How many other dangerous medical devices have ISO involvement?

This is the discredited Essure contraceptive system.

See how it works in the Fallopian tubes?

Think of it as barbed wire for babies that also turned out to be barbed wire for their mothers.

It was tested and approved:

The Essure System for Permanent Birth Control is a Class III medical device. Essure consists of an insert and a disposable delivery system and has undergone clinical investigations since 1996. The Essure System was initially Conformité Européene (CE) Mark approved on 09 FEB 2001 and received US FDA approval on 04 NOV 2002 following the FDA PMA review pathway, the most stringent regulatory review process for devices prior to marketing.

However, Bayer and the FDA obfuscate whether the ISO can also take the blame:

Based on the literature research, testing data, and widespread human use of the device materials, the Essure device testing met the requirements of ISO 10993 for a surface device with permanent contact with mucosal membrane tissue and the FDA determined that the safety profile was acceptable for permanent birth control.

“Met the requirements for ISO 10993” – or did somebody actually certify it to the ISO standard?

Sasha Chavkin investigated for The International Consortium of Investigative Journalists:

Essure injury complaints buried by Bayer, lawsuit claims

Only a fraction of incidents in which women were allegedly harmed by the contraceptive device were reported, experts acting for a class action suit claim…

Maybe more law firms will catch on to the ISO body count.

Let’s have more legal investigations such as those into TÜV Rheinland’s gross negligence in the process of certifying the quality process for PIP breast implants.

Big Four foul-up again

The UK’s Big Four former accounting companies audit the finances of all the other FTSE companies.  They’re ISO-accredited and leaders in ISO certification and accreditation training.  They often get it badly wrong and sign off serious financial corruption.  This has led to the collapse of a number of major companies due to the Big Four having certified financial lies.  How else might they collect their fees?

The ISO’s impartiality requirements have been powerless to stop this repeated corruption.  They simply add busywork to generate inspection fodder.  It persuades gullible buyers that new ISOs are improved.  Might the law be more effective?

Fortunately courts have levied fines big enough to persuade lesser companies not to do it again. But the large fines are a minuscule proportion of their annual incomes.  Like the ISO vanity press, they’re too big to fail.

The accounting regulator seems unconvinced the fines make it worthwhile for them to improve. It has ordered them to separate their auditing practices by 2024.  It’s not urgent.  

Academics explain a little of what’s been going on,

Audit keeps failing – here’s why a fundamental change is needed

Trupublica takes a darker view – and there is much more to tell,

The big four are not objective, or neutral, or in any strong position to judge corruption elsewhere. They are service providers, led by financial interest.

We should treat them as such. We should report on their statements in the media as such – the lobbying of and for interested parties. And we should treat their policy lobbying the same way. And we should certainly limit any public employment, and be highly skeptical of all those kind offers to second staff into government agencies to help draft legislation, or tax reforms, or – frankly – anything else.

It’s time to recognise the big four for what they are — or we’ll keep getting stung.

 

Alleged invalid results from US meat testing labs

John Munsell asks, And . . . What role does pathogen testing play in true HACCP?

His opinion is that Hazard Analysis Critical Control Point (HACCP), that was designed to ensure food product safety, has been compromised to shift responsibility from hegemonic raw meat companies to smaller food producers. 

Dr Pat Basu comments at bottom:

(9)…I strongly believe that consumers and the industry, especially the small and medium-sized industry operations, also need to understand that, although FSIS lab results are considered “official”, there are enough errors in multiple processes in the FSIS labs that can be shown in a court of law to render these results invalid. Therefore, the industry must make the effort to verify all FSIS lab results before any major expense is undertaken by the industry prior to a “voluntary” recall based on what may be a fictitious or inaccurate result.

That’s got to be labs accredited to ISO 17025 that supposedly assures the validity of results. 

UKAS tries to catch up with COVID-19

Fear Not!  You’ll realize by now that all the risk-based thinking and opportunity-spotting that the ISO requires has failed catastrophically.  Everybody’s pretending they didn’t see COVID-19 coming.  It’s a lie.  A number of experts foresaw something similar.

The British Government refused to publish its report on Exercise Cygnus (album aut nigrum?  – to say might open us to accusations of racism).  The consequences were too difficult to plan for, so the possibility was ignored.

What were you expecting – a grey rhino?

Even ISO failed to plan despite pushing unnecessary risk assessment on its victims.  So UKAS has rushed out TPS 73 UKAS Policy on Accreditation and Conformity Assessment During the Coronavirus Outbreak (Edition 1)  to keep the fees coming in and the cover story covering.

If the elaborations of risk-based thinking didn’t work for the inspection cartel with an unprecedented pandemic, how much good are they able to do for you?

The chaos of coronavirus testing could be entirely unaccredited.  There will be a messy uncertainty because of the lack of planning and varying availability of different tests.

