2018 ceai conference august 15-16, 2018 oakbrook terrace il€¦ · however, no other...

Copyright © 2018 by Binseng Wang – All Rights Reserved

Binseng Wang, ScD, CCE, fAIMBE, fACCEPrincipal Consultant, BSI

Cornelius NC

Opinions provided here are solely of the author and does not represent those of his employer or any entity with which he is associated.

2018 CEAI ConferenceAugust 15-16, 2018

Oakbrook Terrace IL

2Copyright © 2018 by Binseng Wang – All Rights Reserved

The audience will be divided into 2 teams with a leader for each one. Each team can only give one answer to each test.

The team must answer within 15 seconds with: REAL NEWS (RN): the statement presented is true FAKE NEWS (FN): the statement presented is false and

• It is a LEGEND (FN-L): because many people believe it (myth)

• It is an ALTERNATE FACT (FN-AF): because whoever made the statement knows it is false (lie)

Ten (or more) tests (statements) will be presented to both teams in alternate order.

The same answer is allowed for both teams.


Correct answerYour answer

UN FN FN-L FN-AFReal News (RN) = True 10 0 0 0Fake News (FN) = False 0 10 0 0

Fake News + Legend (FN-L) = Myth 0 0 +5 0Fake News + Alternate Facts (FN-AF) = Lie 0 0 0 +5

The presenter’s answer is INDISPUTABLE. Whatever arguments you have is nothing but FN-AF (lie)!

If by the end of the 10 tests there is a tie, additional tests will be presented until the tie is broken.

The winning team earns the right to dunk the losers into the pool or use any “enhanced interrogation” technique approved by the new CIA Director, Gina Haspel.


Galileo proved that gravity is a constant by dropping two balls of different weight from the top of the Leaning Tower of Pisa and they landed at the same time.


Answer: FN-L (myth) Justification One of Galileo’s disciple (Vincenzo Viviani) propagated this myth in

his biography of Galileo. However, no other person/document confirms such experiment

according to Prof. JL Heilbron who wrote in “That Galileo publicly refuted Aristotle’s conclusions about motion by repeated experiments made from the campanile of Pisa” in Newton's Apple and Other Myths about Science, RL Numbers (ed), Harvard Univ Press, 2015, “The reason that none of the putative witnesses to Galileo’s singular performance from the campanile ever mentioned it is that it did not take place.”

So while he did prove it, there is NO evidence that he dropped the balls from the Pisa tower. Instead, records show he used balls of different weight on an inclined surface (Galileo’s De Motu.)

Physics: because d = ½ g * t2, t = (2d/g)½, so if the distances and times are identical, g must be constant.


CMS and, thus, TJC, DNV, etc. does NOT allow the use of Alternative Equipment Management (AEM) program for imaging/radiologic equipment, medical lasers, and equipment for which there is insufficient maintenance history.

ALLOWED ANSWERS POINTS IF CORRECT

Real News (RN) The statement above is true 10Fake News (FN) The statement above is false 10

Fake News + Legend (FN-L)

The statement above is false but many people believe it (myth)

15

Fake News + Alternate Facts (FN-AF)

The statement above is false whoever made it (lie)

15


Answer: RN (true) Justification See CMS S&C 14-07-Hospital memorandum issued on Dec 20,

2013, available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-07.pdf


Manufacturers of medical X-ray systems are required to provide service manuals (procedures and frequencies) for their products to equipment owners and service providers.





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Answer: FN-L (myth) Justification Imaging manufacturers are only required to provide “instructions

for assembly, installation, adjustment, and testing” (AIAT), per 21 CFR 1020.30(g), and

“[a] schedule of the maintenance necessary to keep the equipment in compliance with this section and …” per 21 CFR 1020.30(h)

But not maintenance procedures, such as repairs, PM or SPI procedures or frequencies!


Manufacturers of medical laser systems are required to provide “instructions for service adjustments and service procedures” for their products.





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Answer: RN (real news) Justification 21 CFR 1040.10 (h)(2)(ii) requires laser manufacturers to

provide “instructions for service adjustments and service procedures” for their products.

Denials to provide those instructions can be reported to FDA’s Allegations of Regulatory Misconduct Branch (email: [email protected])


OEMs are NOT required by any government (US or foreign) to provide service manual or information to equipment owners or servicers, except for medical lasers and AIAT for medical X-rays in the USA.





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Answer: FN-AF (lie) Justification EU’s Council Directive (MDD) 93/42/EEC of 14 June 1993 states

• 13. Information supplied by the manufacturero 13.6 Where appropriate, the instructions for use must

contain the following particulars:o (d) all the information needed to verify whether the device

is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all time;


According to the recent Netflix exposé The Bleeding Edge, medical devices, including equipment, are dangerous because of FDA lax regulation allowing many devices to be cleared through the “substantially equivalent” (510(k)) process without much clinical testing.





