Preventing the Spread of Infectious

Diseases via Used Sharps

BIOEN 215 AD
Caroline Cannistra, William Donaldson, Nikita Milani, Andy Tan, Jessica Wang
12/12/2012

Team Member Contribution Distribution:

Caroline Cannistra: Manager of project week of 11/9, Identifying problem, Prior
Art, Abstract
William Donaldson: Manager of project week of 11/16, Problem statement, Oral
Report
Nikita Milani: Manager of project week of 11/23, Regulatory Issues, Conclusion
Andy Tan: Manager of project week of 11/30, Solution Generation, Constraints and
Criteria
Jessica Wang: Manager of project week 12/7, Design Description, Ethical
Considerations, Compiling Final Written Report

ABSTRACT
One of the leading causes of infectious diseases in low-income countries is exposure
to hazardous medical sharps. The disposal of medical sharps, when designed or executed
improperly, is the cause of a significant percentage of hepatitis and HIV infections in poorer
regions. In developed countries, there are several solutions that prevent the spread of
infection, but they usually rely on access to disposal facilities for the sharps and so are not
adequate solutions for use in developing countries.
The objective of this project is to design a low-cost, sustainable device that
eliminates the risk of infection from medical sharps and makes them safe to dispose of
without the need for a special disposal procedure.
The best solution evaluated by our method is a chemical treatment process that uses
a biodegradable sanitizing agent to disinfect several sharps at once. A sharps container
with a grate bottom is placed into a tank filled with the sanitizing agent so that the sharps
are cleaned by the agent while in the tank. When not in the tank, the container is held
within another larger container to prevent any contact with the needles.
This solution will prevent the spread of infections via transmission by medical
sharps by sanitizing used sharps and killing viruses and bacteria that could contract
disease, which makes them safe both to handle and to throw away. We project that if our
design were to be implemented, we could minimize the number of occupational health
workers being infected, and any needles salvaged from landfills for secondhand use will
not accidentally spread illnesses.

PROBLEM STATEMENT AND DESCRIPTION

While increasingly advanced medical treatments are becoming available to more
and more of the global population, the necessary infrastructure to dispose of bio-hazardous
waste generated by these procedures is not always present. As a result, improper disposal
of medical waste poses a valid threat to many people around the world, especially in poorer
regions. One form of medical waste that can be especially difficult to deal with is medical
sharps. Sharps are medical implements such as needles, syringes, injection devices, and
lancets, and improper disposal of these puts not only medical professionals but waste
management workers and the general population at risk of needle stick injuries and the
spread of infection and blood borne pathogens.1 Currently, the World Health Organization
estimates that 40% of hepatitis cases and 12% of HIV cases worldwide are caused by
occupational exposure due to improper disposal. Implementation of a safe and effective
medical sharps disposal system is would reduce the spread of these and other diseases and
lessen the risk to medical professionals and sanitation workers around the globe.2
Much can be done to improve the state of medical sharps disposal around the world,
especially in poorer regions where healthcare services do not always include funding or an
adequate budget for waste disposal. The current disposal methods of medical sharps in
these regions typically include incineration and standard municipal waste. Incineration is
responsible for pumping large amounts of dioxin and mercury toxins into the air, while any
sharps that end up in a municipal landfill have further potential to harm an individual or to
be scavenged and resold. The goal of this project is to design a simple, relatively low-cost

