SAVE - Stethoscope Amplifier Voice Enhancer device for PPE wearers

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INTERVENTION FOR HEALTHCARE WORKERS DURING PANDEMIC A device to assist PPE wearers

DEBADRITA BHATTACHARYYA 2021MDES008

&

MOHANA KRISHNAN 2021MDES009

Guided by: Dr. SHANU SHARMA MDES 2021

PROJECT 1


INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

ACKNOWLEDGEMENT We would like to express our special thanks to our college School of Planning and Architecture, Bhopal and the Department of Design for giving us the opportunity to work on this project. We are very grateful to our guide Dr. Shanu Sharma for helping us throughout our journey and to each and every faculty member for encouraging us. We would also like to thank our batchmates for supporting and helping us in our journey. Special thanks goes to all the healthcare professionals who stood with us and provided their valuable suggestions and support towards our project. 1. Dr. Chandramohan T R, NS Hospital, Kollam 2. Dr. Manjunath Pillai, NS Hospital, Kollam 3. Dr. Renu Chandran, NS Hospital, Kollam 4. Dr. Anu Malik, Asst. Prof. LNMIIT 5. Dr. Gayatri, NS Hospital, Kollam 6. Dr. Suranjana Sur , Bankura Medical College, West Bengal 7. Dr. Rajdeep Asian Medical Institute, Russia 8. Dr. Nimisha S Nair, MOSC Medical College, Kolenchery 9. Dr. Nived Ravi, MOSC Medical College, Kolenchery 10. Dr. Shraddha Sreelal, MOSC Medical College, Kolenchery 11. Dr. Mohana Suryan, Kasturba Medical College, Mangalore

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INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

INTRODUCTION The COVID virus pandemic hit people around the world in ways we as humans have never thought it would. Lockdowns and various other restrictions laid down by governments tied us all down for a long time. It's been almost 2 years now since the pandemic hit our lives and took lives of many around us as well. Even though most of us still live and work from the comfort and safety of our homes, there are many active workers who are fighting against the virus, everyday, tirelessly. One such or maybe the majority of them, are healthcare workers. Their fearless and continued efforts have kept us and our dear and near ones as safe as possible. They face many challenges and troubles during their fight against the virus on a daily basis.

AIMS & OBJECTIVES To find points of possible interventions in these healthcare workers’ daily processes and work routines, through design and bring ease and enhanced safety.

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PROBLEM STATEMENT Healthcare workers who wear PPEs everyday face the problem of not being able to listen to others around them and also in using a traditional stethoscope to examine patients while inside the PPE.

PROPOSAL To design and implement an assisting device for PPE suit wearers for auditory ease and enhancement

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INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

WHAT IS PERSONAL PROTECTION EQUIPMENT? PPE protects healthcare workers from two main hazards: ● ●

Radiation (Enhancing radiation safety in health care) Biological agents (virus, bacteria, etc.)

Important transmission pathways that can be inhibited with PPE include: ● ● ● ●

Person to person contact Droplet spread Airborne transmission Contaminated objects (fomites)

COMPONENTS OF PPE FOR COVID-19 AS PER WHO GUIDELINES

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Gloves, medical examination (non-sterile)

Apron, disposable EN 13432

Gloves, surgical (sterile)

Scrubs, tops, pants

Goggles, glasses protective

Gown, isolation

Face shield

Gown, surgical

Fit test kit

Alcohol-based hand rub

Particulate respirator

Biohazard bag

Mask, medical for health care worker

Safety box WHO PQS E010/011

Mask, medical for patient

Soap

Apron, heavy duty EN 14126 and partial protection (EN 13034 or EN 14605)

Gloves, cleaning EN388

Hand drying tissue

Chlorine

DEBADRITA BHATTACHARYYA & MOHANA KRISHNAN


INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

PROBLEMS FACED BY PPE WEARERS

As per NCBI reports

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INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

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INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

CURRENT SCENARIO

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INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

INTERVIEWING HEALTH WORKERS

Psychological impact a. Constant fear of infecting his 4yr old daughter and aged mother (dialysis patient); ensured vaccination of all b. Carries 5 pairs of scrubs and sanitises them at home himself Experience c. Patients prefer direct physical treatment over online / distanced consultation d. Parents suffering from covid-19, would send kids with other family members for check-up causing exposure to everybody e. Considerable salary reduction during covid by previous medical institution Suggestions i. De-fogging of face shields ii. Acoustical issues inside PPE suit

