Enhancing Infection Prevention in Medical Devices Through Quality Systems

Medical devices have advanced significantly over the years, now involving highly complex instruments with intricate features. Utilizing quality systems to prevent infection within these features is essential for optimal use. The American Society for Quality describes a quality system as “a formalized system that documents the structure, responsibility, and procedures required to achieve effective quality management.”¹ To extend the lifespan of a medical instrument and contribute to infection prevention, quality initiatives must be present in the medical device industry.

For these processes to be effective, they must be implemented from the source of creation and throughout the medical device manufacturing process. Various agencies regulate quality systems within medical device manufacturing against highly organized standards. This can include registration for FDA 21 CFR 820: Quality System Regulation (QSR) for Medical Devices² and ISO 13485: Quality Management System (QMS)³ certification. According to these systems, one important aspect of a well-regulated QMS within a medical device manufacturing facility is maintaining the traceability of all instrumentation. This includes ensuring all devices are properly marked according to customer specifications with traceable information such as part numbers and lot codes. This information is essential to include, as it allows the product to be traced back to its origin if an infection occurs.

In addition to traceability, standards are set up by a QMS to assess the integrity of the instrument before leaving the facility. Numerous operations within these systems require inspection to verify conformance with customer specifications. At the final inspection checks, it is crucial to ensure products are free from dents, burrs, and any other defects that could expose the instrument to further damage or provide areas for moisture and bacteria to accumulate.

Generally, when a manufacturer receives a product from a supplier that does not conform to design requirements, the lot of products will be returned to the supplier, and a nonconformance report and corrective action plan will be developed. This step in the process prevents defective instrumentation from being sent to end users and raises manufacturers' awareness of improvements that can be made in their quality systems.

Quality systems are equally important in health care facilities. One department that particularly benefits from a QMS is the sterile processing department. These professionals play a crucial role in infection prevention by ensuring that medical devices are properly cleaned and sterilized between patients. This includes following manufacturer instructions for use (IFUs). The Association for Professionals in Infection Control and Epidemiology (APIC) published a May 2024 whitepaper requesting an update on IFUs. The whitepaper, Modernizing Medical Device Instructions for Use(IFUs): Infection Preventionists Speak Up for Patient Safety,” illuminates the complexities, inefficiencies, and frustrations associated with IFUs.

“One of the most important parts of the white paper was their recommendations. That standardized format for IFUs and making the IFUs last for the lifespan of the product [and] indicate when the IFP was last updated because that's important as well,” Michelle W. King, MT(ASCP), MPH, CIC, told Infection Control Today^® in a roundtable. King is the corporate director of infection prevention and control for the Department of Epidemiology at the McLeod Health System in Florence, South Carolina, and a member of the APIC Communications Committee.

The Joint Commission states that IFUs “include the steps required for cleaning, disinfection, the level of disinfection required (eg, sterilization, high-level disinfection, low- or intermediate-level disinfection), the frequency of disinfection, and the products which are compatible for use on the device.”⁴ Once a piece of instrumentation arrives at a facility, health care professionals must understand how to properly use the device and appropriately decontaminate and sterilize the instruments, according to the IFUs.

For patient safety, health care professionals must also handle instruments properly and use them as intended, allowing for effective bioburden removal and a prolonged lifespan. To reinforce this, certifications like the DNV Advanced Sterile Processing Certification⁵ set high standards requiring extensive planning to ensure proper care of instrumentation. To obtain a certification such as the DNVs, implementing quality systems is required. This certification, in particular, has guidelines for processes regarding metric tracking, including the number of sets and instruments sterilized, compromised instrument trays, and surgical site infection (SSI) rates. These metrics provide insight into areas of improvement within the facility to address potential inefficiencies and ensure consistent prioritization of patient safety.

As medical devices continue to evolve rapidly, it is essential to implement quality systems. These systems can significantly extend a device's lifespan and reduce the risk of infection. By prioritizing quality systems from manufacturing to cleaning and sterilizing, the professionals who handle these products can better protect patients from device-related complications. This can improve outcomes for facilities and, most importantly, the patients on which the devices are used.

References:

1. Peiffer SE, Story PB, Duffy GL. The impact of human factors on a hospital-based quality management system. Journal for Quality and Participation. 2016;42(1). https://asq.org/quality-resources/articles/the-impact-of-human-factors-on-a-hospital-based-quality-management-system?id=2e5fcc7c02b94cc3b9a9c627782b01f3. Accessed May 27, 2024.
2. Office of the Federal Register, National Archives and Records Administration, Quality system regulation. Govinfo. (April 1, 2023), https://www.govinfo.gov/app/details/CFR-2023-title21-vol8/CFR-2023-title21-vol8-part820.
3. ISO 13485 - Medical devices. International Organization for Standardization. March 11, 2020. Accessed May 27, 2024. http://www.iso.org/iso-13485-medical-devices.html.
4. Manufacturers instructions for use - Expectations regarding access To IFUs for medical Instruments and devices. The Joint Commission. October 21, 2021. Accessed May 27, 2024. https://www.jointcommission.org/standards/standard-faqs/ambulatory/infection-prevention-and-control-ic/000002250/.
5. DNV Healthcare’s sterile processing program certification. Det Norske Veritas. Accessed May 27, 2024. https://www.dnv.us/supplychain/healthcare/SterileProcessing/.