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Medical Device Reprocessing Audits: Why Are They Important?


By Chuck Hughes

As an infection prevention consultant with 25-plus years of experience, I frequently audited healthcare facilities regarding proper reprocessing of their surgical, dental and/or endoscopic equipment. With each audit, I found healthcare professionals who had a strong desire to learn and adhere to best practices. This is important, as best practices should be adhered to in any profession because they reflect the values of that profession. In healthcare, adherence to sterilization and disinfection best practices ensures patient safety, as one of our greatest threats is healthcare-associated infections (HAIs). That said, I sometimes found it difficult to get everyone on board with compliance with national standards and guidelines, such as the Association for the Advancement of Medical Instrumentation (AAMI), the Association of periOperative Registered Nurses (AORN) and/or the Society of Gastroenterology Nurses and Associates (SGNA).  In recent years, my efforts were reinforced with help from two very important organizations, the Joint Commission and the Centers for Disease Control and Prevention (CDC).

In May 2014, the Joint Commission issued a Quick Safety Advisory¹ stating that breaches in equipment sterilization and high-level disinfection processes can result in outbreaks of HIV, and hepatitis B and C, as well as the transmission of bacterial infecting agents, such as Pseudomonas aeruginosa, E. coil, methicillin-resistant Staphylococcus aureus (MRSA), salmonella, and Clostridium sordellii. Facilities that undergo an outbreak or shut-down also have repercussions from bad publicity and loss of business, not to mention damage to the organization’s reputation.²ʼ³  While on survey, Joint Commission surveyors are increasingly finding non-compliance with standard IC.02.02.01, which requires organizations to reduce the risk of infections associated with medical equipment, devices, and supplies. 

In 2013, there has been numerous immediate threat to life (ITL) discoveries from surveys, many of which were directly related to improperly sterilized or high-level disinfected equipment. The Joint Commission takes ITLs seriously; if discovered on survey, the organization immediately receives a preliminary emergency denial of accreditation (PDA) and, within 72 hours, must either entirely eliminate the ITL or implement emergency interventions to abate the risk to patients (with a maximum of 23 days to totally eliminate the ITL). Corrective actions may include: reprocessing of all equipment or instruments involved in the infection control breach; evaluating staff competency and conducting training; and implementing an equipment tracking process that traces items used back to the patient, in the event of an infection control breach of recall. 

According to reports from the Joint Commission’s Office of Quality Monitoring, findings from non-complying organizations include:
- The mistaken belief that the risk of passing bloodborne pathogens or bacterial agents to patients is low
- Staff lack the knowledge or training required to properly sterilize or high-level disinfect equipment
- Staff don’t have access to or lack knowledge of evidence-based guidelines
- Lack of leadership support
- Frequent leadership and staff turnover makes sterilization or high-level disinfection of equipment a low priority
- Lack of a culture of safety that supports the reporting of safety risks
- Processes for sterilization or high-level disinfection are not followed (i.e. staff take short-cuts)
- The timeframe for proper sterilization or high-level disinfection of equipment is not followed
- There is no dedicated staff person to oversee the proper sterilization or high-level disinfection of equipment
- Facility design or space issues prevent proper sterilization or high-level disinfection of equipment (e.g. processing takes place in a small room that is also used for storage)
- Lack of monitoring or documentation of sterilization or high-level disinfection of equipment, which makes it difficult to track the use of equipment on a specific patient, complicating the patient notification process when an outbreak occurs
- Equipment is spread throughout the facility and may be processed or stored in numerous locations, making it difficult to track the equip-ment for documentation purposes.

This Joint Commission Advisory recommends the following safety actions to consider:
- Make sure staff are competent and trained in sterilization or high-level disinfection of equipment
- Make manufacturer’s instructions for use available to staff and ensure that the instructions are followed
- Use and follow evidence-based guidelines when sterilizing or high-level disinfecting equipment
- Ensure oversight of sterilization or high-level disinfection of equipment
- Follow your organization’s policies and procedures for sterilizing or high-level disinfection of equipment
- Use a central location to sterilize or high-level disinfect equipment within the facility, when feasible.

In September of 2015, the CDC issued a Health Advisory⁴ stating that infection control lapses due to non-compliance with recommended re-processing procedures highlight a critical gap in patient safety and healthcare facilities (e.g. hospitals, ambulatory surgical centers, clinics and doctor’s offices) that utilize reusable medical devices should regularly audit adherence to cleaning, disinfection, sterilization and device storage procedures.  Audits should assess all reprocessing steps, including:
- Performing prompt cleaning after use, prior to disinfection or sterilization procedures
- Using disinfectants in accordance with manufacturers’ instructions (e.g., dilution, contact time, storage, shelf-life)
- Monitoring sterilizer performance (e.g., use of chemical and biological indicators, read-outs of sterilizer cycle parameters, appropriate record keeping)
- Monitoring automated endoscope reprocessor performance (e.g., print out of flow rate, time, and temperature, use of chemical indicators for monitoring high-level disinfectant concentration).