We must hope that researchers are planning comparisons between the testing regimes in different countries and don’t forget to evaluate any role that accreditation has in the quality of results.

Or maybe we should all wait until all testing is verified, validated and accredited?

Public Health England’s bureaucratic approach isn’t as slow as UKAS would normally require but certainly has invited criticism.

 

Coronavirus relaxes accreditation for a while

National chief scientists issued an NHS joint statement Supporting the healthcare science workforce response to coronavirus… (publications approval reference: 001559) on 30th March 2020…

 

Notice,

“They must bear in mind that healthcare scientists may need to depart, possibly significantly, from established procedures and accreditation processes to provide scientific services for patients in the unique and highly challenging but time-bound circumstances of the peak of an epidemic.”

Sounds like the leaders, when pushed, kind of admitted that accreditation might be a theatrical scam and an impediment to the best quality care.

If accreditation really guarantees the best quality, why do patients who will die not deserve it?

Patient survival trumps ISO 15189 compliance.

Don’t be surprised if it is later argued that the return of enforced accreditation has reduced death by restoring quality.

The Health & Care Professions Council also realizes that regulation must be relaxed during the coronavirus pandemic.

Will anyone be collecting evidence able to distinguish whether practitioner or ISO regulation is more critical during the period of more important things than regulation?

Think it couldn’t get worse?  Oxebridge points out the failure of the risk management gurus in the ISO and elsewhere and the possibility of fully airborne mutations:

“Right now, the novel coronavirus is only airborne as an aerosol, where droplets expelled during coughs or sneezes can travel limited distances; thus, the “social distancing” rules now being implemented by thoughtful countries. But viruses mutate. If coronavirus were to cross species (again) and infect birds, the transmission rate would be phenomenal. If the virus were to mutate and allow for itself to be carried on smaller particles in the air, and not just sneezejuice, you’d again have worldwide transmission that no amount of social distancing could correct.”

 

 

Is ISO 15189 accreditation really the gift that keeps on giving?

Is ISO 15189 accreditation really the gift that keeps on giving?  Yes, for the assessment cartel.  No, for labs.

Green et al. have investigated the effects of ISO 15189 accrediation by INAB in a clinical biochemistry lab (https://doi.org/10.1016/j.plabm.2020.e00159).

These authors developed the methodology used by Wilson et al. and showed rather similar results to the microbiology setting accredited to ISO 17025 by UKAS.

Non-conformities identifed by audits were unlikey to affect quality:

Fig. 1. Estimated impact of audit-identified non-conformities identified by audit between 2012 and 2018. The potential impact on QoS of each of the 483 audit-identified non-conformities documented between 2012 and 2018 was re-assessed. The audit-identified non-conformities were re-sorted into classifications according to their perceived likelihood of causing poor QoS according to a majority decision of three clinical biochemists. The classifications as shown in the Figure were Unlikely (The occurrence had no clear adverse consequences); Possible (Such an occurrence has the potential to cause poor QoS or harm to patients/staff, and has a reasonable likelihood of doing so at some point); and Probable (The occurrence has either lead to poor QoS/harm, or such an occurrence would be considered likely to cause poor QoS/harm).

Audits identified fewer non-conformances each year after accreditation was awarded:

Fig. 2. Breakdown of audit-identified non-conformities and their estimated impacts on QoS by year. The total numbers of audit-identified non-conformities and the estimated likelihood of their having a detrimental effect on QoS are broken down according to year.

Auditing failed to diminish the number of real time non-conformances but few were critical or major:

Fig. 3. Numbers and severity ratings of real-time non-conformities by year. The total numbers and assigned severity ratings of all real-time non-conformities documented between 2012 and 2018 were gathered. Raw numbers are shown in table format (A) and are additionally displayed graphically (B) to illustrate observed trends. Severity ratings are based upon departmental criteria. Observation = A finding warranting clarification/investigation to improve the quality management system; Minor = A minor deficiency or lapse in discipline; Serious = An incident had the potential to have a negative clinical impact or cause a serious technical error; Critical = An incident that would have had clinical impact on a patient, but was stopped prior to having done so; Major = An incident in which there was clinical impact on a patient.

The authors conclude that audit is a poor and inefficient means of quality assurance.

This strikes at the heart of ISO accreditation because the planned internal audits are supposed to validate the annual audits that assessors for which assessment bodies charge fees.

To conclude, the high proportion of non-compliances deemed to be unlikely to have any important effect on QoS indicates that continued auditing for conformity with ISO 15189 (2012) standards may be an inefficient and largely unavailing approach to further improving the QoS in clinical laboratories with a mature QMS. Accordingly, there is room for improvement in the audit process required for compliance with ISO 15189, to promote more efficient and effective use of time and resources to better deliver and sustain a high QoS. There is also need to define better indicators of QoS which could allow the value of compliance with such quality standards to be more meaningfully assessed to enable delivery of a high QoS conducive to the provision of excellent patient care.

