The complexities of the clinical environment of care and reusable medical devices

The risk for contamination of medical equipment and environmental surfaces is ever-present in the healthcare environment. However, risk can be successfully mitigated in most cases through the regular application of core infection prevention and control measures. While the single most important infection prevention intervention continues to be hand hygiene, more and more emphasis is being placed on the role of the clinical environment of care. The clinical environment of care poses a risk for not only microbial contamination but also for transmission to healthcare personnel, patients, and other medical devices and/or equipment.

In September, the Association for the Advancement of Medical Instrumentation (AAMI) held a meeting with the support of the Food and Drug Administration (FDA), American Hospital Association (AHA), Centers for Disease Control and Prevention (CDC), The Joint Commission, and other key stakeholders to specifically evaluate the relationship between reusable medical devices/equipment and infections being acquired in the patient-care environment. Specifically, the scientific concern is the risk for potential transmission of pathogenic microorganisms from surfaces and/or devices to patients and healthcare providers. Of particular note, is the importance of a multifactorial approach to reducing risk which includes device design, cleaning and disinfection instructions for use, reprocessing, equipment maintenance, personnel practices, human factors, training and education, and facility design and maintenance practices. A forthcoming publication summarizing the consensus that was reached at this meeting will be available in the coming months from AAMI. These types of cross-functional stakeholder meetings are critical for improving cleaning and disinfection practices and also engaging Industry in identifying and meeting clinical education challenges and needs across the healthcare continuum of care.

Getting a stronger handle on reusable medical devices

There are unique risks associated with the proper handling and use of reusable medical devices. The FDA defines reusable medical devices as devices that healthcare providers can reprocess and reuse on multiple patients, such as endoscopes, laryngoscope blades, and other semi-critical items that must be reprocessed between patient uses. Anytime that a reusable medical device is used in healthcare settings, it must be reprocessed according to the manufacturer’s instructions for use (IFU) to remove soil and mitigate risk for potential contamination and transmission of infection. Multiple stakeholders play a role in the infection prevention and control process related to reusable equipment and devices including providers, nursing personnel, reprocessing technicians, clinical educators, and manufacturers’ representatives. Only together can risk be mitigated through the deployment of training and education on cleaning, disinfection, and reprocessing requirements in accordance with the device’s IFU provided by the manufacturer.

Medical manufacturers of reusable medical devices are responsible for ensuring that devices are properly labeled for their indications, including adequate IFUs, appropriate warnings, and instructions on properly preparing the device for clinical use. The FDA has issued guidance on this topic, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, which was issued on March 17, 2015. The FDA has convened an ongoing working group of industry and clinical experts, of which I belong, with the intent to work collaboratively to address concerns in device use, reprocessing, and design. The findings of the working group are being published within the next few months to assist facilities with a better understanding of the necessary processes that must be in place to reduce risk for contamination and ensure that all necessary steps are taken to correctly reprocess devices.

The CDC has published evidence-based clinical guidelines specific to Disinfection and Sterilization in healthcare facilities which address the disinfection needs of semi-critical devices such as medical scopes and other reusable medical devices. The guidelines specifically address several key factors that can impact the efficacy of disinfection and sterilization as a process in general. These factors include 1) the number and location of microorganisms, 2) innate resistance of microorganisms, 3) concentration and potency of disinfectants, 4) physical and chemical factors, 5) organic and inorganic matter, 6) duration of exposure, and 7) the presence of biofilms.

Medical devices that contact the mucous membranes of the patient are classified as semicritical devices and must be disinfected using a high-level disinfection (HLD) process in accordance with CDC guidelines and manufacturer’s IFU. Semicritical devices must be reprocessed (which includes cleaning prior to the HLD process) before being used on the next patient. In today’s complex clinical environment, semicritical devices are used in a variety of inpatient and outpatient clinical practice settings, where reprocessing resources may differ. Healthcare facilities must ensure that adequate reprocessing facilities and trained personnel are available to properly reprocess all reusable medical devices. Reprocessing technicians and other healthcare providers that are responsible for the process should be specifically trained on following the manufacturer’s IFU.

Collaboration, education is key

It is important for healthcare administrators to be aware of the full scope of reusable medical device use across the continuum of care, especially in large Integrated Delivery Networks. Materials Management departments must work collaboratively with clinical end users to ensure that all devices are used in accordance with established manufacturers’ IFUs. Manufacturers’ representatives can ease the burden of training by partnering with healthcare facilities to deliver high-quality, and in many cases accredited clinical education. Adult learning is by nature a challenge for ensuring high quality training, and therefore training on reprocessing must be repeated at least annually and preferably more often as necessary to maintain staff competence.

The FDA is leading regulatory efforts to improve medical device registrations and also collaborating with external stakeholders including clinical end users to address any emergent needs related to reusable devices and reprocessing. Given the shift in the continuum of care model to more outpatient procedures, consideration should be given to logistical challenges that might be unique to ambulatory settings. When possible, reprocessing rooms should be designed to meet the needs of the flow of the device as well as to facilitate staff efficiency throughout the overall reprocessing process. Environmental Services Professionals and Technicians, whom are responsible for maintaining the clean clinical environment of care, are important stakeholders in reducing the risk for transmission, and ensure that high touch environmental surfaces are properly cleaned and disinfected according to the CDC Guidelines for Disinfection and Sterilization.

Summary

Reusable medical devices are vital components to delivering life-saving patient care and associated therapies, but must be properly handled and reprocessed to prevent contamination between uses. All stakeholders must be trained on their roles and responsibilities in the process and receive detailed training on the specific reprocessing instructions for each device for which they must reprocess. Ongoing collaboration with the FDA, CDA, clinical end users, and manufacturers will continue to yield proactive approaches to addressing critical issues and developing a pathway for future technological developments. As patients continue to receive more diagnostic and therapeutic procedures in the outpatient setting, additional training on reprocessing should be conducted to ensure that all healthcare providers with responsibility for the reprocessing process receive adequate instruction on the proper steps in the process and also appropriately maintain the necessary records to document validation and competency. As recommended by CDC, FDA, and AAMI, a comprehensive, system-wide approach to reusable device reprocessing is an important tenant of a facility’s infection prevention and control program.

References:

1. Reprocessing of Reusable Medical Devices: Information for Manufacturers, Food and Drug Administration, electronically accessed on September 2, 2016 from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/.

2 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff, Food and Drug Administration, electronically accessed on September 2, 2016 from: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf.

3 Reprocessing of Reusable Medical Devices, Food and Drug Administration, electronically accessed on September 1, 2016 from: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/ucm20081513.htm.

4 Factors Affecting the Efficacy of Disinfection and Sterilization, Centers for Disease Control and Prevention Guideline for Disinfection and Sterilization in Healthcare Facilities, electronically accessed September 2, 2016 from: http://www.cdc.gov/hicpac/Disinfection_Sterilization/4_0efficacyDS.html.

Additional Resources:

AHE Environmental Services Designation Programs, Association for the Healthcare Environment, http://www.ahe.org/ahe/lead/certifications.shtml.

Reprocessing of Reusable Medical Devices, Association for the Advancement of Medical Instrumentation, electronically accessed on September 2, 2016 from: http://www.aami.org/newsviews/content.aspx?ItemNumber=1396.

Centers for Disease Control and Prevention Core Elements of Hospital Antibiotic Stewardship Program, US Centers for Disease Control and Prevention. http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html