How to conduct risk management & vulnerability assessments of medical devices using current ISO/IEC standards as a guidance

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1 How to conduct risk management & vulnerability assessments of medical devices using current ISO/IEC standards as a guidance Stephen L. Grimes, FACCE FHIMSS FAIMBE Chief Technology Officer ABM Healthcare Support Services Wednesday, Nov 5, :30 am 12:00 noon.

2 Conducting risk management & vulnerability assessments of medical devices Today an effective risk management process is critical if HTM programs are to successfully focus their limited resources on the greatest healthcare technology challenges. Using ISO Application of risk management to medical devices and IEC Application for risk management for IT networks incorporating medical devices standards for guidance, this session lays out a process that will enable HTM programs to identify and prioritize which risks and vulnerabilities merit the greatest and most immediate efforts. The process can also serve as a key element in compliance with the new CMS and Joint Commission requirements. 2

3 Evolution of Medical Technology Enterprise Systems Increased Risk because a Failure can have Enterprise Implications

4 Evolution of Medical Technology Increased Vulnerability Single Point of Failure (SPOF)

5 In the Parlance of Risk Management A medical device that does not operate (or is not operated) as intended is considered a Hazard Exposing people (e.g., patients, staff) or assets (e.g., physical, financial) to a hazard (a medical device that does not operate or is not operated as intended) is considered a Hazardous Situation Injury to people or damage to assets as the result of exposure to a hazardous situation is considered Harm Risk is defined as combination of the probability of occurrence of harm and the severity of that harm Risk management is in turn defined as the systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risks 5

6 Hazard Hazardous Situation Harm Medical Device Hazard failure Hazardous Situation exposing people or assets to hazard Harm actual injury or compromise resulting from exposing people or assets to hazardous situation People or Assets 6

7 Guidelines for developing an effective Risk-based HTM Program To effectively manage a spectrum of healthcare technology risks, HTM professionals need to establish a risk management paradigm that is both Relatively Simple (the KISS principal) because complexity discourages implementation Demonstrably Effective because any paradigm or tool that fails to yield actionable & beneficial results is unnecessary and a waste of resources Once risks are identified, PRIORITIZE give priority to managing greatest risks low hanging fruit 7

8 Concept of Risk How risk is typically graphed Risk = Function (Severity, Probability) increasing Probability Risk #1 Risk #2 Risk #3 increasing Severity 8

9 Progressive Scale for Severity & Probability Determining risks requires we establishing progressive scales for both Severity and Probability Severity Probability Level # Level # Level Description Criteria 1 Negligible No or negligible adverse effect (e.g., little or no health effect) 2 Marginal Reversible adverse effect (e.g., minor injury) 3 Critical Permanent adverse effect (e.g., serious injury) 4 Catastrophic Loss of life, mission, financial collapse Level Description Criteria Example: Mean Time Between Failure (MTBF) medical devices averaging 7-10 year life expectancy Example: Annual Harm rate % of total sample 1 Improbable very unlikely to occur MTBF > 20 years < 5% per year 2 Remote unlikely but possible to occur MTBF > 10 and <20 years > 5% and < 10% per year 3 Occasional likely to occur MTBF > 5 and < 10 years > 10% and < 20% per year 4 Probable very likely to occur MTBF <5 years > 20% per year 9

10 10 Overlaying Severity & Probability Levels on the Risk Graph

11 Risk Matrix with Risk Scores Level # Level Description Severity x Probability = Classification 1 Low 1,2,3,4 acceptable risk without additional review 2 Medium 6,8 requires mitigation to further reduce risk or director of service authorization to proceed 3 High 9,12,16 requires mitigation to further reduce risk or senior leadership authorization to proceed 11

