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Best Practices for Handling and Transporting Soiled and Sterile Medical Devices - Updated

Updated: May 13


A hospital transportation truck delivering medical devices
A hospital delivery truck parked in front of a modern building, ready for a crucial medical supplies drop-off.

The process of handling and transporting contaminated medical and surgical devices is often misunderstood by end-users, especially in clinical areas. The lack of proper handling, storage, and transportation is often cited by State and CMS accreditation surveyors. Below are regulations and guidelines that will help you with your compliance with this process.








Internal Transportation of Medical Devices


Point of Use Care has become a focal point during regulatory inspections for several years now. Gross bioburden on instruments should be removed during and at the end of use; a wetting agent (e.g., enzymatic spray, water, specially formulated product) should be used to keep instruments moist until reprocessing occurs. Completing the point-of-use care aids the cleaning process. Contact with bioburden can break down the instrument's protective passivation layer and reduce the longevity of the instrumentation. Another benefit of the point-of-use care is the reduction in the formation of biofilm layers. Instruments should be transported to the decontamination room as soon as possible for reprocessing.


OSHA's Bloodborne Pathogen Standard 1910.1030(d)(2)(viii) states that " Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly reprocessed. These containers shall be: puncture-resistant, labeled, or color-coded in accordance with this standard, leakproof on the sides and bottom, and in accordance with the requirements set forth in paragraph (d)(4)(ii)(E) for reusable sharps. AAMI's ST79: 2017 recommends "separation is best done at the point of use by persons aware of the potential for injury from sharps and the potential infection hazards of the contaminated items." OSHA also states, " Reusable sharps that are contaminated with blood or other potentially infectious materials shall not be stored or processed in a manner that requires employees to reach by hand into the containers where these sharps have been placed."


When instruments cannot be processed immediately, storage of instruments should be kept in a location where the public cannot access them. They should be in a locked container or locked cabinet; the manufacturer's instructions for use should be followed for the contact time when using wetting agents. It has been noted that enzymatic solutions can cause harm to stainless steel instruments during long storage periods.


Following the Federal regulations and national guidelines creates a safer environment for staff, patients, and visitors.


External Transportation of Medical Devices


The previous recommendations remain relevant, but there are additional considerations for the external transportation of medical devices. The AAMI TIR 109:2025 document offers guidance on transporting reusable medical devices between healthcare facilities and off-site reprocessing centers. It highlights the importance of preserving the integrity of sterilized items and ensuring the safe transport of both contaminated and processed items.


Key Considerations


Regulatory considerations for transportation include the DOT Hazardous Materials Regulations, OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030), as well as any specific local, state, or federal regulations.


The TIR 109 document states that medical waste regulations are distinct from the hazardous waste regulations set by the EPA. When dealing with medical devices contaminated with blood or blood products, medical waste regulations are not applicable based on the classification of waste as Infectious Substances or Regulated Medical Waste under Title 49 of the Code of Federal Regulations, section 173.134, Class 6, Division 6.2.


  • Robust policies and procedures should be in place and cover both the entities involved in the transportation process.

  • Loading and unloading areas must be designed to protect both sterile and contaminated items, ensuring the integrity of the products. This design includes the use of tamper-evident items to maintain item control.

  • Separation of clean, sterile, and contaminated items should occur during the loading and unloading processes (i.e., soiled & clean).

  • The physical design should be spacious enough to handle the work volume, ensure the separation of soiled and clean items, and incorporate appropriate distribution equipment and environmental controls.


Other design aspects of the transportation process include:

  • Having a proper transportation carrier for processed items

  • Having the ability to decontaminate the reusable transportation carts and carriers between uses

  • Transportation carriers should be packed securely to prevent damage, and packaged to prevent damage with appropriate protective materials like bubble wrap or foam

  • Transportation carriers should be appropriately labeled

  • Transportation times should be minimized

  • Tracking of the products should occur at both ends of the process with verification of integrity

  • Monitoring of environmental conditions should occur


Conclusion


In conclusion, the proper handling and transportation of contaminated medical and surgical instruments are critical to maintaining safety and compliance within healthcare settings. Adhering to regulations and guidelines, such as OSHA's Bloodborne Pathogen Standard and AAMI's recommendations, ensures that instruments are managed effectively from the point of use to reprocessing. Both internal and external transportation processes require meticulous attention to detail, including the proper storage of instruments, the use of appropriate containers, and the implementation of robust policies that safeguard against contamination.

By following these established protocols, healthcare facilities can significantly reduce the risks associated with contaminated instruments, protect staff and patients, and facilitate smoother operations within the healthcare system. Continuous education and adherence to best practices will enhance the safety and efficacy of medical instrument management, ultimately contributing to better patient outcomes and compliance with regulatory standards.




At Evolved Sterile Processing, our consultants have a greater focus on sterile processing. With our decades of experience, we will help you develop better processes and educational resources for your staff.

1 comentario


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