0011 Schaub 4:00
R21
THE SOCIAL COST OF INFERIOR MEDICAL DEVICES
Avin Khera ([email protected])
ETHICS OF SURGICAL TOOL
DEVELOPMENT
Surgical tool manufacturers provide a service to the
medical industry by enduring high production costs to
develop large quantities of surgical/medical devices [1]. As a
business, a medical device manufacturer expects a return on
its investment [1]. For example, the average cost to a
Magnetic Resonance Imaging machine (MRI) manufacturer
to produce a single unit is approximately $250,000-$500,000
[2]. In contrast, an estimated 500 Magnetic Resonance
Imaging machines (MRIs) are produced every year, each
with a standard sales price of $1-1.3 million [3].
For buyers and sellers in first-world countries, these
prices are reasonable in the long-term. However, medical
device engineering and production for the third-world entails
potential loss in revenue due to the inability of hospitals to
pay for these devices [4]. According to the World Health
Organization (WHO), only $6 per capita is spent on the
purchasing of medical equipment for 86% of the world’s
population, but $290 per capita is spent by developed
countries [5]. The lack of capital from developing countries
forces engineers and manufacturers to cut costs and
resources, leading to the “contribution” of substandard
medical device alternatives or hand-me-down old devices
[A1]. This presents ethical issues that threaten the safety of
patients in the third-world [4].
DEVLOPMENT OF THE HANDHELD
FORCE MAGNIFIER
In 2013, I developed the Handheld Force Magnifier
(HHFM) as the lead engineer of Crytek Medical Co. The
device uses a mechanism called haptic feedback to recreate
the sense of touch by sending forces back to the user [6].
The HHFM is primarily used for a technique called
curvilinear capsulorhexis (CCC) involving removal of the
lens capsule for cataract surgeries. This force feedback
mechanism is designed to reduce complications in
microsurgery, especially cataract removal, by making it
easier and more precise for surgeons [7].
As shown in Figure 1, the modern HHFM utilizes a
pressure sensor and voice coils to generate force feedback
[7]. The voice coil acts as a solenoid that produces a
resistive magnetic field proportional to the applied pressure
detected by the pressure sensor [7]. The current
configuration allows for motion in four mechanical degrees
of freedom. For surgeons, this means the instrument can be
rolled side to side, surged forward and backward, swayed
University of Pittsburgh, Swanson School of Engineering
Submission Date 2014-10-28
left and right, and heaved up and down while still receiving
assistive haptic feedback [8].
Figure 1 [7]
Internal Components of the HHFM (only one coil shown)
Use in Developing Countries
As the lead engineer of the HHFM, I created the device
with funding from Crytek. I created the HHFM to assist with
cataract procedures in the United States, but it also shows
potential as a tool for training cataract surgeons and
conducting surgeries in third-world countries. By recreating
a sense of touch, the HHFM assists the user by coordinating
an enhanced sense of touch with their sight. I realized that
my device would allow inexperienced and improperly
trained surgeons in the third-world to better understand and
perform capsulorhexis. Based on performance data I
developed, I knew there would be significant reductions in
intra-operation complications if my device was put to use.
As part of my final report on the HHFM, I highlighted the
potential uses of the device in assisting surgeons in the
developing world. The report and the device’s implications
were broadcast on the national news. There was now an
expectation for a follow through.
Manufacturer Cuts to Make HHFM Affordable
Crytek popularized the device among U.S. hospitals and
also established an overseas market via affiliate
organizations in other developed nations. These hospitals
were able to pay for the device. However, Crytek was not
selling the HHFM to third-world hospitals because they
lacked the ability to pay for it. I discussed this issue with my
supervising manager, and two weeks later, I received an
offer to give up my patent on the HHFM in exchange for
substantial financial compensation. In the new contract,
Crytek agreed to follow through with my promise of
providing the device to third world hospitals at a price most
could afford to pay, but with significant modification to the
HHFM design. The new design stripped the HHFM of two
of the four voice coils, reducing the degrees of freedom
accordingly to two. This new design prevented feedback
Avin Khera
when moving the instrument left, right, up, and down. The
Crytek engineering consultant incorrectly believed CCC
relied almost solely on the degree of freedom involving
rolling. The reduced design’s other notable flaw was the
dual voice coil configuration within the device. To cut extra
production costs, Crytek was willing to remove the two
voice coils from already-produced devices, without changing
the original configuration that was meant for housing four
coils. This lent itself to significant design flaws that could
result in dysfunction or even breakage after repeated use
[A1]. Under this contract, I would also be restricted from
disclosing any information that would jeopardize sales of the
modified HHFM and I would be removed from the project
entirely.