12 Applying Risk Matrix to Medical Devices/Systems Begin at Medical Device Category (i.e., defibrillators, ophthalmoscopes) and eventually progress to more granular view as appropriate (considering differences in risk between manufacturers, models, locations and even devices) Clinicians are generally most knowledgeable (and their opinions should be given most weight) in assessing severity (i.e., potential consequences of failure) CE/HTM professionals are generally most knowledgeable (and their opinions should be given most weight) in assessing probability (they maintain incident/service histories) 12

13 Elements P 3 P 5 P 11 P 12 P 4 P 2 P 1 spontaneous failure (i.e., component failure that reasonably could not have been anticipated or prevented by maintenance) mishandling, misuse unqualified operator inadequate/inappropriate instructions/procedures/process maintenance (i.e., wear & tear related) failure sabotage, vandalism, malware, hacking theft (including theft of ephi data) 13

14 14 Applying Probabilities for Different Hazards to the Risk Matrix

15 Examples of Mitigation for Various Hazards (Root Causes) Hazards / Root Causes one or more compromises to patient safety, quality/timeliness of care, data availability/integrity (i.e., security), or operations maintenance (progressive wear & tear) related failures spontaneous (unpredictable) failures inappropriate/inadequate instructions/procedures/process unqualified operator mishandling / misuse by staff, patients vulnerability to malware (e.g., virus) sabotage / vandalism / hacking theft (or other loss) of device containing personal health information (PHI) or theft (i.e., copy or removal) of PHI for device damage (e.g., fire, smoke, flood, contamination, electrical accident, etc.) hidden failures (e.g., failures not detectable until use) inadequate or poor quality utility (e.g., water, electricity, gas/vacuum, network) or other necessary component or element inappropriate/inadequate supplies/accessories interference (e.g., EMI) or interaction Examples of Potentially Appropriate Controls and Mitigation scheduled maintenance (e.g., preventive maintenance, calibration) replace with more reliable equipment and/or obtain backup re-engineer process, improve training obtain qualified operators and/or educate to achieve necessary qualifications establish handling/use guidelines, educate, & monitor regular updates of anti-virus software/definitions, regular patches & software updates to eliminate known vulnerabilities introduce and/or update security measures (e.g., isolated networks, firewalls) Introduction of physical, administrative and/or technical safeguards (e.g., alarms, disable unnecessary ports, connections) environmental precautions (alarms, protection, training) pre-use testing by operator, scheduled maintenance establish redundant and backup capabilities, training resource management & quality control, training precautions (e.g., distance, shielding and other hardening ) 15

16 16 Tool for Risk Control the Risk Mitigation Worksheet potential hazards or root causes of harm type of vulnerability under consideration (e.g., clinical, financial, operational) severity level or score as determined by a knowledgeable group of stakeholders (clinicians) current probability level or score determine by an analysis of incident/service histories for this root cause overall risk = function (severity, probability)

17 Risk Mitigation Worksheet the Mitigation Plan description of a mitigation plan elements (e.g., scheduled maintenance, training, backup systems, security measures) designation of party(ies) responsible for various elements of the mitigation plan (e.g., owner/operator, HTM services, clinical education, information technology, etc.) target date(s) for completion of various elements of the mitigation plan the probability level or score of this root cause leading to a hazardous situation after control/mitigation the overall risk where risk = function (severity, probability after mitigation) appropriate signoff (by organization leadership or department manager if risk remains exceeds generally acceptable level after mitigation) 17

18 Using this HTM Risk Management Paradigm to meet the New CMS/TJC/DNV Requirements Any device category with a Severity score of 3 (i.e., could result serious injury) or 4 (i.e., could cause loss of life) would be considered Critical by CMS and High Risk by TJC Any device with a Risk of maintenance-related failure (= Severity of failure x Probability of maintenance-related failure) is LOW based on incident/service histories can be placed in an Alternate Equipment Maintenance (AEM) Program as long as risks to patients or staff does not increase 18

19 19 Risk Level by Device Category

20 20 The Iterative Risk Management Process

21 ? Thank you! ABM Healthcare Support Services

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