What’s The Difference Between TIR12-2010 And TIR12-2020?
What’s New?
TIR12-2020 is designed to further support medical device manufacturers in developing their processing instructions for reusable medical devices. To this end, additional information has been added to this standard regarding typical processes and resources health care facilities have for reprocessing reusable medical devices.
Specifically, the new TIR12-2020 document contains entire sections dedicated to:
- Risk analysis & management
- Processing instructions to be provided by the medical device manufacturer & further information about health care facility practices
- Presentation of information.
The new section on risk analysis and management covers risk-based approaches, labeling considerations, risk considerations during device processing, human factor considerations, and risk mitigation strategies. The section on processing instructions to be provided by the medical device manufacturer & further information about health care facility practices covers three important concepts. These concepts are pretreatment at the point of use, preparation before cleaning, and the cleaning process itself. Details on health care facility practices for each of these concepts are provided. TIR12-2020’s presentation of information section includes tips on how to create clear and concise instructions, use graphic elements, train personnel regarding device use and reprocessing, and appropriately deliver presented information.
How is TIR12-2020 different from TIR12-2010?
The old 2010 version of Section 3, which encompassed device design considerations, is now the current TIR-12 Section 4. The new Section 4 for device design has incorporated disinfection and sterilization design considerations from previous TIR12-2010 Section 4 and Section 5 along with four new device design considerations.
The new device design considerations for Section 4 are:
- Risk of patient infection based on intended clinical use
- Human factors
- Cleaning
- Packaging design considerations.
The new TIR12-2020 standard provides restructuring of the old TIR12-2010 guidance with much of the old TIR12-2010 Section 4-6 material falling into Section 5, Section 7.4, Annex D, and Annex F of the new TIR12-2020 document. Most of the Annex content is the same. However, TIR12-2020 Annex E provides new information on processing instructions for Category 4 devices.
Summary
Overall, the TIR12-2020 document now provides medical device manufacturers further information on risk management considerations, health care facility resources, and tips for presenting information such that manufacturer instructions for use are followed. Additionally, medical device design considerations for risk of patient infection based on intended clinical use, human factors, cleaning, and packaging design have been highlighted.
MycoScience is a contract manufacturing organization specializing in sterile syringe and vial filling. MycoScience also offers Preservative Efficacy Testing, Sterilization Validations, Bioburden Testing, Cleaning Validations, Microbial Aerosol Challenge Testing, Accelerated Aging, Microbiology Testing, Cytotoxicity Testing, Bacterial Endotoxin Testing, EO Residual Testing, Package Integrity Testing & Environmental Monitoring services medical devices and allied industries. MycoScience is an ISO 13485 certified facility.
References
Association for the Advancement of Medical Instrumentation Technical Information Report. Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers. Arlington, VA, USA. AAMI; 2020. (AAMI TIR12-2020)
