Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, January 23, 2014

Health Activists Push Medical Device Accountability

Has Your Hip Been Recalled?


The Women's Health Activist
January/February 2014
By Kate Ryan
When cars, baby cribs, or even microwaves are recalled because there’s a safety problem or the product doesn’t work, you can check the unique serial number on your car, crib, or microwave to immediately discover if the one you own has been recalled, or if there’s no need for you to worry. Having systems that facilitate the quick and accurate identification of unsafe and ineffective devices is just common sense — so most people would be surprised to learn that, until six months ago, the system for tracking problems with medical devices was so ineffective that many people never even found out about recalls of defective products — which has the potential to put their health at risk.1
If, like me, you watch cop shows such as CSI or Bones, you probably think that implanted medical devices can be traced back to the medical record of the person whose body they’re implanted in. Shows like that have plenty of episodes where the murder victim is speedily and accurately identified because she has a hip replacement or pacemaker that can be tracked by its unique identification number. Unfortunately, until now that’s been fiction! In reality, the lack of a basic, commonsense system that allows someone to find out if she has a recalled device has left U.S. women and health care providers struggling to get their questions about specific products answered -- even basic information like whether the product a woman is using has been recalled.
That’s the scary news. The good news is that health advocates have finally persuaded Congress and the Food and Drug Administration (FDA) to establish a unique device identification (UDI) system and the National Women’s Health Network (NWHN) is working with the FDA to develop that system.
This is an important advance for women. The NWHN has advocated for a medical device UDI system for many, many years. This system is key to the FDA’s ability to protect millions of people from the harm caused by flawed and dangerous products.
The new protections will begin this summer, starting with the highest-risk devices like certain pacemakers, heart valves and joint replacements. Over the next seven years, the FDA will roll out requirements for medical device manufacturers to include a unique number and bar-code on the label of certain medical devices so patients, consumers, health care providers, and hospitals can track and identify these devices.2 The new UDI system will provide women who use medical devices with better information and prevent the unnecessary harm that results when recalled devices remain inside the body. The system also has the potential to improve how device problems are reported to the government, so the FDA can more quickly identify dangerous devices and remove them from the market — which will help all of us.
How much do you know about your device?
Currently, women do not have enough information about the specific devices they use or have had implanted to be able to tell if they’re affected by a specific device recall. Many patients leave surgery without knowing what company made their new hip, let alone what brand of hip they have — and it can be very difficult to track down those details later. The general information you get from scary lawsuit ads that warn of safety problems with surgical mesh or from news reports about a recall of hip implants do not provide enough detailed information about the recall, or the specific hip or mesh, for anyone to be able to tell if the product they have is affected.
You could try going to the FDA’s website to get more information about the recall, but you will only find the brand name and description of the device being recalled….which still won’t tell you if you have the specific recalled hip. The most likely place to find the relevant information is from the health care provider who either provided or implanted your device. The best-case scenario is that your provider documented which manufacturer and what specific brand or model of device you received. Unfortunately, labels for implanted devices are usually on the packaging, which is often thrown away during surgery, and the information doesn’t always make it into a patient’s medical records. Even if your provider did keep good records, it can be next to impossible to find that information if your provider has retired, moved, or gotten rid of her old patient files. The lack of a system has — until now — created enormous barriers to patient’s access to vital information.
Women are safer with more information
Once the new UDI system is fully implemented, women will be able to ask for their device’s specific UDI number when they get the device. That way, a woman will have all of the information she needs when she hears about an FDA device recall, and that may minimize both unnecessary worry and unnecessary harm. If her device hasn’t been recalled, she can stop worrying about the potential harm immediately – no need to make an unnecessary trip to her provider because she kept a record of what device she has and hopefully so has her provider. If her device has been recalled, she can promptly schedule an appointment with her health care provider and talk about whether she needs to stop using the device — or, if it's an implanted device, if she should get it removed and replaced.
The new UDI system will also improve the device recall system and decrease the amount of harm caused by slow or incomplete device recalls. With UDIs, it will be easier for hospitals and providers to stay current on the latest safety information and list of recalled devices. They will have the information that will allow them to check medical records for affected UDI numbers so they can contact patients directly with the recalled device, rather than waiting for patients to learn about the recall and seek information themselves.
Making it easier to for hospitals to identify and track recalled devices will also prevent unsafe devices from being given to patients in the first place. Without UDIs, recalled devices are, unfortunately, likely to remain in use, and a patient could have surgery and receive a device that has already been identified as flawed and potentially dangerous. While we’d all like to believe this is extremely rare, right now there’s no way to know how often it occurs. Of the approximately 700 medical device recalls that happen each year, about half of the faulty devices (53 percent) stay on the market, because manufacturers currently have no way to track their devices electronically. The UDI system will allow hospitals and providers to scan the bar-codes of all the medical devices in their supplies and assess the safety of the devices they intend to use. When a hospital or other health care provider is notified of a recall, the new UDI system will allow them to quickly find and remove any recalled devices from their storerooms.
Tracking devices will improve public health
The UDI system will have broader benefits for everyone, including people who do not have a medical device. That’s because it will also increase the accuracy of the information about all of the devices on the market.
Currently, when someone experiences a problem with a medical device, she or he can report it to the FDA, which maintains lists of what are called “adverse events.” But, these reports often lack detail, and may only state that a patient had a problem related to surgical mesh, or a hip, in general. While reports from health care providers sometimes include more information about the problematic brand or manufacturer, it still isn’t usually enough information to help the FDA estimate the extent of the problem. Is there just one faulty device out there? Do the adverse event reports indicate there’s a problem with one batch of a device stemming from a manufacturing problem? Or, do the reports signal that there is a larger issue with the design for a particular device model?
Under the new system, patients and providers will be able to include a UDI number in their adverse event reports, and the FDA will gain access to better information to help answer those questions and more quickly flag bigger problems.
Making the UDI system work for you!
Once the UDI system is fully in place, when you hear about a device recall, you’ll be able to find out whether the recall affects your specific device by checking the UDI number on the label against the FDA recall alerts and safety notifications. To do this, you’ll need to keep the label of any device you purchase or are given at a health care facility (like an insulin pump) and/or have surgically implanted (like an artificial hip). If you have a medical device implanted through surgery, make sure that the UDI number is included in your medical record and ask for a copy of the number to keep on hand. That way you can check the FDA’s safety notifications and recall alerts to see if your UDI number is on the recall list.
At the NWHN, we will continue to watchdog the roll-out of the UDI system to ensure that it meets women’s needs. We will advocate for the FDA to raise awareness about the new UDI system and to clearly communicate to patients and other consumers any recalled UDI numbers. We will also continue to push for more devices to be directly marked with the UDI number so people won’t need the label to keep track of their UDI number.
We want to ensure that you have the information you need as quickly and easily as possible. Knowing your UDI number will empower you to take action to protect your health when you hear about a possible safety problem or recall.
Kate Ryan is the NWHN Senior Program Coordinator
Additional resources
                NWHN’s article about device regulations: http://nwhn.org/blog/medical-mishaps-what-you-need-know
                NWHN’s article about Metal-on-Metal (MoM) hip replacement devices: (http://nwhn.org/newsletter/node/1369).

1. The Food and Drug Administration’s definition of a “medical device” is available here: http://www.fda.gov/aboutfda/transparency/basics/ucm211822.htm

2. Read more about the new rules on the FDA’s website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDevi...

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