In the 1980s, medical device manufacturers started labeling devices “single-use”, instructing hospital staff to discard the device after one use. Since these devices were exactly the same as the devices that had until that point been re-usable, hospital staff started reprocessing “single-use” devices; cleaning, testing, inspecting and sterilizing them so they became ready for another use. Up to 2000, most hospitals made great use of (in-house) reprocessing without FDA oversight

In-house reprocessing was characterized by excessive cycles as compared to current cycle limits. There was a lack of sophisticated validated testing and quality system controls. As a result, great clinical and administrative concerns about reprocessing were voiced.

At the same time, original equipment manufacturers began campaigning actively to make FDA regulate the practice of reprocessing – the practice was hurting their revenue. In response, in 1999, FDA’s Government Accountability Office published their first report on reprocessing, which concluded that while the practice did not seem to be harmful, regulation was needed. In the years that followed, such legislation was put into place and, while this was probably not what the original equipment manufacturers had intended when they put pressure on FDA, the result was that reprocessing became a regulated and safe practice.

Essentially, FDA made it mandatory that reprocessors, similar to manufacturers, should submit technically complex and extensive 510(k)s before they would be allowed to market a reprocessed device. Additional rules were put in place that effectively regulate reprocessors even more strictly than manufacturers.

The strict criteria under which reprocessors had to practice effectively made it impossible for hospitals to do it themselves, and this gave rise to rapid growth of third-party advanced reprocessing operations.

The second GAO report, published in 2008, concluded that after increasing oversight, “available information does not indicate that use presents an elevated health risk”. From this point onward, reprocessing became a standard practice. In fact, leading US hospitals have extensive reprocessing programs and hail these as a key financial and environmental sustainability strategy and as a fundamental condition for their provision of quality care and access to new technologies. 19 out of the 20 top US News and World Report hospitals use reprocessing – some of them promoting their dedication to patient care by pointing to their reprocessing programs.

Strict FDA limits to reprocessing, and industry oversight, continues to ensure that reprocessed devices are substantially equivalent to new devices (no differences in efficacy and safety). Ongoing monitoring of failure rates shows that reprocessed devices do not fail more frequently than new ones: A recent study has actually shown that reprocessed devices have a substantially lower failure rate than new devices.

Even the manufacturers appeared to align with new perspectives in healthcare, including the Triple-Aim principles, as well as shifting market trends by accepting and even promoting reprocessing

  • In November 2009 the largest 3rd Party US Reprocessor was purchased By Stryker
  • Shortly after, the second largest 3rd party Reprocessor was purchased in 2010 by Johnson & Johnson-Biosense Webster

However, today, it seems more like reprocessing has been stolen from hospitals by manufacturers attempting to reduce or halt the success of this savings initiative. Reprocessing programs today carry none of the characteristics of successful reprocessing results of the past. The lack of service, minimal presence in the hospital and sketchy data to manage the program leave hospitals with over-burdened staff and reduced savings. In addition, new 510(k)s have almost stopped, so reprocessing savings go down every time a device becomes obsolete.

Safety & Efficacy

The practices put in place through FDA regulation mean that reprocessing companies need to go through the same process and provide the same materials to FDA in order to achieve a so-called 510(K) clearance. Without this, they cannot sell the reprocessed devices. It typically takes engineering teams months to develop a 510(K) submission.

The outcome of the 510(K) process is that reprocessed devices have been proven, due to the cleaning, testing, reprocessing, and sterilization processes, to be substantially equivalent to new devices.

When it is sometimes brought up that reprocessed devices are functionally “less” than new devices, the fact is that rigid function testing of each and every reprocessed device ensures that they are just as functional as new devices.

Current regulation of single-use device reprocessing ensures that reprocessed devices are as safe and effective as new devices

  • Medical device reprocessors must obtain 510(k) clearances from FDA – similar to the OEMs – but with added demands on testing
  • Reprocessors that have the ability to obtain a 510(k) clearance are highly sophisticated companies under tight FDA scrutiny
  • 510(k) clearance determines that devices are “substantially equivalent” to original devices – there is no difference in efficacy

Original manufacturers can obviously feel the financial impact of the continued growth of reprocessing, and are therefore launching anti-reprocessing campaigns and designing devices so that hospitals cannot reprocess their devices and reduce supply costs. Due to these campaigns, some physicians still believe that new devices are more safe than reprocessed ones.

Physicians are not necessarily incentivized by the financial benefits of reprocessing and prefer a new device because it “seems more safe”. However, the validated processes that reprocessors must follow, render the devices just as safe as new ones. In fact, cleaning, validation and testing requirements render reprocessed devices arguably safer than original devices

The MAUDE database registers medical device failures – and reprocessed devices do not fail more frequently than new ones. In fact, a recent study from Banner (Surgical Products Magazine, February 2017) showed that new devices failed 4.9 times more frequently than reprocessed ones.

Developing a 510(k) to achieve FDA Clearance to Reprocess Single-Use Devices

The FDA requires reprocessors to demonstrate that a reprocessed device is substantially equivalent to that of the Original Manufacturer (OM) device prior to marketing the device. The FDA is able to determine that the device is substantially equivalent from the evidence presented in a 510(k) submission.

Innovative Health evaluates OM devices to determine their eligibility for reprocessing. This evaluation includes, but is not limited to, reverse engineering, OM characterization, and testing to ensure the finished reprocessed devices meet the appropriate product specifications and are safe and effective as the original device.

