1. Risk Management Workshop for the HF & E Practitioner with Healthcare-related Case Studies GEORGE M. SAMARAS, PHD, DSC, PE, CPE, CQE, CBA & LIBBY A. SAMARAS, DNP, MSN, CPE, RN, NP, HEM SAMARAS & ASSOCIATES, INC., PUEBLO, CO USA

2. Session 1: Foundations of and Rationale for Risk Management Objectives Session 1: Participants will be introduced to why risk management is important to HF &E practitioners in the healthcare arena. Participants will be able to: ◦Describe why risk management (RM) is a critical engineering activity and relevant to HF &E practice; ◦Articulate the historical roots of risk and relevant milestones in its development; ◦Define fundamental concepts such as hazard, harm, risk, etc. ◦Differentiate between system use and individual use errors

3. Why do we care about good risk management? It is the Standard of Care Manufacturer, not user, responsible for safe and effective product; system use errors from: ◦design, including labeling & training ◦construction, and ◦distribution Inadequate risk management (RM) result in manufacturer ignorance RM is all about knowledge & awareness Ignorance (lack of knowledge & awareness) falls below the Standard of Care, can result in harm and liability

4. Part 1:Evolution of Risk Concept What is Risk?

5. The boundary between modern times and the past is the mastery of risk: the notion that the future is more than a whim of the gods and that men and women are not passive before nature.” - P. L. Bernstein, AGAINST THE GODS: The Remarkable Story of Risk, Wiley, 1998

6. The evolution of our modern concept of RISK and the accompanying mathematics of probability and statistics were driven first by interest in gambling and then by the realization of risk management’s value in decision-making

7. Numbers were Fundamental  Absent numbers, there can be no knowledge of odds or probabilities.  “Without odds and probabilities, the only way to deal with risk is to appeal to the gods and the fates” Bernstein, Loc 543  Before the adoption of Arabic numbers, Greek and Roman numbering made calculation extremely cumbersome, if not practically impossible.

8. Probability & Statistics  Risk is a choice, not a fate, unless you are uninformed  Probability tries to look into the future (forecasting), but is hobbled by its reliance on the past  Statistics is a tool for trying to make sense of observations (samples) from the past, in an attempt to forecast the future  Over the past half millennium, we have made progress; we continue to do so now

9. Historical Perspective 1550  Gerolamo Cardan manuscript addressed probability of certain outcomes in rolls of dice, the problem of points, and presented a crude definition of probability.  Manuscript lost until 1576 and printed in 1663.  He would have been known as father of probability theory, except … 1654  Blaise Pascal & Pierre de Fermat worked on a gambling problem set by (non-nobleman) Antoine Gombaud, Chevalier de Méré.  Title was an affectation  Pascal and Fermat laid the basic ground work for the theory of chance and probability

10. Historical Perspective (continued) 1713  Jacob Bernoulli, uncle of Daniel Bernoulli of fluid dynamics fame  Publishes Law of Large Numbers (LLN) and methods of statistical sampling  LLN implies that the empirical results of a large number of repeated (independent) trials will tend toward the expected value  It basically says that the effects of noise and other disturbances will average out 1730  Abraham de Moivre  First statement of “normal curve” – binomial successes approximate normal distribution for large number of trials (special case of Central Limit theorem)  Concept of standard deviation and how ignorance of sample size affects statistical variation

11. Historical Perspective (continued) 1812  Laplace publishes modern formulation of Bayes notion of conditional probability  Relates current (posterior) probability to prior probability (distribution)  P(A|B) ≡ P(B|A) x P(A)/P(B)  A, B = Events: set of outcomes of an experimental trial  Probabilities here not frequency or propensity, but beliefs (objective or subjective) regarding outcomes 1875  Francis Galton (Darwin’s cousin) & Regression Fallacy  Ascribes cause where NONE exists  Also known as Regression Towards The Mean  NON-Random Resampling yields results that move toward or away from the true mean

12. Understanding RISK The word “risk” derives from the early Italian “risicare” – “to dare”. From this perspective, RISK is a choice, rather than a fate -Bernstein, Loc. 262-3 BUT, never forget that choices cannot be made in ignorance!

13. Basic Definitions  HAZARD (al zahr, Arabic for dice):  Potential source of harm  HARM:  Physical injury or damage to the health of persons, property, or environment  RISK:  Future uncertainty of the deviation from an expected outcome  PRACTICAL MEASURE OF RISK:  Combination of probability of occurrence of harm and severity of that harm

14. Risk  RISK (R) has TWO Components  Probability of a Hazard Occurring [P]  Probability of Exposure to Hazardous Situation  Probability of Harm Actually Occurring  Severity of Consequences of Hazard Occurring [S]  Practical Measure of Risk R = S x P … actually, just a relative risk index  not mathematically sound (do the dimensional analysis)  Detection or Detectability [D]  NEVER, EVER a part of RISK: D is a risk CONTROL (and a poor one, at that!)

15. Risk Perspectives  Slice & Dice risk a wide variety of ways:  Internal versus External  Strategic versus Tactical (Operational)  Financial versus non-Financial  Technological versus Socio-Economic  Political/Regulatory versus Environmental  Product versus Process  Design versus Manufacturing

16. What is Modern Risk Management? The fundamental elements of managing risk are basic to decision-making.

17. “Risk management guides us over a vast range of decision-making, from allocating wealth to safe guarding public health, from waging war to planning a family, from paying insurance premiums to wearing a seatbelt, from planting corn to marketing cornflakes.” - Bernstein, Loc. 141

18. Benefit versus Cost  Major driver in risk management is benefit versus cost  But the word “we” means us collectively, NOT just “us” locally!  Need to consider ALL costs  Most tabulate all benefits, but tend to ignore or forget many costs  We cannot eliminate risk; we must MANAGE it!

19. Lifecycle Process

20. International Consensus Standards (some examples relevant to medical devices)  ISO 9001:2015  All Products Quality Management System  New version is highly risk-based  ISO 15288: 2008 § 6.3.4  Systems & Software Engineering  Specifically defines risk management process  ISO 13485:2003 §7.1 Note 3  Medical Device Quality Management Systems  Specifically calls out ISO 14971  ISO 14971:2007 (:2012 is EU-harmonized version)  US Medical Device Risk Management

21. Setting Boundaries  Just not possible to engineer products for all infinite possibilities (no matter how awesome we claim to be)  Must set boundaries: intended use, intended users, and intended use environment  Must recognize: expected use, novel use, misuse, and abuse.  Must discriminate System Use errors from Individual User errors

22. SYSTEM USE vs INDIVIDUAL USER TAXONOMY OF ERROR

23. Individual USER Errors

24. Some System USE Errors