This month I have asked a frequent contributor and
Orthopedics Today Editorial Board member, Dr. Seth Greenwald, to
share with us his insight into the obligations and methods for orthopedic
surgeons to define and report
adverse events. The Food and Drug Administration has
implemented the MedWatch product reporting program for adverse events and it is
important for us to understand. Adverse events differ from surgical
complications and through surgeons reporting them, we can offer potential to
benefit our patients and our specialty.
Douglas W. Jackson, MD
Chief Medical Editor
Douglas W. Jackson, MD: What is a definition
of an adverse event in orthopedics that should be reported?
A. Seth Greenwald, D.Phil.(Oxon): The Safe
Medical Devices Act (SMDA) of 1990 and its subsequent amendments is a law
enacted by Congress to ensure that medical devices entering the market,
including those used in orthopedic procedures, are safe and effective,
monitored and quickly removed if found defective. To assure this, the Food and
Drug Administration (FDA) implemented the MedWatch product reporting program.
In this context, an adverse event is defined as death or
serious injury potentially caused by a medical device. The latter may require
medical or surgical intervention to preclude impairment or damage to the
bodys function or structure and can involve observation, medical
treatment, device removal or hospitalization.
Events particular to orthopedic devices can result from
inadequate design, manufacturing deficiency, device malfunction/failure,
technical proficiency and patient use, as well as inappropriate labeling. While
exact cause is not always evident; it is the occurrence of the event that must
Jackson: How does a busy surgeon report these
adverse events and how complicated is it to do?
Greenwald: The MedWatch program is threefold in
its approach and mandates adverse event reporting for medical device
manufacturers and user facilities. The latter is inclusive of hospitals,
nursing homes, ambulatory surgical and outpatient treatment facilities.
Surgeons are encouraged to file voluntary reports as well as other health care
professionals on an individual basis.
The surgeon can go to
This web page has the instructions and the link to beginning the forms. Part 5
(Describe Event, Problem or Product Use Error) is the most important for
surgeons to provide an interpretation of the event. While most government forms
are longwinded, this one is an exception, being brief at only one page.
Jackson: Why is it the ethical responsibility
of an orthopedic surgeon to report adverse events?
Greenwald: Orthopedic surgeons provide the most
relevant and useful clinical information regarding the cause and effect of the
event. The most important role they play is to differentiate whether the device
failed or the disease process or patient biological issues caused the problem.
If the United States is to remain a leader of technological advances in
orthopedics, the FDA must rely on input from end-product users to determine the
safety and effectiveness of manufactured medical devices in the clinical
setting. Although this adds to the burden of surgeon responsibility in the care
of patients, it is requisite that the most experienced and informed contribute
to this aspect of the health care process.
Jackson: What are the most beneficial
considerations of a successful reporting system for our patients and
Greenwald: While the MedWatch program attempts to
serve as a timely tripwire to ensure product safety, it does so in the absence
of knowing the total number of the particular product being utilized, making it
difficult to gain an indication of its overall safety. This information is
vital to both manufacturers and the FDA in determining voluntary or mandated
product recalls. Beyond this, the Centers for Medicare & Medicaid Services
(CMS) as well as private insurance carriers need to know what works and what
doesnt as they are most often the payers for these technologies.
Oftentimes, the timeline required for publication in
peer-reviewed journals of medical devices that have resulted in clinical
complications, albeit definitive, does not provide the prompt reporting needed
to facilitate removal of defective products from the market. This conundrum may
be addressed by ultimately creating a national, mandatory, electronic medical
record database with patient-specific protected identifiers that retains all
aspects of medical treatments received throughout ones life. In this
regard, The American Joint Replacement Registry (AJRR) may be seen as a
demonstration project that not only reports adverse events and population use,
but shortens the timeline to identify defective arthroplasty products.
- A. Seth Greenwald, D Phil.(Oxon), can be reached at Orthopaedic
Research Laboratories, 2310 Superior Ave. East, Cleveland, OH 44114;
216-523-7004; e-mail: email@example.com.