TTAC

Electronic Stethoscopes – Deployment and Support

It doesn’t matter if you are an individual purchasing one electronic stethoscope or a program purchasing multiple electronic stethoscopes, there are many variables to consider when purchasing an electronic stethoscope model that will most fully meet your programs needs. It is best to spend the majority of your time and energy planning for your purchase ahead of time. After the initial planning phase, minimal additional work must go into purchasing, deployment and support.

Planning

Thorough planning will pay off in the end, resulting in your program purchasing the most appropriate equipment. It is best to conduct an internal programmatic needs analysis to help you choose the most appropriate equipment that will be best suited to your program. An adequate planning process will include conducting a programmatic needs analysis that considers many elements, such as potential use cases for the device, your organization’s equipment budget, initial and ongoing training and support needs, and existing equipment compatibility concerns.

Needs Analysis

One could easily assume that it should not be difficult to pick an electronic stethoscope from the market and make it work for a program’s needs. However, the electronic stethoscopes on the market vary widely in level of complexity and functionality, and may fit multiple applications. When you are thinking about applying an electronic stethoscope to your program, you need to consider the user, existing systems, equipment available for adjunct use, and the specialties that will utilize the equipment. A thorough needs analysis is a fact-finding mission that will arm you with the best information available when it is time for you to make a decision.

Use Case

In determining a technology’s use case, you are assessing the technology as it applies to your program and how it will be used by your user population. Some things to consider:

  • Do you have a specific program, specialty application, or group of clinicians in mind for this technology application?
  • Is there an idea present that clearly leads to the development of a clinical program, or is this an idea that needs further development before a clinical program can be put into place?

It is useful know the users that you plan on deploying a technology to so that you can make the most appropriate technology selection. Defining the users ahead of time will save effort in the end. Some things to consider:

  • Who are the users of this technology?
  • Have these clinicians as a group been a part of the process involved with selecting and utilizing this new technology?
  • Is there clinical buy-in and support for the use of this technology?
  • How much time do the clinicians have to devote to an encounter with the patient?
  • What types of technology are they already accustomed to as a group?
  • What is the clinician’s level of comfort with technology in general?
  • Is this a technology currently utilized by this clinical group or will this be adding a new element to an existing workload?
  • By deploying this new technology, how will you be augmenting or improving an existing clinical workflow?

When considering the incorporation of electronic stethoscopes into a clinical workflow, some additional considerations must be addressed, such as:

  • Do you plan to make use of this technology in an asynchronous, synchronous, or combined fashion?
  • Do you plan to purchase new electronic stethoscopes, or will you utilize previously purchased/obtained electronic stethoscopes?
  • What additional adjunct equipment will be required to operationalize these electronic stethoscopes?
  • What, if any, additional staff will be required to operationalize these electronic stethoscopes with their accompanying clinical program?

Budget

After a use case has been defined, it allows you to then go on to make sure you represent every element of the program in your budgetary analysis. For some organizations, these initial steps of use case analysis and budgetary estimation and analysis must be first completed before funding can be secured. This will depend on your funding sources for your program. Regardless, the financial requirements of this purchase and deployment take thorough planning and mindful consideration.

Capital

When considering capital budget for electronic stethoscopes, one needs to consider:

  • Actual equipment costs, to include:
    • Equipment to be immediately used
      • Electronic stethoscopes
      • Additional or new PCs or laptops
      • Additional or new videoconferencing equipment
    • Equipment that will be maintained in stock
      • Replacement parts and/or units
    • Warranties
    • Upgrade plans
    • Training/Demo units
    • Assessment budget for upgrades as replacement devices are needed in the future
  • Accompanying or adjunct software costs
    • Store-and-forward applications
    • Tele-Auscultation applications
  • Accompanying or adjunct hardware costs
    • Audio and data cables
    • Mobile platforms and carts
  • Associated network-related fees
  • Program development, program administration, and training support staff costs
    • Staff
    • Training space
    • Computer-based user-training tools
    • Development of training materials
Consumables

Some electronic stethoscopes have reliable consumables related to their use, while others do not. In general, consumables to consider:

  • Batteries
  • Supplies to clean equipment after each patient use
  • Replacement parts
  • Potential equipment servicing required
  • Service technician fees
  • Shipping and handling fees when sending units in for repair and/or replacement
Personnel

It is important to consider all the people that are required to make a technology work, and make sure they are budgeted for. Some personnel to consider:

  • Clinicians
  • Training and support personnel
  • Biomedical and technical support personnel
  • Network personnel
  • Administrative personnel
  • Consultants
  • Additional far site employees/clinicians
Training & Support

