New Lungs for SimBaby!


We are pleased to announce that the  ASL 5000 Lung Solution  will soon be compatible with Laerdal’s new SimBaby. This will enable you to use the new SimBaby to conduct advanced ventilator management training in anesthesia, critical care, emergency medicine, pulmonology, and respiratory care.

With the ASL 5000 Lung Solution, SimBaby can breathe spontaneously while being ventilated and hold PEEP at any clinically relevant level. You can use any ventilator and any ventilator mode, including NIV. Resistance and compliance are minutely adjustable, allowing you to simulate a vast number of patient disease states. This will allow you to teach mechanical ventilation topics such as:

  • Managing IRDS and RSV
  • Adjusting the ventilator in response to a change in patient condition
  • Identifying and resolving patient-ventilator dysynchronies

Developed in collaboration with Laerdal, the popular ASL 5000 Lung Solution is currently compatible with SimMan®, SimMan 3G Trauma, SimMan Essential, and SimMan Essential Bleeding.

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SimMan® is a registered trademark of Laerdal.

IngMar Medical ISO 9001:2015 Certified

IngMar Medical is proud to announce that our Quality Management System has been successfully re-certified to ISO 9001 compliance by TÜV Rheinland  (Registration Nr. 74 300 3727). Certification is to the newest version of the standard, ISO 9001:2015.

The scope of registration is the “Design, Manufacture, Calibration, System Training, Consulting and Worldwide Distribution of Respiratory Simulation Devices and Systems.”

“Our certification to the new ISO 9001:2015 means that our customers can rely on our commitment to quality,” said Dr.-Ing Stefan Frembgen, President of IngMar Medical. “We are proud to have reached this milestone a year ahead of required compliance.”

Stefan Frembgen, Dr.-Ing, President, IngMar Medical proudly announces ISO 9001:2015 certification.
Stefan Frembgen, Dr.-Ing, President, IngMar Medical

ISO 9001:2015 is an internationally recognized standard for quality management. Complying with the rigor of this standard helps ensure that customers get consistent, high quality products and services. Annual audits are required to maintain certification.

IngMar Medical’s Calibration Lab is accredited by A2LA to ISO/IEC 17025:2005 (Certificate Nr. 4172.01). To learn more about calibration, click here.

ISO Standards and Requirements for Test Lungs

IngMar Medical’s high-fidelity ASL 5000 Breathing Simulator meets or exceeds the requirements for test lungs used for volume testing as specified in the following standards:

  • ISO 80601-2-12:2011 (Critical Care Ventilators)
  • ISO 80601-2-13:2011 (Anesthetic Workstations)
  • ISO 10651-6:2004 (Home Care Ventilatory Support Devices)
  • ISO 10651-3:1997 (Emergency and Transport Ventilators)

IngMar Medical 17025 Accredited

IngMar Medical is proud to announce that our calibration lab has been accredited by A2LA to ISO/IEC 17025:2005 (Certificate Nr. 4172.01). This accreditation demonstrates technical competence for a defined scope and for the operation of a laboratory quality management system.ilac-mra-a2la-accredited-symbol-4172-01

Confidence in Testing

Accreditation to 17025 provides third-party confirmation that you can be confident in your results when using IngMar Medical’s ASL 5000 Breathing Simulator for your critical research, development, and quality testing.

Laboratories that are accredited to this international standard have demonstrated that they are technically competent and able to produce precise and accurate test and/or calibration data. In fact, ISO/IEC 17025 is the single most important standard for calibration and testing laboratories around the world.

Moreover, as part of accreditation, our laboratory’s quality management system is thoroughly evaluated on a regular basis by A2LA, a highly respected third-party accreditation body. This ensures continued technical competence and compliance with ISO/IEC 17025.

Other Relevant ISO Standards

IngMar Medical is ISO 9001:2015 Certified (Registration Nr. (74 300 3727).

The ASL 5000 Breathing Simulator meets or exceeds the requirements for test lungs used for volume testing as specified in the following standards:

  • ISO 80601-2-12:2011 (Critical Care Ventilators)
  • ISO 80601-2-13:2011 (Anesthetic Workstations)
  • ISO 10651-6:2004 (Home Care Ventilatory Support Devices)
  • ISO 10651-3:1997 (Emergency and Transport Ventilators)

 

IngMar Medical Recertified to ISO 9001:2008

IngMar Medical’s Quality Management System has been recertified to ISO 9001:2008 compliance by TÜV Rheinland (Registration Nr. 74 300 3727).

The scope of registration is the “Design, Manufacture, Calibration, System Training, Consulting and Worldwide Distribution of Respiratory Simulation Devices and Systems.”

“Customer satisfaction and continuous improvement are key principles for our company. This recertification validates our progress,” said Dr.-Ing Stefan Frembgen, President of IngMar Medical. “We are proud of our entire team’s commitment to the Quality Management System.”

Stefan Frembgen, Dr.-Ing, President, IngMar Medical
Stefan Frembgen, Dr.-Ing, President, IngMar Medical

Planning is already underway to transition to the ISO 9001:2015 standard well before the 2018 deadline.

