Why do performance goals change – has human physiology changed?

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[Photo is Cape Cod Canal] Ok, the title was a rhetorical question. Some examples of the changes:

Blood lead lowest allowable limit:

1960s 60ug/dL
1978   30ug/dL
1985   25ug/dL
1991   10 ug/dL
2012     5 ug/dL

 

Glucose meters:

2003 ISO 15197 standard is 20% above 75,
2013 ISO 15197 standard is 15% above 100,
2014 proposed FDA standard is 10% above 70.

The players:

Industry – Regulatory affairs professionals participate in standards committees and support each other through their trade organization, AdvaMed. The default position of industry is no standards – when standards are inevitable, their position is to make the standard as least burdensome as possible to industry.

Lab – Clinical chemists and pathologists are knowledgeable about assay performance. ALERTpathologists are not clinicians. Also, lab people are often beholden to industry since clinical trials are paid by industry, conducted in hospitals by clinical chemists or pathologists.

Clinicians – Sometime, clinicians are part of standards but less often than one might think.

Regulators – People from FDA, CDC, and other organizations have to decide to approve or reject assays and are often part of standards groups.

Patients – Patients have a voice sometimes – diabetes is an example.

Medical Knowledge – As the title implies, the medical knowledge related to performance goals is probably of little consequence. For example, the harm of lead exposure is not a recent discovery.

Technology – Improving assay performance due to technical improvements probably does play a role in standards. All of a sudden the performance standard is tighter and coincidently, assay performance has improved.

Cost – Healthcare is rationed in most countries so cost is always an issue, but it is rarely discussed.

Note that the earliest standard for these two assays is 100% or more lenient than the current standard.

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