The Toxicity and Safety Testing of Disposable Medical and Pharmaceutical Materials**Received August 21, 1959, from the Biological Research Laboratories, Hynson, Westcott & Dunning, Inc., Baltimore, Md.
✍ Scribed by Brewer, John H. ;Bryant, Harold H.
- Publisher
- Elsevier
- Year
- 1960
- Weight
- 464 KB
- Volume
- 49
- Category
- Article
- ISSN
- 0095-9553
No coin nor oath required. For personal study only.
✦ Synopsis
Many disposable surgical and pharmaceutical materials are not adequately tested for their toxicity and compatibility with tissues. Suggested techniques are described for testing these items. By the use of such tests the various items available may be checked and a choice made between those which should not be used and those which have been adequately tested and are found to be satisfactory.
ECAUSE of high labor cost and an inadequate
supply of properly trained personnel, the demand for disposable, ready-to-use medical and pharmaceutical materials has resulted in the introduction of many such items in the commercial market. Disposable syringes, needles, vials, catheters, drain tubes, and countless other items are now available. For the most part these are made of plastic or one of the newer, lighter weight alloys. Many of these items offer advantages over the original re-usable item. The throwaway hypodermic needle, for instance, cannot transfer infectious hepatitis from one patient to another, and, since the needle point does not have to withstand repeated injection, it can be made much sharper. More care can be given to its sterilization in autoclaves or gas sterilizers with the proper controls than by the busy physician with an office sterilizer. Also, the individual needle can be sealed in the final package before sterilization, and it maintains sterility until the time of use.
Other disposable items have similar advantages over the original re-usable ones. By changing the plasticizers or other chemicals in the plastic formulations, catheters may be made with any flexibility desired. From a pharmaceutical point of view, bottles and pharmaceutical "glassware" which will not break have many advantages. The pharmacist must take care, however, in the use of these materials, since some of the plasticizers may be leeched out and react with the drugs stored in them. Or they may be permeable to, or soluble in, the solvents which they contain.
The individual plastic or alloy formulations