The Association for the Advancement of Medical Instrumentation (AAMI) and the Parenteral Drug Association (PDA) are pleased to announce a call for abstracts for sessions and posters for the 2025 KILMER Conference, which will be held from February 3-6, 2025, in Orlando, Florida. The theme for the 2025 KILMER Conference is Next Generation Microbiological Quality and Sterility Assurance. We are seeking submissions broadly reflecting this theme and addressing topics related to industry innovations in sterilization, sterility assurance, and microbiological quality for medical devices and pharmaceuticals, including but not limited to the following areas:
- Emerging technologies or approaches for cleaning, disinfection and sterilization
- Microbiological quality control, aseptic and sterilization process validation and monitoring
- Microbiological or alternative testing method
- Sterilization processes and modalities
- Pathways to facilitate or innovate regulatory approvals
- Quality control and assurance
- Materials compatibility
- Device and drug product packaging innovation
- Application of process control or parametric approaches
- Successes in industry-academia research partnerships
- Industry approaches and innovations for infection prevention and contamination control in clinical settings
- Sustainability
- Leveraging lessons from pandemics or outbreaks (e.g., supply chain.)
- Career development
Abstracts should be submitted here by August 31, 2024. If your proposal is accepted, you will be notified by October 1, 2024. Note that most sessions at the 2025 KILMER Conference will take between 15 and 20 minutes, and single presenters are preferred. Proposals not accepted for a session may still be considered for a poster presentation.
We encourage all interested parties to submit their abstracts for consideration. Questions may be directed to Amanda Benedict, AAMI vice president of Sterilization at abenedict@aami.org.
Risk Management During Reprocessing – The State of Play
At the 2024 AAMI eXchange, Atila Nozari, Ph.D., senior medical liaison and global standards manager at Solventum, discussed the importance of risk management during medical device reprocessing.
What factors should be considered during medical device reprocessing? First, the process targets reduced costs and environmental impact while adhering to strict standards for patient safety. Second, human factors, process validation, emerging technologies, and industry best practices are all key considerations.
The Basics
Nozari offered the disclaimer that his talk was based on current regulations, standards, guidelines and best practices as of June 2024. Based on ANSI/AAMI/ISO 14971 (2019), he offered some definitions.
- Harm: Injury or damage to the health of people, or property, or the environment.
- Hazard: A potential source of harm.
- Risk analysis: Systematic use of pertinent information to identify hazards.
- Risk assessment: A process comprised of risk analysis and risk evaluation.
- Risk management: The application and management of policies meant to control, evaluate, and monitor risk.
Risk management remains a “complex project” because stakeholder groups, which include medical practitioners, patients, government agencies, industry, and the public, often have different definitions of acceptable risk.
But these stakeholders are nevertheless tasked with studying the probability that harm will occur and then responding. This will include factors such as the economic and safety impact of reprocessing. Nozari pointed out that medical device reprocessing has an environmental impact, with hospitals in the United States producing more than 5 million tons of medical waste per year, with 30% of this originating from the operating room.
There are also principles of safety in reprocessing, including regulatory compliance. Depending on your jurisdiction, this may include FDA regulations, the EU’s MDR & IVDR, or other regulatory standards. Nozari pointed out that noncompliance comes with legal, financial, and reputational impacts. Ensuring continuous compliance will require audits, training, and cultivating a culture of safety.
Nozari also drew attention to the inherent variability of sterile processing. Variability is “associated with more risk,” and arises because medical devices have different materials, mass, shape, volume and packaging. Further, human factors matter, and the sterile processing field is characterized by high turnover and time pressures. The diversity of sterilization modalities and manufacturer IFUs also creates complexity that can incur risk.
New Technologies
But how will new technologies and sterilization modalities impact sterile processing? According to Nozari, advancements in technology are unlikely to make devices or reprocessing simpler even if they streamline certain medical procedures. While the outcome of ongoing innovation is impossible to predict, technologies that are currently being studied or developed for implementation include:
- Advances in physical sterilization and disinfection, including supercritical fluids, ultra-high pressure, and pulsed light.
- Advances in chemical sterilization disinfection, including chlorine compounds and nitrogen dioxide.
Applying Standards
What standards are important to risk management for device reprocessing? Per Nozari, several are vital to the process.
- ANSI/AAMI/ISO 13485
- ISO 14971
- ANSI/AAMI ST79
- ANSI/AAMI ST90
According to Nozari, he has never seen two sterile processing departments with identical policies, and more guidance would be helpful. But until then, what should risk policies include? When developing or amending a policy, the key question should be “is it really effective?” Other necessary components include routine monitoring, aa scheduled review of the risk management program, regular updates to risk assessment and documents, and reporting of results throughout the broader organization. Personnel should keep in mind that risk assessment is defined by teamwork, and that reducing variability and increasing consistency are effective strategies to mitigate risk. Further, risk assessment plans should be subjected to annual review. Finally, Nozari concluded that further guidance is needed to ensure that sterile processing departments can adequately assess and manage risk.