1
2

Disposal of Medical Sharps | Medical Waste| Wastes | US EPA

Issues | Waste Management | Health Care Without Harm | Global Projects

measure to dispose of medical sharps that minimizes or eliminates the risk to people and
the environment.
PRIOR ART
Most current solutions to the problem of medical sharp disposal focus on the safe
containment of medical sharps in order to prevent the spread of disease in the short term.
Medical facilities in developed countries typically use sharps containers with narrow
openings to hold used syringes or other hazardous materials such that the materials can be
placed into, but not removed, from the container. Different containers vary in cost
efficiency based on the material used to form the container walls. Plastic and metal, for
instance, are commonly used materials, but are more expensive than corrugated fiberboard,
which is equally effective.3 Usually, these solutions either do not address the problem of
disposal of the sharps or simply burn them, which is an environmental hazard. In some
cases, the needles are disposed of with other waste without any special conditions,
allowing a risk of illegal use after disposal. Furthermore, such containers for use in medical
facilities are often too expensive on the market for use in low-income regions.
Other solutions do not focus on the containment of medical sharps but rather
attempt to make hazardous medical sharps safe to handle. Such solutions include a needle
cap that seals the hazardous sharp and prevents needle sticks4, or a device that dissolves
the sharp and disinfects the syringe, allowing the remaining, nonhazardous components to
be recycled.5 The former solution, while effective at preventing the spread of disease, still
does not suggest an environmentally friendly disposal method for the sharps, nor is it self-

Sharp, Patent EP1143868 A1

Sincock, Patent US 5047019
5
Britton, Patent US 6637587 B2
4

1.

sustaining, as a cap is needed for each individual sharp. The latter solution addresses both
of these problems, as the sharp is dissolved into metallic ions in the dissolvent, and the
remaining plastic is recycled rather than burned. Both of these solutions prevent illegal use
of the needles after disposal.
The prior art in this field shows a need for environmentally friendly procedures for
disposal of the medical sharps, as well as a cost effective use of materials so that lowincome countries would be able to afford the device. Development of a disposal procedure
is especially crucial as there is a lack of disposal facilities in developing countries, whereas
developed countries usually send medical waste to facility where it is destroyed.6
DESIGN SPECIFICATIONS
Need #

Unit of Measure

Design Constraint /
Criteria
Cheap

Safe

Efficiency

Lightweight

Acceptable
Value
<$70

Ideal Value

# of potentiallyrisky procedures*
required in
procedure
# of sharps treated
per use

0-2 risky
procedures

0 risky
procedures

1 - anything
larger than 1

Pounds

<100 pounds
(manageable
for two people
to carry/to
transport by
air or
automobile)

More than 1 at a
time (goal is
that all sharps
accumulated in
a doctors office
in a day can be
treated with one
use)
<50 pounds
(Easy enough
for one person
to carry)

US dollar

<$50

Issues | Waste Management | Health Care Without Harm | Global Projects

Sustainable/
Environmentally
friendly

NA

NA

Easy to use

Amount of
Average Joe
education/expertise Hospital
worker

As
environmentally
friendly as
possible
Average Joe (or
something
similar)

*We defined potentially risky steps as steps that may put the user of the design at risk of infectious
diseases via accidental prick by a medical sharp. This includes steps in which the sharps are
momentarily exposed to the outside and therefore could inflict harm on a person who unknowingly
touched the edge of a sharp.

Generation of Design Specifications:

Price: Because the target audience for our solution is in low resource settings, one of
highest priorities is that our design be low-cost and affordable. Our target market is
hospitals and some larger clinics that administer injections and involve the use of
sharps. While an environmentally friendly disposal system here could cost
thousands of dollars, we set the limit for an acceptable price at $70 with our ideal
set at under $50.
Safety: The driving force behind our project is, of course, to design a solution that will
dispose of sharps more safely in low resource settings. We understand that because
we are trying to come up with a design that treats used sharps, inevitably there will
be one or two instances where sharps could be exposed to a health worker working
to dispose of them (i.e. when were transporting the sharps, it may be possible that a
sharp point us momentarily exposed during this transportation). The goal of our
solution is to eliminateor at the minimum, reducethis risk, so safety is taken
into high consideration. We decided that we would at most allow two instances in
our design where sharps may be momentarily exposed, but the idea is that our
design would never pose as a threat to a health worker.
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Efficiency: Part of the reason why some disposal methods are impractical has to do with
their efficiency. If the process for disinfecting or properly disposing a sharp takes a
long time, it is often easier for a health care workerwho is already extremely busy
(as shown by the high nurse and doctor-patient ratios7)to just throw it into the
garbage. Thus, our design must be able to either sanitize individual sharps relatively
quickly or be able to disinfect and dispose of them safely in bulk.
Weight: How easy it is to transport our design is directly related to how much it weighs. In
some low resource locations, it is required to travel by foot or bike to reach the local
clinic or hospital. In countries with limited infrastructure, the transport of most
machines and devices used in American hospitals would be impractical. Assuming
foot travel is involved, our design will be limited to 100 pounds, which should be
enough for two adults to carry. The ideal specification is for it to be below 50
pounds, which will be manageable for one person to carry.
Sustainability: When dealing with how to dispose of contaminated medical sharps, the
problem of environmental sustainability becomes a vital concern. Disposing of
medical sharps without first disinfecting them allows infections to spread back into
the community. This is why we envision a design that would work to disinfect and
clean these sharps. This, in turn, asks us to consider our choice of the cleaning agent.
Optimally, few to no chemicals that we use in our solution will be detrimental if
released into the environment8. Additionally, we should be able to reuse them a
number of times to reduce environmental waste.

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8

Nurse-Patient Ratio Remains Critical Issue for Health Care Workers

Environmental Impacts

Ease of Use: In low resource settings, healthcare workers do not always receive a high
level of education or training9. Our engineered solution has to be operable and
intuitive without too much instruction. This is because detailed instructions are
often difficult to obtain in the native languages of those in low resource settings. The
design for the solution must be relatively simple, yet effective, at the same time.
SOLUTION GENERATION AND SELECTION
Our method for generating possible solutions was essentially through doing many
brainstorming sessions and being able to come up with one or two new ideas each session.
When we were coming up with ideas, we thought of all the possible ways that one could
make a sharp safe, including ideas that would physically alter the sharp so that it could no
longer inflict harm, sealing the sharp so that it is no longer exposed, and sanitizing the
sharp so that even if it happened to stick someone, it would not be able to pass on
infectious diseases. As we began to consider each method of sharps disposal, we did some
research on current designs that accomplish these goals and focused on how we could
improve the design that currently exists to be more efficient and straightforward for
someone to use in a rural area.
After we generated these possible solutions, we had to evaluate critically the
different possible solutions. Using the criteria that we defined as important in our design
constraints and criteria, we came up with the Pugh Chart below:

How Can We Achieve and Maintain High-quality Performance of Health Workers in Low-resource Settings?

Total

Weighted
Total

Efficiency
(# of
sharps
treated
per use)
3

22

50

16

34

17

39

22

51

2
4

2
4

3
4

1
1

4
1

2
3

14
17

30
38

Criteria

Ease of
Cost Ease of
Transport ($)
use

Safe

Sustainable/
Environmentally
friendly

Weight

Disposal
box
Soldering
iron
Sharps
Grinder
Chemical
treatment
Crushing
Burying

Explanation of our Pugh Chart:

In order to determine the best possible solution, we decided that each of our criteria
should have different levels of importance with regards to how important that specific
criteria is to a design that would serve a rural area. Thus, we implemented a system of
weights where each criterion was weighted according to how important it was to the
quality of the solution. We assigned weights on a scale of 1 to 3 with a score of 3 being the
most important criteria and 1 being not as important. This being said, we ranked efficiency,
safety, and cost as the three most important criteria since these are the criteria being not
met currently by existing designs. We put ease of use as our lowest priority because we
figured, in our target audience being rural hospitals, there is bound to be at least one
medical professional we could educate on how to use our design if necessary.
We awarded points to each solution on a scale of 1 to 5, a score of 1 being that this
design does not meet our criteria at all and 5 being that it did. The scores were assigned on