When considering training and support, a plan needs to be developed for initial, ongoing, and maintenance training and support. Some things to consider:

  • How many new pieces of hardware and/or software will a user need to learn to be able to use the new electronic stethoscope?
  • Is the hardware and/or software intuitive enough to use that it does not need initial training?
  • Can your organization provide:
    • Hands-on support to a few challenged users?
    • Online support modules?
    • User manuals?
    • An in-house support phone line to handle support phone calls?
    • Access to the manufacturer’s online or telephonic support system?
  • Does the initial training have to be hands on and/or face-to-face?
  • Can initial training be accomplished in an online format?
  • Can the initial training period be decreased with online training modules completed preceding an in-person class?
  • How many users will require initial training?
  • What type of ongoing training will be required for the units?
    • Will yearly compliance training be required?
  • How many new users are expected on a yearly basis?
    • What is your organization’s policy for new user training?
  • How often will training be offered as equipment, hardware, and processes are changed?
    • How will this training be accomplished?

Existing Equipment Compatibility Concerns

If you are deploying new electronic stethoscopes, software packages, PC/laptop hardware, and videoconferencing equipment, you will be less likely to have any compatibility concerns to contend with initially.  Even then, this will only be the case if you have done your homework ahead of time. You have to make sure that vtc units are compatible when combined with the electronic stethoscopes, and that you purchase all of the same make and models of electronic stethoscopes. This is a case when working closely with the vendors can be very important. Also, purchasing units to mock up your intended use case and checking yourself on the compatibility as a pilot project could be invaluable before purchasing all of the new equipment. However, even if you are able to purchase all new compatible equipment, also being mindful in your long-term planning can save you compatibility concerns in the future when it comes to upgrades and updates. Some of the compatibility issues that will arise cannot be planned for or prevented, and are simply artifact of changing technology.

Support Plan

You can use the elements that you have already budgeted for to help you further define your support plan. You should have already budgeted for the main components of your support plan, but if new elements are discovered, make sure to add them to your budget. A support plan is very cyclical, and depends widely on the lifecycle of the type of technology that you are deploying. It starts with purchasing equipment, installing equipment, providing initial and ongoing training for users, supporting the equipment, updating and repairing the equipment, and then preparing for the next equipment deployment cycle.

Initial

You will have an initial investment in the purchase and installation of the new equipment, as well as training the users on the new technology. You may want to consider a pilot to see how the deployment goes and give your program a cushion to work out the kinks associated with any new program deployment. A pilot can aide you in identifying elements that you may not have known to consider and make concessions for them, and sometimes determining the future success or failure of your clinical program.

Warranty

Each manufacturer offers different warranties and warranty terms. It is essential to understand the terms for the equipment that you have purchased. Many organizations have biomedical technicians that service medical equipment used within their organization, but many of the electronic stethoscope warranties will be voided if you attempt to repair the units yourself. You need to consider the price of the units that you are purchasing related to the estimated product lifetime when considering additional warranties for equipment that you purchase. Many of the electronic stethoscope units require that a unit be sent back to the manufacturer for repair, and therefore be completely taken out of use. This option is often inconvenient in a large organization or for a clinical program that depends on the equipment for regular operation. You might want to consider having additional back up units for use while damaged units are being repaired.

Training

Proper training in the use of the equipment may prolong the lifespan of the equipment, because theoretically users who know what they are doing will avoid misusing the equipment and leading to support issues. Also, having users who are trained in the use of the technology initially will reduce the amount of ongoing support that is required. Use the section on Training and Support to guide you in creating a training plan.

Ongoing

Deploying a technology into the field is like gardening. You work hard initially planning and preparing, then you plant it and hope for the best. Any good gardener knows without weeding and watering your harvest will be marginal at best. You need to plan for ongoing support for the technology in just the same way.

Upkeep/Upgrades

The technology that you deploy will eventually break and/or malfunction with repeated use. You can plan for this with an ongoing support plan. When considering ongoing support you have to remember all of the technology associated with the electronic stethoscopes use. You may have repairs, warranty related replacements, replacements that are not covered by warranty, and equipment updates to contend with. Consider:

  • Associated software and firmware upgrades may need to be deployed
  • Technology will age and need to be refreshed as part of its product lifecycle
Technology Refresh

Depending on your initial investment and the involved technology’s lifecycle, you will have to make some decisions surrounding a technology refresh at some point. Some of this technology is ever-evolving, with new units coming out every year, while others are more durable and may last longer. At times it will not be the actual electronic stethoscope technology or its associated technology that necessitates a refresh; rather, the role of the technology in the clinical program may change and require new technology to be considered and purchased. When considering a refresh, you have to decide:

  • Will you refresh all the technology at once, or do it incrementally?
  • Will you blend old and new technologies?
  • Will you keep old technologies around after new ones are introduced?
  • How comprehensive of a technology assessment will you conduct before selecting your next technology?

