Session Descriptions


OPENING KEYNOTE SPEAKER – Victoria Nahum

In 2006, Victoria Nahum became the face the American health care system has come to associate with the problem of health care acquired infections after 3 members of her family became infected in 3 different hospitals in 3 different states in 10 months’ time, culminating with the death of her stepson, Josh. He was 27.

Just weeks after Josh’s death, she and her husband Armando created Safe Care Campaign (www.safecarecampaign.org) to bring a sharper focus on infection prevention within the American health care environment.

Safe Care Campaign partners with health care systems, hospital administrations and frontline caregivers to remind, provoke, motivate and inspire all who work within the continuum of care of their most noble challenge and moral duty to prevent these infections that annually infect more than 1.7 million and kill more than 99,000 patients in the U.S.

The story of Safe Care Campaign’s work has been featured on many national and local television and radio programs including:

  • The Dr. Oz Show
  • The Situation Room with Wolf Blitzer
  • CNN’s The Empowered Patient
  • The CBS Evening News with Katie Couric
  • FOX News

It has also been featured in numerous articles in journals and publications including:

  • The Wall Street Journal
  • The Washington Post
  • The New York Times
  • Infection Control Today

In 2011 she wrote the book, “How to be Safe While Receiving Medical Care.” It is available in the Apple iBook store, on Amazon and at Barnes and Noble.

The same year she also produced (along with partners the CDC, The Joint Commission’s Speak Up Campaign, the Patient Channel and Kimberly Clark) a free patient safety education program now in use (called the same name as her book) in hundreds of hospitals across the U.S. and the world. This program allows patients and their families to instantly access important safety videos 24/7 at the bedside simply through the use of strategically placed posters, smartphones and QR codes. It allows patients to access safety information right when they need it without any staff time requirements, training or cost.

In 2012 Victoria was invited to work with President Obama’s Partnership for Patients as a member of the National Priorities Partnership. From her affiliation with that work she co-created H2Pi (The Healthcare and Patient Partnership Institute) along with Dr. Tim McDonald and Martin Hatlie. This institute is a free offering to hospitals wanting to engage patients and their families as well as reach the stated goals of President Obama’s Partnership for Patients.

She currently sits on the Joint Commission’s Patient and Family Safety Advisory, is a past member of the Board of Directors at Consumers Advancing Patient Safety and is part the Georgia Hospital Association Advisory Board to Prevent Infection.

Read A Mother’s Letter to a Hospital CEO, by Victoria Nahum, whose stepson Josh died from a healthcare-acquired infection.


Certification Exam Success: Improving Your Score on the CSA Medical Device Reprocessing Technician Exam
Thursday October 13, 0800-1200

Barbara Bolding, MDR Consultant

Learning Objectives: At the end of this session, participants will be able to:

  • In general terms, discuss the content (objectives) of the CSA Medical Device Reprocessing Technician certification exam.

  • Identify those objectives that are most challenging for learners who are preparing to write the exam.

  • Explain key concepts and content related to those challenging areas.

Key concepts that often pose learning challenges for CSA certification exam writers, and so may be addressed during this session include:

  • Microbiology and infection prevention

  • Selection and use of cleaning agents and disinfecting chemicals

  • Classes of chemical indicators

  • Low temperature sterilization methods

  • Flexible endoscopy anatomy and general reprocessing requirements

However, the actual content that will be presented in this interactive session will depend on the needs of the participants.

So, here’s a chance to improve your MDRT certification exam performance. Bring your questions and concerns. Be prepared to study and learn, and to leave the session with a better understanding of some of the theoretical concepts that are essential to medical device reprocessing practices (and to exam success).


What’s New with CSA Standards
Thursday October 13, 0800-1200

Colleen Landers, Weeneebayko Area Health Authority

Ian Pequegnat, STERIS Canada

Catherine Williamson, Alberta Health Services

Learning Objectives: At the end of this session, participants will be able to:

  • Summarize how the CSA standards are developed and their importance.

  • Explain how to use CSA Z314.0 Medical device reprocessing – General requirements with the other standards.

  • Explain the changes to CSA Z314.14 Selection and use of packaging (sterile barrier systems) in healthcare settings.

This presentation will review the purpose of the CSA Standards and how they are developed. The use of CSA Z314.0, Medical device reprocessing – General requirements standard with other Z314 series will be explained. CSA Z314.15 Storage, transportation, and distribution of single use and reusable medical devices changes that have occurred will be reviewed. CSA Z314.14 Selection and use of packaging (sterile barrier systems) in healthcare settings will be discussed and attendees shown how this standard has changed drastically from the old Z314.14 which only covered rigid sterilization containers.


