My Understanding of Standards and Regulations for Reprocessing Reusable Medical Devices (RMD) in Healthcare Sterile Processing

Martin Li, MA, CRCST, CER, CIS, CHL

 

Reusable medical devices (RMD), including flexible endoscopes and probes, play a critical role in healthcare and are central to the Sterile Processing Department (SPD). Proper reprocessing of these devices is essential for patient safety and infection control. Agencies such as the Food and Drug Administration (FDA), the Association for the Advancement of Medical Instrumentation (AAMI), and the International Organization for Standardization (ISO) establish standards and guidelines to ensure that reprocessing procedures are both effective and safe. This multistep process includes cleaning, disinfection, and sterilizing reusable devices to prevent cross-contamination and infection.

Key Steps in Reprocessing Medical Devices:

1. Cleaning: Involves removing visible organic and inorganic materials from devices using detergents or enzymatic solutions. Cleaning can be manual or automated, preparing devices for the next stages.
2. Disinfection: This step uses chemical disinfectants to kill most microorganisms on devices that meet mucous membranes (e.g., endoscopes). Spores are typically not eliminated at this stage.
3. Sterilization: Critical devices, such as surgical instruments, undergo sterilization to eliminate all microorganisms. Methods include steam sterilization or low-temperature processes like hydrogen peroxide gas plasma and Ethylene Oxide (ETO).

Standards and Regulations/Guidelines

• FDA Guidance: The FDA highlights the importance of robust reprocessing procedures. Devices must be designed for proper cleaning and sterilization to minimize infection risk [2].
• ANSI/AAMI ST91: This standard provides comprehensive guidelines for reprocessing flexible and semi-rigid endoscopes, including verification of cleaning and contamination control strategies [3].
• ISO 13485:2016 This international standard specifies the requirements for a quality management system. It ensures that organizations can deliver medical devices that meet regulatory standards, including those for reprocessing [4].....

Simplified Reprocessing Workflow:

Reusable Device → Cleaning → Disinfection → Sterilization → Storage → Reuse

Table 1: Overview of Reprocessing Steps and Associated Standards

Step	Description	Applicable Standards
Cleaning	Removal of debris and contaminants	FDA Guidance, ANSIAAMI ST91
Disinfection	High-level disinfection using chemicals	ANSI/AAMI ST91, ISO 13485
Sterilization	Complete elimination of microorganisms	FDA Guidance, ISO 13485
Storage/Transport	Safe handling to prevent contamination	AAMI ST91, FDA Guidelines

 By adhering to these standards, Sterile Processing Departments can ensure the safe reuse of medical devices while reducing infection risks.

Roles of Related Bodies in Sterile Processing:

1. The Joint Commission (TJC): TJC accredits healthcare facilities and emphasizes adherence to sterile processing protocols, including secure communication for patient safety [1].
2. Occupational Safety and Health Administration (OSHA): OSHA enforces safety protocols in Sterile Processing, particularly in handling hazardous materials, protecting healthcare workers from risks during reprocessing [11,12].
3. Environmental Protection Agency (EPA): The EPA oversees the disposal of medical waste and chemicals used in Sterile Processing, ensuring environmental safety [6].
4. Department of Transportation (DOT): DOT regulations cover transporting both sterilized and contaminated medical devices, ensuring compliance with hazardous materials handling [8].
5. Centers for Disease Control and Prevention (CDC): The CDC offers guidelines for infection control, outlining critical steps for cleaning, disinfection, and sterilizing instruments to prevent healthcare-associated infections [7].
6. Association of Perioperative Registered Nurses (AORN): AORN provides best practices for perioperative care, including sterilization and handling of surgical instruments, which are crucial for Sterile Processing [9].
7. Society of Gastroenterology Nurses and Associates (SGNA): SGNA creates guidelines specifically for reprocessing endoscopes, addressing the complexity of cleaning and disinfecting these devices [10].

HSPA's Role in Sterile Processing

The Healthcare Sterile Processing Association (HSPA) is a key organization that promotes high standards, education, and certification for sterile processing professionals. The organization ensures that technicians are equipped to maintain patient safety through effective reprocessing of medical devices [13].

Key Contributions of HSPA:

1. Standardization: HSPA sets guidelines for cleaning, sterilizing, and handling medical devices, promoting consistency across healthcare settings.
2. Education and Certification: HSPA provides essential certification programs like the CRCST (Certified Registered Central Service Technician), ensuring that technicians meet the demands of the healthcare industry.
3. Advocacy: HSPA advocates for sterile processing professionals, providing resources and ongoing support to improve safety and effectiveness in medical instrument handling.

References

1.      https://www.jointcommission.org/who-we-are/

2.      fda.gov - Reprocessing of Reusable Medical Devices | FDA

3.      ANSI/AAMI ST91 2021 | AAMI https://www.aami.org/ST91

4.      ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (ansi.org)

5.      U.S. Environmental Protection Agency (EPA). Clarification of HIV (AIDS Virus) Labeling Policy for Antimicrobial Pesticide Products. Federal Register 54, No.26:6288-6290. https://www.epa.gov/aboutepa/our-mission-and-what-we-do

6.      U.S. Environmental Protection Agency (EPA). National Emission Standards for Hazardous Air Pollutants for Source Categories, Code of Federal Regulations, Title 40, part 63, Subpart 0 (Updated 1996).

7.      Centers for Disease Control and Prevention. Guidelines for Disinfection and Sterilizing in Healthcare Facilities. Guidelines for Handwashing and Hospital Environmental Control, 2008. https://www.cdc.gov/infection-control/hcp/disinfection-and-sterilization/index.html

8.      Transporting Infectious Substances Safely | PHMSA (dot.gov)

9.      https://www.aorn.org/

10. SGNA | Society of Gastroenterology Nurses and Associates, Inc. > Home

11. Occupational Safety and Health Administration (OSHA). Occupational Exposure to Bloodborne Pathogens; Needlestick and Other Sharp Injuries: Final Rule. Amended and effective April 18,2001: and 29CFR 1910,1035 Occupational Exposure to Tuberculosis, Proposed Rule. October 17, 1997. https://www.osha.gov/bloodborne-pathogens

12. OSHA. Occupational Exposure to Ethylene Oxide. Federal Register 53, No.66: 53:11414-11438. Code of Federal Regulations, Title 29, Part 1910.1047.1988.

13. HSPA. Sterile Processing Technicial Manual, 9th Edition, 2023.HSPA Printing, pages 83-95.