Aronoff M S
Aronoff Associates, New York, NY 10022, USA.
J Biomater Appl. 1995 Jan;9(3):205-61. doi: 10.1177/088532829500900303.
The withdrawal of DuPont as a supplier of key raw materials created a major dislocation in the medical device industry. We studied the present and future impact caused by the market removal of polyethylene terephthalate (PET) yarn ("Dacron"), polytetrafluorethylene (PTFE) fiber and resin ("Teflon"), and polyacetal resin ("Delrin"). Findings were: 1) Dollar values of the permanent medical implant markets for PET yarn, PTFE fiber and resin, and polyacetal resin are a minute fraction, of their values for their other commercial markets; 2) The implant market value is clearly not commensurate with the liability risk; and 3) The majority of these materials consumed by this market are used in the production of lifesaving, permanent medical implants [e.g., vital blood vessel replacements made from knitted polyester (PET)]. The remainder is used in life-enhancing, permanent implants [e.g., hernia patches made of polyester (PET) fabric].
杜邦作为关键原材料供应商的退出在医疗器械行业造成了重大混乱。我们研究了聚对苯二甲酸乙二酯(PET)纱线(“涤纶”)、聚四氟乙烯(PTFE)纤维和树脂(“特氟龙”)以及聚缩醛树脂(“赛钢”)从市场上移除所造成的当前及未来影响。研究结果如下:1)PET纱线、PTFE纤维和树脂以及聚缩醛树脂在永久性医疗植入物市场的价值,仅占它们在其他商业市场价值的极小一部分;2)植入物市场价值显然与责任风险不相称;3)该市场消耗的这些材料大部分用于生产挽救生命的永久性医疗植入物[例如,由针织聚酯(PET)制成的重要血管替代品]。其余部分则用于改善生活的永久性植入物[例如,由聚酯(PET)织物制成的疝气修补片]。