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Important Information - Coronavirus (COVID-19)
Instrument Reprocessing Recommended Practices

Instrument Reprocessing Recommended Practices

DECONTAMINATION LIFE CYCLE

The decontamination life cycle model highlights the extent to which decontamination affects the whole of any health care facility and not just those areas processing equipment. Traditionally, decontamination has been the responsibility of the departmental heads of specialist units, for example sterile services, endoscopy units, theatre surgical suites, etc. Management arrangements within health care facilities often divided these functions and made it difficult for a totally coordinated approach to the application of decontamination standards and practices to be achieved.

Effective decontamination requires the attainment of acceptable standards at all stages of the life cycle. Failure to address issues in any of these stages will result in inadequate decontamination. At all stages of reprocessing, the following issues need to be taken into account:

  1. The location and activities where decontamination takes place;
  2. Instrument reprocessing facilities and equipment at each location;
  3. Ensuring that equipment used is validated, maintained, and tested in accordance with manufacturer’s guidelines and legislation;
  4. The existence of effective management arrangements;
  5. The existence of policies and procedures for all aspects of decontamination work.

The aim of decontamination is to make reusable medical devices safe for use on a patient and for staff to handle without presenting an infection hazard. Source: Depot Health

Guidelines & Recommendations

Instrument processing functions should be performed in one central department for safety and cost-effectiveness.

A. Personnel doing the reprocessing should be capable of critical thinking.
B. The supervising organization is responsible for ensuring appropriate training, education, and competency of the staff.
C. Sterilization cycles with little or no dry time are efficacious when used in compliance with validated written instructions provided by the device manufacturers, sterilization equipment manufacturers, and (if applicable) container manufacturers and when done in accordance with professional guidelines.
D. Cleaning, decontamination, and rinsing are critical and users must follow and complete all required processing steps regardless of the sterilization exposure parameters being used.
E. Aseptic transfer from the sterilizer to the point of use is critical to protect items from contamination.
F. Only items sterilized and packaged in materials cleared by the FDA for maintenance of sterility can be stored.
G. The device manufacturer's written instructions for reprocessing any reusable device must be followed. The cycle parameters required to achieve sterilization are determined by the design of an instrument, the characteristics of the load, the sterilizer capabilities, and the packaging (if used).
H. Survey personnel involved in evaluating organizations that sterilize medical items should be knowledgeable and capable of exercising critical thinking and judgment. The regulatory or accrediting agency should evaluate whether the organization's leaders ensure that training, education, and resources are provided and the competency of staff is validated.
I. Quality management is important to ensure compliance with processes and relating those processes to outcomes.
J. Sterilization process monitoring is essential to ensure that sterilization practices are efficacious.
K. Examples of process monitoring tools are physical indicators, biological indicators, and chemical indicators.
L. Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing.

Source: www.apic.org


Guidelines & Recommendations

The following recommended practices for Cleaning and Care of Surgical Instruments and Powered Equipment were developed by the Association of Perioperative Registered Nurses (AORN) Recommended Practices Committee. These recommended practices are intended as guidelines adaptable to various practice settings.

  1. The manufacturer's written, validated instructions for handling and reprocessing should be obtained and evaluated to determine the ability to adequately clean and reprocess the equipment within the healthcare facility before purchasing surgical instruments and powered equipment.
  2. New, repaired and refurbished instruments should be examined, cleaned and sterilized according to manufacturer's written instructions before use in a healthcare organization.
  3. Borrowed or consigned (i.e., loaner) instruments should be examined, cleaned and sterilized by the receiving healthcare organization before use, according to manufacturer's written instructions.
  4. Instruments should be kept free of gross soil during surgical procedures.
  5. Cleaning and decontamination should occur as soon as possible after instruments and equipment are used.
  6. Contaminated instruments must be contained during transport and should be transported in a timely manner to a location designed for decontamination.
  7. Instruments should be decontaminated in an area separated from locations where clean activities are performed.
  8. The type of water available for cleaning should be consistent with the manufacturer's written instructions and intended use of the equipment and cleaning agent.
  9. Surgical instrument, medical device, and equipment manufacturer's validated instructions should be followed regarding the types of cleaning agents (i.e., enzyme preparations, detergents) to be used for decontamination.
  10. Surgical instruments, medical device, and equipment manufacturer's validated instructions should be followed regarding the types of cleaning methods (i.e, manual, automated) to be used for decontamination.
  11. Surgical instruments should be inspected for cleanliness and proper working order after decontamination.
  12. Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces.
  13. Powered surgical instruments and all attachments should be decontaminated, lubricated, assembled, sterilized and tested before use according to manufacturer's written instructions.
  14. Special precautions should be taken for reprocessing ophthalmic surgical instruments.
  15. Insulated electrosurgery instruments should be decontaminated after use according to manufacturer's validated, written instructions and inspected for damage.
  16. Special precautions should be taken when cleaning robotic instruments.
  17. Special precautions should be taken to minimize the risk of transmission of prion diseases.
  18. Personnel handling contaminated instruments and equipment must wear appropriate personal protective equipment (PPE) and should be vaccinated against the hepatitis B virus.
  19. Personnel should receive initial education and competency validation on procedures, chemicals used, and personal protection and should receive additional training when new equipment, instruments, supplies or procedures are introduced.
  20. Documentation should be completed to enable the identification of trends and demonstrate compliance with regulatory and accredited agency requirements.
  21. Policies and procedure regarding the care and cleaning of surgical instruments and powered equipment should be developed using the validated instructions provided by the medical device manufacturers, reviewed at regular intervals, revised as necessary and readily available in the practice setting.
  22. The healthcare organization's quality management program should evaluate the care of instruments to improve patient safety.

For further explanation of these recommended practices, please visit www.aorn.org