Medical device standards and regulations generated substantial discussion at the HealthPack 2014 show, held in Norfolk, VA in early March.Financial considerations are a top concern of the medical device packaging community throughout the supply chain, be it medical device manufacturers (MDMs) looking to cut costs or nurses minding the bottom line at hospitals.
At a question-and-answer session following a standards update, one MDM attendee asked, “Do we see a trend in over-engineering our packaging to meet all of these standards? Meeting them is very expensive, especially when you add it to the 2 percent medical-device tax. Packaging should be one of the easiest things to change to affect and possibly lower costs, but when we keep adding standards we’re increasing our costs.”
Mocon的Ed Emerson是一家全球工具，测试服务和咨询气体检测，测量和分析的咨询的制造商，他表达了他对MDMS关注的理解，并建议参与帮助制定此类标准的组织，可以使他们发表精神的声音。他们。从长远来看，他补充说，符合适合您设备的标准及其应用可以提高患者的安全性，并防止可能更加昂贵的问题。
Still, Emerson related that, on one occasion, a U.S. Food and Drug Administration person commented to him that “the packaging community tests 10 times more than it needs to.”
Presenters throughout the day encouraged HealthPack attendees to get involved and have a voice in moving standards forward and ultimately serving patient safety. Sounds good, but time demands can make that challenging. In a separate conversation on time demands, one industry veteran asked how he could effectively do his job with 1,200 unread e-mails in his inbox.
Time constraints and other factors seemed to contribute to a modest number of attendees at the event’s annualInstitute of Packaging Professionals’ Medical Device Packaging Technical Committee Meeting, where a subcommittee on Electrostatic Discharge was considered for dissolution.
同时，组合产品小组委员会将其名称更改为温度控制的包装小组委员会。在该编辑的主持下，修订后的小组委员会将扩大其范围，包括组合产品和医疗设备以及与包装，存储和分配它们在温度和/或湿度敏感的环境中有关的问题。最初的目标将是在该领域建立具有经验的医疗设备制造商代表，然后确定存在哪些指导文档或标准来帮助MDMS使用此类产品。感兴趣的？
Jim Butschli,butschli@packworld.com，是医疗包装的总编辑，www.healthcarepackaging.com.