This CDC Health Advisory recommends healthcare facilities arrange for a healthcare professional with expertise in device reprocessing to immediately assess their reprocessing procedures. This assessment should ensure that reprocessing is done correctly, including allowing enough time for reprocessing personnel to follow all steps recommended by the device manufacturer.
The following actions should be performed:
Healthcare facilities should provide training to all personnel who reprocess medical devices.
o Training should be required and provided:
• Upon hire or prior to provision of services at the facility
• At least once a year
• When new devices or protocols are introduced, including changes in the manufacturer’s
   Instruction’s for use during the device’s life cycle
o Personnel should be required to demonstrate competency with device reprocessing (i.e., trainer 
   observes correct technique) prior to being allowed to perform reprocessing independently. 
o Healthcare facilities should maintain current documentation of trainings and competencies.
o If the healthcare facility hires a contractor for device reprocessing, the facility should verify that
    the contractor has an appropriate training program and that the training program includes the
    specific devices the healthcare facility uses.
o Copies of manufacturers’ instructions for operating and reprocessing each type of reusable 
    device should be readily available to staff and inspectors. This file should include instructions
    for use of chemical disinfectants.

This CDC Advisory recommends that healthcare facilities should regularly audit (monitor and document) adherence to cleaning, disinfection, sterilization, and device storage procedures. Audits should assess all reprocessing steps, including:

o Performing prompt cleaning after use, prior to disinfection or sterilization procedures
o Using disinfectants in accordance with manufacturers’ instructions (e.g., dilution, contact time,
   storage, shelf-life)
o Monitoring sterilizer performance (e.g., use of chemical and biological indicators, read-outs of
   sterilizer cycle parameters, appropriate record keeping)
o Monitoring automated endoscope reprocessor performance (e.g., print out of flow rate, time,
   and temperature, use of chemical indicators for monitoring high-level disinfectant

• Audits should be conducted in all areas of the facility where reprocessing occurs.
• Healthcare facilities should provide feedback from audits to personnel regarding their adherence to
   cleaning, disinfection, and sterilization procedures.
• Healthcare facilities should allow adequate time for reprocessing to ensure adherence to all steps
   recommended by the device manufacturer, including drying, proper storage, and transport of
   reprocessed devices.
o Considerations should be made regarding scheduling of procedures and supply of devices to
   ensure adequate time is allotted for reprocessing.
• Healthcare facilities should have protocols to ensure that healthcare personnel can readily identify
   devices that have been properly reprocessed and are ready for patient use (e.g., tagging system,
   storage in a designated area).
• Healthcare facilities should have policies and procedures outlining facility response in the event of a
   recognized reprocessing error or failure. Healthcare personnel should assess the cause of the error
   or failure and the exposure event in order to determine the potential risk of infection. The procedure
   should include how patients who might have been exposed to an improperly reprocessed medical
   device would be identified, notified, and followed.
• Individuals responsible for infection prevention and reprocessing at the healthcare facility should be
   consulted whenever new devices will be purchased or introduced to ensure that infection control
   considerations are included in the purchasing decision as well as subsequent implementation of
   appropriate reprocessing policies and procedures and to ensure that the recommended reprocessing
   equipment is available at the healthcare facility.
• Healthcare facilities should maintain documentation of reprocessing activities, including maintenance
   records for reprocessing equipment (e.g., autoclaves, automated endoscope reprocessors, medical
   washers and washer-disinfectors, water treatment systems), sterilization records (physical, chemical,
   and biological indicator results), and records verifying high-level disinfectants were tested and
   replaced appropriately.
• Healthcare facilities should follow manufacturer recommendations for maintenance and repair of
   medical devices that are used to perform reprocessing functions as well as medical devices that are
   reprocessed. If healthcare facilities contract maintenance and repair of these devices to third-party
   vendors, healthcare facilities should verify that these vendors are approved or certified by the
   manufacturer to provide those services.

As you can see from these recent health and safety advisories, healthcare facilities must provide their medical device reprocessors with critical resources to ensure compliance with best practices.  And while it is important to note that accreditation agencies are now looking very closely at sterilization and high-level disinfection compliance during surveys, let’s not forget that patients are looking for compliance as well.  Not some of the time, not most of the time, but all of the time.

Chuck Hughes is the recently retired founder of SPSmedical Supply Corp. based in Rochester, N.Y.  He has 25-plus years of experience in healthcare, speaking at conferences, contributing to national standards on medical device reprocessing and providing mock surveys to hundreds of healthcare facilities globally. A respected educator and strong supporter of SPD, Hughes has received awards from numerous chapters, including  IAHCSMM's Award of Honor in 2005.

1. The Joint Commission, Division of Health Care Improvement.  Improperly Sterilized or High-Level Disinfected Equipment.  Quick Safety – An advisory on safety & quality issues. Issue Two. May 2014.
2. Outpatient Surgery. Maryland Hospital Rocked by Auditor’s Sterile Processing Report.  February 2015.
3. Becker’s Hospital Review E-weekly. UMC in Texas stops elective surgeries after issues in sterile processing department. July 13, 2015.
4. CDC Health Advisory. Distributed via the CDC Health Alert Network. Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. Sept. 11, 2015.


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