Psychological impact ○ Constant fear of contamination and confusion regarding govt. protocols and loopholes in existing structure ○ Had to witness death of too many patients within a short time spans Experience ○ Wrong information imparted by journals and organisations; misleading data provided by faulty oximeters and fake instruments ○ D-dimer tests couldn’t be relied upon completely- had to opt for CT, X-ray,etc. ○ Many patients called up for psychological counselling Suggestions i. More comfortable PPE products

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INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

Psychological impact a. Patients were psychologically down ,living in constant fear b. Too much of misinformation misleading people Experience c. People prefer direct counselling; physical touch over virtual platforms d. Lack of variation in sizes of PPE suits, oversized or undersized; hampering work e. Menstrual hygiene related problems for many Suggestions i. The PPE products need redesigning to facilitate patient doctor relation ii. Problems of fogging and audibility need attention

Psychological impact a. Fear of imparting infection to 2 yr old kid b. Family had covid despite all measures c. Had to keep kid away with her grandparents for safety Experience d. Carries own box of nitrile gloves, changes after checking 2-3 patients e. Prefers to keep own apron, jacket, face shield separately for hospital purpose, doesn’t carry them home Suggestions i. Donning and doffing area for PPE needs redesigning ii. PPE products need to be more comfortable

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INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

INFERENCES FROM INTERVIEWS ● ● ● ● ● ●

Need for interventions assisting the existing PPE design Low scopes of changes in existing PPE design owing to chances of compromising on safety and sterility Additional assistance needs to be removable and reusable No scope for stethoscope insertion in existing design of PPE suits Lack of human touch has severely hampered psychological health and created barriers for medical personnel in treating people The intervention can be in the form of a device which will not compromise with safety and will sustain radiation

EXISTING PRODUCTS IN THE MARKET

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INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

POLYMERS AND RADIATION Literature reveals that glasses undergo densification and other attendant physical property changes when exposed to radiation. The threshold for damage in pure silica is close to 100 Mrad, while for multicomponent glasses, it is certainly lower. While several studies show no changes in physical properties such as strength, toughness, and thermal expansion in the 10 – 100 krad range, one study shows a 20% strength loss in soda-lime glass as low as 8.8 krad exposure. There are no reports of radiation studies on multi-component glasses of interest in NW; however, it is safe to assume that their damage threshold would be significantly lower than that for pure silica, ie., <<100 Mrad. Any change to the mechanical and elastic property would lead to some changes in the residual stress states in the glass components. Loss of strength observed in some studies could lead to cracking even if the residual stress state itself does not change. It is likely that any radiation effects in our applications will be negligible (save for some darkening). However, because data on materials to be used in the seals are non-existent, it is recommended that a materials-based study be commissioned to explore these effects. In this study, commonly used glass and glass-ceramics should be tested in the GIF, and relevant properties such as density, thermal expansion, elastic moduli, strength, and toughness should be monitored as a function of dose. Acrylonitrile-Butadiene-Styrene Acrylonitrile-butadiene-styrene (ABS) is a widely used co-polymer because of its ease of processing (e.g., injection molding), light weight, toughness, and chemical resistance. A large portion of the radiation research for ABS plastic has been dedicated to the area of ultraviolet (UV) light and photo-oxidation; for example, ABS is often used in outdoor applications like automotive bumpers. However, Hassan recently published an investigation on the effect of gamma radiation on polyamide 6 (for example, PA-6 or Nylon 6), PA-6/ABS blends, and ABS.30 As can be seen in the figures, no degradation in tensile strength (Fig. 8(a)) was observed for ABS irradiated up to 50 kGy (5 Mrad, the dose rate was ~5 kGy/hr); however, the tensile elongation decreased by ~40%, indicating that the ABS became more brittle (see Fig. 8 (b)).30 The relatively high dose rate again suggests that material degradation in this case was explored under non-oxidative and perhaps dominant cross-linking conditions. As shown in this work, ABS plastic performs well at moderate to low doses of radiation; for example, at less than 10 kGy it exhibits no change in mechanical performance. For more details regarding ABS performance, in particular weathering, a comprehensive chapter written by Massey is available in the open literature.

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DISINFECTION AND STERILISATION Disinfecting or defogging for 30-45 minutes:

Ultraviolet germicidal irradiation (UVGI) plus two minutes to six hours of ventilation depending upon UV light position, wattage of the light source, and room size. UV-C disinfection is most effective against microbes and viruses in the present scenario.