the basis of our research and rough estimates on how well each design met the criteria in
question.
Summary of the different designs in the left-most column:
Disposal box: This is the most common current method of sharps disposal and the main
design that we seek to improve. The design is a box with a lid structured such that a
person from the outside could not access the inside but can still put sharps inside. We
used this solution as essentially our control in that we knew we wanted to create a
design that was at least as good as this and possibly better.
Soldering iron: We had the idea of capping each sharp with a piece of solder or something
similar so that the sharp is no longer exposed. Our main concern with this idea was its
efficiency since effectively this design could only deal with one sharp at a time.
Sharps grinder: This idea was to find a way to grind the point of a medical sharp down so
that it could no longer be used for its purpose. The main concern with this solution was
that a sharp that was ground down could still have rugged edges and pass on
transmittable diseases.
Chemical treatment: This design was to treat the medical sharps with a sanitizing agent that
would kill infectious pathogens, making it such that even if a person were to stick
themselves with a used medical sharp, the chances of them contracting a deadly virus is
much lower. The main issue with this solution is sustainability and impact on the
environment.
Crushing: This design resembled that of a soda can crusher except for medical sharps. Our
main concern with this design was that the crushing does not effectively get rid of sharp

points that could stick a person, and the person operating this device could very well be
exposed to shards of sharp metal and hurt while operating the device.
Burying: Our last idea was simply to bury the sharps in the ground. This idea was rejected
for its potential for a negative impact on the environment and safety concerns.
Evaluation:
In the end, we decided that the solution design involving chemical treatment would
be the most effective because of its efficiency, ability to sterilize sharps such that the risk of
contracting infectious diseases is minimal, and capacity to be designed so that the process
of sharps sterilization is relatively simple. This is reflected in our Pugh Chart, where
chemical treatment received the highest weighted score. In addition, it was the only design
that actually surpassed the current design widely used today, namely the disposal box.
DESIGN DESCRIPTION
Our final solution is an improvement on the current method of sharps disposal,
namely the combination of using a traditional sharps container and modifying it so that the
sharps contained inside can be easily sanitized using chemical treatment. The goal of this is
so that when these sharps containers end up in landfills and public waste disposal facilities,
the sharps would not be dangerous and able to transmit infectious viruses via an accidental
needle stick.
There are three main parts in our design: 1) Modified Sharps container, 2) Bin to
hold Modified Sharps Container, and 3) Tank with Sanitizing Agent.

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3) Tank with
Sanitizing Agent
1) Modified
Sharps
Container

2) Bin to hold
Modified
Sharps

Figure 0. The overview of our design

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1) Modified Sharps Container (Figure 1)

Figure 1. Modified Sharps Container

The design for the modified sharps

container is essentially a traditional sharps
container but with the bottom removed and
replaced by a cheap plastic grate. Traditional
sharps containers can come in shipments of 40
to 100 for approximately $4 for a quart-sized
container, and the grates that we would use
can come from Home Depot for under $3 each.
In addition to the grate on the bottom, a knoblike handle would be added to the top of the
sharps container making it so that transporting the container is easier without having to
touch the bottom. This would be to minimize the risk of getting an accidental prick from a
used medical sharp should the tip of a needle stick through the grate. Cheap wooden knobs
that we would glue on top of sharps containers come at under a dollar each.
2) Plastic Bin (Figure 2)
Because our modified sharps container has the grate on the bottom, we were
Figure 2. Plastic Bin for Storage

concerned with sharps possibly sticking out of

the bottom of the grate. Our solution to this
was to provide a plastic bin that the modified
sharps containers would be placed into when
stored in doctors office or hospital. The bin is a
simple plastic bin resembling the standard

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office garbage bin. These can easily come at under a dollar in a regular dollar store.
3) Tank with Sanitizing Agent (Figure 3)

