Comparison of several control standard endotoxins to the National Reference Standard Endotoxin--an HIMA collaborative study.

A collaborative study, initiated under the auspices of the Health Industry Manufacturers Association (HIMA), was designed to establish the relationship of Escherichia coli O55:B5 endotoxin (the control standard endotoxin of HIMA and the Food and Drug Administration's Office of Medical Devices) to the U.S. National Reference Standard Endotoxin and to two internationally used control standard endotoxins. By using two Limulus amoebocyte lysate test systems, it was established that the E. coli O55:B5 endotoxin lot originally used by HIMA and the Office of Medical Devices to establish Limulus amoebocyte lysate release test criteria for pyrogen testing of medical devices contains approximately 4.5 endotoxin units (EU) per ng. Thus, the 1.0-ng/kg endotoxin dose limit currently established for medical devices is approximately the same as the 5.0-EU/kg endotoxin limit (on an activity basis) established by several other Food and Drug Administration agencies for human and animal parenteral drugs and biological products.

Drinking-water-induced copper intoxication in a Vermont family.

Three of four family members reported recurrent episodes of gastrointestinal illness while residing in a house in a small northwestern Vermont village. The father and two daughters repeatedly experienced episodes of emesis and abdominal pain after drinking water drawn from their kitchen faucet. One early-morning water sample taken from the family household contained a copper level of 7.8 mg/L, which is above the standard for drinking water (1.0 mg/L). Values for the second daughter's copper in hair analysis (1,200 micrograms/g) and copper in nail analysis (100 micrograms/g) were elevated (normal range 11 to 53 micrograms/g). The household was at the end of a 3/4-in (19.05-mm) copper main, and it is suspected that copper levels increased in water when the water remained stagnant in the main. All symptoms of the family resolved when they stopped drinking water in their home. This is the first report of copper-induced gastrointestinal illness attributable to a public supply of drinking water.