Endoscopes & Biofilms
Friday October 14, 1030-1200

Dr. Michelle Alfa, St. Boniface Research Centre

Learning Objectives: At the end of this session, participants will be able to:

  • Describe how build-up biofilm develops in endoscopes.

  • List factors that contribute to infectious outbreaks associated with contaminated endoscopes.

  • Explain how cleaning and dry storage are critical factors in preventing biofilm development.

Recent outbreaks of multi antibiotic-resistant bacteria associated with contaminated duodenoscopes will be dissected to better understand the “Root causes” for these hospital acquired infections (HAIs). The human factors that contribute to these outbreaks will be discussed. The role of biofilm in infection transmission will be reviewed. Finally – there will be a discussion of what healthcare facilities offering duodenoscope procedures can do to reduce the risk of contaminated endoscopes and infectious outbreaks.


Endocavity Probes
Friday October 13, 1315-1415

Dr. Michelle Alfa, St. Boniface Research Centre

Gale Schultz, Winnipeg Regional Health Authority

Learning Objectives: At the end of this session, participants will be able to:

  • Describe how to reprocess endocavitary probes.

  • Discuss the risk of HPV transmission by probes.

  • List 3 ways to provide HLD for endocavitary probes.

  • Explain why probes still need HLD despite use of sheaths.

  • List the three parts of endocavitary probes and why the handle requires cleaning and HLD.

This is a joint presentation (Alfa and Schultz). Michelle Alfa will describe the issues related to contamination and inadequate cleaning and HLD of intracavitary probes, in particular the risk of HPV transmission despite use of probe sheaths. Gale Schultz will describe the practical implementation issues related to use and reprocessing of intracavitary probes.


Measuring “Competency & Quality” in Endoscopy
Friday October 13, 1315-1415

Catherine Williamson, Alberta Health Services

Learning Objectives: At the end of this session, participants will be able to:

  • Discuss Quality in Endoscopy MDR.

  • Explain Competency in Endoscopy MDR.

  • Discuss Adverse Events in Endoscopy MDR.

  • Discuss Implementation of Safe Quality Measures.

 


Decontamination and Infection Prevention & Control in Non-Hospital Reprocessing Areas
Friday October 13, 1315-1415

Barbara Bolding, MDR Consultant

Learning Objectives: At the end of this session, participants will be able to:

  • Describe key concepts of microbiology and infection prevention & control as they relate to the decontamination (cleaning) of medical devices.

  • Discuss CSA and Best Practice standards for the decontamination medical devices.

  • Describe how these decontamination standards can be applied or adapted to reprocessing areas outside of hospital settings e.g. clinics or offices.

Decontamination (cleaning) of medical devices is an essential part of the reprocessing cycle. The science of microbiology and the principles of infection prevention & control form a foundation for safe decontamination practices. This session will present a quick review of key microbiology concepts and principles of infection prevention & control as they apply to decontamination practices in non-hospital settings. It will then review specific decontamination requirements to ensure patient and staff safety in these settings.


Equipment Qualification (IQ,OQ,PQ): Demystification and a Practical Approach
Friday October 13, 1430-1530

Madeleine Patenaude, Advanced Sterilization Products, a division of Johnson & Johnson Medical Companies Canada

Learning Objectives: At the end of this session, participants will be able to:

  • Realize that regulatory bodies such as CSA are turning their attention increasingly to the area of Equipment Qualification by having clear statements in their standards.

  • Comprehend the different steps of Equipment Qualification and their implications.

  • Assume ultimate responsibility for initiating and implementing the required qualifications in a timely manner using the available and recommended resources.

  • Incorporate this process in their departmental policies and procedures as part of an ongoing Quality and Risk Management.

According to regulatory bodies such as CSA , it is recommended that specific qualifications of medical equipment be done as part of a Quality and Risk Management Program. Some parts of the qualification process should be repeated on an annual basis or following specific situations. How can it be achieved? The presentation will provide a comprehensive and practical approach to this requirement.


From Star Trek to MDRD – Replicators (3D Printers) are Making Medical Devices. Are we ready?
Friday October 14, 1430-1530

Janet Bristeir, Vancouver Coastal Health

Learning Objectives: At the end of this session, participants will be able to:

  • Discuss 3D printing as a concept.

  • Realize the range of items that can be produced by this technology.

  • Discuss the importance of validated MIFUs for these custom made items.

  • Realize the diversity of materials that can be used for these items.

This session will provide an overview of 3D printing technology – the applications it is currently being used for, and examples of the medical devices that may be manufactured with this technology in the very near future.


