EAST CAROLINA UNIVERSITY
INFECTION CONTROL POLICY
Reprocessing of Medical Devices
Date Originated: 2/26/08
Date Approved: 3/4/08
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Approved by:
Date Reviewed: 3/1/11;
12/02/14;
___________________________
Vice Chancellor Health Sciences
___________________________
Director, Prospective Health
________________________________
Chairman, Infection Control Committee
____________________________
Infection Control Nurse
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Reprocessing of Medical Devices
I.
Policy: It is the policy of East Carolina University and Brody School of
Medicine to ensure patient clinical care items are decontaminated,
disinfected, and/or sterilized according to the guidelines outlined in this
policy and in compliance with all applicable regulatory agencies.
I.
Purpose: The purpose of this policy is to ensure decontamination, highlevel disinfection, and sterilization policies and procedures are
standardized throughout the facilities in order to ensure the safety of
patient care items.
II.
Procedures:
A. Departments within the institution that process reusable medical
devices/equipment within their department must develop written
procedures for the components of reprocessing these items.
B. The written procedure should be compliant with applicable standards and
regulatory agencies. This includes but is not limited to: the method of
sterilization or high-level disinfection, the physical facilities/work flow
patterns, proper attire, and necessary training and educational
requirements.
C. The infection control practitioner will have oversight authority for the
reprocessing of medical devices/equipment throughout ECU.
D. General Requirements
1. Departments/Units must determine the feasibility of reprocessing
reusable medical devices/equipment within their department
utilizing the guidelines outlined in Appendix A.
2. Department /units that can comply with General Requirements
may reprocess devices/equipment provided there are written
procedures developed for the components of reprocessing
performed.
3. Departments/Units that reprocess medical devices/equipment will
adhere to the guide lines established in the following Infection
Control Policies.
 Autoclave Use and Monitoring.
 Cleaning, Disinfection, and Sterilization of Patient
Care Items
 Gluteraldehyde Usage Guidelines
 High level Disinfection of Endoscopic Equipment and
Accessories
 Thermometer Use and Care
 Management of Clean, Soiled, and Sterile Supplies
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Appendix A
General Reprocessing Requirements
I.
Work Area Design, Work Flow Pattern, and Physical Facilities
A. Work Areas: There must be designated areas for decontamination,
preparation/packaging, high-level disinfection, sterilization, and storage.
Infection Control must be involved in any of the planning, renovation or
construction of existing space for these activities.
B. Functional Work Flow Pattern: Functional work areas should be physically
separated by walls or partitions to control contaminants generated during phases
of reprocessing. Work flow and traffic patterns should be designed to flow
from clean to soiled areas.
C. Traffic Control: Traffic in all areas in which decontamination, preparation and
packaging, sterilization processing, and sterile storage and distribution are
performed should be restricted to facility personnel. Sterilizers should not be
located in high traffic areas or near any potential sources of contamination such
as cleaning/handwashing sinks or containers for the disposal of linen and trash.
D. Physical Facilities:
1. Hand washing facilities:
Hand washing facilities should be conveniently located in or near all
decontamination, preparation, sterilization, and sterile storage areas.
Hand washing sinks are not appropriate receptacles for the collection of
soiled items.
2. Preparation and Assembly
The area used for preparation and assembly of instruments to be sterilized
should be physically separate from the decontamination area. If physical
separation is not possible due to lack of space, at a minimum, plexiglass
shields should separate the areas and each area thoroughly cleaned and
decontaminated before it is used for clean preparation and assembly.
3. Housekeeping Procedures:
Floors and horizontal work surfaces must be cleaned daily.
Other surfaces, such as walls and storage shelves, should be cleaned on a
regularly scheduled basis and more often if needed. Care should be taken
to avoid the integrity of packaging during cleaning procedures. Special
attention should be paid to the sequence of cleaning, to avoid transferring
contaminants from dirty to clean areas.
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II.
Personnel Considerations
1. Qualifications
a. All departments/units that perform reprocessing must have at least one
supervisory individual who is prepared for this function by education,
training, and experience.
b. All personnel involved in reprocessing of reusable medical
devices/equipment must, as a minimum, receive initial orientation, and
on-the-job training, and continuing inservice education.
2. Personal Protective Equipment Requirements- Protective attire must
provide suitable protection for the task being performed and must comply
with OSHA regulations for the prevention of occupational exposure to
bloodborne pathogens.
a. Personnel who perform the decontamination process should wear:
i.
Heavy duty rubber or plastic gloves
ii.
Impervious shoe coverings
iii.
Water-proof apron/gown
iv.
Fluid impervious mask
v.
Eye protection
3. Health and Hygiene
a. Personnel must comply with all applicable infection control policies
and procedures.
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