Medical devices under Class III category are discussed a lot compared with Class I – reusable devices whenever there is a discussion on EU MDR compliance. However reusable devices which make an important size in EU medical devices sector should not be undermined. Under the new MDR, a new subclass is incorporated for Class I Reusable devices (we simply say it as Class Ir), These are medical devices which are reused after application; for instance a variety of surgical instruments which includes surgical scissors, forceps and endoscopes are known as reusable devices. These devices are under an increased level of scrutiny and the new MDR is putting it to additional regulatory scrutiny. Extensions won’t be provided for Class Ir, and exemption for legacy devices won’t be allowed. Starting from 26th May 2020, all Class Ir reusable devices must have an MDR CE mark to reach to the market.
MDD Versus MDR on Resuable Medical Devices
For the regulations at the present; Medical Device Directive (MDD), place stress on validation goals, and International Standards show how to develop a design study, each EU member state has established a unique set of understandings and expectations based on that, because validation standards have not been implemented uniformly. Normally it was thought that medical device manufacturers were themselves liable for understanding, implementation and self-designation as to what a validation require fulfilling MDD compliance.
Under the new MDR, it is not allowed for OEMs to self-determine devices that lie in Class Ir category. So as to acquire a new CE mark for a Class Ir device, a comprehensive technical file should be maintained which proves its safety aspects related to usability and effectiveness of activities related to disinfection, cleaning, and sterilization given in the device’s instructions for use (IFUs). The technical file must be submitted. Without a standard definition of “clean”, the responsibility goes to device manufacturers to ascertain disinfection, cleaning and sterilization instructions are sufficient and complete. Regulators look towards manufacturers to validate their instructions to show a consistent and reproducible process even under scenarios where everything goes wrong.
TS Quality & Engineering is dedicated to help companies for the new EU regulations. For this reason, TS Q & E has provided expert insights into various issues related to MDR, EUDAMED, MDSAP & MEDDEV 2.7.1 Rev 4.TS Q & E
Guidance for Reusable Medical Devices Manufacturers in EU
Review of Technical File for Reusable Devices
As a medical device manufacturer, review class Ir technical files for each of reusable devices. Reusable devices that have been on the market for an extended time will be require more efforts, so one should begin with these. Remember, notified bodies will not depend on past product performance or reviews to comply MDR requirements, organizations should prove it with data.
When doing the gap analysis, review past data and recognize missing or obsolete issues in medical device design history files (DHF). Organization will need to make sure that validations are there in the DHF that support organization’s IFU claims. Remember that if a product family comprises of multiple Stock keeping units – SKUs, validation proof must be documented to encompass all devices in that family. If gaps are recognized within the technical files, it is recommended to get consultation from a consultant or a contract research organization (CRO) to have recommendations for suitable validation tests that can correct gaps and offer supporting data. As an organization, working with a consultant or a laboratory testing partner will help organizations establishing experimental design and validation methods that are conforming to the latest regulatory documents and guidance.
Validation Studies for Reusable Devices
To demonstrate the effectiveness of a process design and to validate that process variables (for making devices reusable) do not influence a device acceptance criteria, a cleaning validation should be implemented. A validation package should confirm that the manual or mechanical cleaning methods permits the medical device to be reprocessed efficiently, and for devices cleaned in healthcare facilities, organizations have to transmit proper instructions for the users in cleaning facilities in healthcare.
The objective is to produce evidence and documentation that the processing methods for re-usability reliably generate prearranged results. Some of the key validation principles which organizations need to incorporate are:
- Robustness: It is about an examination which needs to be performed to check how device will perform in worst-case situation.
- Repeatability: It is about the study to check and confirm the variability of measurement. Repeatability should also confirm data consistency and consistency of process for specified outputs.
- Reproducibility: It is about the study to check possible variation in the system and to support data integrity. Multiple effectiveness cycles should be implemented to explain variations in the test system. Reproduciblity checks whether validation study can be re-conducted with the same results or not.
Validation Services for Reusable Devices
There are numerous validation services that can be employed to confirm the safety and effectiveness of disinfection, cleaning and sterilization processes.
- Protocol Documentation & Development: A tailored protocol should be documented for each study, customized precisely to the device and instructions for device reuse.
