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:
- 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.
- 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.
- 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:
- The
Joint Commission (TJC): TJC accredits healthcare facilities and
emphasizes adherence to sterile processing protocols, including secure
communication for patient safety [1].
- 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].
- Environmental
Protection Agency (EPA): The EPA oversees the disposal of medical
waste and chemicals used in Sterile Processing, ensuring environmental
safety [6].
- Department
of Transportation (DOT): DOT regulations cover transporting both
sterilized and contaminated medical devices, ensuring compliance with
hazardous materials handling [8].
- 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].
- 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].
- 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:
- Standardization:
HSPA sets guidelines for cleaning, sterilizing, and handling medical
devices, promoting consistency across healthcare settings.
- 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.
- 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
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)
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.