Fumigation:

This method can be performed by electric boiler fumigation and potassium permanganate method. Formaldehyde, phosphine, 1,3-dichloropropane, hydrogen cyanide, chloropicrin, methyl isocyanate are the different agents used for Fumigation.

Fogging:

Foggers generate a fog or mist formed by Ultra-low Volume (ULV) uniform sub-micron size

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liquid particles (Dry Fog) Glutaraldehyde, Glucoprotamine, Hydrogen Peroxide + Silver Nitrate are different chemicals used for fogging procedure. Fogging is done using equipment called Fogger.

Ultraviolet (UV) light: Ultraviolet (UV) is the part of electromagnetic light constrained by the lower wavelength extreme of the visible spectrum and the X-ray radiation band. Using the Commission of Illumination classification, the UV spectrum is subdivided into three bands: • UVA (long-wave) from 315 to 400 nm • UVB (medium-wave) from 280 to 315 nm • UVC (short-wave) from 100 to 280 nm UVC disinfection has attained more favour among these types because of its efficacy against a wide range of microbial and viral agents in various environments. The cellular RNA and DNA absorb high energy from the short-wavelength UVC light, damaging nucleic acids and preventing microorganisms from infecting and reproducing Surface disinfection: Human coronavirus may live up to nine days at room temperature on an inert surface with a higher preference for humid circumstances. Sanitize inert surfaces using chemicals confirmed against COVID-19 and keep a dry atmosphere to reduce the increase of 2019-nCoV. Such surface sanitizers include 62–71% ethanol, 0.5% hydrogen peroxide, and 0.1% (1 g/L) sodium hypochlorite. Sterilization of instruments All instruments are to be immersed in Sodium Hypchlorite+Detergent Solution 24 hours and then transferred to Ultrasonic cleaner the next day. Instruments must be wrapped in a sterilization pouch, and packaging should be done in a clean and low contamination area [13]. Patient Evaluation The waiting room in the dental practice/center should be adequately ventilated. Prior to the patient’s entry to the dental chair-side, patients should be provided with a surgical or face mask and disinfectant gel. The patient’s temperature must be measured using a International Journal of Dental Materials 2020;2(4): 135-144

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sterile or contact-free forehead thermometer. A pulse oximeter should be used for pre-screening to rule out reduced blood oxygen saturation levels, respectively. A detailed medical history should be taken from the patients, and a designated screening form must be precisely completed and signed by the patient (Figure-2). If a patient is suspected to be positive, such a patient should be immediately identified, quarantined and referred to the department of infection control in a hospital/center or the local health department. In case of emergency dental complications, patients can undergo required treatments even if they are in the acute phase of the disease. According to WHO, the doubtful and healthy patients must be moved with negative pressure ventilation to precautionary rooms (12 air changes/hour "ACH" or 160 L /s/patient). Patients who do not report any symptoms can receive dental care and treatments.

STEPS FOR DONNING A PPE SUIT Rational use of Personal Protective Equipment (Ministry of Health & Family Welfare) Personal Protective Equipment (PPEs) are protective gears designed to protect workers' health by minimiz-ing their exposure to a biological agent. Sequence for Donning of components of PPE: First step: wear a head cap - Individuals using gowns, should use a headcover that covers the head and neck while providing clinical care for patients. Hair and hair extensions should fit inside the headcover. Second step: Hand Hygiene – Hand hygiene is one of the principal pathways for reducing the transfer of microorganisms to the patients. According to WHO, SARS-CoV-2 can remain alive on different surfaces from the number of hours to several days. Since oral-faecal transmission of the virus has been reported for COVID-19, hand hygiene has become of the greatest importance for dental professionals/personnel. Hand hygiene can be achieved in two ways; handwashing with water and soap and hand disinfection using alcohol-based solutions, both for 20 seconds. Third step: Put on Gown - Coverall/gowns are designed to protect the torso of healthcare providers from exposure to the virus. Coveralls typically provide 360-degree protection. Using suitable protective clothing makes it viable to create a barrier to eliminate or reduce contact and droplet exposure, both known to transmit COVID-19.

