The Women's Health Activist,
National Women’s Health Network NWHN.org
January/February 2014
By Kate Ryan, NWHN Senior Program Coordinator
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.
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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