Figure 3. Tank with Sanitizing Agent

The last piece of our design is a tank that

holds an environmentally friendly, biodegradable sanitizing agent. In our design, we
based our project off of a Simple Green One-Step
Disinfectant that is both bio-degradable and
strong enough to kill the most deadly of viruses,
including Hepatitis B and C. Off of Amazon.com, the price is roughly $17-8 dollars a gallon.
The tank itself is a simple acrylic tank that resembles a fish tank and could easily be
constructed by students given the supplies and time. We envisioned the tank to hold about
2.5 gallons of sanitizing agent at max, and so, when full, it would weigh about 25 pounds.
Approximate dimensions for the tank are at 8 length x 11width x 14 height. A quick
search for the materials off of a home supply store such as Home Depot suggests that the
approximated cost to manufacture such a tank is roughly $20, including acquiring acrylic
sheets, a cutting tool, and appropriate glue and construction sealants.
When used all together, a full sharps container with our modified bottom would be
transported to a facility with the tank of our sanitizing agent. Once there, the sharps
container could be lifted out of its plastic bin and then submersed in the tank of sanitizing
agent, where sanitizing liquid could flow through the grate at the bottom and up to where
the sharps are in the container. After letting the container soak in the tank for a couple
minutes, the sharps would be disinfected and the sharps container suitable for disposal.

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Our major issue and potential problem with our design is how to handle the
sanitizing agent and chemical waste. In rural areas, people may not know how to handle
strong chemicals safely nor have good means of making sure it is disposed of in a safe place.
However, our design allows it so that a large number of sharps could be sanitized at once,
and the tank full of sanitizing agent could be reused for multiple sharps containers before it
has to be changed. Comparing the number of times the sanitizing agent would have to be
changed to the number of sharps one tank can sanitize, our design is still relatively efficient.
Another potential issue with regards the distribution of our design would be making sure
enough modified sharps containers are given to the places that need them so that we can
keep up with the number of sharps needing to be sanitized in rural areas. Distributing
tanks is less of an issue since one tank can easily serve a couple medical facilities or a large
hospital jointly and be reused many times.
ETHICAL AND SOCIETAL CONSIDERATIONS
As suggested by the data that shows how people are being infected by sharps that
are not disposed of properly, there must be shortage of convenient, accessible methods of
sharps disposals worldwide. One factor we would have to think about includes the fairness
in how new technologies for sharps disposal are distributed. Which populations are more
in the need for sharps disposal? Should we give populations that show a greater frequency
of having diseases such as HIV or hepatitis or drug abuse priority because those
populations are more at risk? Should we prioritize the distribution of sharps sanitation to
hospitals and/or caretakers offices that provide for more women and children? Are we
morally allowed to take a regions socio-economic statuses into consideration when
deciding where to distribute?

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Another ethical consideration we should take into account would be whether or not
it would be suitable for us to introduce a new method of sharps treatment to an area that
may not be used to having to sustain such a method. For example, our design does involve
handling sanitation chemicals and eventually having to execute the proper disposal of such
chemicals. In an area where the people may not be used to doing these kinds of procedures,
there is the chance that these chemicals will be misused and mistreated. Therefore, we
would have to take into consideration whether or not the people of the area we are
introducing our new technology to would be able to follow rules and safety regulations in
addition to having proper methods of waste disposal.
In addition, we also have to consider environmental ethics and how
environmentally considerate our solution is. The disposal of the sanitation chemical does
have potential to have an impact on the environment in which we are choosing to use our
technology. As a result, we have to consider this and choose a method that minimizes the
amount of waste we create in the environment.
REGULATORY ISSUES
This solution is classified as a medical device so it would go through the CDRH
center of the FDA.10 The CDRH ranks medical devices in three classes based on the
estimated risk level involved with the device, with Class 1 being low risk, Class 2 medium
risk, and Class 3 high risk. It can be reasonably assumed that our device would be Class 1.
For a Class 1 medical device, the FDA requires a 510(k) but there is a possibility of
exemption. The goal of the 510(k) is to prove that the device is substantially equivalent (SE)
to another device that has already been approved and is legally marketed. The basic

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Device Approvals and Clearances