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Answer: FN-L (myth) Justification The European Union does not have such a “loophole” and yet

end up approving the same devices even faster than FDA, with no significant difference in recalls or adverse events.

Example, the metal-on-metal hip implant was actually invented in England. It was approved by UK-MHRA (and, thus, EU) and later by FDA through 510(k).

Also, 510(k) was imposed by Congress on FDA due to intense manufacturer lobbying, not invented by FDA.

Dr. David Kessler was highly critical of this “loophole” in The Bleeding Edge but did nothing to it while his was FDA commissioner for ~7 years.


The “Cost of Service Ratio” (COSR)—service cost/purchase cost—is the best financial benchmark to compare a CE/HTM team against others and protect them from being outsourced.





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Is service cost truly linearly dependent of asset cost?


Actual COSR from acute care hospitals


Answer: FN-AF (lie)

Justification There is no reason for service cost to be a constant ratio of

purchase cost (see SUV case). Actually, COSR is higher for prestigious major teaching

hospitals. Often either or both numerator and denominator are inaccurate

(incomplete accounting or lack of actual data) and neither has been audited => COSR is easily manipulated

Instead, you should use multiple audited data (e.g., total hospital expenditure and adjusted patient discharges) because the hospital can be penalized (by CMS and others) if these data are inaccurate


CE productivity should be measure by adding all the hours documented in workorders and dividing the sum by the total number of hours paid after subtracting holidays and vacations. The result should be in the range of 70-85%





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1,000

10,000

100,000

1,000,000

1 10 100

Tota

l # H

ours

Wor

ked

Total # CE FTEs

Major teaching

Minor teaching

Non-teaching

Unknown

Questionable

2000hrs/FTE

r = .998p = 0

0%

20%

40%

60%

80%

100%

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

"Produ

ctivity" (%

doc hou

rs/paid ho

urs)

year

A

B

C

D

E

F

G

H

I

J

K

L


1

10

100

10 100 1,000

CE F

TEs

Staffed Beds

Model

Major Teaching

Minor Teaching

Non-Teaching

Undeclared


Answer: FN-AF (lie) Justification Documented worked hours are self-declared and, thus, subject

to manipulations (“you get what you asked for”) Should be intuitive that people who spend less time on a

particular task is more productive than others who spend more time => In fact, Bureau of Labor Statistics (BLS-DOL) defines labor productivity as “the ratio of the output of goods and services to the labor hours devoted to the production of that output” (http://www.bls.gov/opub/hom/homch10_e.htm)

“Non-productive hours” such as rounding with clinical staff often is more productive in reducing service calls and downtime, as well as patient safety


Reliability-Centered Maintenance (RCM) is the best method for determining maintenance strategy when placing an equipment into the Alternative Equipment Management (AEM) program.





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Planning Asset selection Characterization of function & failure patterns Failure mode and effect analysis (FMEA) Decision process Develop performance measures Define maintenance schedules & work instructions Staff training

Implementation Implement adopted strategies Maintenance data collection

Evaluation Evaluate maintenance performance Use evaluation results to revise & update strategies

FM&E unknown due to closed

software

Difficult without OEM assistance

Do OEMs readily provide service manuals in

Illinois?


Adapted from Moubray, 1997

Violates FDA

regulation

Will the failure be noticed?

Does the failure impact

operational capability?

Could the failure harm a person or the environment?

Is the cost of PM less than

the operational impact plus cost of CM?

Can PM reduce the probability of failure to an

acceptable level?

Can PM reduce the probability

of multiple failures?

Is the cost of PM less than

the cost of CM?

Yes No No

No Yes Yes

Perform PM

Check for

failure

Let it fail

Perform PM

Redesign Perform PM

Perform PM

Let it fail

Y Y Y YN N N N Follow-Up Actions


Answer: FN-L (myth) Justification RCM became popular because it was mentioned in CMS S&C 14-

07 issued in 2013 (http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-07.pdf ).

Unfortunately, RCM was misunderstood and misquoted in that document (also by many famous CE/HTM professionals).• CMS: “RCM - a maintenance strategy that not only considers

equipment condition, but also considers other factors unique to individual pieces of equipment, such as equipment function, consequences of equipment failure, and the operational environment.” (Remember Fennigkoh-Smith?)

• Moubray: “a process used to determine what must be done to ensure that any physical asset continues to do what its users want it do to in its present operating context.”