ISO 9001:2008 is an internationally recognized standard for quality management, designed to help organizations ensure that they meet the needs of customers and other stakeholders. Over one million organizations worldwide are certified to ISO 9001:2008.

Annual audits are required to maintain ISO 9001:2008 certification, which is based on eight quality management principles to help improve organizational performance including customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact-based decision-making, and mutually beneficial supplier relationships.

ISO Standards and Requirements for Test Lungs

IngMar Medical’s high-fidelity ASL 5000 Breathing Simulator meets or exceeds the requirements for test lungs used for volume testing as specified in the following standards:

  • ISO 80601-2-12:2011 (Critical Care Ventilators)
  • ISO 80601-2-13:2011 (Anesthetic Workstations)
  • ISO 10651-6:2004 (Home Care Ventilatory Support Devices)
  • ISO 10651-3:1997 (Emergency and Transport Ventilators)

Is Simulation Training Effective for Ventilator Management?

Residents could touch and manipulate ventilators to develop familiarity and reduce anxiety - without putting patients at risk.
Simulation training lets medical residents practice ventilation management skills…without putting patients at risk.

Simulation training has been shown to be an effective method for medical education. But what about mechanical ventilation management specifically? A recent study at Summa Health System in Akron, Ohio, looked at the effectiveness of a mechanical ventilation boot camp for first year medical residents in surgery and emergency medicine.

The Summa Health study found that the boot camp was effective in increasing competency, knowledge, and confidence with ventilator management.

The three-day training incorporated hands-on scenarios using human patient manikins connected to IngMar Medical’s ASL 5000 Breathing Simulator.

“The ASL 5000 is the only simulator on the market that can manifest the wide variety of pathologic states necessary to provide cutting-edge training to my residents and fellows.“

Rami A. Ahmed, DO, FACEP, Simulation Medical Director, Summa Health System.

In addition to hands-on simulation, other didactic elements were used including: independent reading, a focused PowerPoint presentation, personalized feedback, and a supportive learning environment.

Learners were given identical pre- and post- intervention assessments in the course of the three-day training.

Three-Day Mechanical Ventilation Simulation Curriculum

Day 1: Pre-intervention Evaluation

  • Pre-test confidence survey (5 minutes)
  • Pre-test cognitive multiple-choice exam (25 minutes)
  • Cases and evaluation by critical actions checklist (10 minutes each for 30 minutes total)
    • ARDS
    • Complete lung atelectasis secondary to mucus plugging
    • Pneumothorax in a mechanically ventilated patient
  • Distribution of supplemental readings for independent study (estimated 4 hours of reading)

Day 2: Curriculum and Educational Intervention

  • Case structure:
    • Two to three residents participated in the case (10 minutes)
    • Evaluation by critical actions checklist (evaluated during case)
    • Bedside debriefing by intensivists (20 minutes)
    • PowerPoint presentation review (15 minutes)
  • Pathology reviewed:
    • ARDS
    • Complete lung atelectasis secondary to mucus plugging
    • Altered mental status secondary to overdose
    • Pneumothorax in a mechanically ventilated patient
    • Dynamic hyperinflation

Day 3: Post-intervention Evaluation

  • Post-test confidence survey (5 minutes)
  • Post-test cognitive multiple-choice exam (25 minutes)
  • Cases and evaluation by critical actions checklist (ten minutes each for 30 minutes total)
    • ARDS
    • Complete lung atelectasis secondary to mucus plugging
    • Pneumothorax in a mechanically ventilated patient

Results: 

The post-test evaluation found significant increases in cognitive knowledge, clinical performance, and confidence.

“This study demonstrates the feasibility and effectiveness of a boot camp curriculum for residents on the basics of mechanical ventilation.“

The increase was attributed to numerous factors including the utilization of multiple teaching methodologies to accommodate different learning styles, the supportive learning environment, personalized feedback, and the opportunity for residents to touch and manipulate the ventilators to develop familiarity and reduce anxiety.

Read the full study.

Using Simulation to Predict Aerosol Drug Deposition in Humans

 

Michael Hindle, PhD.
Michael Hindle, PhD.
Peter R. Byron, PhD.
Peter R. Byron, PhD.

More realistic device testing in the lab can save valuable time on clinical trials. A research team at Virginia Commonwealth University’ s School of Pharmacy led by Peter Byron and Michael Hindle is using realistic mouth, throat, and airway models, coupled with the realistic breathing profiles of the ASL 5000 Breathing Simulator to investigate the relationship between in vitro experimental aerosol drug deposition and in vivo drug deposition behavior in patients. Read the full story.

Ventilator Asynchrony Workshops

Patient-ventilator synchrony is a key concern in respiratory care. With sponsorship from IngMar Medical, Pulmonary Critical Care Specialist Eric Kriner will demonstrate how to identify and resolve asynchrony during several workshops at regional and state respiratory conferences over the next eight months.

