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Industry directory/Healthcare

INDUSTRY COLLECTION

Healthcare

Clinical evidence, patient safety, device risk, and the systems surrounding care.

Read across the boundaries.

The organization’s goal, the delivery system, and the conditions of use rarely sit within one discipline. Study this collection alongside cases from other fields to identify which safeguards and decision patterns travel across contexts.

These are illustrative drafts with source references. Collection membership is an editorial classification, not a claim that every case has the same mechanism.

Cases in this collection

5 exhibits

First page of the 25 January 2016 CMS letter to Theranos concerning its Newark laboratory; regulatory-document context preceding the 2018 SEC action.

CONTEXT / SOURCE DOCUMENT

EXHIBIT 005

Theranos: when the promise outran the proof

The SEC challenged claims about blood-testing technology and investor disclosures.

Unvalidated assumptions

Regulatory documentation 5 min

Illustrative draft · United States · Regulatory action · High

Stafford Hospital in 2011; contextual exterior of the hospital examined by the Mid Staffordshire inquiry.

CONTEXT / PHOTOGRAPH

EXHIBIT 064

Mid Staffordshire: organizational signals displaced patient care

The public inquiry examined serious failures in care and institutional responses.

Metric substitution

Primary documentation 8 min

Illustrative draft · United Kingdom · Investigated · Critical

DePuy ASR XL hip replacement components shown in Figure 2 of Wienroth, McCormack and Joyce’s 2014 study: femoral head, acetabular cup, and femoral stem.

EXHIBIT 065

DePuy ASR: implant performance after release

The ASR system was recalled following higher-than-expected revision rates.

Post-market surveillance

Regulatory documentation 8 min

Illustrative draft · Global · Recalled · Critical

Philips Respironics Trilogy ventilators shown in an FDA product recall photograph from 2014. Trilogy 100 and 200 models were also included in the 2021 foam recall.

CONTEXT / PHOTOGRAPH

EXHIBIT 066

Philips: a material inside the breathing pathway

Certain devices were recalled because sound-abatement foam could degrade and release particles or chemicals.

Material degradation

Regulatory documentation 8 min

Illustrative draft · Global · Recalled · Critical

Bristol Royal Infirmary in July 2019; contextual exterior photographed after the period examined by the pediatric cardiac surgery inquiry.

CONTEXT / PHOTOGRAPH

EXHIBIT 067

Bristol: clinical outcomes needed an independent voice

A public inquiry examined failures in children’s heart surgery and the institutions responsible for oversight.

Failure to escalate

Primary documentation 8 min

Illustrative draft · United Kingdom · Investigated · Critical

Questions to take into the archive

Which assumption went untested?

Use the case evidence to test the question. Avoid treating a plausible explanation as a documented fact.

Who owned the warning?

Use the case evidence to test the question. Avoid treating a plausible explanation as a documented fact.

Were the defenses independent?

Use the case evidence to test the question. Avoid treating a plausible explanation as a documented fact.

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