Purchasing

Once you have completed the extensive planning process, purchasing the equipment will not be difficult, assuming that you have been able to secure the budget you planned for. Each organization has different methods and processes that they use when purchasing equipment, but the good news is you will know exactly what you need to purchase in order to get your program operational. In this instance, included in the purchase process may be the hiring of new or additional staff or repurposing existing staff members. You need to allow adequate time if you need to hire new staff before a project can be operationalized, and you may need a contingency plan in the case you are not be able to find adequate staff.  Also, as part of your planning process you need to consider your timeline for purchasing the necessary equipment so you receive equipment in a timely fashion and do not inadvertently stall the start of your program.

CE & UL Markings and FDA Classification          Back to Whitepaper

The majority of the electronic stethoscopes on the market have a FDA Class II medical device classification. Most have a CE mark and some have a UL mark. Depending on your plans for using the technologies that you are adopting, it may be important for you to consider using technologies that are CE & UL marked and have a FDA classification.

A CE Marking is a European marking of conformity that indicates a product complies with the essential requirements of the applicable European laws or directives with respect to safety, health, environment, and consumer protection. Generally, this conformity to the applicable directives is done through self-declaration. The CE Marking is required on products in the countries of the European Economic Area (EEA) to facilitate trade among the member countries. The manufacturer or their authorized representative established in the EEA is responsible for affixing the CE Marking to their product. The CE Marking provides a means for a manufacturer to demonstrate that a product complies with a common set of laws required by all of the countries in the EEA to allow free movement of trade within the EEA countries.

Unlike the UL Mark, the CE Marking:

  • Is not a safety certification mark
  • Is generally based on self-declaration rather than third-party certification
  • Does not demonstrate compliance to North American safety standards or installation codes

A product that bears a CE Marking may also bear a certification mark such as a UL Listing Mark. However, the CE Marking and the UL Mark are not associated. The UL Mark indicates compliance with the applicable safety requirements in effect in North America and is evidence of UL certification, which is accepted by model North American installation codes such as the National Electrical Code (NEC) and the Canadian Electrical Code.

The CE Marking on products is not a certification mark. Look for the UL Mark on products to determine if a product complies with applicable safety requirements for North America.

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA.

Working with Vendors

Many times you may be able to work with a vendor, possibly even forming a partnership, when purchasing and utilizing equipment for your program. Sometimes they may offer bulk pricing, demo units for trial periods, and special accommodations to serve your programs needs. It is best to approach vendors as partners, as you both have opportunities for gain in successful arrangements. Keeping open lines of communication to establish needs and provide feedback can be very useful to both parties. If you have a pending large scale deployment and know there is a technical change that stands between an existing technology and your ideal technology, don’t be afraid to approach a manufacturer with suggestions. If the changes will make their product better or more useful, some vendors are very open to working with your requests.

Working with International Vendors

It has been our experience that many international vendors are also eager to form partnerships and work with your program. The only word of warning is to make sure you are cautious and make wise decisions when forming partnerships. Many new and emerging technologies are being designed and implemented overseas, and should not be counted out as viable technology possibilities. Many overseas companies have US FDA device classifications and form partnerships with American companies as manufacturers for their products. It is prudent to lay hands on any questionable equipment, and make your own decisions about workmanship issues.  You may also encounter some language incompatibilities related to ordering, and later their product information sheets and user manuals.

Deployment

Deployment of the ordered equipment should run smoothly with a thorough assessment and planning process having already taken place. However, there are some remaining considerations related to equipment deployment:

  • Will you ship equipment directly to project sites or utilize a warehouse for staging and assembly?
    • Did you budget for warehouse space and staff?
  • Do you have an equipment tracking plan in place to keep tabs on the equipment?
  • Is any assembly required before the units are deployed?
    • Do you have the staff for the assembly?
  • If you are shipping equipment directly to project sites:
    • Do you plan on having existing clinical staff assemble the technology?
    • Is the staff aware they are receiving the shipment?
    • Is there space at the project site to receive, stage, and assemble the equipment?
    • Did you plan training for the clinic staff to be able to assemble the equipment?

Once the equipment has successfully been deployed and installed, it is time to put the training and support plans into action and eventually start your program.

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