Workshop Organizer: Gary H. Harding, SrMIEEE, Greener Pastures LLC

Speakers:

Alice L. Epstein, MHA, CNA Financial Corporation, Chicago IL
Robin Maley, BSN, MPH, Maley Healthcare Strategies, Inc., NY, NY
Jasjit S. Suri, PhD., Biomedical Research Institute, Idaho & Biomedical Technologies, Inc.

Abstract:
Movement of the diagnosis of disease and provision of health care out of the acute care environment into increasingly less sophisticated environments is important to cost containment and meeting the public interest.  However, advances in technology will be needed and should be accomplished in a practiced and safe manner.  This session provides a discussion of the Distributed Diagnosis and Home Healthcare (D₂H₂) Network as a base for exploring how health care is provided and how services may migrate in the near future.  It subsequently provides a discussion of the characteristics of both patients and technology users, for these are the individuals for whom emerging technologies must be designed. Designers can gain an understanding and perspective of the special characteristics of people and the environments in which technologies will need to function.
Important milestones in developing and introducing emerging technologies into the D₂H₂ Network will be identified and discussed.  Designers and others responsible for creating new technologies or adapting old technologies for new applications can find a framework for how to approach the task.  A discussion of current and near future areas of emerging technologies where strides must be made to innovate and improve will be provided.  Methods for identifying needs and determining emerging technologies in the pipeline will also be discussed.

Part I - What is the Distributed Diagnosis and Home Health Care (D₂H₂) Network

Financial and other drivers are pressuring the clinical health care system in the United States to move care into increasingly lower levels of care facilities with shorter and shorter stays and less support.  Then too, the public interest is in least invasive care in locations convenient to them.  Similarly, advances in technology are providing increasing opportunities to enhance both of the above.
Attendees will be provided with an understanding of the hierarchy of health care:  

• What are acute care facilities, how are they organized and why are they necessary;
• Historically, how has diagnosis and care moved from a base in acute care facilities to freestanding clinics, physician’s offices, long term care facilities and even the home;
• What have been and are currently the drivers to move from a higher level of care to a lower level of care for the same diagnostic or treatment procedure.

Attendees will gain an understanding of the governmental and other entities that recognize and affect the D₂H₂ Network.

Part II - Provider and Patient Demographic Implications for Device Design

The Institute of Medicine found in 2004 that nearly half of all American adults - 90 million people--have difficulty understanding and using health information. Health literacy includes reading abilities, writing, listening, speaking, arithmetic, and conceptual knowledge. Health literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand basic information regarding their health.

At some point, most individuals will encounter health information they cannot understand. For equipment to be safe and effective, when used in the home care setting – it must be simple to understand, easy to use, and not prone to user or caregiver over-rides. One notable university teaching hospital suggests that the instructions provided with infant car seats can not be comprehended by more than half the parents and suggests that all health care information to be processed by patients and nonprofessional providers be written at the sixth grade level. Device design elements must take into consideration the health literacy rates of Americans.

The D₂H₂ Network services are unique in that they are provided in both clinical (physician office, clinic, etc.) and non-clinical, non-managed (i.e., the home) settings. Surroundings differ from case to case. Some clinics and homes are neat and pleasant, whereas others are untidy and depressing. Some patients are pleasant and cooperative; others are angry, abusive, depressed, or otherwise difficult. The services can be self-administered or provided by trained professionals, paraprofessionals, and volunteers. Services for the treatment of medical conditions usually are prescribed by an individual's physician. Supportive services, however, do not require a physician's orders.

Health care devices within the home care setting might be managed by the patient, family member or even a non-licensed paraprofessional such as:

• home care aide/home health aide
• certified nursing aide
• homemaker
• chore worker
• companion/sitter
• volunteer

No prior work experience or high school diploma may be necessary for any of the positions listed above. In some States, the only requirement for employment is on-the-job training. Other States may require formal training, which is available from community colleges, vocational schools, elder care programs, and home health care agencies.

According to the National Bureau of Labor personal and home care aides held about 700,000 jobs in 2004. The median hourly earnings of personal and home care aides were $8.12 in May 2004. The lowest 10 percent earned less than $5.93, and the highest 10 percent earned more than $10.87 an hour. 

One job source web site portrays the career and job highlights for nursing and home health aides as:

• modest entry requirements,
• little pay,
• high physical and emotional demands,
• high turnover rates creating a workforce of novice caregivers, and
• few promotion opportunities.

The non-hospital based patient care environment has similar patient and provider demographics, although the provider training is somewhat better. Patient health literacy is still an issue, especially if the patient is required to be monitored or treated while at home or while ambulatory. The devices and user instructions must meet the low literacy demands of the populace.

