Medical inspectors

Thomas Legge, ex Chief Medical Inspector of Factories, in Industrial maladies, 1934. 

In April 1774, there appeared in Abbe Rozier s Journal de Physique a remaikable paper by Pierre Bayen, a pharmacist who later became a medical inspector in the armies of the French Republic. In discussing his experiments with mercuric oxide, Bayen stated that, when mercury is... 

I. From the reports of Medical Inspectors and the Sanitary reports to this office, it appears that the administration of calomel has so frequently been pushed to excess by military surgeons as to call for prompt steps by Ibis office to correct this abuse an abuse the melancholy effects of which, as officially reported, have exhibited themselves not only in iimumerable cases of profuse salivation, but in the not infrequent occurrence of mercurial gangrene. 

E.H. Greenhow, the first medical inspector of factories in England, in 1864 identified particles of... 

Dr Thomas Legge (1863-1932 first UK national medical inspector of factories,... 

Inspection Team Leader / Senior Medical Officer Inspectorate, Organization for the Prohibition of Chemical Weapons (OPCW), Johan de Wittlaan 32 2517 JR Den Haag. The Netherlands Tel. +31 (0)70-416.31.74 Fax +31(0)70-306.35.35 E mail Clarence.Brown ,opcw.org... 

The first reports from Tulsa led the FDA to dispatch the agency s chief medical officer, Theodore G. Klumpp, accompanied by an inspector, William T. Ford, from Cincinnati, to the plant in Bristol at which Elixir Sulfanilamide had been conceived and first prepared (21, 22) ... 

In 1975, after reviewing all available documents, the Army IG (Inspector General) team had found nothing to indicate that anyone above the level of the President of the Intelligence Board or the Director of the Medical Research Laboratories at Edgewood had ever approved this proposal. Indeed, when interviewed in 1974, the former Commander of the Intelligence Center testified that he was completely unaware of the plan beforehand. The Intelligence Project Officer and the responsible physician at the Medical Research Laboratories (presumably Dr. Sim) evidently assumed the project had all the authorization it... 

Normally, the study subject is informed both verbally and in the ICF that certain other individuals besides the investigator site staff wiU view his or her medical records. In clinical studies sponsored by pharmaceutical companies or institutions, the monitoring and quality assurance (QA) personnel from the sponsors and CROs, and inspectors from a regulatory agency wiU review the medical records of the study subject. 

Does the protocol state that personal medical data obtained from the clinical trial will be made available to monitors, auditors and inspectors from regulatory authorities ... 

The protocol should specify what should be recorded directly into the CRF and what will also be recorded in the medical records. The CRF will contain all the pertinent data associated specifically with the clinical trial but some will be repeated in the medical records, for example, the protocol identification number, date of consent, date of commencement of the study, key baseline medical findings, visit dates, start and finish dates of the study drug/placebo or treatment, concurrent medication, adverse events and key efficacy and any unscheduled or scheduled actions or interventions (such as escape medication). Additional information obtained from biopsy reports, radiographs and similar documents will provide confirmation that the data in the CRF are recorded correctly. Monitors, QA auditors and inspectors need to see all the medical records available to the investigator. It is not appropriate to create copies of data from CRFs or checklists derived from medical records and claim that these are source documents. 

Inspectors will visit the investigator site and may possibly wish to visit the sponsor s office. They will review the documentation of the study file (see Box 7.1). Approval documents of the lEC will be compared with any amendments made to the protocol or to the subject s information sheet/ICR Consent forms for the study subjects will be inspected to establish who actually gave consent and whether this was before entry into the clinical study. A thorough source data verification of the CRF with the source documents, including the medical records, will be undertaken. Documentation relating to drug accormtability wiU be matched with each subject s CRF The facilities wiU be reviewed and the site staff interviewed. Further information can be obtained from... 

On returning to the United States he continued his medical education and accepted a position as a public health inspector in Kansas City, Missouri. Within a year he took a better paying job as an analytical chemist for Armor Packing Company in Buenos Aires, Argentina. He returned to the United States, and finally completed his medical training from the Kansas City College of Medicine and Surgery in 1922. 

DSHEA severely limited when the FDA could take action to protect the public and what actions could be taken. The burden of proof to show harm is now placed on the FDA. Moreover, dietary supplement manufacturers are not required to report adverse dietary supplement events. In fact, between 1994 and 1999 fewer than 10 of the 2500 adverse events associated with dietary supplements and reported to the FDA were reported by the manufacturer (53). The Office of Inspector General concluded the spontaneous adverse event reporting system has difficulty generating signals of possible public health concern due to limited medical information, product information, manufacturer information, consumer information, and ability to analyze trends (57). One weight loss supplement manufacturer is reported to have withheld from the FDA 14,684 complaints of adverse events regarding ephedra, which included heart attacks, strokes, seizures, and deaths (53). 

For medical devices, inspectors expect to see a process improvement program in place encompassing all activities within the supply chain, including the systems that support it. Activities that would provide evidence that such a program is in place include the implementation of documented processes such as Corrective and Preventative Action (CAPA), self-inspection, and internal audits." Organizations should ensure that where an SOP has been put in place to initiate a process improvement activity, the SOP is adhered to. For example, if a quality audit SOP states that all areas shall be subject to audit at least once every 2 years, then inspectors will expect to see evidence that this has been the case. Failure to do so is likely to result in a citation similar to that issued to Krieger Medical, Inc. ... 

To control the radiation exposure of workers, medical patients and the public, many countries have developed laws, which are supported by administrative measures and enforced by inspectors. Equally important is to have internationally agreed standards. 

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