By Robert C. Broschart

Demand for hospitals to increase patient throughput is escalating, putting a strain on sophisticated equipment used to treat the volume of patients. In response, the clinical engineers who service, maintain, and repair the devices are working to keep equipment operational by making repairs on-site when possible and purchasing replacement parts when available. Whether repairing or replacing, finding a solution that keeps downtime minimal and costs low, all while ensuring patient safety and compliance, is imperative in today’s biomed environment.

When repairs on-site are not an option and equipment is not at the end of its life, replacement is inevitable. However, when it comes to purchasing replacement parts on medical equipment, clinical engineers often run into several roadblocks, such as the difficulty of finding specific parts and the risks of dealing with the unknown of aftermarket replacements.

Shopping for replacement parts in the aftermarket often forces clinical engineers to buy blindly: not knowing where the part has been and how much longer it will last can make for a dangerous investment.

Buying from the OEM poses a different set of challenges. Manufacturers build complete, sophisticated systems by engineering or sourcing every piece of the machine—from switches and encoders to circuit boards, buttons, and connection cables. However, the manufacturer of the device typically will not sell replacement service parts like switches, buttons, and connectors. Understandably, OEMs instead offer subassembly parts (the more expensive and complex parts of the machine). This often leaves clinical engineers feeling like they must select the least favorable option for replacing faulty parts, which usually means having to buy more than is needed to fix the equipment, and at a much higher cost.

When repairing with replacement parts is unavoidable for equipment, there is a much more cost-effective solution that not only saves money but allows for higher-quality parts with improved reliability and at a much faster repair time. Reversed engineering (or re-engineering) parts give clinical engineering departments the ability to buy the exact parts needed at a favorable cost.

High-use equipment that experience high failure rates (buttons, cables, and circuit boards, for example) are the most likely candidates for re-engineering. Many service providers who make repairs to medical equipment are able to create the exact specification of those parts and sell them to biomed departments at a fraction of the cost. Re-engineered parts can increase uptime during repairs by affording the ability to fix it quickly, reducing costs both immediately with the initial replacement and longer-term by extending the life of the equipment.

Re-Engineer or Replace?

Deciding on re-engineering versus replacement parts starts with a cost analysis: taking a deep look at individual parts of the equipment allows for an informed decision on whether to repair by using a re-engineered part or replace with an aftermarket or OEM subassembly. Biomeds must ask these questions to determine the most cost-effective solution:

  • Which parts are high-usage products?
  • What parts are running at high failure rates?
  • How many are installed globally?
  • Is the break/repair an actual trend or one-off?
  • Is the part a subcomponent or subassembly of a larger assembly that OEMs will not sell as a spare?
  • Can the part be manufactured, or is it available to buy direct? (Component parts)
  • Is the part easily reproduced, and can you find a supplier?
  • What is the life cycle of the part?
  • Is the equipment/device at the end of life or near end of life?

Knowing the answers, or having the data readily available, can mean the difference between ordering a re-engineered replacement part for a few hundred dollars and buying a subassembly from the OEM for several thousand dollars. There are some instances when re-engineered parts should not be specified. For instance, you should never alter the original part’s fit or function. Nor should you use a re-engineered part if it does not or cannot meet OEM specifications, if it changes the original design of the product, or if the part cannot be re-engineered because it is part of a larger assembly. When you are able to order a re-engineered part, always be sure the service provider uses the same materials and component design of the original part.

Re-engineered, Aftermarket, or OEM?

When equipment is damaged, often the first instinct of clinical engineers is to call an aftermarket parts supplier or OEM to replace the part that is broken. Those organizations will happily send a replacement part that has been refurbished. The challenge with this approach is not only the higher cost but also the loss of data. The cost to repair equipment with replacement parts is 40% to 50% of total replacement cost with the OEM. However, the loss of data on the replacement part costs even more. Knowing where the part was prior to arriving at a facility, what type of environment it was performing in, how old it is, and how many procedures it has completed are all invaluable data points for the biomed department. They not only help with determining the life cycle of the equipment but will also help in remaining compliant should there be hazards or recalls in the future.

By repairing on-site with re-engineered parts, critical data needed to remain compliant with regulatory bodies is maintained by the original owner. Just be sure the integrity of the serial numbers is preserved in case of a product recall or hazard alert.

With re-engineered parts, improvements are gained in the manufacturing process through increased component efficiencies, the use of higher-grade components, and better materials.

Let’s take ultrasound equipment as an example. From screening and diagnostics to therapeutic intervention, the reliance on ultrasound technology is escalating in the healthcare system, forcing some high-use component parts to report high failure rates. These component parts do not justify a complete replacement of the ultrasound equipment, and most OEMs only sell subassemblies, which require biomed departments to purchase more equipment than needed.

The ultrasound system control panel is the gateway to the sophistication of the equipment. Through crucial push buttons on the panel, sonographers are able to access all of the clinical operations of the machine. But when one button breaks, the OEM can only offer to sell the entire control panel for approximately $2,500. However, through re-engineered parts, control panel buttons can now be replaced at a cost of around $500. Now instead of a new control panel, a system can be back up and running quickly—and with the original control panel.

When manufacturing ultrasound probes, OEMs weld connectors for the probe and array side of the equipment, making them prone to breaking. With a re-engineered snap-on connector, repair times can dramatically decrease from 2 weeks to less than 5 days, improving the longevity of the probes with less breaking, and at about 30% of the cost of an exchange for OEM connectors.

Here are a few specific examples of ultrasound re-engineered parts:

Platform Power Supplies

  • OEM price: $8,000+
  • Average aftermarket price: $6,000
  • Re-engineered part price: $4,000

Control Panel/UI Kits

  • OEM price: $8,000 (requires manufacturer service call or whole control panel)
  • Aftermarket price: N/A
  • Re-engineered part price: $500, includes installation CD

Button Cluster (Control Panel Buttons)

  • Aftermarket price: N/A
  • OEM price: $2,500 for entire control panel
  • Re-engineered part price: $500

Sourcing and buying of electronic components such as the switches and encoders can be done through researching and contacting electronic component suppliers. The other parts have to be manufactured, and the best option is to find a supplier who has already done the redesign and can provide the parts. It’s nearly impossible for a single biomed department to have parts specially made, because the quantities are not large enough for a production company to provide.

The Bottom Line

When forced to send equipment out for repair, make sure the service provider is focused on driving cost out of a product or getting optimal use of existing equipment by repairing and replacing the original parts. If the technician advises you to replace with aftermarket or OEM subassembly parts, it will unfortunately cost more time and money, not to mention a loss of data due to replacing original equipment. Repairing equipment and systems with re-engineered replacement parts when available is a cost-effective approach that helps maximize the life of equipment and saves facilities 40% to 50% of OEM costs. 24×7

Robert C. Broschart is director, technical services, for Axess Ultrasound, Indianapolis. For more information, contact 24×7 editorial director John Bethune at [email protected]