Making it Work in Your Medical Device Reprocessing Environment
Friday October 13, 1430-1530

Sue Lafferty, MDR Consultant

Learning Objectives: At the end of this session, participants will be able to:

  • List published standards and guidelines for design requirements for Medical Device Reprocessing (MDR) areas.

  • Explain the concept of one-way work flow.

  • Summarize the challenges and opportunities encountered within MDR areas in community settings.

Performing medical device reprocessing (MDR) activities in an office, clinic or community setting can present unique challenges. Published standards for area requirements often appear to reflect what is possible in large hospital departments and seem to be difficult to achieve in smaller spaces. Whether you are dealing with an existing space or planning for a renovation or a new MDR, there are tools to assist you. During this presentation, MDR design standards and guidelines will be reviewed and suggestions for how these can be implemented in a community setting will be discussed.


When Knowledge and Understanding is Shared, Improvements to IFU’s can be Impactful – A Case Study
Saturday October 15, 0845-1015

Dr. Rod Parker, Stryker

Learning Objectives: At the end of this session, participants will be able to:

  • Provide an overview on the current surgery practice in total knee arthroplasty.

  • Present actual time study data showing requirements of the manufacturer’s instructions for use.

  • Discuss reasons for the times, improvements for the study, and the response to the proposed improvements.

  • Explain how study data are powerful in gaining recognition for issues in medical devices and processing instructions.

This will be a session to reveal actual time study data for processing a common total knee system through the processing steps in adherence to the current instructions for use from the manufacturer. There has been a lot of attention on the importance of these instructions and regulatory bodies have cited specific non-compliance to these documents as a potential for causes of recent cases of infection and other adverse patient reports due to inadequate reprocessing. This session will provide a look into why so many sets are needed, the cause of the increases in set numbers, the actual time required to follow the instructions and some reasons why the times many be longer than needed. The focus will show challenges in a reprocessing department and the manufacturers validation requirements and practices. It will conclude with suggestion how each of these critical areas can learn and communicate for the improvement of these documents in the future. Following the presentations attendees are encouraged to formulate studies where data can be used to better demonstrate their primary issues with more manufacturer’s instructions, today and for the future.


The Development of Instructions For Use and How We Can Ensure They Are Being Followed
Saturday October 13, 1445-1545

Gerald McDonnell, DePuy Synthes Companies, Johnson & Johnson

Sherryl Merritt, University Health Network

Learning Objectives: At the end of this session, participants will be able to:

  • Provide an overview on the current standards and guidelines for the development, validation and approval of instructions for use.

  • Outline an example of the validation of instructions for use.

  • Discuss best practices for to compliance to instructions for use and future implications for central processing.

This will be an interactive session to discuss the challenges in the development, validation and use of instructions for use for device processing. Instructions for use are an important link between manufacturers and reprocessing departments to ensure patient safety with reusable instrumentation and devices. There has been a lot of attention on the importance of these instructions just to recent cases of infection and other adverse patient reports due to inadequate reprocessing. This has led to an increased focus on improving device design, development of instructions for use and compliance with these instructions in healthcare facilities. This session will provide an update on the development of ISO and regional standards/guidance on instructions for use and device reprocessing requirements. An example of a typical approach for the development and validation of instructions for use will be provided from the manufacturer’s perspective. The impact of these instructions from use, how they can be employed at a facility as part of a standardized process and challenges in a reprocessing department will be presented. Following the presentations attendees are encouraged to participate in the debate and provide their experiences and perspectives for the future.


Reprocessing of Reusable Medical Devices Standards
Saturday October 13, 1445-1545

Janice McVeety, Accreditation Canada

Learning Objectives: At the end of this session, participants will be able to:

  • Explain the role of Accreditation Canada.

  • Describe how the standards for Infection Prevention Control and Reprocessing of Reusable Medical Devices relate to one another.

  • Describe the Reprocessing of Reusable Medical Devices standards revision process.

  • Identify the revisions to the Reprocessing of Reusable Medical Devices standards.

  • Identify challenges for quality improvement in Reprocessing of Reusable Medical Devices.

The presentation provides an overview of Accreditation Canada and the processes used to revise and develop accreditation standards. The Infection Prevention and Control standards and Reprocessing of Reusable Medical Devices standards are compared and how the standards are applied to different organizations is explained. The recent revisions to the Reprocessing of Reusable Medical Devices standards are presented. The presentation concludes with an overview of strengths and areas for improvement in Reprocessing of Reusable Medical Devices.


Table Top Sterilizers – 10 Common Practices that are not Best Practices!
Saturday October 13, 1445-1545

Chuck Hughes, Crosstex/SPSmedical Supply Corp.

Learning Objectives: At the end of this session, participants will be able to:

  • Discuss why compliance with best practices is so important when reprocessing reusable medical devices.

