Towards crucial oral care of long term bed ridden elderly -Need for a medical device 4th WHO Global Forum on Medical Devices, Vizag, India , 15th December 2018, 14.30 PM Dr. Steward Gracian BIRAC SIIP Fellow 2018-19 KIIT TBI, Bhubaneswar

Sufficient evidence to link HAP and the importance of oral care

Literature evidence- Preventive effect of Oral Hygiene on Pneumonia in Elderly - J Am Geriatr Soc. Nov 2008 (Systematic review by Sjogren P et al): Mechanical oral hygiene has a preventive effect on mortality from pneumonia, and non-fatal pneumonia in hospitalized elderly - JADA. Sept 2010 (Ralph Rosenblum Jr) : Mechanical Oral hygiene practices reduces the progression of respiratory disease in high risk elderly. It may prevent the death of 1 in 10 elderly residents from health care associated pneumonia (1). - J Am Geriatr Soc. Sept 2016 (Systematic review by Sjogren P et al): Oral care interventions given by dental personnel may reduce mortality from HAP whereas oral care interventions given by nursing personnel probably result in little or no difference from usual care - Cochrane Oral Health Group review 2018: Professional oral care may reduce the risk of pneumonia-associated mortality compared with usual oral care at 24-month follow up (this finding must be considered with caution)

Clinical Guidelines and Recommendations - CDC 2003 Guidelines for the Prevention of HAP state that all patients in acute care settings or residents in long term care facilities should receive comprehensive oral care - International Nosocomial Infection  Control  Consortium (INICC) and National Infection Control  Guidelines (India 2017) recommend comprehensive oral care  in  Pneumonia  prevention protocols. -American Nurses Association (2012) recently updated their Oral Care protocol and their nurse led oral care initiative as part of HAP prevention initiative (HAPPI) reduced NV-HAP incidence by 60%.  

Existing Innovations for Oral Care of Bed ridden Elderly Modified Handle tooth brush (Self-use) Suction Tooth Brushes (Recommended) Automatic tooth brush and Water Floss Gaps in existing solution: Bio film removal efficiency is completely dependent on the caregiver's efforts and attitude towards Oral hygiene/Mouth care.

Need assessment process(5) Generic Standards & Examples - Need in Long term care - Suction tooth brush (recommended) Prioritized need Prioritization Baseline data - 8 million bed ridden/ homebound elderly (3,4) -Overburdened nurses -Critical to follow prevention protocol for HAP - Limited focus area in recent Medical device innovations Overall Need Budget Analysis Analysis Need Statement: An effective way to provide better Oral Hygiene and Care in bed ridden elderly patients to prevent the associated complication of Aspiration Pneumonia.

Immediate need for an assistive Oral Care Device - Smart, assistive, automated devices with elderly specific designs (esp. for bed ridden elderly) - Efficient removal of Oral Bio film to prevent associated respiratory problems - Less dependant on the caregiver or the nurses (wearable technology) - Simple and non cumbersome to use - Affordably priced for urban and rural customers - Clinically Tested and Validated on Bed ridden elderly   Crucial factors - Common Medical Conditions/Limited Movement/ Dry Mouth - Polypharmacy - Caregiver's psychology

Stakeholders and Business Models   Critical Stakeholders Why should they associate? Bed Ridden Elderly Less dependancy on Caregiver. Prevents complication associated with negligent care Care givers / Nursing care professionals Reduces the burden associated with repeated manual oral care for elderly Hospitals/Long term care facilities/Doctors Better Oral Care for bed ridden elderly. Offers a new business model Business to Business (B2B) - Hospitals or long term care homes as customers Business to Customers (B2C) – Elderly patients as customers

Medical device category of proposed solution   Based on the recent Guidance document (4) published by Indian Pharmacopoeia Commission, the proposed solutions may fall under the following medical device category, Class B- Invasive (body orifice) Medical Device- Intended for use in an Oral Cavity as far as the pharynx- Intended to be connected to active medical device. According to a WHO report on Medical Device regulation & reforms in India, for Class B devices the general regulatory requirements for approval of Product are as listed below: 1. QMS (Quality Management System) 2. Electrical Safety/EMI/EMC testing data 3. Risk Analysis report 4, Device Master file 5. Biocompatibility data [Class B Medical Device- Low Moderate Risk]

References 1. Ralph Rosenblum Jr. Oral Hygiene can reduce the Incidence of and Death Resulting from Pneumonia and Respiratory Tract Infection; JADA 2010 Sept; 141(9):1117-1118 Available from: https://doi.org/10.14219/jada.archive.2010.0342 2. Dey A.B, Srinivas T, Vanessa S, Nicholas P. Long-term Care of Older Persons in India; SDD-SPPS Project Working Papers Series 2016; 22-25. Available from: https://www.unescap.org 3. Ministry of Statistics and Programme Implementation. Situation analysis of Elderly in India; 2011 June; Central Statistics Office, Government of India. 4. Kumar, D., Yadav, V. and Mathewson, M. A . New Regulatory Paradigm for Medical Devices in India; Regulatory Focus. November 2017; 4-6 5. http://apps.who.int/medicinedocs/documents/s21562en/s21562en.pdf  

Disclosure THANK YOU Source of Funding: This Project is undertaken as part of the 18 month Social Innovation Immersion Program (SIIP) on ‘Ageing and Health’ funded by Biotechnology Industry Research Assistance Council (BIRAC) facilitated by KIIT Technology Business Incubator(TBI) under KIIT University, Bhubaneswar Conflict of Interest: NIL   Contact me at : Dr.Steward Gracian stuvia2j@gmail.com +91-99407 87153 THANK YOU