“The problem of patient-ventilator asynchrony is complex. The ability to recognize the problem requires a strong knowledge of ventilator waveforms. The ability to fix the problem requires a strong knowledge of how every set parameter controls each portion of the respiratory cycle.”

Eric Kriner BS, RRT; Pulmonary Critical Care Specialist at MedStar Washington Hospital Center in Washington, D.C.

Kriner uses IngMar Medical’s ASL 5000 Breathing Simulator to create the patient waveforms he uses to teach recognition and correction of patient-ventilation asynchrony.

IngMar Medical’s ASL 5000 Breathing Simulator was used to generate these waveforms that simulate a trigger dysynchrony.

Click here for information on how to simulate a patient-ventilator asynchrony using the ASL 5000 Breathing Simulator.
Click here to view a short webinar on patient-ventilator dysynchrony.

You can catch one of Kriner’s workshops at the following conferences:

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Eric Kriner

Eric Kriner (BS, RRT) is a pulmonary critical care specialist at MedStar Washington Hospital Center in Washington, D.C.

Eric Kriner instructs Pulmonary/Critical Care Fellows at MedStar Health's SiTEL in Washington, DC.
Eric Kriner instructs Pulmonary/Critical Care Fellows at MedStar Health’s SiTEL in Washington, DC.

At Medstar, Eric oversees the management of all mechanically ventilated patients; sits on numerous hospital-wide committees (ECMO, organ donation, emergency airway); and is responsible for the clinical practice and policy of the Respiratory Care Department.

He is also responsible for the educational advancement of the respiratory care staff, nursing, physician assistants, use practitioners, as well as the resident and fellow physician staff. In that capacity, Eric wrote and implemented a live lecture and simulation-based curriculum for Advanced Mechanical Ventilation consisting of 39 hours of lecture and over 40 mechanical ventilation and critical care clinical simulations. This program is now used in part by the Pulmonary Services Department, Pulmonary Critical Care Fellowship, Medical Resident and Emergency Medicine programs.

In 2015, Eric presented at 14 state conferences on the topic of patient-ventilator dysynchrony. Several of the conference presentations were mechanical ventilation clinical simulation workshops. He is also on faculty for the Mid-Atlantic Pulmonary Critical Care Fellows Education collaborative, lecturing on patient-ventilator dysynchrony, mechanical ventilation in ARDS and APRV, High Frequency Oscillatory Ventilation, non-invasive ventilation, and oxygenation support using high flow nasal oxygen. As faculty, he also writes and precepts dozens of mechanical ventilation clinical simulations.

In 2012 Kriner was awarded the Acute Care Specialty Practitioner of the Year by the American Association for Respiratory Care. Previously Eric served as Director of Clinical Education for the Respiratory Therapy program at prince George’s Community College. He continues to serve there as the chair of the Respiratory Therapy Medical and Curriculum Advisory Committee. Eric holds a BS in Respiratory Therapy from Salisbury University.

The Need to Standardize Training in Ventilation Management

The lack of standardized nomenclature for ventilator modes complicates clinical care and puts patients at risk. One popular textbook lists 298 mode names on 36 ventilators in the US alone. There is a great deal of confusion around these many names. Sometimes different ventilator manufacturers use different names for the same mode, but sometimes the same mode name can mean different things on different ventilators – and patients respond differently. Advanced ICU ventilators have features which can actually transform a mode into a different mode completely, without a change in the name to mark the transition.

Thus memorizing a list of mode names and parameters is not enough. Clinicians must understand the principles behind the names. Until now, there has been no standardized training program that would help clinicians understand and properly use all modes of ventilation.

Robert Chatburn et al. have created a “Taxonomy for Mechanical Ventilation: Ten Fundamental Maxims” as a tool to develop the ability to identify, classify, and compare all modes of ventilation. This system been adopted by two leading general respiratory care textbooks and has passed many peer reviews in medical journals. Learn more.

IngMar Medical will soon be releasing Taxonomy for Mechanical Ventilation Curriculum Modules to teach these ten  maxims through hands-on skills practice with the ASL 5000 Breathing Simulator and a ventilator.  The hands-on skill practice not only helps connect knowledge and psychomotor skills, it also provides an experience closer to the situation the clinician will experience when they need to apply their skills. Learners can experiment with different ventilator settings without putting patients at risk.

“Real-Patient” Simulation Helps Transition to Home Care Ventilator

Transitioning a patient from an ICU ventilator to a portable home care ventilator can be a challenging process involving between 24 and 96 hours of trial and error at the bedside. Respiratory therapists at Akron Children’s Hospital have improved this transition by using “real-patient” simulation. The process involves downloading information from the patient’s ICU ventilator to the ASL 5000 Breathing Simulator to create a model of the pulmonary characteristics of the individual child. The respiratory therapist can then experiment with the simulated patient to determine the ventilator and the settings which optimize the patient/ventilator interaction.

The “real-patient” simulation process takes a few hours working with the ASL 5000 followed by approximately an hour tweaking ventilator settings at the bedside. Read the full story.