DANIEL J VUKELICH | Commercially reprocessed medical devices ‘as safe as originals’

Medical device reprocessors body sets the record straight after recent article on single-use devices

13 May 2021 - 20:27 By Daniel J Vukelich
Medi-Q MD Ebrahim Jappie. The company is ready to enter the regulatory framework SAHPRA created to allow South African-based commercial reprocessors to operate under the same standards as those in the US and Europe.
SETTING STANDARDS Medi-Q MD Ebrahim Jappie. The company is ready to enter the regulatory framework SAHPRA created to allow South African-based commercial reprocessors to operate under the same standards as those in the US and Europe. 
Image: Medi-Q

Healthcare is at a critical juncture. There are limited resources, growing demands and increased damage done to our environment in delivering care. Covid-19 has revealed the vulnerability of our healthcare supply chain and worsened environmental waste and costs. The lessons learnt include a demand that we abandon our “disposable” healthcare culture and move to a more resilient, sustainable, circular cost-savings model.

As the president of the global trade association that advocates for the safe reprocessing of so-called “single-use” medical devices, I know how wasteful our healthcare system has become, but also am intimately aware of immediate solutions. Unfortunately, the Sunday Times Daily article, “Sahpra (South African Health Products Regulatory Authority) vs medical company: would you want a used catheter in your heart?” included misinformation about current regulation, lacked relevant context and overlooked data that would have greatly informed readers. We write to provide this information.

Greenhouse gas emissions from hospitals make our planet and people sick

Our “take-make-waste” approach to healthcare is costly and environmentally unsustainable. The health sector generates 4.4% of global greenhouse gas emissions according to Healthcare Without Harm, a global non-profit organisation dedicated to helping the health sector reduce environmental impact. A growing body of evidence shows the health sector creates more than twice the amount of greenhouse gasses than the entire aviation industry. Researchers estimate that wasteful hospital supply chains and reliance on disposable medical products contribute significantly to the problem. The incineration of disposable medical products adversely impacts human health, resulting in thousands of years of life lost annually, according to published data by Prof Andrea MacNeill from the University of British Columbia

Many medical devices are labelled for single use because they should not be used on more than one patient. But hundreds of types of devices are labelled for single use simply because manufacturers want to sell more devices. Their profit model is built on volume sales. This business model has resulted in billions of rand wasted unnecessarily at hospitals worldwide. And significantly, it has generated tons of medical waste and contributed, in their use of raw materials, manufacture and shipment through a global supply chain, significantly to greenhouse gas emissions that contribute to global warming and human sickness. 

Addressing climate change can’t end at the doors of hospitals. It should begin there. Healthcare is predicated on the principle of “do no harm”.  We can’t treat the patient in front of us and forget about the adverse health impacts for everybody else. The race is on for hospitals worldwide to reduce waste and the threat they pose to climate change.

Medical device reprocessing is an immediate, resilient, local, sustainable and cost-saving option. In head-to-head studies, researchers find the use of reprocessed single-use devices cuts carbon emissions in half compared with using only “new” equipment. And to boot, it saves our health system money while providing the exact same patient outcomes.

Growing list of high-income countries find reprocessing safe and effective

While reprocessed devices include cardiac catheters, they also include patient transfer mats, pulse oximeters, blood pressure cuffs and other devices critical to the fight against Covid-19. Our member reprocessors spend millions of rand yearly to prove to accrediting bodies and regulatory authorities around the world that these devices can be cleaned, inspected, disinfected or sterilised and safely reused. 

More than 7,600 hospitals worldwide have responded to the urgent call to reduce waste, minimise their carbon footprint and lower costs by sending once-used devices to commercial reprocessors. These businesses employ thousands of people in green jobs. The industry has doubled in size globally, on average, every year for 21 years. In 2019 alone, reprocessors worldwide helped hospitals save more than R7,6bn. 

The key to the reprocessing industry’s success is strong regulations, for which we advocate worldwide. The US was the first to pass strong regulations more than 20 years ago. Canada, the UK, Japan, Germany and now the EU have adopted regulatory controls that hold the reprocessing of single-use medical devices to the same standards as the original manufacturer of the device. 

Despite millions of single-use devices commercially reprocessed and used again on patients, not a single regulatory authority in the world has found an increased risk to patient safety. In fact, the opposite appears true.

Despite millions of single-use devices commercially reprocessed and used again on patients, not a single regulatory authority in the world has found an increased risk to patient safety. In fact, the opposite appears true. Sometimes new devices fail. When that happens, the surgeon throws out the device. The resulting circular stream of reprocessed devices is more likely to be error free and evidence shows reprocessed devices may fail less than original equipment. 

We regret that the author of the article never asked us about the safety and track record of regulated, reprocessed devices, because the evidence is strong and consistent — commercially reprocessed devices are as safe and effective as original devices.

Bringing reprocessing to SA

Regulations in SA are in line with the US and Europe. The South African Medicines and Related Substances Act of 1965 was amended in 2016 to include reprocessing as a manufacturing activity. The definition of “manufacturer” includes companies that “design, manufacture, package and label medical devices” and “any other person who assembles, packages, reprocesses, refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a medical device ... Further, article 22 of the 2016 amendments places certain additional and specific labelling requirements for reprocessed products.”  These are quotes taken directly from the regulations that make it clear that, contrary to the reporting, reprocessing is legal in SA.  

One South African company, Medi-Q (in partnership with Northeast Scientific, Inc, an established, specialised reprocessor of single-use devices in the US), is ready to enter the regulatory framework that Sahpra created to allow South African-based commercial reprocessors to operate under the same standards as those in the US and Europe. 

A few additional inaccuracies should be cleared up for your readers.

The article falsely notes that used devices labelled by the original manufacturer for single use would “normally be destroyed after operations”. This too is false. In SA, as in many other countries, hospitals reuse many of these devices. The distinction is that the reprocessing of the devices within a hospital as currently conducted is not well regulated and potentially unsafe. Accordingly, the US (more than 20 years ago) and the EU (this year) have discouraged the practice in hospitals by requiring higher standards that are better suited to commercial reprocessing companies which conduct their work in clean room settings outside hospitals where strict regulations can be applied and monitored.

Because SA is only beginning to see a shift from hospital-based reprocessing to commercial reprocessing, the premise of the article is incorrect. The choice is not between safety and reprocessing of these devices, as the headline would have readers believe; it is between the less safe practice of reprocessing these devices at hospitals, where there is little oversight and no licence to permit the activity versus reprocessing them in commercial facilities where the devices can be cleaned, disinfected/sterilised and repackaged to the identical standards as those required for new devices under strict regulatory oversight.  

The amendments to South African law make clear that SA, like leading regulated markets in the world, has put in place the regulatory tools to stop the inappropriate reuse of single-use devices by opening up to a world of safe, regulated reprocessed devices by commercial firms. Med-Q, the domestic commercial reprocessor held to these strict international standards, should be applauded for creating green, domestic jobs and keeping these devices within SA and out of the waste stream, extending limited healthcare dollars, reducing waste and greenhouse gas emissions. 

The article correctly notes that the agency issued a licence to Medi-Q, then suspended the licence to evaluate whether this is allowed in the regulations. But nowhere in the law or regulation does it stipulate that single-use device reprocessing is “illegal”. Perhaps this is due to confusion at the agency given Medi-Q is the first domestic reprocessor of single-use devices seeking the regulatory oversight promised by law. Readers should note that there is no accusation of wrongdoing by Medi-Q nor any evidence of safety issues from the practice of reprocessing, only ambiguity from the regulator.

Daniel J Vukelich is president of the Association of Medical Device Reprocessors.

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