Ethics, Safety, and Engineering Standards

Ethical Considerations

• Environmental

  • Electrical Waste - Our minimal design limits potential for failure, reducing electrical waste. Additionally, modeling prevented the development of ineffective devices pre-testing in order to reduce waste from ineffective designs. 

  • Biohazard Waste - A device that kills the cells wastes large amounts of resources and money, and is unconscionable. Ensuring the safety of the device toward the cells was imperative in order to prevent the destruction of cells, not only to prevent the delay of research but also to prevent the undue wastage of materials. Additionally, considerations were taken regarding how much waste would be produced throughout cell culturing in the device setting.  

• Cost-Effectiveness

  • Given the limited funding for laboratories, our goal was to create as cheap (and effective) of a device possible to limit capital waste. 

Risk Considerations

• Technical

  • Incompatibility with CytoStretcher - Integration with the existing device has been a consideration from the beginning, including meeting with representatives of CuriBio to determine compatibility. 

• Resources

  • Supply chain issues - resolved by decreasing the complexity of the device to accommodate existing lab materials/devices. 

  • Money constraints - similar resolved by limiting resources to those present in the lab already. 

• Safety

  • Electrocution - PPE standards have been strictly maintained in order to prevent electrocution, including grounding technique. Decreasing complexity reduces the risk individual failure of distinct parts, and introducing a buffer decreased electrocution risk. 

  • Crushing/Pinching Injury - As the Cytostretcher mechanically stretches the tissue, consideration was taken to the method of integrating our device in order to prevent crushing/pinching injury of users during operation. 

IEC 60601-1

Applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment, applicable regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. 

Though this device is not intended necessarily for home healthcare use, the standard gives an applicable guideline for use when healthcare personnel are not present. This device is still in the research phase and not yet subject to regulatory approval, yet still used in a lab setting. As a result, it's necessary that this device should meet high standards of safety and functionality, and be operable without the design team present; thus, reducing the risk of electrical hazards or unintended thermal effects on cells and increasing ease of operation for lab personnel. 

ISO 10993-5:2005

Describes test methods to assess the in vitro cytotoxicity of medical devices, specifying the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. This outlines methods for assessing whether a device material induces cell death, inhibits cellular growth, or alters cellular morphology when incubating cultures.

Our device must be able to maintain cellular health and viability, especially considering the cells will be placed under electrical and mechanical stress while stimulating and pacing them. This standard provides a structured approach to verifying safe and reproducible cell culture conditions

ISO 11137-2:2013

Specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization does to achieve a sterility assurance level (SAL) of 0.000001. Specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. Defines product families for sterilization dose establishment and sterilization dose audit. 

This product will be used in the culturing of stem cells (hiPSC-CM), and therefore these standards must be maintained in order to prevent the proliferation of potentially harmful bacteria and other microorganisms that coudl taint testing and stem cell growth. Additionally, sterilization standards are key for the CuriBio Cytostretcher, as the Cytostretcher is an external device that the stem cells will be cultured in for weeks, and thus must be sterilized as detailed by the standards in order to ensure the health of the cells and validity of testing results. 

ISO 15190:2020

Specifies requirements for safe practices in the medical laboratory. 

This standard significantly refers to the effectiveness of treatment and maintaining propriety to benefit the patients. Although this product does not directly impact patients, maintaining these standards is important to accurately and safely designing the device, so that on longer time scales, its use in clinical and research settings will positively benefit patients.