CRCST
Technical Continuing Education (TCE)
SELF-STUDY PLANS

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 90
Federal Regulations: Overview and Update
[Reprinted from Communiqué: September/October 2006]

Objective 1: Identify the three major federal regulatory agencies that govern the work of Central Service personnel

• The Occupational Safety And Health Administration (OSHA) is part of the U.S. Department of Labor and protects workers from occupationally-caused illnesses and injuries. The OSHA regulations most relevant to Central Service pertain to occupational exposure to potentially toxic chemicals and bloodborne pathogens.1 In addition, the General Duty Clause of the
  Occupational Safety and Health Act (Sections 5[a] [1]) allows OSHA to intervene in matters of worker protection, even if there is no applicable regulation. Twenty-three states have OSHA offices whose standards may be more (but not less) restrictive than those of the federal OSHA agency.

• The Environmental Protection Agency (EPA) enforces federal laws concerning air and water pollution, and other environmentally-related statutes, and coordinates and supports research and anti-pollution activities at the state and local levels.
  
  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes the EPA to insure the safety and effectiveness of pesticides, including 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 for these products involves reviewing the manufacturer’s labeling claims and safety and effectiveness data. Labels on EPA-approved products must provide the EPA registration number, ingredient information, precautions and warnings, and directions for storage, use, and disposal. Central Service technicians must read labels for this information and follow directions when using chemicals of any kind.

• The 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 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. These are subject to general controls, including 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). Most Class I devices, however, are exempt from any 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 postmarketing surveillance study, specific guidelines, or special labeling. Manufacturers of most Class II devices must submit a 510(k) premarket notification application to the FDA before they introduce 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 provisions of the Clean Air Act Amendments, Safe Medical Devices Act (including Medical Device Reporting), Medwatch Program, Labeling Document, and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

The EPA and FDA have issued numerous regulations that affect Central Service. Some of the most significant of these are:

• The 1990 Clean Air Act Amendments which 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)— approved under the Clean Air Act—was developed and is now a replacement for the CFC sterilant mixture.
  
  As of July 25, 1997, hospitals are affected by further Clean Air Act Amendments designed to reduce air pollution from medical waste incinerators. Since 2002, there has been ongoing activity in the U.S. Senate regarding possible rollbacks to pollution control provisions. Web sites such as
  www.environmentaldefense.org/ documents/2695_cleanairact.htm can
  provide up-to-date information on this topic.

• 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.
  
  Under updated medical device reporting regulations [21 CFR 803.3(f)] in effect as of March 27, 2000, user facilities (hospitals, ambulatory surgical facilities, nursing homes, or outpatient treatment facilities which are not physicians’ offices) must report suspected medical device- related deaths to the FDA and the manufacturers within ten working days. User facilities must report medical device related serious injuries only to the manufacturer within ten working days. If the manufacturer is unknown, the serious injury should be reported to the FDA.
  
  A “serious injury” is defined as an injury or illness that is life-threatening, or results in—or requires medical or surgical intervention to prevent—permanent impairment of a body function or permanent damage to a body structure [21 CFR 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 and diagnostic devices are more likely than Central Service personnel to be affected directly by the law, 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 and biologics. In recent years, the FDA has used both voluntary and mandatory reporting programs to collect information about
  specific potential problems.² The FDA now encourages Central Service staff experiencing problems with inadequate manufacturers’ instructions for reprocessing, or receiving instructions that call for other than standard procedures, to use the Medwatch program to file their complaint.

• 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. The document 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 executed by the user. The users are responsible for ensuring that they have the facilities and equipment to execute the instructions, and that the instructions are followed.”³
  These criteria represent a major step in providing healthcare professionals with manufacturers’ reprocessing recommendations. They are also helpful for users who are selecting equipment to successfully reprocess the devices.

• Medical Device User Fees and Modernization Act of 2002 (MDUFMA). On October 26, 2002, the Medical Device User Fee and Modernization Act of 2002 amended the Federal Food, Drug and Cosmetic Act (the Act) by adding a new section, 510(o), that provided new regulatory requirements for reprocessed SUDs (single-use devices). According to this new provision, in order to insure that reprocessed SUDs are substantially equivalent to a similar legally marketed U.S. device (called a “predicate device”), the 510(k) for certain reprocessed SUDs, identified by the FDA, must include validation data. Additional information regarding the MDUFMA is available at the FDA site, www.fda.gov/cdrh/ mdufma/faqs.html.

Objective 3: Discuss the FDA Enforcement Priorities Document as it applies to
reprocessing single-use devices (SUDs).

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 third-party reprocessors and hospitals reprocessing SUDs must be in compliance with the premarket and postmarket 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.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 and Class II devices. Depending upon its type, a Class III device 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.⁶ Although a 510(k) is sometimes adequate, a PMA is generally required for Class III devices that have not been previously marketed or for an existing device for which a new use is being proposed.⁷ A PMA is more complicated to submit than a 510(k) because it does not involve a device of substantial equivalence. Instead, one must prove that the device has a reasonable assurance of safety and effectiveness for its intended use based on valid scientific evidence. Sometimes submission of clinical data is necessary to prove safety and effectiveness. As of October 1, 2002, the FDA charges a fee to review a Premarket Notification 510(k) and a Premarket Approval.
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.

Postmarket Requirements. Postmarket 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; 21 CFR Part 801)⁸

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

Endnote

This lesson is adapted from: Anne Cofiell. Legal Issues: Regulations and Reuse. Chapter 14 in: Central Service Technical Manual. Sixth Edition (revised, August 2005). Chicago, Illinois. International Association of Healthcare Central Service Materiel Management.

References

1. These regulations are: 29 CFR Part 1910.1030 Occupational Exposure to Bloodborne Pathogens; Final Rule; effective March 6, 1992; 29 CFR Part 1910.1030 Occupational Exposure to Bloodborne 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.
2. Healthcare personnel who wish to report device problems, potential hazards, or problems with manufacturers can call Medwatch (800-FDA-1088) or go to the IAHCSMM Web site www.iahcsmm.org and select "iahcsmm news" then "Reporting manufacturer problems to the FDA" and follow the instructions.
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 the Food, Drug, and Cosmetic Act (the Act), Sections 510, 513, and 515, and in 21 CFR Parts 807 and 814. The Act provides the regulation; the CFR indicates the classification and what is needed to comply with the regulation.
6. Information concerning the substantial equivalence decision-making process can be found online at www.fda.gov/cdrh/k863.html. Information for successfully completing a 510(k) notification is available on the FDA 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 preparation of a PMA may be obtained from www.fda.gov/cdrh/ode/448.pdg.
8. Additional information about each postmarket requirement is available through the CDRH home page: www.fda.gov/cdrh/; select "Postmarket requirements." Guidance documents on these postmarket requirements are also available on the CDRH "Device Advice" site: 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]). Additional information is available on the FDA home page: www.fda.gov/.