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This series of self-study lessons on Central Service topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM). The lessons are administered by Purdue University’s Continuing Education Division.

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Lesson Plan CRCST 400
Legal Issues: Regulations and Reuse¹

Objective 1: Identify the three major federal regulatory agencies governing workin Central Service.

Occupational Safety and HealthAdministration (OSHA). OSHA is part of the U.S. Department of Labor, that provides guidelines to protect workers from occupationally-caused illnesses and injuries. The OSHA regulations of most relevance to Central Service pertain to occupational exposure to potentially toxic chemicals and blood-borne pathogens.¹ 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.

State OSHA offices exist in twenty-six states. Their standards may be more (but not less) restrictive than those of the federal OSHA agency.

Environmental Protection Agency (EPA). The EPA enforces federal laws pertaining to air and water pollution and other environmentally-related statutes. It coordinatesand 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 insure their effectiveness and safety. This includes all products with anti-microbial claims, such assterilants, disinfectants, and sanitizers. The anti-microbials 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 products EPA registration number, ingredient information, precautions and warnings, and directions for storage, use, and disposal. Central Service technicians must read labels and follow directions when using chemicals of any kind.

Food and Drug Administration (FDA). The FDA is part of the U.S. Department of Health and Human Services. The FDA’sCenter for Devices and Radiological Health (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 post-market requirements such as registration and device listing, medical device reporting, corrections and removals, quality system regulation, labeling and, if non-exempt, a premarket notificationapplication (510k). However, most Class I devices are exempt from premarket submission requirements.

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-marketing surveillance study, specific guidelines, or special labeling. Manufacturers of most Class II devices must submit premarket notification applications (510ks) to the FDA before the yintroduce a new product. The manufacturer must use the 510(k) application to demonstrate that the new product is substantially 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 .

Class III devices are the most stringently regulated. These include heart valves, infant radiant warmers, pacemakers and other implants, and life-sustaining devices significantly different from products already on the market. Manufacturers of new Class III devices must obtain premarket approval (PMA) from the FDA by submitting extensive test data demonstrating product safety and effectiveness.

Objective 2: Discuss major provisionsof 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 Central Service. Some of the most significant are discussed below.

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. In January,1996, production of the ozone-depleting chlorofluorocarbons (CFCs) used in 12/88 ethylene oxide 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 the1990 Clean Air Act Amendments. These were updated in 1996. NESHAP regulations established national emission standards for ethylene oxide (EtO) for commercial sterilization facilities. There are no established national emission standards for EtO used by hospitals, but itis 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 retro fitting 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.

Before this Act, medical device manufacturers were required to notify the FDA whenever they learned of 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 ten work days. User facilities must report medical device-related serious injuries only to the manufacturer within ten work days. 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 ofdeaths 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 bedirectly affected by the law than are Central Service personnel, certain sterilization failures may have to be reported if they can be linked to patient illnesses.

Medwatch Program. The 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 andbiologics. 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, to help FDA reviewers who evaluate premarket approval applications for medical devices.

Manufacturers must comply with seven new criteria, mostly involving reprocessing instructions, when they submit medical device applications to the FDA for evaluation. It places the responsibility for safe and effective reprocessing of medical devices with both the manufacturer and user: “Manufacturers are responsible for supporting the claim of reuse with adequate labeling; the labeling must provide sufficient instructions on how to prepare the device for the next patient; and the manufacturer is responsible for the documentation of tests which show that the instructions are adequate and can be reasonably executedby the user. The users are responsible for ensuring that they have the facilities and equipment to execute the instructions, andthat the instructions are followed.”3Thisis a major step in providing healthcareprofessionals with manufacturers’reprocessing recommendations. These criteria are also useful for users selectingequipment to successfully reprocess the devices.

Objective 3: Discuss the FDA Enforcement Priorities Document applicable to reprocessing single-use devices.

In August, 2000, the FDA released its final guidance document, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals. Barring future exceptions, the phase-in period is now over, and all hospitals and third-party reprocessors reprocessing SUDs must be in compliance with the premarket 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 documentare still possible.⁴)

Premarket Requirements. The FDA retained the use of the device classifications (Class I, Class II, Class III) listed in the CFR to set enforcement priorities for premarket submission requirements.⁵ Unless the device is listed as specifically exempt from regulation, a 510(k) submission is required for Class I andClass II devices. Depending upon its type, Class III devices may require either a 510(k) submission or a premarket 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. 6A 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.⁷ A PMA is more complicated to submit than a 510(k) because substantial equivalence is not involved. One must prove the device has areasonable 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 CFRPart 803)
• Medical Device Tracking (Section519(e) of the Act; 21 CFR Part 821)
• Medical Device Corrections andRemovals (Section 519(f) of the Act;21 CFR Part 806)
• Quality System Regulation (Section520(f) of the Act; 21 CFR Part 820)
• Labeling (Section 502 of the Act; 21CFR Part 801)⁸

Because regulatory language can be difficult to understand, the FDA Web site provides printed material and assistance.⁹

References

1 These regulations are: 29 CFR Part 1 910.1030 Occupational Exposure to Blood-borne Pathogens; Final Rule; effective March 6, 1992; 29 CFR Part 1 910.1030 Occupational Exposure to Blood-borne Pathogens; Needle stick 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.

2 Healthcare personnel who wish to voluntarily report device problems or potential hazards can call Medwatch (1-800-FDA-1088) or use the Web site (www.fda.gov/medwatch/report/hcp.htm) to report on-line or to obtain additional information or forms.

3 Labeling Reusable Medical Devices for Reprocessing Healthcare Facilities FDA Reviewer Guidance, Office of Device Evaluation, April, 1996. (page 2).

4 Up-to-date FDA reuse information is found on its Web site: www.fda.gov/cdrh/reuse/index.shtml.

5 Premarket requirements are found in theFood, Drug, and Cosmetic Act (the Act), Sections 510, 513, and 515, and in 21 CFR Parts 807 and 814. The Actprovides the regulation; the CFR indicates the classification and what isneeded to comply with the regulation.

6 Information concerning the substantial equivalence decision-making processcan be found on-line at www.fda.gov/cdrh/k863.html. Information for successfully completinga 510(k) notification is available on the Web site www.fda.gov/cdrh/devadvice/314.html.

7 PMA information is contained in Sections 513 and 515 of the Act and 21 CFR Part 814. Guidance for preparationof a PMA may be obtained from www.fda.gov/cdrh/ode/448.pdg.

8 Additional information about each post-market requirement is available through the CDRH home page: www.fda.gov/cdrh/ – select Post-market requirements. Guidance documents are also available on these post-market requirements by accessing the CDRH home page and selecting “Device Advice; www.fda.gov/cdrh/devadvice/.

9 When working on reuse matters, it is helpful to use Title 21, Code of Federal Regulations (CFR), Parts 862-892 (available from the U.S. Government Printing Office in Washington, D.C. or through the Division of Small Manufacturers International and Consumer Assistance, telephone: 301-443-6597). Both sections of the Food, Drug, and Cosmetic Act (FDCA) and the CFR needed for reference are available through the FDA home page: www.fda.gov/.

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