whole [9]. The second canon of the BMES Code of Ethics
states, “Strive by action, example, and influence to increase
the competence, prestige, and honor of the biomedical
engineering profession” [9]. Unethical or morally
questionable decisions by high-profile biomedical engineers
can jeopardize perceptions the public has of the field. We are
obligated to ensure our decisions lend themselves to the best
possible outcomes for patients in the United States and
abroad. My support for the new HHFM may tarnish the
public reputation of other biomedical engineers and put their
work under unnecessary scrutiny.
INDUSTRY ETHICAL OBLIGATIONS
Biomedical manufacturers and their engineers have
ethical as well as financial obligations. Within this balancing
act, companies will at many times, sacrifice these ethics to
meet their business goals. In their report on the Ethical
Issues Associated with the Introduction of New Surgical
Devices, Dr. Sue Ross et al. states, “The imperative of
industry is to satisfy company owners and shareholders by
seeking market share and financial success” [10]. The
primary purposes of businesses are to generate revenue and
meet their production expectations by the end of the fiscal
quarter in the hopes of increasing their stock value. To meet
expectations, biomedical industries will approve and market
products that receive favorable initial safety and efficiency
reports [10]. By obligation, biomedical companies will fund
research for follow-up clinical trials with the device in use
[10]. Unfortunately, with the devices expanded to the
international marketplace, it becomes complex to carry out
effective randomized trials [10]. As a result, data published
on the device’s safety and effectiveness can be inconclusive
[10]. Without this data, physicians concerned with the health
of their patients may be hesitant in utilizing these new
surgical instruments, but withholding them can also be
considered unethical [10]. From a legal standpoint, Food and
Drug Administration (FDA) regulations can provide a buffer
to prevent the release of unsafe technologies, however major
incidents have still occurred through the exploitation of
loopholes [A2]. According to Atty. Raymond Mullady,
“Medical devices are put through the highest level of
scrutiny by the best scientists in the FDA, but loopholes
exist that can jeopardize the safety of the public if [the
technology is] left in the wrong hands” [A2]. This means it
is essential for engineers to ensure their medical devices
coincide with proper safety standards before they can be
considered complete. Without proper review of the new
HHFM’s long-term implications by engineers, Crytek was
still willing to put the device on the market.
ENGINEERING CODES OF ETHICS
As a professional biomedical engineer, I am subject to
the ethical codes established by The National Society for
Professional Engineers (NSPE) and Biomedical Engineering
Society (BMES) of America. As shown in Figure 2, the
primary canon of both the NSPE and BMES codes of ethics
is to “Hold paramount the safety, health, and welfare of the
public” [8]. An improperly designed or optimized device
such as the modified HHFM has the potential to cause
physical harm to patients undergoing cataract removals. This
may involve dysfunction of the device itself, and thus
inability for the surgeon to continue the procedure, or even
total breakdown in which the device can accidentally
puncture further into the patient’s eye. According to the
NSPE code of ethics, all professional engineers have an
obligation to notify the public of industry negligence [8].
According to the third NSPE canon, engineers must also
avoid deceptive acts by not being participant in reports that
deceive or omit facts from the public [8]. As the professional
engineer who created the original device, it is my
responsibility to ensure information about the new HHFM
model is written clearly for the public and without
misinformation about its functionality or lack thereof.
Figure 2 [8]
Engineering Codes of Ethics Canons (NSPE)
Personal Ethical Obligations
In addition to the canons of the NSPE Code of Ethics,
BMES’s own code holds biomedical engineers accountable
for their actions and their influence on the profession as a
The duty of engineers working in industry is to
understand how to balance medical device production
2
Avin Khera
timeframes, quality, and cost [11]. To put forth less focus on
even one of these variables would be a detriment to the
project as a whole [11]. It is impossible to achieve the best
case scenario in quality, but the ethical engineering model of
safety-through-design can be followed to limit the safety
hazards that medical devices may impose on the user or the
patient [11]. Projects that incorporate “safety-throughdesign” as a fundamental principle integrate risk assessment
early in the design and engineering stages [11]. In my
original rendition of the HHFM, these measures were taken
before designing the quadruple voice coil configuration, but
it was obvious that none of these considerations were made
for the new model. By simply removing voice coils, the
manufacturer and other engineers put too much focus on the
cost of the device, thereby jeopardizing the original safety
measures taken in the original design. The cost for damage
reparations would outweigh the savings of the stripped-down
device in the long term.