  • Identify common errors when reprocessing reusable medical devices in table top steam sterilizers.

  • Recommend solutions to these common errors based on documented “best practices”.

This presentation emphasizes the need for users of table top sterilizers to know and follow “best practices” for safe patient care. Common errors are discussed, along with solutions based on national standards.


Reprocessing of ‘Single-Use’ Orthopaedic Implants: A Study on the Effects of Repeated Reprocessing of Single-Use Screws in Screw Caddies
Saturday October 15, 1600-1715

Terry McAuley, Director STEAM Consulting Pty Ltd.

Learning Objectives: At the end of this session, participants will be able to:

  • Define the terms ‘single-use’, ‘open but unused’ and ‘single patient use’.

  • Explain the risks and benefits of placing ‘single-use’ implants in screw caddies.

  • Discuss the rates of contamination, deterioration and corrosion as observed on control screws versus reprocessed screws.

There has been strong resistance from Australian clinicians to moving towards the use of individually packaged and sterilised plates and screws and elimination of the use of screw caddies. Clinicians claim lack of evidence that current practices are sub-optimal and that a change in practice poses more risk to patient safety through prolonged surgical procedures and increased risk of post-operative infection.
The aim of this study was to establish whether reprocessed ‘single-use’ screws showed any differences in rates of contamination, corrosion, deterioration or damage when compared to new screws. The results demonstrated that reprocessed single-use screws showed increased rates of contamination, corrosion, deterioration and damage and this could be correlated to increased exposure to reprocessing cycles.


Day to Day Problems/Solutions (Hot Topics) / Problèmes/solutions au jour le jour
Sunday, October 16, 0845-0945

Michelle Davis, Eastern Health

Dalyce Fredette-Percy, Portage District General Hospital

Andrée Pelletier, Institut national de santé publique du Québec

Samantha Shone, Vancouver General Hospital

Objectifs d’apprentissage : Lors de cette séance, vous :

  • Acquérir une expertise scientique en matière de retraitement des dispositifs médicaux.

  • Développer une capacité d’évaluation des problèmatiques rencontrées en retraitement des dispositifs médicaux.

  • Mettre à jour les connaissances en matière de retraitement des dispositifs médicaux.

Cette conférence abordera les problèmes/solutions au jour le jour en retraitement des dispositifs médicaux (RDM) en lien avec les activités du Centre d’expertise en retraitement des dispositifs médicaux: le mécanisme décisionnel pour résoudre les problèmes reliés aux retraitements des dispositifs médicaux ainsi que les moyens de communication mis en place pour faciliter la résolution de problèmes. On présentera également un aperçu sur la formation et les documents relatifs au RDM.


Monitoring of Cleaning Effectiveness Advantages & Disadvantages
Sunday, October 16, 1000-1100

Dr. Michelle Alfa, St. Boniface Research Centre

Learning Objectives: At the end of this session, participants will be able to:

  • Discuss why monitoring cleaning compliance of housekeeping staff can reduce HAI rates in healthcare.

  • Describe at what stage in reprocessing of flexible endoscopes where rapid monitoring is appropriate.

  • Discuss the pros and cons of monitoring environmental cleaning and medical device cleaning.

Monitoring of cleaning compliance has a cost and it is sometimes unclear whether healthcare facilities should implement such processes. The role of the healthcare environment as a reservoir for infection transmission has been well proven but how to best monitor of cleaning compliance is controversial. Furthermore, monitoring cleaning of flexible endoscopes using rapid methods is also controversial. This presentation will discuss the issues relevant to cleaning monitoring, review the published data and discuss the pros and cons of implementation of such processes.


Routine Monitoring of Tabletop Steam Sterilizers in Non-Hospital Settings
Sunday, October 16, 1000-1100

Barbara Bolding, MDR Consultant

Learning Objectives: At the end of this session, participants will be able to:

  • Describe 3 ways in which table top steam sterilizers should be monitored.

  • Identify users’ responsibilities for each monitoring method.

  • Describe how to construct a biological indicator process challenge device (BI PCD) appropriate for the type of load that is being sterilized.

  • State how to incubate, read and record the results of a biological indicator test.

Routine monitoring of steam sterilizers includes observations of displays and gauges on the sterilizer, the use of chemical indicators in and on wrapped packages that are being sterilized, and regular tests of the sterilized load that demonstrate biological kill. This session will explain the routine monitoring observations and tests that users must perform when using a table top steam sterilizer.


Closing Keynote Speaker: Medical Device Reprocessing… What is my purpose? Is it worth it?
Sunday, October 16, 1115-1215

Dr. Wava Truscott, Truscott MedSci Associates, LLC.