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INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

Shoe covers: Shoe covers have to be made up of impermeable fabric to be used overshoes to facilitate personal protection and decontamination. Fourth step: Put on N-95/FFP2/FFP3 - Protecting the airway from the particulate matter generated by droplets. Commonly used surgical face masks in dentistry when correctly worn and frequently changed offers around 80% filtration rate. COVID-19 measures around 120 nm (0.12 μm) and aerosol particle dimensions range from 3–100 nm. The use of FFP3 respirator provides a filtration rate of 99% of all particles measuring up to 0.6 μm. An N-95 respirator mask is an airborne particle-protective respiratory system with high filtration capacity. To supply the requisite air seal to the wearer, such masks are designed to attain a very close facial fit. Fifth step: Put on Goggles and Face shield-Contamination of mucous membranes of the eyes, nose and mouth is more probable due to droplets generated by cough, sneeze of an infected person or during aerosol-generating procedures carried out in clinical situations. Hence it is important to protect them by using face shields/ goggles. Sixth step: Put on Gloves - Nitrile gloves are preferred over latex gloves because they withstand chemicals, inclusive of certain disinfectants such as chlorine. There is an elevated rate of allergies to latex and contact allergic dermatitis among health workers. Non-powdered gloves are preferred to powdered gloves An Overview of Basic Radiation Effects on Polymers and Glasses ( Operated for the U.S. Department of Energy by Sandia Corporation) Occupational risk factors and preventive measures for COVID-19 in prosthodontics International Journal of Dental Materials 2020; 2(4)

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PATH OF SOUND

PRIMARY CONCEPTS IN FORM DEVELOPMENT

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FORM ITERATIONS AND PHYSICAL MASSING

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INTERVENTIONS FOR HEALTHCARE WORKERS DURING PANDEMIC

MOOD BOARD AND MATERIAL STUDY

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FINAL FORM

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COMPONENT BREAKDOWN

1. Outer shell made of Terluran HD-15, a type of ABS, with stethoscope insertion well and touch controls 2. Condenser microphone 3. Qi standard wireless charging coil 4. Control board with in-built li-ion battery (representative image) 5. Speaker 6. Neodymium magnets for fixing the device to PPE 7. LED ring indicator 8. Speaker grill 9. Digital volume control ring 10.Metal plate to hold device in place magnetically

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MASSING AND PROTOTYPING

The dimensions of the actual product was decided after block modelling to be 8cm in diameter across and 2.5cm or 1 inch thick (excluding metal plate).

COMMENTS BY JURY MEMBERS Q. WHY WAS A MAGNET CHOSEN FOR THE LOCKING MECHANISM? A. Magnet was chosen for the locking mechanism because of its innate contactless attractive property with metal. It prevents scope of damage of PPE and does not need to cling to the user’s body or be dependent on it. Q. WHAT ARE SOME OF THE ISSUES YOU FACED DURING THE DESIGN PROCESS? A. The magnet was initially designed to be placed inside the PPE near the user’s ear. That might have caused heating of the magnet due to heat accumulation inside the suit and a sense of cold, metallic touch on skin could create discomfort. So the product was re-designed with the magnet being placed inside the main device and a fabric covered metal plate was placed inside the PPE instead.

Q. WHY DID YOU NOT IMPLEMENT THE EXISTING DESIGN FORMAT OF A HEADPHONE? A. The existing headphone design needed the user to wear the product over the head and the device would have kept pressed against the user’s head and ear. This could have caused discomfort and severe headache on prolonged usage. So any method that would need the device to press on or mount on the user's body was discarded.

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REFERENCES 1. https://www.google.com/url?sa=i&url=https%3A%2F%2Froyalsocietypublishing.org%2 Fdoi%2F10.1098%2Frsos.210287&psig=AOvVaw0HhfPINnOAwDbBQNn5FZ74&ust=163 9543962084000&source=images&cd=vfe&ved=0CAwQjhxqFwoTCIiytK-_4vQCFQAAAAA dAAAAABAD 2. https://www.bostonglobe.com/2020/04/06/opinion/post-coronavirus-how-will-we-addre ss-trauma-health-care-workers-have-suffered/e 3. www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-techn ology/medical-devices/ppe/ppe-covid 4. www.ncbi.nlm.nih.gov/pmc/articles/PMC7686919/ 5. www.chicagoprotective.com/size-charts.html 6. blog.sellerscommerce.com/why-wearing-a-uniform-is-important-at-work-and-school/ 7. www.intljourtranur.com/article/S0099-1767(20)30287-7/fulltext 8. www.time.com/5808992/healthcare-workers-lack-ppe/ 9. An Overview of Basic Radiation Effects on Polymers and Glasses ( Operated for the U.S. Department of Energy by Sandia Corporation) 10. International Journal of Dental Materials 2020; 2(4) ISSN:2582-2209 11. https://www.bostonglobe.com/2020/04/06/opinion/post-coronavirus-how-will-we-addre ss-trauma-health-care-workers-have-suffered/

THANK YOU

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