Zimmer Expected to Comply with FDA’s New Tracking System
The healthcare community will soon have a new weapon in the fight against potentially defective or dangerous medical devices, which is likely to be well received by those who have reported Zimmer hip replacement complications. The FDA has released comprehensive guidance information for its new medical device labeling and tracking system.
The Global Unique Device Identification Database (GUDID) has been a long time in the making. In 2012, the FDA called for an effective unique device identification system (UDI), which is intended “to reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, (and) identify problems relating to a particular device…”
Although the existence of such a system to track medical devices was first mandated in 2007, criticism from the medical device industry led to significant delays. The final version of the UDI requirement was released by the FDA in September 2013. It calls for medical devices to have both a production identifier and a device identifier. It also standardized a system of alpha-numeric elements for identification purposes, which is featured in the GUDID.
Once the system is fully implemented by manufacturers, doctors will be able to scan a medical device before it is used on a patient. This enables them to access key information, such as the package status (whether it is recalled, discontinued, or available), package components, and package type.
Finalized version provides step-by-step instructions
In its Federal Register announcement dated from June 2014, the FDA released what it called its final version of a guidance document. The document assists manufacturers in complying with the UDI requirement. However, the FDA further clarified the status of the guidance document by announcing that the 14 sections contained within the instructions would be finalized separately. An FDA spokesperson explained that the agency wanted to make information available to manufacturers as quickly as possible, regardless of whether the document was complete.
Now that the final version has indeed been released, manufacturers will have access to step-by-step instructions on how to create a GUDID account, register a device and packages, and edit submissions. The guidance document also assists individuals with searching and retrieving pertinent information on medical devices.
Reports of Zimmer hip replacement complications
The new tracking and labeling system may help the healthcare community lower the rates of medical errors due to allegedly defective medical devices. Unfortunately, it came too late for many hip implant patients who received the Zimmer Durom Cup device. The Durom Cup is a metal-on-metal hip implant that has garnered a substantial amount of criticism for its unacceptably high failure rate and complications.
Many patients who have filed lawsuits against Zimmer noted that the hip implant complications included heavy metal poisoning. This occurs when the metallic components rub together during movement, releasing metallic debris into the local tissue and bloodstream. Other patients have reported that they required hip revision surgery after the Durom Cup failed to bond to the bone as intended. While Zimmer has yet to issue a recall for the hip implant, the company did temporarily suspend sales during 2008. Although the hip implant was later reintroduced to the market, the temporary discontinuation of sales would have been information available in the new tracking database.
Joint replacements command a significant share of the medical device market. However, other medical devices may also be registered with the GUDID.
- Regulatory Affairs Professionals Society, FDA Releases Final, Slimmed-Down GUDID Guidance, Leaving Many Details for Later, http://www.raps.org/regulatory-focus/news/2014/06/19437/FDA-Publishes-GUDID-Final-Guidance/
- Plastics News, FDA offers guidance on meeting new medical devices tracking rules, http://www.plasticsnews.com/article/20140701/NEWS/140709988/fda-offers-guidance-on-meeting-new-medical-devices-tracking-rules
- Regulatory Affairs Professionals Society, FDA Unveils Final Details about Medical Device Tracking System, http://www.raps.org/regulatory-focus/news/2014/06/19587/FDA-Finalizes-GUDID-Guidance/