Premature Market Distribution of Hip Implants
Hip implants are routinely provided to people with
advanced arthritis [13]. In 2005, DePuy Orthopaedics
introduced a new hip prosthetic to the market made
completely out of metal, in contrast to the plastic and metal
combination seen in other models [13]. The hip replacement
was marketed without previous clinical trials through an
FDA approved process called a 510(k) because the company
was able to “prove” that the device worked like other models
[13]. Because of the lack of trials in this case, the
implications of a full-metal prosthesis were not investigated
and the implant ended up having a failure rate of almost 50%
due to metal erosion and blood contamination [13]. These
effects caused extreme pain and patients had to get these
prosthetics removed [13]. This case highlights the
importance of clinical trials for medical devices. While
medical devices can still be approved through a 510(k), it is
significantly more difficult. In the case of the modified
HHFM, the case could be made that it meets the same safety
and functionality standards of my original model. Through
this route, Crytek would have been able to send this inferior
device to third-world countries where it would have been
considerably more difficult to conduct clinical trials. It is my
job as an engineer to provide my input to the appropriate
governmental regulatory agency.
BIOMEDICAL CASE STUDIES
Professional biomedical engineers make tradeoffs for
efficiency and cost to remain within established and personal
ethical boundaries, preventing malpractice that can
potentially harm the reputation and prestige of the
profession. In certain cases however, incidents occur
because of improper understanding or minimal focus on
safety by the engineer. In examination of these cases, one
can better understand the errors that must be avoided to
ensure a medical device can be marketed with proper safety
components.
Repeated Error in Surgical Mesh Development
Surgical mesh is a biomedical device used to treat pelvic
organ prolapse and stress urinary incontinence in women
[14]. In this case study, a 40 year old woman received
reconstructive surgery with the surgical mesh to fix a
prolapse [14]. After a year following surgery, the patient
began experiencing a high degree of pain [14]. Following
mesh removal, doctors discovered that the mesh was
produced with a higher than necessary tension [14]. Similar
to other manufacturing revisions, clinical trials were not
undertaken prior to market release [15]. Johnson and
Johnson began marketing their higher-tension surgical mesh
to hospitals through the 510(k) plan offered by the FDA
because they were able to convince reviewers that it was
substantially equivalent to previous models [15]. In an
attempt to reduce the surface area of the device (and thus
consume fewer resources), Johnson and Johnson caused
significant damage to patients with pelvic organ disorders.
The Drawback of Breast Implants
Breast implants have been available to the public since
the 1960s, but they went largely unregulated by the FDA
until 1991 [12]. Up until the 1990s, the FDA only regarded
implants as a cosmetic medical device, and therefore did not
find it necessary to conduct randomized trials or assessments
of these women [12]. Without previous trials, the FDA relied
solely on anecdotal claims by implant receivers who
acquired rheumatoid and autoimmune disorders [12]. The
delayed FDA trials and absence of review boards by the
companies providing the implants caused significant
business shutdowns. Amid the reports, demand for breast
implants fell and the largest provider, Dow Corning, filed for
bankruptcy [12]. Although most biomedical firms now fund
research into their products, the long-term consequences of
defective products can lead to the termination of a business.
It is the job of engineers to follow-up with medical device
users to ensure no major complications occur in the future.
A BIOETHICAL DECISION
Bioengineers must work in accordance with professional
ethical standards established by the NSPE and BMES.
Before making decisions, it is the role of bioengineers to
review these guidelines and to take time in understanding the
implications of their actions. Previous bioengineering ethical
mistakes serve as lessons for engineers to improve upon
3
Avin Khera
[8] “NSPE Code of Ethics for Engineers.” National Society
for
Professional
Engineers.
(website).
http://www.nspe.org/resources/ethics/code-ethics
[9] “Biomedical Engineering Society Code of Ethics.”
Biomedical
Engineering
Society.
(website).
http://bmes.org/files/2004%20Approved%20%20Code%
20of%20Ethics(2).pdf
[10] S. Ross, M. Robert, M.A. Harvey, et al. (2008). “Ethical
Issues Associated With the Introduction of New
Surgical Devices, or Just Because We Can, Doesn’t
Mean We Should.” Journal of Obstetrics and
Gynaecology Canada. (online article). JOGC 07/2008;
30(6):508-13.
[11] G.D. Baura. (2006). “Engineering Ethics : An Industrial
Perspective.”