Cleaning validations through independent laboratories, based on the industry standards AAMI TIR30 and FDA guidelines, are completed to ensure that the cleaning process reduces residual biomarkers (i.e. organic soil, bioburden and endotoxins) on devices to acceptable levels to ensure the cleanliness. Exhaustive extractions are performed to determine the number of viable organisms and contaminates that are present on inoculated devices. Repeated extractions are performed to calculate extraction efficiencies which determine the effectiveness of the cleaning process.

Biocompatibility testing was performed in accordance with AAMI/ANSI/ISO 10993 (and related subparts) Biological Evaluation of Medical Devices to ensure that devices are not toxic, injurious, or physiologically reactive and do not cause immunological rejection. In vitro and in vivo safety evaluation studies are conducted and may include: chronic cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity and hemocompatability testing.

Detailed test plans are developed for each device that are intended to test the mechanical, electrical, and simulated use properties of the device under worst-case conditions. For example, all devices must be IEC 61508 Compliant. Moreover, revolutionary software testing technology is often used for this purpose. You can learn more about IEC 61508 Compliance by taking a look at some of the resources over on the Parasoft website. Moreover, Innovative Health engineers work closely with clinicians to understand clinical use and translate this into appropriate testing methods.

During production, each device is inspected and function tested prior to packaging and labeling and all production lots are tested to ensure an acceptable level of bacterial endotoxins in accordance with ANSI/AAMI ST72 to support the non-pyrogenic labeling.

Innovative Health devices are sterilized using Ethylene Oxide (EO). The EO sterilization process includes preconditioning, sterilization and aeration. The EO sterilization cycle is validated in accordance with applicable industry standards and requirements such as AAMI/ANSI/ISO 11135 to achieve a minimum Sterility Assurance Level (SAL) of 10-6. In addition, devices are validated to have acceptable sterilant residual levels after aeration.

For a more detailed description of what goes into an Innovative Health 510(k) submission, please ask your contact for additional information.

Optimizing Device Utilization

Medical device reprocessing is not about buying cheap, used devices instead of new ones. Reprocessing is about optimizing device utilization; ensuring that when the investment in a medical device is made, it is utilized to the full value before a new device is purchased. Therefore, optimal device utilization involves much more than just collecting new devices – it involves:

  • Ensuring that the facility is adopting new technologies in a mindful manner, so that the total value of the adoption is considered – clinical advantages, operational consequences and financial implications. Most new device technologies are launched at a higher price point than the devices they replace. This extra cost needs to be weighed against incremental clinical improvement as well as the financial consequences to the facility’s operations overall. When a facility pays more for a device than they used to, they have to cut cost in a different area.
  • Assessing the impact on reprocessing programs in terms of continued savings and ability to reprocess the device: Due to the R&D and regulatory process, when a new device is launched, it takes months for the reprocessor to offer the reprocessed device. Savings from reprocessing the old device that the facility has come to rely on are lost during this period. At times, such reprocessing lags have cost facilities $500,00 – $1,000,000. Also, in some cases, the manufacturer builds functional obsolescence into new devices, which means that chips or software “blocks” make it impossible for the device to be reprocessed. Some of these “functional obsolescence” designs are done purely to keep facilities from reprocessing and to increase manufacturer revenue.
  • Determining the impact of new technologies on overall operational flow: Do the new devices work with existing capital equipment and accessories such as cables or wires? Is there additional cost involved with implementing the new technology beyond the extra cost of the device?
  • Understanding the relationship between technology adoption and reprocessing: In electrophysiology and in cardiology in general, the rate of device innovation is very high: New devices are made available constantly with clinical and technical improvements. But they are also very expensive. Many facilities are losing money on simple cardiology cases and cannot afford to buy and use new technologies. Securing and continuing effective reprocessing programs in high-use devices can enable the facility to adopt improved technology faster – because reprocessing savings are used to free up financial resources.
  • Optimizing the flow of product from collection to shipping and buy-back: Many facilities have reprocessing programs in place that play only a nominal role. For reprocessing programs to have optimal financial impact, three things must be maximized:
  • Collection rate – how many devices are collected after use
  • Acceptance rate – how many devices are received by the reprocessor that can actually be reprocessed
  • Buy-back rate – how many devices that are available from reprocessor are actually being purchased and used
  • Managing the reprocessing program: Successful reprocessing programs require constant attention. Monthly savings reviews and action plans support the growth and overall success of the program. Without these savings reviews, reprocessing does not deliver on its promises.

What You Should Expect From Your Reprocessor

Reprocessing became a very successful supply chain strategy in the cardiology and electrophysiology space in the 2000s. Reprocessors submitted new 510(k) applications frequently to grow the number of devices that could be reprocessed, and programs were managed closely to ensure that all that could be saved was saved.

Since medical device manufacturers bought out the biggest reprocessors in 2009 and 2010, this effort has stalled. In fact, the largest reprocessor in the country has not submitted a 510(k) application clearance in this clinical area since 2012.

When reprocessors don’t submit new 510(k)s, reprocessing savings go down. Why? Because devices are obsoleted very quickly, and if new 510(k)s are not submitted and cleared, savings are lost.

Similarly, when reprocessors stop actively servicing accounts and supporting a culture of reprocessing, collection, acceptance, and buy-back rates go down, reducing savings dramatically.

Meanwhile, reprocessing is not a new activity, and the premises for a successful reprocessing program are well known: