CINQ387 Blog 1

Step 1: Determine the facts in the situation

1. If the syringe includes the auto-disable function, the total cost of the design will be expensive, where this could affect hospitals and clinics due to it being highly unaffordable.

 

1. If the auto-disable feature is included in the design, the potential for the spread of disease will likely decrease

 

1. If the auto-disable feature is not included, this enables the potential for the spread of disease

 

Potential ethical issues:

1. Without the auto-disable function, there is a higher chance for patients to become infected by the disease, which can lead to consequences that could affect life expectancies, and even cause a possible epidemic. The larger the group of patients affected, the harder it will be for the disease to be controlled. This can lead to hospitals and clinics having to quarantine people until they are well enough to leave. 
2. If patients were to be put at risk to the disease, this could put the hospital/clinics under poor handling of medical treatment or in other words, medical abuse. To be exact, patients would be receiving unnecessary or even harmful care if these syringes were not safe to use. 
3. Hospitals and clinics are often paid for their medical services by the patients themselves or through their medical insurance companies. So, if so much money is being spent on these syringes that don’t even provide accurate service, this could well cause patients to trust the designers and hospitals less. This could lead to them boycotting the service even if they are ill, which could cause a domino effect of others losing trust and even being sick but refusing to visit the hospital.

 

Step 2: Define the Stakeholders

 

Stakeholders objectives: The stakeholders are the hospitals/clinics, patients (consumers), doctors/nurses and the company producing the syringes. The company’s objective is to  produce an auto-disable syringe after a single use as a safety feature, but at the same time make the syringe affordable. The hospitals/clinics objective is to be able to efficiently distribute and administer these syringes to use on their patients. The patient’s objective is to receive a safe (possibly a vaccination) to protect themselves from the disease.

 

Relevant values/issues: For the hospitals and clinics, it is protocol that an auto-disable function is needed, so although the addition of the function makes the syringe more expensive, it is necessary. This makes them potentially value protocols more. Similarly, the company producing the syringe needs to have the safety function in order to avoid liability issues or having the product recalled, which would affect their business in the long-run. However, for the consumers like the patients who will be using these, some may see the price as an obstacle making them to opt out of using the syringe or the whole treatment in general if it affects their life. 

 

Step 3: Assess the motivations of the Stakeholders

Relevant Duties and Rights: All stakeholders are overall motivated with a common goal to do exercise control and influence. Together they come up with taking a strong and impactful action that is capable of affecting a group of people or a community. They will often contribute assistance, advice and support to those that are related to their goal. For example, the designer has a duty to design an effective, one-of-a-kind sellable product that could support their business for a while. For hospitals/clinics, they have the duty to treat and admit the injured/ill. For patients, they are all looking to live an increased quality of life and if their life is threatened, it is natural to want treatment and people are entitled to receive their demanded standard medical care.

 

Step 4: Formulate (at least three) alternative solutions

Potential Solution: Needle-free injectors (NFIs) is an alternative drug distributor that performs the same task as syringes without utilizing a needle. Instead, an NFI is able to force liquid through a nozzle orifice, which produces a liquid jet at high-velocity which can puncture the skin, allowing the drug to be delivered beneath the skin to fat or muscle. 

Ethical Principle or code: NFIs have the potential to propel a certain amount of pre measured dosage of specific drugs, stored in cassettes. These forces are generated from multiple practices such as high-pressure fluids like gases, electro-magnetic forces, shock waves or generally any form of energy that has the energy to induce motion for the drug.

Pros: Due to the lack of a needle, disposal of NFIs are safe, and there are no need for needle sterilization to happen. There is also no risk of sharing needles, accidental needle puncturing and a sharps disposal container is not necessary. In addition, some NFIs also have the capability to increase vaccination rates since the drugs are delivered at the most external part of the skin, where a person’s immune response first takes place. Also, by decreasing the amount of dosage for the vaccination, consistent delivery makes this process affordable for point-of-care treatments and materials in the long run.

Cons: In comparisons to point-of-care injections, NFIs are limited to injections in a certain position, variability in the amount of medication being administered and variability of how deep the drug can be injected. It is also possible for the high pressure to damage weaker molecules under the skin’s layer especially if monoclonal antibodies are being delivered.

 

Step 5: Seek additional assistance, as appropriate

Engineering code of ethics: Engineers must perform at the utmost level of ethical conduct, with fulfilling their professional duties of ensuring and promoting safety, health and welfare of the general public.

Previous cases: Medical malpractice is common and remains a major cause of personal injuries or even unjust death. Not every engineer will perfectly produce a product that will 100% work at all times. Defective medical devices are out there, and a common one is metal hip implants, which have caused thousands of patients to suffer metal poisoning and millions of dollars for the many lives the designers have affected.

Peers: Those who are medical workers would strongly like to avoid problems like these, because they are the ones who specialized in delivering surgery and treatment. This is the reason why they focus on following a strict protocol, so medical device engineers or designers must have a working and outstanding device to even be acknowledged.

Reliance on personal experience: Everyone goes through health check-ups and medical treatments at least once or many times in their life. If you worked as a doctor knowing the syringes were defective, you would not allow your family to receive this treatment. It is the same for others, we wish for the best for others, so defective devices or medical negligence is not accepted by the general norm.

For my BIOE 225 class, we were suggested to watch a documentary called “The Bleeding Edge”, it was horrifying to see how lenient the FDA were approving medical devices that haven’t even gone through clinical trials to be on the market. It was even more horrifying knowing that it has become a societal norm that we trust doctors, health clinics, the FDA and medical device companies to know what they are doing. But to see that these people or organizations that we trust, have such a dark-side, makes me doubt medicine today. 

Inner Reflection: Like this syringe, many of the medical devices shown in The Bleeding Edge was created for “the greater good”, and I understand most engineers and doctors do in fact want to help as many people as they want. However, it seemed like, in this generation, it was more about releasing “the next greatest innovation” into the market instead of actually helping patients. More damage was done, as people believed the newest medical gadget meant it was perfect. Instead the opposite happened, therefore I strongly believe every device should go through multiple clinical trials, multiple approvals to even be on the market, such as this syringe. It SHOULD be as safe as possible for patients to use for the long-run, and definitely there are other options for better sustainability and recycling, instead of not including the safety function at all.

If I was the designer, I would preferably choose the option that benefits the greater good. If I had designed a syringe that did not include a safety feature, I don’t think I could hold the responsibility of possible hurting so many people and causing a large-scale problem. 

 

Step 6: Select the best course of action

It would be morally preferable to include the auto-disable safety feature because this involves using them on people. If the syringes were unsafe, this could involve legal issues, such as medical abuse due to harming human life.

In the case that this does happen, all the hospitals/clinics that are using these syringes could be sued by the patients who were harmed by them. Then the hospitals/clinics will end up boycotting the use of these syringes. This will force the company that produced the syringes to recall them back, causing them to face charges for selling/producing a medical defect. Not only that, the FDA that may have approved of this syringe to even go on the market will also face charges for allowing something that is harmful to human life. If these syringes had the capability of affecting patients short-term or in the worse case, long-term, this could strike up a greater conversation or discussion on how medical devices are actually being approved. 

 

Step 7: (If applicable) What are the implications of your solution on the venture

Impact of proposed solution on venture’s technology: There are many alternatives out there, but there are always drawbacks for every type of medical-related process. I believe that patients should have the option or choice to receive a different type of treatment, while being educated on the pros and cons. However, there is also the uncertainty of certain treatments as they are still under clinical trials. To fix this, there are many large free healthcare initiative (FHCI) organizations willing to fund medicine that needs improvement.

Economic: Although including the safety feature is expensive, it will prevent significant problems in the future. It would be more difficult for those who lack medical insurance or have no money to even pay for treatment. However, I do believe, a safe and working syringe will help the designer’s company and increase the trust/participation of patients to use this syringe. 

Social: The public would have common ethical requirements for the best technology. It needs to encompass fixing problems such as making the drug affordable, having workplace safety healthcare settings, medical data privacy, no misuse of antibiotics and etc.

Environmental: The proposed solution should be recyclable, but at the same time not capable of being easily contaminated. If it was able to be reused multiple times by the same patient, it makes the process more affordable. Also, the solution must be environmentally friendly if disposed of.