Challenges in both RCM process and follow-up actions


The risk classification method (Fennigkoh & Smith) is a good tool for deciding which equipment should be placed on AEM, i.e., if an equipment is classified as critical/HR, it should not be placed on AEM.





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Answer: FN-L (myth) Justification Risk could be considered when placing a piece of equipment into

AEM but it should NOT be the primary criteria. Also risk = severity & probability, i.e., need to have failure rate data.

SM is primarily determined by the technology used in building the device. So if a mechanical or chemical component is known to wear out, PM should not be skipped (but could be less frequent).

If past data/experience shows SPIs have detected significant amount of HF or PF, then it should not be skipped either.

In essence, past data/experience with and knowledge about the equipment is much more important than risk.

Example, ICU monitor is high-risk but not high maintenance because SPIs can’t prevent electronic failures => can use AEM. (George Mills said in his 2015 AAMI session: High risk ≠> high maintenance).


Evidence-based maintenance (EBM) relies not only on the observed history of failures, but the theoretical probability of certain types of failures. This second type of analysis is typically beyond the capabilities of most service organizations.





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Answer: FN-AF (lie) Justification While this statement was indeed made in ANSI/AAMI

EQ89:2015, EBM does NOT rely on “theoretical probability of certain types of failures”

EBM is based on the root-cause analyses (RCA) of service records and only use rudimentary statistical principles

Fishing = Process Catching = OutcomeTackle = Structure


Evidence-based maintenance (EBM) is simply trend analysis and the later has been carefully performed by OEMs, so CE/HTM professionals should never second guess OEMs and adopt AEM.





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Answer: FN-AF (lie) Justification EBM is different from trend analysis because the former is based

on a (simplified) root-cause analysis (RCA) while the latter is based on service (actually, parts replacement) statistics.

Trend analyses help OEMs to determine recommendations for true PMs or to improve their parts or sub-assemblies but do not help to reduce unnecessary SPIs.

For example, John Collins analyzed a very large service database and concluded that PCB was the most frequently replaced part. This may help the respective OEMs but not for CE/HTM professionals because electronic failures are random in nature (Department of Defense. Reliability Prediction of Electronic Equipment, MIL-Hdbk-217F, 1991).


All laboratory equipment, regardless of size and complexity, must be maintained per respective manufacturer’s recommendation. E.g., balance/scale, optical microscope, fluid warmers





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Answer: RN (true) Justification This is required by the Clinical Laboratory Improvement Act

(CLIA) of 1988 and codified in 42 CFR 493.1254


To decide which pieces of equipment should be classified as “critical” (or “high risk”) one should use a classification algorithm like the Fennigkoh-Smith (aka “risk-based criteria”): EM = Equipment Function + Physical Risk + Maintenance Requirements.





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Answer: FN-L (myth) Justification CMS defined “critical equipment” as "... equipment for which there

is a risk of serious injury or death to a patient or staff person should the equipment fail." (S&C 14-07 of 2013)

While the word “risk” is used, CMS actually meant “severity” because it is too difficult to determine the probability of equipment failure in different applications (per ISO 14971, risk = severity & probability).

Since the purpose of this classification is to allow surveyors to select equipment for verifying scheduled maintenance completion and AEM inclusion, the best approach is to limit this classification to as few as needed.

In case of doubt, you could consult clinical staff but don’t have to, as CMS said “In the case of medical equipment, a clinical or biomedical technician or engineer would be considered qualified.”


Electrical safety test (EST) must be performed if it is recommended by the respective manufacturer even if the equipment is in AEM.





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Answer: FN-AF (lie) Justification NFPA 99-2012, which has been adopted by CMS, states

unequivocally that All patient care–related electrical equipment … shall be tested…

before being put into service for the first time and after any repair or modification that might have compromised electrical safety.

So EST does NOT have to be performed unless one of the conditions above is present.


TJC LS.02.01.70-EP1 “Smoking is prohibited in any room, ward, or compartment where flammable liquids, combustible gases, or oxygen is used or stored…” only applies to traditional cigarettes and not to e-cigarettes.





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Answer: FN-L (myth)

Justification Incorrect. George Mills answered this question clearly in 2017

AAMI conference. Data collected by US Fire Administration/FEMA shows e-

cigarettes have caused fires and explosions at the rate of ~100/year in 2016 and this rate has been growing exponentially since 2009 due to low-quality lithium ion batteries used.

I.e., this is not to promote health but prevent fires and explosions in healthcare facilities where fire is extremely dangerous.


Hopefully you learned something from this “test.”

Please contact me if you have any questions, comments or suggestions Binseng Wang [email protected]

2018 ceai conference august 15-16, 2018 oakbrook terrace il€¦ · however, no other...

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