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11 !"#E The manufacturer must analyze, specify, design, verify and validate usability, as related to safety of the device Application specification Frequently used functions Known or foreseeable hazards and hazardous situations Primary operating functions Usability Specification Usability validation plan Device design Usability verification Usability Validation )(!"# 1 % HI B0 )++< ))
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17 %!? THE ANNEX X ON CLINICAL EVALUATION: CONTENT AND IMPLICATIONS,, References 1. Directive 93/42/EEC and changes introduced by Directive 2007/47/EC. 2. Guidelines on Medical Devices Clinical Evaluation: A Guide for Manufacturers and notified Bodies. December
18 Overview 1. What does the Directive says about clinical evaluation? 2. Example: What does this mean for CPOE evaluation? 3. Summary: Implications for health informatics MDD Annex I: Demonstration of conformity Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X. (for all devices) E 5 7E
19 MDD Annex X: Clinical evaluation Clinical evaluation must follow a defined and methodologically sound procedure Critically evaluation of the scientific literature Clinical investigation MDD Annex X: Scientific literature critical evaluation of the relevant scientific literature where: there is demonstration of equivalence of the device to the device to which the data relates, and the data adequately demonstrate compliance with the relevant essential requirements.
20 Process of clinical evaluation (- # '4" )- #"" 4,- # " " "#.- 3- B " # Guidelines on medical devices, 2009 Example: CPOE as medical device Assumption: A CPOE system (computerized physician order entry) that offers decisionsupport during drug ordering and drug management is a medical device. CPOE system must meet essential requirements (performance and safety, see Annex 1).
21 Some questions 1. What are essential requirements for CPOE? 2. What does this mean for evaluation criteria? 3. What does this mean for the evaluation study? 4. How to deal with local adaptations? 1. What are essential requirements? Does not compromise patient safety : Works correctly, does not produce errors Must perform as intended : Offers expected functionality As stated in documentation or promotions Benefits and risks must be weighed : Benefit: Improved medication safety, Risks: Adverse side effects
22 2. What does this mean for CPOE evaluation criteria? Functionality as promised: Supports drug management Offers certain type of decision support Correctness (does not produce errors): Algorithms, data handling Verification of rule base, alerts Usability and ergonomic features Unexpected side effects and their impact 3. What does this mean for the CPOE evaluation study? Clinical investigation must follow a defined and methodologically sound procedure : Written study protocol Adequate selection of qualitative and/or quantitative methods and study design
23 3. What does this mean for the CPOE evaluation study? Perform investigations in situations similar to normal conditions of use Pre-clinical evaluation usually not sufficient Include adequate number of observations Record & communicate serious adverse events Performed by authorized qualified person Written evaluation report 4. How do deal with local adaptations? CPOE vendor wants to confirm conformity of his CPOE system: MDD allows literature review instead of clinical investigation, but only where: there is demonstration of equivalence of the device to the device to which the data relates There are several studies on CPOE. But:
24 4. How do deal with local adaptations? For CPOE of different vendors: CPOE systems are not equivalent : Maybe comparable software functionality But different rule bases Different user interfaces.. (See also different outcome of evaluation studies of different CPOE systems) 4. How do deal with local adaptations? Even for CPOE of the same vendor: Local adaptations may influence performance and safety! 9A 80? 9A 80? B 9A 80? 9
25 4. How do deal with local adaptations? Examples: Adaptations of the user interfaces Adaptations of drug information Adaptations of the rule base and of the alerts Different integration with other systems (LIS, HIS) Different usage patterns Different access rights.. 4. How do deal with local adaptations? So: Even when same product is used, local adaptations and organizational context are quite different. It seems thus challenging to use published data to prove the performance and safety of a given CPOE system.
26 Summary (1/4) Rising regulatory pressure that medical software used for diagnostic and therapeutic purposes has to undergo individual clinical evaluation before bringing it to the market. Strong pressure to develop safe software. Either literature review of equivalent software or clinical trials. Summary (2/4) 9 'K ' " # & -
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