CENTRAL SERVICE The Occupational Safety and Health Administration (OSHA) is the part of the U.S. Department of Labor that provides guidelines to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance. 1 The OSHA regulations of most relevance to CS pertain to occupational exposure to potentially toxic chemicals and bloodborne pathogens. 2 Also, the General Duty Clause of the Occupational Safety and Health Act (Sections 5[a] [1]) allows OSHA to intervene in a matter of worker protection, even if there is no applicable regulation. 3 These regulations cover the use of personal protective equipment (PPE) and have set exposure limits to chemicals, such as ethylene oxide (EtO) and glutaraldehyde. The General Duty Clause has provisions for reporting worker safety issues, and for the protection of those that report those issues. State OSHA offices exist in 26 states. 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, Provider Number 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. The certificate of course completion issued at the conclusion of this course must be retained in the participant s records for at least four (4) years as proof of attendance. In order to receive credit you must go to www.pfiedlerenterprises.com/iahcsmm/616 and complete the test, evaluation and registration forms. Once completed, you will be directed to print your certificate of completion. Scoring: IAHCSMM will award credit for this Self- Study Lesson Plan toward the renewal of a CRCST certification. To receive IAHCSMM credit, please visit www.iahcsmm.org for online grading (nominal fees will apply). Each online quiz with a passing score of 70% or higher is worth two points (2 contact hours) toward CRCST re-certification of 12 CEs. For more information: For questions or problems about Nursing Credits available for this lesson plan, please contact tonia@pfiedlerenterprises.com. For questions about IAHCSMM Credit available for this lesson plan, please contact us at 312.440.0078 or mailbox@iahcsmm.org.
Their standards may be more (but not less) restrictive than those of the federal OSHA agency. When in doubt, the most stringent standard (federal or state) should always be followed. U.S. ENVIRONMENTAL PROTECTION AGENCY The mission of the U.S. Environmental Protection Agency (EPA) is to protect human health and the environment. 4 The EPA enforces federal laws pertaining to air and water pollution and other environmentally-related statutes. It coordinates and supports research and anti-pollution activities at the state and local levels. The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) gives the EPA responsibility to regulate pesticides to ensure their effectiveness and safety. This includes all products with antimicrobial claims, such as sterilants, disinfectants and sanitizers. The antimicrobials Division of EPA s Office of Pesticide Programs evaluates and registers surface disinfectants and sanitizers. The approval process involves the review of manufacturers labeling claims and safety and effectiveness data. Labels on EPA-approved products must provide the product s EPA registration number, ingredient information, precautions and warnings, and directions for storage, use and disposal. CS professionals must read all applicable labels and follow the specific directions when using chemicals of any kind. U.S. FOOD AND DRUG ADMINISTRATION The U.S. Food and Drug Administration (FDA) is part of the U.S. Department of Health and Human Services. The FDA s Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. 5 The CDRH regulates the manufacture of all medical devices and requires premarket clearance of new medical devices. The level of regulation applicable to a medical device depends upon its FDA classification. Class I devices are relatively simple, low-risk products, such as ultrasonic cleaners and most hand-held surgical instruments. They are subject to general controls, which include postmarket requirements, such as registration and device listing, medical device reporting, corrections and removals, quality system regulation, labeling and, if non-exempt, a premarket notification application [510(k)]; however, most Class I devices are exempt from pre-market submission requirements. 6 Class II devices pose potential risks great enough to warrant a higher level of regulation. They may be subject to performance standards or other special controls, such as post-market surveillance study, specific guidelines or special labeling. Manufacturers of most Class II devices must submit premarket notification applications [510(k)] to the FDA before they introduce a new product. The manufacturer must use the 510(k) application to demonstrate that the new product is equivalent to a product already on the market. Class II devices include most types of sterilization-related equipment and products, such as EtO and steam sterilizers, and biological and chemical indicators. 6 Class III devices are the most stringently regulated. These include heart valves, infant radiant warmers, pacemakers and other implants, and lifesustaining devices significantly different from products already on the market. Manufacturers of new Class III devices must obtain pre-market approval (PMA) from the FDA by submitting extensive test data demonstrating product safety and effectiveness. 6 OBJECTIVE 2: OUTLINE MAJOR PROVISIONS OF THE CLEAN AIR ACT AMENDMENTS, SAFE MEDICAL DEVICES ACT (INCLUDING MEDICAL DEVICE REPORTING), MEDWATCH PROGRAM AND LABELING DOCUMENT The EPA and FDA have issued numerous regulations that affect CS. Some of the most significant include: 1990 CLEAN AIR ACT AMENDMENTS The 1990 Clean Air Act Amendments established a regulatory program administered by the EPA to protect the stratospheric ozone layer. 