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Dechoker's Road to MDSAP Certification

July 23, 2021

Dechoker's Road to MDSAP Certification

MDSAP,  or the Medical Device Single Audit Program, is a program that “ allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements.”  Medical device manufacturers, like Dechoker, are rigorously audited by MDSAP for compliance with both standard and regulatory requirements. In the medical device industry, MDSAP, is the best global certification you can have. The DeChoker® device  hopes to achieve this certification within the next 6 months.


Dechoker® takes this process extremely seriously as they constantly, and consistently strive to provide the highest quality and efficacy in their product.  The main mission has, and will always be, to SAVE LIVES.


The process of manufacturing a life-saving device has sometimes been a long and arduous one. Through all of the ups and downs, the Dechoker® device keeps bettering their product, and their team, from Quality and Risk Management to Marketing.  They understand their role, and aspires to make the Dechoker the best globally compliant product it can be.


This month, Dechoker LLC is pleased to welcome Kaitlyn, their new Quality Engineer, with an acute expertise in Risk Analysis and Validation Protocol.With a Biological Engineering emphasis from the University of Georgia, as well as a Masters of Business Administration, with a Concentration in Healthcare Administration from Texas A&M University, Kaitlyn is a skilled and versatile Quality Engineer with an acute expertise in Risk Analysis and Validation Protocol. She is American Society for Quality (ASQ) Certified Biomedical Auditor (CBA)  and American Society for Quality (ASQ) Certified Six Sigma Green Belt (CSSGB).  She will act as Dechoker’s Risk Management / Procedures and Validation Specialist.


The University of South Wales is currently performing several studies involving Dechoker.  One will be a retrospective analysis of the over 176 lives known and documented to have been saved thus far by the Dechoker® devce which will be prepared for publication in the near future.  Another will be a prospective study starting on July 1, 2021, which will include all patients rescued by Dechoker after this date.  The prospectively studied patients will complete an online data collection form to better document the situation, what they choked upon, concurrent medical conditions, outcomes and any complications of using the device.  Data will be collected for 18 months, and publication of this data will occur upon completion of the study. 


This University of South Wales study comes in advance of an International Liaison Committee on Resuscitation (ILCOR) global study which will, among other things: “ monitor and reporting incidence, process of care and outcomes to improve patient care, conduct “Rigorous and continuous review of scientific literature focused on resuscitation, cardiac arrest, relevant conditions requiring first aid, related education, implementation strategies and systems of care” and lead “ the international resuscitation research agenda to address gaps in knowledge and promote funding related to resuscitation and relevant first aid practices” ( ref: ILCOR website)


John Tipton, Lead Engineer at The Global Center for Medical Innovation, 575 14th St. NW., Atlanta GA 30318, led pressure testing on the Dechoker® airway clearance device on December 16, 2019.  The study team tested 3 different scenarios, bread in the upper airway, bread in the lower airway, and hot dogs in the airway.  Pressures during the test were continuously measured by sensors in the mouth, upper airway, and lower airway in two cadavers.  The DeChoker was tested eight times, four with a hot dog causing airway obstruction, and twice each with bread in the upper and lower airway.  Two tests were performed using abdominal thrusts to try to clear hot dog airway obstructions and one test with abdominal thrusts to clear an airway obstructed by bread. Chest compressions were used to try to clear airway obstructions in three scenarios, one obstruction from a hot dog and two obstructions from bread.  Bronchoscopy was used to evaluate the airway for clearance of the obstruction following either the use of the the Dechoker® device or the use of either chest compressions or abdominal thrusts. Pressures were continuously recorded from the mouth, upper, and lower airway during the abdominal thrusts and chest compressions as well. The Dechoker® device generated substantially more pressure than the chest compressions or the abdominal thrusts.

 

Medical experts, such as Dr. Christopher Rumana, believe that the increased pressures generated by the Dechoker® device will result in a higher rate of clearance of the airway with Dechoker as compared to traditional methods of treating choking victims and a greater number of lives saved.  

 

Another successful study of the use of Dechoker® devices to treat choking victims occurred in adult care homes in the United Kingdom, a setting equivalent to nursing homes in the US. Dechokers were supplied to four adult care homes and the staff was trained in their use.  The Dechoker® device was used 27 times over 18 months, with patients ranging in age from 45-101 years (mean = 80, mode = 86, median = 84).  In 26 of the 27 cases the DeChoker successfully removed the obstruction, and in the other case the DeChoker partially removed the obstruction and opened the airway, with the choking victim being able to cough out the remaining obstruction.  


Twenty one of the 27 patients did not require a trip to the emergency room, and of the six who did go to the ER, 4 were promptly discharged and the two that were not discharged were admitted specifically for their care plan to be updated.  Two complications were reported, both felt to be minor.  One involved some trauma to the lip when the victim clamped her mouth shut and force was used to open her mouth for Dechoker insertion, the other involved a victim who had dentures and bit her tongue as she began to choke and it was unclear if the DeChoker had exacerbated the bleeding at all.  Overall, the device was felt to be simple and easy to use by the staff of the care homes and was a comfort to have available for the treatment of choking.    

Dechoker LLC is committed to its growth and intends to continue to produce a top-quality, anti-choking device that will save lives. Dechoker LLC will always step-up to the challenges of making a better product, learn from the processes and studies surrounding the quality of their medical device and share information with the general public. Inventor and CEO, Alan Carver adds, ”We would rather not have any issues, but that is not the real world.  On the other hand, issues make us better and more productive and keep us climbing high to avoid them.  Always be gracious and kind. That is true success.” 


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