In evaluating recent events at UCLA, it is important that industry, regulatory, healthcare facilities, and end users continue working together to help deliver the safest devices to market.
Emily Mitzel and John S. Bolinder
Questions about the safety of reprocessing medical devices are back in the news with two deaths at University of California, Los Angeles’s (UCLA) Ronald Reagan Medical Center being blamed on contaminated duodenoscopes, spreading drug-resistant carbapenem-resistant enterobacteriaceae (CRE) bacteria to patients. CRE, like all hospital acquired infections or, more broadly, healthcare associated infections (HAIs), is a concern not only for patients, but also medical device companies, Food and Drug Administration (FDA), and healthcare facilities.
For years FDA and the medical technology industry have partnered to develop standards related to reusable medical devices and the cleaning, disinfection, and sterilization parameters for reprocessing these devices at healthcare facilities. In evaluating recent events at UCLA, it is important that we acknowledge there are many factors that contribute to HAIs, and that industry, regulatory, healthcare facilities, and end users continue working together to develop additional controls, guidance, and practices to help deliver the safest, life-enhancing, life-saving devices to market.
Understand Current FDA and Industry Guidance for Reprocessing
It is extremely important to follow guidance that has been published by FDA as well as accepted guidance documents from the Association for the Advancement of Medical Instrumentation (AAMI), and the International Organization for Standardization (ISO). Regulatory agencies partner with the medtech industry and healthcare practitioners in writing these standards and guidance documents to ensure that reprocessing is safe and effective in healthcare facilities.
Everybody has to do their part to keep patients and healthcare personnel safe from infectious diseases and to reduce HAIs. Together FDA, AAMI, Association of perioperative Registered Nurses (AORN), Centers for Disease Control and Prevention (CDC), and other groups have developed standards, guidance documents, webinars, seminars, round table discussions, summits, etc. to ensure greater patient safety. Some of these standards include:
- FDA Guidance: 2015, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff”
- FDA Guidance: 2000, “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management”
- CDC Guidance: “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008” by William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC)
- FDA Draft Guidance: 2011, “Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design”
- FDA Draft Guidance: 2011, “Draft Guidance for Industry and Food and Drug Administration Staff – Processing/Reprocessing Medical Devices in Healthcare Settings: Validation Methods and Labeling”
- AAMI TIR 12:2010, AAMI TIR 30:2011 and AAMI TIR 34:2014 for reprocessing guidance to manufacturers and healthcare facilities
- AAMI TIR55:2014 – “Human factors engineering for processing medical devices”
- ANSI/AAMI HE75:2009/(R)2013 – “Human factors engineering—Design of medical devices”
- ANSI/AAMI/IEC 62366:2007(R) 2013 – “Medical devices - Application of usability engineering to medical devices”
- AAMI TIR50:2014 “Post-market surveillance of use error management”
- AAMI TIR51:2014 “Human factors engineering – Guidance for contextual inquiry”
- AAMI TIR61:2014, “Generating reports for human factors design validation results for external cardiac defibrillators”
Device Designers and Manufacturers Must Account for Human Factors
Both manufacturers and device designers need to deliberately build in a human factor safety margin to better manage device safety once in the healthcare setting. Manufacturers must consider complexity of device design, accuracy of validated reprocessing instructions, and practical use of cleaning instructions in healthcare settings. Common human factor consideration practices that are recommended by FDA and industry include:
- Reprocessing instructions that are clear, legible, and written in a step-by-step manner (chronological) from the initial processing step through the terminal processing step
- Instruction should be written in simple language
- Charts, pictures or diagrams that provide visual aids for each reprocessing step should be provided to healthcare facilities
- Specific instructions for critical or difficult to clean locations on the device
- Visual inspections procedures for both manual and automated reprocessing
Human factors in medical device reprocessing can be as seemingly harmless as a variation in cleaning steps, for example a healthcare technician brushing the device softly, when the reprocessing was validated to vigorous cleaning action; or scrubbing laterally instead of in a circular motion as prescribed by the manufacturer’s cleaning instructions for the device. In addition, some healthcare facilities have elected to develop facility-specific cleaning processes instead of following the device manufacturer’s validated cleaning instructions. These and other human factors represent major challenges when it comes to ensuring a reprocessed device is safe.
Ensure Healthcare Facility Personnel are Trained on Reprocessing
Healthcare facility reprocessing personnel must be trained and able to follow the manufacturer’s written cleaning instructions when reprocessing each device. This is the most critical part of the entire process. If these instructions are not followed exactly for each device the next patient that comes into contact with that device is at risk for HAIs. Device manufacturers validate reprocessing instructions and FDA ensures that these validations are performed correctly. It is then the responsibility of the reprocessing personnel to follow the correct reprocessing parameters for each device between patient uses.
For complex devices it is critical that healthcare facility reprocessing personnel perform visual inspections and additional cleaning when needed. In some cases the central processing unit at a healthcare facility may cross-contaminate devices that come into the area (e.g. devices may be set in a bin with surgical instruments or devices from another procedure). It is imperative that cross-contamination events are minimized and additional cleaning, sterilization, disinfection, or visual inspections are performed when this occurs.
In a recent safety communication FDA noted, “Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection. Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible. In addition, a recent FDA engineering assessment and a growing body of literature have identified design issues in duodenoscopes that complicate reprocessing of these devices. For example, one step of the manual cleaning instructions in device labeling is to brush the elevator area. However, the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush. Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”
Additional Guidance Issued by FDA and CDC
Due to the life-enhancing and life-saving procedures that these unique devices offer, FDA has determined, based on risk assessment, that their ongoing use is acceptable and safe. However it is important to understand and adhere to the additional guidance coming from regulatory agencies like FDA and CDC.
Since the duodenoscope incident at UCLA, FDA has issued additional safety guidance for healthcare facilities including their newest guidance document on March 17, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff,” outlining a summary of changes to their May 11, 2011 draft guidance.
FDA also updated their safety communication on March 4, highlighting their efforts to study the situation, including:
- “Collaboration with CDC and the Environmental Protection Agency (EPA) to test the antibiotic-resistant organisms to assess their susceptibility to high-level disinfectants.
- Exploration, with CDC, of additional potential strategies to reduce the risk of infections, such as microbiological surveillance testing of duodenoscopes. CDC issued an Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing on 11 March.
- Communication with international public health agencies to study the extent of the problem and identify possible solutions being considered outside the United States.
- Reviews of reprocessing validation data from each of the three manufacturers marketing duodenoscopes in the United States (FUJIFILM, Olympus, and Pentax).”
In addition to FDA guidance, CDC in their “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008” suggest healthcare facilities contemplate random bacterial surveillance cultures, “As part of a quality assurance program healthcare facility personnel can consider random bacterial surveillance cultures of processed endoscopes to ensure high-level disinfection or sterilization.” CDC has referenced several papers regarding surveillance cultures of endoscopes in the published guidance. Consult with the device manufacturer for validated, product-specific techniques.
While manufacturers and professional societies do not currently require culturing of scopes at the clinical site, healthcare facilities may consider evaluating their reprocessing of scopes, in which case the appropriate test method for detecting cross-contamination is by culturing the scopes. This can be accomplished at the healthcare facility or in collaboration with a third-party testing facility.
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Emily Mitzel is a consulting manager at Nelson Laboratories. John Bolinder is vice president of marketing & communications at Nelson Laboratories.