By Joseph Haduch AND Patrick Flaherty
When health care professionals think of equipment warranties it is in terms of uptime, parts coverage (not objective performance), overtime labor rates, and length of term, all terms and definitions established by manufacturers. Sadly, few health care professionals think of a medical equipment warranty as a guarantee of equipment performance diagnostically or therapeutically or a contractual commitment for objective functionality or delivered value.
The former (the overwhelmingly dominant warranty) protects against equipment manufacturing specifications and materially poor quality of build or inconsistent performance, both of which must be objectively proven to the manufacturer. The latter, though far less common but more valuable, protects against operational performance. Does the unit perform the way sales and marketing said it would perform? Does the unit deliver the values and outcomes which were included in the contract? Even though this version is better, it still is controlled by the manufacturer and generally misses a care provider’s needs given that sales and marketing’s definition of how equipment is used rarely, if ever, align with how a provider produces revenue and quality outcomes. Given this state of affairs, what recourse or resolution is available to my organization as a consumer of medical equipment?
One of the first things providers must do is take inventory of their own knowledge gap. There is almost no connection between the use of diagnostic equipment to the variable quality and efficiency of therapeutic interventions, despite a significant part of the sales and marketing for the affected equipment being based on the eventual results of the therapeutic interventions. Any provider self-assessment also would need to focus on the use of configurable equipment, most commonly being based on the variable use of software. Significant expense is connected to the acquisition of software, but data connected to the use of software for specific patients or procedures is, if not completely undocumented, almost impossible to access. Over time, the variable configuration of use has the potential to significantly impact care but, it is isolated from both contract and warranties.
If you’ve been around long enough you probably have your own story, maybe stories, of how new equipment failed to deliver as promised by the supplier and as described by the physician in the rationale for equipment purchase. Perhaps the new system couldn’t interface with your existing network infrastructure or you couldn’t increase your patient throughput because the equipment required additional workflow steps which were not identified by the manufacturer or maybe the quality of the device didn’t provide you with fewer follow-ups or a reduction in false negatives. What happens in these instances? Where is your guarantee against performance failure? In most instances the vendor will attempt to correct the issues from a very limited playbook. A playbook that varies greatly from the marketing playbook used to make the sale. Sometimes the buyer is satisfied with the resolution, but many times the resolution process takes on a life of its own and results in finger-pointing and a dissatisfied customer. This situation is usually the result of a provider buying equipment for a specific set of diagnostic and therapeutic functions, many of which are implied as capabilities in the manufacturer’s marketing-materials but which were never submitted for specific FDA approved indications for use; this is the fatal gap between measuring and warranting value based on the patient (for whom it was purchased) and the engineering specifications and dimensions. So, what is your recourse when the proposed resolutions don’t meet your expectations or minimum clinical needs? All too frequently, the result may lead to a limited or highly specialized use of a new device or the creation of unexpected and unwanted work arounds to achieve acceptable performance. What steps can you take to better protect your organization, not against manufacture or build quality, but against performance and operational integrity?
An OEM’s implied warranty has very specific terms and conditions that primarily apply to the engineering conformance and build quality of the parts of clinical equipment and devices. Unlike industry, few of these parts are connected to objective life cycles nor are they tied to metrics like “number of uses” or “maximum months of electrical storage or conveyance.” Also missing are failure conditions and costs related to parts which could be, but are not, included in clinical equipment – like torque delimiters in endoscopes. In order to shift to the more mature warranty of clinical value, a warranty of fitness for a particular purpose has to have specifically defined terms and conditions. Essentially, the marketing material and all the deliverables promised by the sales team or implied to the physicians as “off-label” uses needs to be categorized and mapped into a contract to create a binding document that addresses each and every promise, commitment and obligation used to justify the sale.
Rather than defining what parts are covered, what labor hours are covered, what calculation you’ll use for uptime – all of which have their values – the new warranty is on how the equipment meets the clinical needs of the patient. Guaranteed interoperability, workflow performance, cybersecurity, quantitative and objective quality metrics, and specific patient outcomes are the areas of focus moving forward as they are the drivers of financial sustainability and patient viability. Unless providers require manufacturers to objectively warrant the solutions which they are selling from the perspective of patient access, outcome, and affordability, we will continue to make clinical decisions on inflated price tags and insufficient capital budgets.
Patrick Flaherty is the vice president of operations for UPMC BioTronics.
Joseph Haduch, MBA, MS, is the senior director of clinical engineering for UPMC BioTronics.