7 In January 1996, production of the ozone-depleting chlorofluorocarbons (CFCs) used in 12/88 EtO sterilant mixtures was phased out. An alternative gas mixture using hydrochlorofluorocarbons (HCFCs) was developed, approved under the Clean Air Act, and is now a replacement for the CFC sterilant mixture. National Emission Standards for Hazardous Air Pollutants (NESHAP) regulations were also established in the 1990 Clean Air Act Amendments; these were updated in 1996. NESHAP regulations established national emission standards for EtO for commercial sterilization facilities. There are no established national emission standards for EtO used by hospitals, but it is important to know about state or regional regulations that may exist. As of July 25, 1997, hospitals are affected by further Clean Air Act Amendments designed to reduce air pollution from medical waste incinerators. Full compliance with these standards has closed most of all hospital incinerators. The options of retrofitting existing equipment, choosing off-site disposal, or finding new technology presented a considerable financial challenge. MEDICAL DEVICE REPORTING Until 1990, FDA regulations applied exclusively to medical device manufacturers. With the passage of the Safe Medical Devices Act of 1990, however, healthcare facilities became subject to user reporting requirements. 8 Before this Act, medical device manufacturers were required to notify the FDA whenever they learned of
NURSING LESSON PLAN patient deaths or serious injuries that may have been caused by or contributed to by their devices, and whenever they learned of a device malfunction that, if it recurred, could cause a death or serious injury. Healthcare personnel are the manufacturers primary source of this information. Under updated Medical Device Reporting regulations in effect as of March 27, 2000, user facilities (hospitals, ambulatory surgical facilities, nursing homes or outpatient treatment facilities which are not physicians offices) [21 CFR803.3(f)] must report suspected medical device-related deaths to the FDA and the manufacturers within 10 workdays. User facilities must report medical device-related serious injuries only to the manufacturer within 10 workdays. If the manufacturer is unknown, the serious injury should be reported to the FDA. A serious injury is an injury or illness that is life-threatening, results in permanent impairment of a body function or permanent damage to body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure [21CFR 803.3(bb)(1)]. An annual report of deaths and serious injuries must also be submitted to the FDA on January 1 of each year. While end users of therapeutic or diagnostic devices are more likely to be directly affected by the law than are CS personnel, certain sterilization failures may have to be reported if they can be linked to patient illnesses. THE FDA MEDWATCH PROGRAM The FDA MedWatch program provides a vehicle to notify the FDA about medical device malfunctions, labeling inadequacies and other problems, including those involving other products regulated by the FDA, such as drugs and biologics. In recent years, the FDA has used both the voluntary and mandatory reporting programs to collect information about specific potential problems. 2 LABELING DOCUMENT The FDA is concerned about the potential for transmitting infectious diseases caused by improper reprocessing of medical devices. In April 1996, it released a document, Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: FDA Reviewer Guidance, to help FDA reviewers who evaluate pre-market approval applications for medical devices. On March 17, 2015, the FDA issued an updated document titled Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff. This new document supersedes the April 1996 guidance document. 7 The updated document was created to coincide with the development of new complex, reusable medical device designs, which are more difficult to reprocess. In addition, there has also been a significant advance in knowledge and technology involved in reprocessing reusable medical devices. The new guidance reflects the scientific advancements. Manufacturers of reusable medical devices are responsible for producing and supplying labeling that bears adequate instructions for use (IFU), including directions on preparing a device for use (e.g., Cleaning, disinfecting, sterilizing, etc.). The FDA guidance tells manufacturers to use FDA-recognized test methods. During the validation testing manufacturers should ensure users will be able to successfully understand and follow the IFU. They should take into considerations human factors to ensure reprocessing staff can accomplish the specific recommended reprocessing procedures. For instance, if users need to wear PPE, such as goggles, full-length face shields, heavy-duty utility gloves or liquidresistant covering with sleeves, then the validation study participants should also wear them. In addition, manufacturers must also comply with specific criteria that mostly involve reprocessing instructions when they submit medical device applications to the FDA for evaluation. Prior to the validation studies, manufactures should consult relevant clinical practice guidelines and recommendations for infection prevention and control published by professional societies and associations, standards developing organizations, and government agencies. For example, during testing the manufacturers should consider commonly-used sterilization cycles and avoid the need for any extended sterilization exposure times. The newly-updated FDA labeling document places the responsibility for safe and effective reprocessing of medical devices with both the manufacturer and user: Manufacturers of reusable medical devices are responsible for having labeling that bears adequate directions for use, including instructions on preparing a device for use. 9 The users are responsible for ensuring that they have the facilities and equipment to execute the instructions, and that the instructions are followed. These criteria and the subsequent IFU are useful for users selecting equipment to be able to successfully reprocess the devices. OBJECTIVE 3: ADDRESS THE U.S. FOOD AND DRUG ADMINISTRATION ENFORCEMENT PRIORITIES DOCUMENT APPLICABLE FOR REPROCESSING SINGLE-USE DEVICES In August, 2000, the FDA released its final guidance document titled Enforcement Priorities for Single-Use Devices Devices (SUDs) Reprocessed by Third Parties and Hospitals. All hospitals and third-party reprocessors reprocessing SUDs must be in compliance with the pre-market and post-market requirements outlined in the enforcement document. The document does not currently apply to
permanent pacemakers, hemodialyzers, healthcare facilities that are not hospitals, or unopened but unused SUDs; however, changes in the document are still possible. 10 PRE-MARKET REQUIREMENTS The FDA retained the use of the device classifications (Class I, Class II, Class III) listed in the Code of Federal Regulations (CFR) to set enforcement priorities for premarket submission requirements. 11 Unless the device is listed as specifically exempt from regulation, a 510(k) submission is required for Class I and Class II devices. Depending upon its type, Class III devices may require either a 510(k) submission or a pre-market approval application (PMA). A 510(k) is not a form, registration or listing. It is a package of information that claims substantial equivalence to one or more legally marketed predicate devices. 11 A PMA is required [although sometimes a 510(k) is adequate] for Class III devices that have not been previously marketed or for an existing device seeking a new intended use. 12 A PMA is more complicated to submit than a 510(k) because substantial equivalence is not involved. One must prove the device has a reasonable assurance of safety and effectiveness for its intended use based on valid scientific evidence. Submission of clinical data is sometimes necessary to prove safety and effectiveness. The FDA requires a satisfactory inspection of a facility before a PMA application is approved. In addition, the PMA must include a comprehensive manufacturing section which clearly identifies all appropriate controls. POST-MARKET REQUIREMENTS Post-market requirements that apply to third-party and hospital reprocessors include mandates applicable to: Registration and Listing (Section 510 of the Act; 21 CFR Part 807) Medical Device Reporting [Sections 519 (a) (b) and (c) of the Act; 21 CFR Part 803] Medical Device Tracking [Section 519(e) of the Act; 21 CFR Part 821] Medical Device Corrections and Removals [Section 519(f) of the Act;21 CFR Part 806] Quality System Regulation [Section 520(f) of the Act; 21 CFR Part 820] Labeling [Section 502 of the Act; 21CFR Part 801] 13 Because regulatory language can be difficult to understand, the FDA website provides printable materials and assistance. 14 IN CONCLUSION Government agencies have issued regulations to protect healthcare workers while they perform important tasks. Regulations have also been set regarding the manufacturing of medical devices and how to effectively process these devices. When Central Service technicians follow the government regulations they not only protect themselves and their co-workers, but they also protect their patients from receiving devices that have defects or have been improperly processed. REFERENCES 1. Occupational Safety and Health Administration. www.osha.gov/about.html. 2. Occupational Safety and Health Administration. Regulations: 29 CFR Part 1 910.1030 Occupational Exposure to Bloodborne Pathogens; Final Rule; Effective March 6, 1992; 29 CFR Part 1 910.1030 Occupational Exposure to Blood-borne Pathogens; Needlestick and Other Sharp Injuries; Final Rule. Amended and effective April 18, 2001; and 29 CFR 1910.1035 Occupational Exposure to Tuberculosis, Proposed Rule, October 17, 1997. 3. Occupational Safety and Health Administration. www.osha.gov/pls/oshaweb/ owadisp.show_document?p_ table=oshact&p_id=3359. 4. U.S. Environmental Protection Agency. www2.epa.gov/aboutepa/our-mission-andwhat-we-do. 5. U.S. Food and Drug Administration. www.fda.gov/aboutfda/centersoffices/ OfficeofMedicalProductsandTobacco/CDRH/. 6. U.S. Food and Drug Administration. http://www.fda.gov/medicaldevices/ DeviceRegulationandGuidance/Overview/ ClassifyYourDevice/. 7. U.S. Environmental Protection Agency. Clean Air Act. www.epa.gov/clean-air-act-overview/ clean-air-act-text. 8. U.S. Food and Drug Administration. Medical Device Reporting. www.fda.gov/medicaldevices/ Safety/ReportaProblem/default.htm. 9. U.S. Food and Drug Administration. www.fda.gov/downloads/medicaldevices/ deviceregulationandguidance/ guidancedocuments/ucm253010.pdf. 10. U.S. Food and Drug Administration. www.fda.gov/regulatoryinformation/ Guidances/ucm107164.htm. 11. U.S. Food and Drug Administration. Premarket requirements. Food, Drug, and Cosmetic Act (the Act): Sections 510, 513 and 515, and 21 CFR Parts 807 and 814. 12. U.S. Food and Drug Administration. Substantial equivalence decision-making process. www.fda.gov/cdrh/k863.html. Successfully completing a 510(k) notification. www.fda.gov/cdrh/devadvice/314.html. 13. U.S. Food and Drug Administration. Postmarket requirements. www.fda.gov/cdrh. 14. U.S. Food and Drug Administration. Code of Federal Regulations. (CFR), Parts 862-892. ADDITIONAL RESOURCES Healthcare personnel who wish to voluntarily report device problems or potential hazards may call MedWatch (800.FDA.1088) or visit www.fda. gov/medwatch/report/hcp.htm to report online, or to obtain additional information or forms. PMA information is contained in Sections 513 and 515 of the Act and 21 CFR Part 814. Guidance for preparation of FDA PMA may be obtained at www.fda.gov/cdrh/ode/448.pdg.