- Cleaning Efficacy & Effectiveness Studies: Manufacturers must confirm the efficacy of cleaning processes. After the manufacturer’s cleaning guidelines, cleaning efficacy studies examine those processes with prearranged conditions like worst-case considerations for instance artificial contaminated soil to prove test acceptance criteria.
- Sterilization Efficacy & Effectiveness Studies: Manufacturers must offer healthcare settings with comprehensive instructions for sterilization for each of their specific medical devices. Sterilization parameters are examined to identify capability of providing a sterility assurance level (SAL) of as a minimum of 10-6.
- Support for Functionality Studies: These studies comprise coverage to numerous disinfection, cleaning and/or sterilization cycles as a preface to the functionality studies necessary to define the useful life of a medical device.
- Disinfection Efficacy Studies: Disinfection studies define the efficacy of a process by assessing the capability of the designated disinfectants to minimize microorganisms to a level that is acceptable on the specific device.
- Dry Time Validations Studies: Manufacturers must offer healthcare settings with an efficient dry time to be utilized in combination with the necessary steam sterilization cycle. Drying cycles are also tested to confirm that the cycle operates as per the specified parameters.
Validation Testing Rules
- At least, appropriate test controls and two appropriate markers are needed. Controls incorporate the device control which are positive and negative, along with the sample control which are positive and negative. Normally employed endpoint markers consist of carbohydrate, hemoglobin, protein and total organic carbon (TOC). The determined test markers should be existent in the appropriate artificial soil selected.
- Simulated usage cycles need to imitate the life of the product and to perform test with at least six cycles. The complication of the device risk profile, product design, and product life-cycle are all inputs to define the number of cycles. Moreover, simulated usage should take into consideration all the practices in a reusable cycle. This incorporates cleaning but also counts disinfection or sterilization founded on the device IFU.
- Assessment and examination of residuals from cleaner and detergent is also critical. Recovery efficiency should be implemented for all examinations and studies. Methods used for Extraction have their own limitations on the capability to dislocate residual soil into testing solution. As an outcome, the recovery efficiency validation provides documentation on the efficacy of the extraction process and creates a correction factor that is utilized in the calculation when defining total endpoints of the marker.
- Elimination of cleaner and detergent residuals must also be assessed and examined.
- Cleaning effectiveness and disinfection effectiveness studies are implemented independently. Therefore a cleaning validation and its paradigm are distinct from the paradigm of a disinfection validation. Hence autonomous protocols and reports for each must be produced to document the efficacy of every reprocessing step.
Challenge of Re-Use Device Validation Failure
Inappropriately accompanying a validation study for reusable devices is costly from a time and financial standpoint. Failing to offer suitable validation may end up in decelerated time to market, amplified total budget of pre-clinical testing and loss of market share. Pay attention for the following usual reasons why reusable device validation studies fail:
- Not choosing worst-case validation soil test
- Not employing worst-case device and parameters
- Not incorporating proper test controls
- Not utilizing appropriate markers
- Not identifying accumulation cycles
- Recovery effectiveness not done or it is too low
- Doing cleaning and disinfection validation organized as one
- Not signifying and recording suitable test soil drying times
Work together with a Consultant for Class Ir Reusable Medical devices
Choosing a consultant who can help you with all testing solution is just as imperative as the testing itself. The Consultant can help you as a testing partner. It is important to ask questions to your consultant before you go on signing contracts. One should select a consultant; who is educated with the progressing technical and regulatory updates. Validation Study designs should fit in industry practices, lessons learned from studies on similar products, process validation codes and contemporary regulatory recommendations. While general scientific principles are significant, one should work with a Consultant as a partner, who holds onto organization’s interest in mind. The consultant must consider the new requirements of the MDR, process complexities related to reusability, device design and IFUs.
The year 2020 is approaching very fast, 26th May 2020 is not too far for organizations; remember there is lesser number of consultants and CROs left to consult you on Class Ir reusable devices as they need a higher level of expertise for the new regulations. Therefore it is important for you to think and plan your Class Ir devices now. TS Quality & Engineering is well acquainted with the new regulations and can help companies in planning and preparing for their Class Ir Reusable medical devices according to the new MDR. Companies can contact TS Q & E for support in their regulatory compliance for Class I Reusable Medical Devices.