The proficiency and training of health care providers is variable. While these outpatient-type settings may employ trained health care professionals, they may also employ medical assistants (certified and non-certified), “grandfathered” technicians, as well as those without a high school diploma whose only training is on-the-job.

The challenges to the D₂H₂ industry are the identification of limitations and obstacles inherent with a patient population in control of their surroundings and a workforce that varies in training, skills and competencies.

Part III - Characteristics Important to Emerging Medical Device Technology

Having gained an understanding of the people who will make use of emerging medical technologies in the D₂H₂ environment, it is important to create a bridge to understand how this can and should factor into device design.  In this Part, attendees will be provided with an understanding of the importance of application of human factors engineering practices to ensure eventual safe introduction and use of a product.  They will also be provided with a discussion of the environmental factors (e.g., lighting, electrical services and outside sources) that must be addressed.

Regulatory and similar practice guidelines in human factors engineering and environmental factors will be presented and discussed.  Products with inherent flaws in, for example, human factors engineering that have led to user error will be provided.  Products that have failed in the environment of use, for example as a result of electromagnetic interference, will also be provided.  In Part IV, an example of a product that successfully addresses both human factors engineering and environmental concerns will be provided.

Part IV - Emerging Medical Device Technology Development and Introduction

Technology does not just jump from an idea immediately to clinical use.  There are procedural and regulatory hurdles that must be surmounted before an actual medical device can be offered for sale and actual use.  For devices intended or likely to be used in the Distributed Diagnostic and Home Healthcare (D₂H₂) Network, mimicking product, design or application for acute health care use may be appropriate at a very basic level, but adaptation to and assurance of performance in the expected environment of use must be of paramount importance.  This session will provide a framework that a design team can follow in order to develop and introduce emerging medical devices.  It will provide an in-depth discussion of Needs Analysis and Risk and Hazard Analysis.  It will discuss property protection, such as patents, and lesser known methodologies.

Medical Device Regulatory Requirements, such as FDA medical device establishment registration, will be discussed.  The issue of Pre-Market Submission and the various routes that can be followed will be presented and analyzed.  Use of Third Party Reviewers and User Fees will be presented.

Additional medical device regulatory requirements such as compliance with Quality Management Guidelines will be presented.  The following items will be presented

• Conceptual Design
• Prototype Development, Testing and Revision
• Production, Distribution, Support and Maintenance

In accordance with cGMP guidelines and other needs, the following items will be presented:

• Design controls;
• Process validation;
• Personnel;
• Buildings and environment;
• Equipment and calibration;
• Device master record;
• Document and change control;
• Purchasing and acceptance activities;
• Labeling;
• Product evaluation;
• Packaging;
• Storage, Distribution and Installation;
• Complaints;
• Servicing;
• Risk and quality management systems;
• Insurance; and
• Factory Inspections.

During the conclusion of this session, examples of successful and unsuccessful development and introduction projects will be presented.  Handouts of forms, references and slides will be provided to attendees.

Part V - Managing the Risks of D₂H₂ Product and Professional Liability

Unfortunately, things can and do go wrong.  Often, the result may be insignificant to the care or wellbeing of a specific patient, staff member or visitor.  That is, while the incident could have occurred in an injury, it did not.  Other times, however, the incident does result in some type of injury to patient, staff member or visitor.  Financial loss from malpractice, product liability or workers’ compensation claim may result.

In this session, insurance industry and risk management analysts will examine what can and has gone wrong in the past, with a specific emphasis on D2H2.  Examples of medical malpractice, product liability and other claims will be provided and discussed.  “Lessons learned” will be developed in this interactive presentation.  Examples of lessons not learned and result will also be provided.

Attendees will be provided with the bridge to understand why it is so important to prospectively gather and address information about potential product users and environments of use.  They will also be provided with a basic understanding of how risks and hazards that cannot be mitigated are sometimes accepted – that is, how the financial risk they represent may be handled through insurance.  Discussions of risk management standards, guidelines and practices will be included.

Part VI - Recent, Concurrent and Prospective Emerging Medical Technologies

Medical devices have been used in the Distributed Diagnostic and Home Healthcare (D₂H₂) Network for many years.  Much can and should be learned from the experience gained.  Devices with a significant history in home use will be presented and analyzed for “lessons learned” that can and should be applied to those emerging technology medical devices recently, soon to be, and projected in the future to be released.

This session will present emerging technologies for use in the D₂H₂ Network that have recently been released, those that are currently in a known phase of development and introduction, and those that are recognized to be need.

This session will also address methodologies for identifying technologies that are in development and determining those technologies where there is a need that has not yet been met.