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...