Academic
Press.
(book).
http://site.ebrary.com/lib/pitt/detail.action?docID=1013
8013
[12] D. Schultz. (2008). “New surgical devices and ethical
challenges. A collection of perspectives and panel
discussion.” Cleveland Clinic Journal of Medicine.
(online article). DOI: 10.3949/ccjm.75.Suppl_6.S7
[13] L. Groeger. (2012). “Four Medical Implants That
Escaped FDA Scrutiny.” Propublica. (website).
http://www.propublica.org/special/four-medicalimplants-that-escaped-fda-scrutiny
[14] “Acute Vaginal Pain from Posterior Vaginal Wall
Mesh.” International Center for Laparoscopic
Urogynecology.(website).
http://www.meshsurgeons.com/casestudy2.php
[15] A. Nussbaum and D. Voreacos. (2011). “J&J Mesh
Approved by FDA Based on Recalled Device.”
Bloomberg.
(online
article).
http://www.bloomberg.com/news/2011-10-20/j-jvaginal-mesh-approved-by-fda-based-on-older-recalleddevice.html
their decision-making and provide them with further
incentive to ensure safety standards are met by their devices.
In the case of the HHFM, it was clear that Crytek wanted to
provide an inferior and potentially dangerous medical device
to third-world hospitals to maintain profitability. The HHFM
would have likely become one of the 70% of devices sent to
African and other developing countries that would be put to
no use [A1]. As an employee of Crytek, I had an obligation
to my employer to produce a medical device, but as a
bioengineer, I have an obligation to place the safety of
patients first in my decision-making. Crytek’s plan to reduce
its own costs and shut their product engineer out of the
project was a clear indication of malpractice. They no longer
held paramount the safety and welfare of the public and
were willing to provide misinformation before clinical trials
could be conducted on the new HHFM. With this taken into
consideration, I kept my patent on the device and distanced
myself from Crytek. It became clear that Crytek placed
profits above ethics.
REFERENCES
[1] Biotech Ethics: Modern Man and the Pursuit of
Happiness." American Enterprise 1 Mar. 2004: n. pag.
Web.
[2] J. Block. (2012) “MRI Machine Cost and Price Guide.”
Block
Imaging.
(website).
http://info.blockimaging.com/bid/92623/MRI-MachineCost-and-Price-Guide
[3] “Today’s MRI Market.” Magnetica. (website).
http://www.magnetica.com/page/innovation/todays-mrimarket/
[4] L.B. Parsons. (1996). “Engineering in Context:
Engineering in Developing Countries” Journal of
Professional Issues in Engineering Education and
Practice. (online article). DOI: 10.1061/(ASCE)10523928(1996)122:4(170)
[5] A.J. Nimunkar, J. Baran, D.V. Sickle, et al. (2008). “Low
Cost Medical Devices for Developing Countries.”
University of Wisconsin-Madison. (online article).
http://ewh.slc.engr.wisc.edu//publications/conferences/20
09/IEEE_EMBC/Medecal_LowCostDevicesIEEEMBS2
009_v14.pdf
[6] H.V. Gimbel. (2009). “Capsulorrhexis”. Achieving
Excellence in Cataract Surgery;
A Step-By-Step
Approach.
(online
article).
http://phaco.ascrs.org/sites/phaco.ascrs.org/files/textbook
s/Achieving%20Excellence%20in%20Cataract%20Surge
ry%20-%20Chapter%203.pdf
[7] R. Lee, B. Wu, R. Klatzky, et al. (2013). “Hand-Held
Force Magnifier for Surgical Instruments: Evolution
toward a Clinical Device.” Lecture Notes in Computer
Science. (online article). DOI: 10.1007/978-3-64238085-3_9. Pp. 77-89
ADDITIONAL SOURCES
[A1]
M. Miesen. (2013). “The Inadequacy of Donating
Medical Devices to Africa.” The Atlantic. (magazine).
http://www.theatlantic.com/international/archive/2013/0
9/the-inadequacy-of-donating-medical-devices-toafrica/279855/
[A2]
“Corporate Responsibility in Medical Devices:
Atty. Raymond Mullady Comments.” YouTube, n.d.
Web. 27 Oct. 2014.
ACKNOWLEDGMENTS
The author thanks Dr. George Stetten and Randy Lee of the
University of Pittsburgh for use of the Imaging Analysis
Laboratory and input on the HHFM. The author also thanks
Dr. Richard Schaub for assistance in information acquisition.
4