监管机构和商界领袖进入2019冠状病毒病的第三个日历年, some new challenges are emerging atop the lingering supply chain and service issues brought on by the pandemic.
The Biden administration continues to push for more consumer safeguards as 医疗器械召回s rise and regulators consider stricter rules for traceability of tainted food products. 正如我们最新一期的报道 2022年召回指数报告, it’s a crucial time for companies at every level in the supply chain to be aware of regulatory changes and the threats to their businesses and reputations posed by 回忆s and other in-market product incidents.
This latest report offers a year-in-review analysis of 2021 回忆 activity and predictions for 2022. We also feature insights from some of our strategic partners at leading law firms to help you prepare for the increased risks created by product innovations and changes in the regulation of automobiles, 食物和饮料, 药物, 医疗设备, 消费产品.
Advancements in vehicle technology leads to safety and regulatory challenges for 汽车 industry
召回活动连续第八个季度增加, 2021年的汽车召回总数最终超过了2020年. 该行业在2021年召回了770次，而2020年全年召回了739次. 随着召回率的上升, advancements in vehicle technology continue to create more safety and regulatory challenges, 哪些汽车制造商必须监控和适应. 对“联网”汽车的数据隐私担忧, 新技术的安全性, and the newest crash-safety features rolling out on autonomous and electric vehicles must all be considered.
消费品行业继续加强监督和执法
Some experts predict that the Consumer Product Safety Commission’s (CPSC) request for an increase in budget will inevitably lead to more 回忆s. 2021年仅召回218次, 该行业的此类活动达到了15年来的最低水平. 但即使召回率下降, the agency’s newfound bare-knuckle approach to oversight and enforcement is full speed ahead. 和新主席, t在这里 is no sign of the commission pulling back on the aggressive stance it’s taken on compliance and enforcement.
Consumer product companies need to be thinking about their 回忆 and corrective action plans from end-to-end, as well as closely reviewing processes and procedures for everything from compliance with reporting requirements, 召回实施, 危机沟通.
Food industry to expect significant changes to reporting and tracing regulations in 2022
过去五年来，食品召回事件一直在稳步下降, 2021年，现场检查减半, 有记录的事件总数降至11年来的最低水平(414起)。. 但所有迹象都表明，食品监管将在2022年收紧. 几个新建议, including the Food and Drug Administration’s (FDA) Foodborne Outbreak Response Improvement Plan, 会在2021年推出. The plan makes it clear that manufacturers will see significant changes in reporting and tracing regulations in 2022 and beyond. 这些规定将如何改变尚不清楚, but businesses should review the guidelines and start planning for how their operations and reporting structures will adapt.
疫情继续影响着医疗器械行业
In 2021, the medical device industry saw the highest number of units 回忆ed in the past 10 years (602.500万). 很明显，我们还不能宣布战胜新型冠状病毒肺炎大流行, and so the FDA is starting to think about what happens next for 医疗设备 granted Emergency Use Authorizations (EUAs), 或者属于特殊公共卫生紧急执行范围的.
Another change the pandemic brought to the medical device sector was 3D printing at the point-of-care (PoC). The FDA is gathering input on how to regulate this and w在这里 the responsibility and liability resides for production conducted outside a manufacturing facility. Companies will have to think carefully about whether the value of having a large quantity of products made quickly at the PoC outweighs potential legal liabilities.
紧急使用授权(EUAs)正在改变制药行业
EUAs使用的急剧增加改变了制药业. The FDA is expected to continue to grant EUAs in an effort to contain the pandemic. 随着公司寻求这些特别授权, 他们应该确保在合规和召回准备方面不要操之过急. The industry should also be planning for post-pandemic life and how to navigate the transition from EUAs to normal regulatory approvals. 至于数字, the industry saw a five-year low for the number of 回忆 events with a total of 274 in 2021. 同时, the industry hit the second-highest number of units involved in 回忆s in the past ten years.
We can expect that 2022 will bring even more aggressive enforcement action across all the key agencies. 虽然我们仍然希望全球卫生危机将最终得到控制, 我们知道，目前面临的许多挑战将继续存在. Companies across all industries would be wise to closely re-evaluate all manufacturing processes, 仔细审查供应链合作伙伴, 投入时间和资源准备召回管理, 危机和沟通计划.
Companies should also seek out expert partners for their experience and abilities. 这样做可以节省数百万美元的监管和诉讼成本, 并帮助您履行对客户的承诺, supply chain partners and regulators while protecting your reputation among the stakeholders that matter most.
获取更多召回数据, 趋势和预测, along with additional insights and commentary from some of our strategic partners in the latest edition of our 记得指数 report – available for download 在这里.
标签: 汽车, 汽车召回事件, 品牌保护, 品牌保护和召回, 品牌, 消费产品, 新型冠状病毒肺炎, 食品召回趋势, 医疗器械召回, 医疗设备, 药品召回, 药品, 回忆, 记得指数, 召回计划, 回忆的趋势, 监管, 供应链, 技术, 品牌观