15

components are a cover letter, Indications for Use statement, multiple different summaries
of research, Proposed Labeling, safety requirements, and performance testing. There is also
a possibility of being approved for an Abbreviated 510(k) which would contain mostly the
same components but would be less thorough. 11 There are no clinical trials involved with a
510(k). Clinical trials are only required for pre-market approval (PMA) of Class 3 medical
devices. It is also reasonable to assume that this device would not be Class 3 so clinical
trials and IRB involvement would not be issues. 12
CONCLUSIONS
We accomplished coming up with a viable design that would solve the problem of
unsafe and improper medical sharps disposal. Skills we developed included being able to
identify a worldwide global health issuedisposal of medical wasteand narrowing it
down further to sanitation of sharps and prevention of accidental needle stick. This
narrower focus allowed us to more thoroughly address a specific issue. In addition, through
the course of this project we practiced our research skills and gained valuable insight into
the sheer amount of work involved in the process of turning an idea into an actual product
that would hopefully save lives. To the best of our estimates, our design really would have
the potential to dramatically reduce the number of infections via accidental needle stick.
This would mean thousands of health care workers who would not have to put themselves
at risk in order to save lives. However, if this project as it is were to be taken further and
marketed to low resource hospitals, we believe we would see only limited success. Our
concept is sound, but the necessity of harsh chemicals that would have to be disposed of

11
12

Content of a 510(k)
Device Regulation and Guidance

16

and regularly replaced still remains an issue to be dealt with and could dissuade some
hospitals from using this method.
REFERENCES
1. Disposal of Medical Sharps | Medical Waste | Wastes | US EPA, n.d.
http://www.epa.gov/osw/nonhaz/industrial/medical/disposal.htm.
2. Disposal of Sharps | Pfizer: The Worlds Largest Research-based Pharmaceutical
Company, n.d.
http://www.pfizer.com/responsibility/protecting_environment/disposal_of_sharps.
jsp.
3. Issues | Waste Management | Health Care Without Harm | Global Projects, n.d.
http://www.noharm.org/global/issues/waste/.
4. Sharp, Fraser R. Container for Supplying Medical Products and Disposal of Medical Waste
Material. Fraser Rosslyn Sharp, assignee. Patent EP1143868 A1. 17 Oct. 2001. Print.
5. Sincock, Brian F. Device for the Safe Removal and Disposal of Sharps from Medical Tools.
Ausmedics Pty. Ltd., assignee. Patent US5047019. 10 Sept. 1991. Print.
6. Britton, Richard B. Disposal Unit for Medical Sharps. Hetex Holdings, LLC, assignee. Patent
US 6637587 B2. 28 Oct. 2003. Print.
7. "Making Health Care Safer." Health Care Waste Management. PATH, 2012. Web. 11 Dec.
2012. <http://www.path.org/projects/health_care_waste.php>.
8. "Nurse-patient Ratio Remains Critical Issue for Health Care Workers." The Pennsylvania
State Education Association. PSEA.org, 2007. Web. 12 Dec. 2012.
<http://www.psea.org/general.aspx?id=1252>.
9. "Environmental Impacts." Green Choices. N.p., 2012. Web. 12 Dec. 2012.

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<http://greenchoices.org/green-living/cleaning/environmental-impacts>.
10. Rowe, Alexander K., Don De Savigny, Claudio F. Lanata, and Cesar G. Victora. "How Can
We Achieve and Maintain High-quality Performance of Health Workers in Lowresource Settings?" Review. (n.d.): n. pag. Www.kcco.net. Thelancet, 9 Aug. 2005.
Web. 11 Dec. 2012. <http://www.kcco.net/Lancet_maintaining_high_quality.pdf>.
11. "Device Approvals and Clearances." FDA.gov. N.p., n.d. Web. 12 Dec. 2012.
12. "Content of a 510(k)." FDA.gov. N.p., n.d. Web. 12 Dec. 2012.
13. "Device Regulation and Guidance." FDA.gov. N.p., n.d. Web. 12 Dec. 2012.

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