Extending Medical Device Lifecycles with High-Quality Replacement Parts

American hospitals, already operating under lean budgets, are facing significant increases in costs across a range of vectors, according to a recent report released by the American Hospital Association. As labor, supply, and drug expenses skyrocket, over 33% of US hospitals are now operating on negative margins. Medical equipment managers are feeling more pressure than ever to increase ROI on capital biomedical equipment, without sacrificing patient safety or care quality or increasing repair costs.

Understandably, it can be tempting to prioritize the price tag when purchasing replacement parts for infusion and telemetry systems. However, very inexpensive parts can and do result in other costs. They tend to break more often and may compromise functionality, affecting care quality or patient safety. In some cases, lower-quality parts produced overseas have been implicated in device recalls.

Therefore, the importance of using high-quality replacement parts can’t be understated.

Any vendor can claim they offer quality replacement parts, but unfortunately, that doesn’t always mean OEM-level quality. Read on to learn the defining characteristics of top-notch infusion and telemetry parts and how they help to prevent the issues that shorten the lifespan of mission-critical devices.

It’s all about the design: reverse-engineering

Third-party manufacturers often copy OEM components, meaning they take measurements of the part and use those specs to duplicate the product. This process doesn’t cost much or take much time, but mistakes are more likely to occur because of oversights when copying OEM parts. Furthermore, the materials used in copied components are more likely to be inferior to those used by the OEM.

Reverse-engineering means that the 3rd-party manufacturer’s engineering team carefully analyzes the design and construction of the OEM product. In fact, reverse-engineering provides the opportunity to improve on the OEM part if the engineers discover a flaw and to select higher-grade plastics and other materials when possible. Although reverse-engineering is a little slower and a bit more expensive than copying, it consistently results in high-quality parts.

Reverse-engineering results in the most significant quality features that contribute to longer device lifespans:

Good form and fit

High-quality replacement parts are identical in size and shape to the OEM product. That means the part won’t rub against other components, which can cause chafing, chipping, or displacement. A poor fit can degrade the integrity of the replacement part or the components it contacts, accelerating the impact of daily wear and tear.

Proper device function also depends on a good fit. Depending on the part, an improper fit could seriously affect patient care. Compromised infusion pump functionality, for example, can result in over- or under-delivery or the free flow of fluids, potentially leading to a fatality.

Durable materials

Durable materials are essential for longer equipment lifecycles and they’re critical for patient safety. Durability protects the pump hardware and keeps the device functioning optimally.

Fluid damage

Disinfection of medical devices is a must to prevent healthcare-related infections, but cleaning and disinfecting solutions take a toll on biomedical equipment. Even OEMs fight an ongoing battle between durable plastics and harsh cleaning agents. Damage related to cleaning resulted in two Class I recalls and one Class II recall for reusable OEM infusion devices between 2020 and February 2022.

The external device casing of infusion pumps and other medical devices is highly susceptible to cleaning products. The harsh cleaning chemicals frequently cause the plastic to crack. Once cracks have exposed the interior, the internal parts also become vulnerable to fluid damage.

Physical stress

Durable resins and polymers also withstand more physical stress. That means they don’t crack easily due to the stress of daily usage or because of being dropped or banged around during hectic hours on the hospital floor. Standing up to heavy hospital use is synonymous with longer device lifespans.

Cheaply produced overseas 3rd-party bezel posts have been responsible for infusion pump recalls because the plastics selected cracked easily–a costly, distressing issue for hospitals whose fleet had been repaired with those products.

So, a 3rd-party replacement case must have at minimum the same level of durability as the OEM casing. Internal parts, such as bezel posts, should also meet or exceed OEM specifications. When the 3rd-party company can access an even higher-grade resin than the original part, even better.

Consistent product quality

To keep infusion and telemetry machines up and running, and to ensure devices last as long as possible, BMETs need access to parts they know will reliably meet or exceed OEM specifications. Otherwise, repair quality will be inconsistent, compromising the lifespan of certain devices, or even the entire fleet.

The FDA ensures consistent quality across new medical devices by requiring that OEMs comply with Quality System Regulation (QSR; 21 CFR Part 820). However, 3rd-party biomedical equipment manufacturers fall into a regulatory grey area–replacement parts are considered “after-market” products, so they aren’t subject to 21CFR 820. This means that the quality of 3rd-party parts varies considerably.

The best way to ensure consistent product quality is to partner with a 3rd-party manufacturer who uses a robust quality management system (QMS). A QMS is a risk mitigation system that provides operational consistency, reducing the likelihood of errors and allowing for the identification of design and production flaws that can lead to serious product failures.

Most 3rd-party biomedical manufacturers that invest in a QMS are ISO 13485 certified. This international, non-governmental certification outlines a robust QMS similar to the requirements of 21CFR 820.

Quality is a business value

Some 3rd-party biomedical businesses prioritize profit, cutting corners and sacrificing durability, form, fit, and potentially safety to lower their operating budget. It’s the companies that prioritize integrity that are more likely to put extra time and resources into designing and producing longer-lasting products that keep patients safe.

A 3rd-party partner who makes safety and reliability their primary values can provide the level of quality that will substantially increase device longevity. Read our latest guide for in-depth advice on partnering for success with 3rd-party biomedical manufacturers.

Elite Biomedical Solutions manufactures OEM quality biomedical equipment replacement parts in the USA. Our products and repair services help extend the lifespan of telemetry and infusion devices. Contact us to learn more.