Capstone Week 10 Kierstin Parker

 In Class: 

Solidworks: 

Valve component with holes 

Need to make a mold for silicone to be poured into (Shown Below) 

Lab: 

Lab work with Team: 

The orange connector is too small for the tubing, so I drummled Fady’s printed part down.

It seems too small to drill through though, so Alex ordered some bigger needle connectors. 

Found connectors that with some silicone wrapped around will allow us to hook up a pressure sensor to the shakedown systems to

measure the pressure at the time of the leak. 

Brinkley and I also tested the resistance that a scalpel incision would have, but it dripped differently depending on the position of the tube

and the cut, which means it would not be a reliable resistance for our shakedowns.

I think that putting silicone resistors would work better for future testing. 

I also cleaned out half a resistor to create a resistance-free air pocket that I can drill into and put in tubes.

It needed to be reepoxied because the bottom did not seal. 

Ethics: 

• Thus far, Teleflex Medical has received 179 complaints and 192 issues where the ETT became disconnected from the breathing circuit.  There were two deaths and one injury reported thus far.

• In one report from the FDA MAUDE Adverse Event database, a health facility described an incident where the Hudson ET tube connector came apart three times in the same patient, requiring reintubation. The health facility also noted other reports of the same issue occurring across its entire organization, with additional reports of cuff failure and cuff tearing. The health facility has since pulled the product from its shelves. In the report to the FDA, the health facility stated that the information it received from the company representative was that Teleflex started having issues in 2016 and changed its manufacturer due to an issue with the plastic. 

• The cuff of the endotracheal tube (ETT) is designed to provide a seal within the airway, allowing airflow through the ETT but preventing passage of air or fluids around the ETT.

• The information we received from them was that they started having issues in 2016 and changed manufacturer due to an issue with the plastic. They have since had complaints (wouldn't share how many) however, they stated that they are unable to reproduce these same issues in the lab during simulation. They stated that they are going to start a "complaint inquiry" which sounded like the first step in an investigation that could potentially lead (depending on the findings) could result in a recall. (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=8508629&pc=BTR) 

•  Nov. 28, 2018 and June 5, 2019 was when the products got recalled, but they had been having complaints about the product since 2016 when they changed manufacturers 

• FE Handbook code of ethics: 

• A. Licensee’s Obligation to the Public

•  1. Licensees shall be cognizant that their first and foremost responsibility is to safeguard the health, safety, and welfare of the public when performing services for clients and employers. 

• 2. Licensees shall sign and seal only those plans, surveys, and other documents that conform to accepted engineering and surveying standards and that safeguard the health, safety, and welfare of the public. 

• 3. Licensees shall notify their employer or client and such other authority as may be appropriate when their professional judgment is overruled when the health, safety, or welfare of the public is endangered.

Solidworks: 

I drew and submitted parts to drill into and put in the correct size tubing to get a prototype, so we can start working on trying different resistances once we have this housing figured out. 

I also drew the concept out on the Ipad to fill it out a little more. The green spikes are just imaging conversion errors.