Go to Practical Laboratory Medicine and read this paper to see further evidence that accreditation is a confidence trick void of the proof that could establish its claims.

This validation of the earlier paper points other researchers to investigate further.

However, a suggestion that audits or other QoS indicators can usefully be done better is an example of  what John Seddon has described as “doing the wrong thing wronger”.  It makes nothing better and appeals to obsessive and controlling personalities.

 

COVID-19 – credibility crisis for accreditation

UKAS has stated it plans to conduct all its assessments remotely during the coronavirus pandemic.  Well, they have to.  As assessors succumb, they won’t be able to maintain their schedules. If the organisations they parasitise continue to deliver their services just fine, smart customers might recognise the low value of accreditation.

If critical COVID-19 testing ought to be delivered to the world population without accreditation, so can everything else.

Meanwhile, Oxebridge has issued a public call for the IAF to extend all certifications and accreditations for one year.

 

COVID-19 tests

Only accreditation sufferers know how long it takes to get a diagnostic tests accredited to ISO standards (count it in months).  However, doctors and the public want millions of COVID-19 tests now.

This Daily Mail article describes the options available.  Some are “for research use only.  Not for use in  diagnostic procedures.”

No labs or tests are described as accredited but the demand is huge.  Nobody understands or cares about accrditation outside the inspection cartel that monitise it.

Will the tests turn out to be useless and invalid because they’re not ISO 15189-accredited?

Or will accreditation turn out to be invalid because the unaccreditated tests actually are “fit for purpose”?

Accreditation is beautifully irrelevant to all commentators.  They just want the job done. Accredited or not, tests will give a large number of misleading results.

Prof John Ioannidis gives a balanced opinion on COVID-19 testing,

A fiasco in the making? As the coronavirus pandemic takes hold, we are making decisions without reliable data

 

 

 

 

 

 

 

Hard times for policing

The forensic work of Randox Testing Services was compromised by rogue employees they had taken on.  Police money was needed to bail the service out.

More recently Eurofins Scientific and Eurofins Forensic Services have been hit by a ransomware attack.  Eurofins analyse half of the UK’s forensic cases.  Court work has had to cease but UKAS accreditation continues.

UKAS’s list of sanctions still omits these companies.  Their customers have worked out what to do even if UKAS hasn’t.

Criminals have no regard for UKAS certificates.  But UKAS has regard for its fee income.  UKAS spreads its warm, yet strangely unquantifiable, feelings of confidence while the police and courts have lost confidence and gone elsewhere.

The police don’t do much about online fraud and cybercrime anyway, so can this attack have been to interfere with evidence?

A knowledgeable commentator opined,

“Supply chain attacks are often coordinated, so relying on one company for a significant portion of your operations demands an effort to validate the defences they have in place before awarding a contract, and ideally on a regular ongoing basis,” said Mimecast’s Sloshberg. “Otherwise, the knock-on effect of a successful attack can expose serious risks for your organisation.”

Relying on a monopoly provider of ISO accreditation provided assurance rather than protection.  This fact is being ignored here.

Truthfully, it’s the ISO accreditation certificates that never mattered.  The police and courts can work out the implications for themselves.

 

Cholesterol and atherosclerosis deception

Worried about your cholesterol?  Ravnskov et al. say, don’t be.

They allege decades of misleading statistics and selective reviews to sustain the hypothesis that high cholesterol is the major cause of CVD.

9. Conclusion

The idea that high cholesterol levels in the blood are the main

cause of CVD is impossible because people with low levels

become just as atherosclerotic as people with high levels and

their risk of suffering from CVD is the same or higher. The

cholesterol hypothesis has been kept alive for decades by

reviewers who have used misleading statistics, excluded the

results from unsuccessful trials and ignored numerous contradictory

observations.

What difference would it make if your bloods had been analysed in a lab accredited to ISO 15189?

When someone conducts a critical review of the literature supporting ISO accreditation, will we see similar dishonesty to sustain the inspection cartel’s power?

Read the paper here:

Uffe Ravnskov, Michel de Lorgeril, David M Diamond, Rokuro Hama, Tomohito Hamazaki, Björn Hammarskjöld, Niamh Hynes, Malcolm Kendrick, Peter H Langsjoen, Luca Mascitelli, Kilmer S McCully, Harumi Okuyama, Paul J Rosch, Tore Schersten, Sherif Sultan & Ralf Sundberg (2018) LDL-C does not cause cardiovascular disease: a comprehensive review of the current literature, Expert Review of Clinical Pharmacology, 11:10, 959-970, DOI: 10.1080/17512433.2018.1519391.