ACOG呼吁警惕再加工的一次性医疗器材

鉴于目前越来越多的医院为了缩减成本而使用再加工的一次性医疗器材，美国妇产科医师协会(ACOG)提醒妇产科医生警惕手术中是否会用到这类再加工的医疗器材，如需使用一定要确保其安全性。

ACOG妇科实践委员会在《妇产科学》(Obstetrics & Gynecology) 10月刊上发布了一份委员会意见：应告知医生其手术中用到的器材是原厂一次性包装的还是经过再加工反复使用的。不过医生最终也有责任本着“诚信”的态度来寻找答案。如果医生对医疗器材的质量或安全性存在担忧，那么从伦理上讲有责任不予使用(Obstet. Gynecol. 2012;120:974-6)。

对于再加工的一次性医疗器材是否应该用于妇产科，ACOG委员会没有就此发表意见，认为目前关于这类器材安全性、质量和成本效益关系的数据还不足。例如，2008年美国政府问责办公室 (GAO)公布的一份报告称，推广使用再加工的一次性医疗器材似乎并不会增加健康风险。但ACOG委员会指出，GAO的评估仅仅基于自发报告的不良事件，因而很可能遗漏了一些安全性问题。

ACOG委员会写道：“使用再加工的医疗器材的确可以为医院节约成本，但尚不清楚这是否也会减轻患者的经济负担或者第三方支付机构的开支。”

其他一些关于骨科和腹腔镜手术的研究表明，与再加工的一次性医疗器材相关的物理缺陷、性能问题以及消毒不当的发生率较高，但这些研究都是由原产厂家资助开展的。

委员会呼吁就妇科手术可能用到的再加工的一次性医疗器材开展更多的独立研究，以进一步了解其安全性、质量和成本效益关系。

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By: MARY ELLEN SCHNEIDER, Ob.Gyn. News Digital Network

With more hospitals seeking to cut costs through the use of reprocessed single-use medical devices, the American College of Obstetricians and Gynecologists is urging ob.gyns. to be alert about whether reprocessed instruments will be used in their surgeries and if they are safe.

ACOG’s Committee on Gynecologic Practice issued an opinion stating that physicians should be informed whether surgical instruments are original or have been reprocessed for additional use. Ultimately, though, it’s the physician’s responsibility to make a "good faith" effort to find out, according to the opinion. Physicians who have concerns about the quality or safety of an instrument have an ethical obligation not to use the instrument, the committee wrote.

The committee opinion was published in the October issue of Obstetrics & Gynecology (Obstet. Gynecol. 2012;120:974-6).

The ACOG committee didn’t take a position on whether reprocessed single-use medical devices should be used in obstetrics and gynecology, citing a lack of information on the safety, quality, and cost-effectiveness of these instruments.

For instance, in 2008 the Government Accountability Office issued a report saying that there appeared to be no increased health risk as a result of the greater use of reprocessed single-use devices. The ACOG committee pointed out, however, that the GAO assessment may have missed some safety issues because it relied only on voluntarily reported adverse events.

"Reprocessed devices result in cost savings for the hospital, but it is not apparent that there is any financial benefit to the patient or third-party payers," the committee wrote.

Other studies in orthopedics and laparoscopic surgery have found a significant rate of physical defects, performance issues, and improper decontamination of reprocessed single-use devices, according to the ACOG opinion, but those studies have been funded mainly by original device manufacturers.

The committee called for more independent studies on the safety, quality, and cost-effectiveness of reprocessed single-use medical devices in gynecologic surgery.