Why hospitals Should Stop Re-use of Single-Use Devices but Explore Regulated Remanufacturing 

New EU Rules Outline Reprocessing and Remanufacturing Requirements

In recent years, great advances in design, manufacture and use of medical devices have provided enormous patient benefit during surgery and treatment.

Important safety, ethical and legal concerns arise when devices, originally designed and labelled for single use, are, despite the manufacturers’ express instructions, reused and repackaged by hospitals.  However, with the passage of the EU Medical Device Regulation and adoption by Guidance from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, European hospitals now have clear guidance.  In short, UK hospitals are already prohibited, and now EU hospitals should follow suit. This essentially means that the reuse or reprocessing of single-use devices (SUDs)  must be carried out in accordance with the EU Medical Device Regulation. So, if an entity reuses a single-use device, it becomes the manufacturer and therefore is legally responsible for complying with all medical device manufacturing requirements including the application and approval of receiving an official “CE” mark. 

Until now, most reuse of SUDs in Europe has taken place in hospitals.  So urgent attention needs to be brought to Ministries of Health and EU hospitals to ensure the new rules are understood and adhered to.  There is a solution, however, in that some medical device makers are stepping up and obtaining CE marks for “remanufactured” SUDs.  Hospitals that have been reusing SUDs to save money and reduce waste have a path, albeit for fewer products, to obtain safe, regulated and professional remanufactured devices that meet all EU rules.

There are three main reasons why hospitals should not be reprocessing their own single-use devices:

1) Risks to Patient Safety

➤ The risks of cross-contamination and the spread of serious hospital-acquired infections that are extremely debilitating and potentially fatal. This is one of the biggest public health challenges facing all European healthcare systems. Regulated remanufacturing, however, ensures that all devices are as clean and sterile as original equipment.  

➤ The risks of device malfunction during surgery or intensive care due to the device being second-hand.  Regulated remanufacturers, however, must demonstrate their devices are functional and indeed, AMDR member reprocessors test or inspect 100 % of their devices.

➤ There is no guarantee that a hospital reprocessed single-use device will perform to its original standard; when a device is commercially reprocessed, the reprocessor stands behind the product and assumes legal responsibility as the manufacturer.

2) Economic Value

➤ Lack of evidence for the supposed economic value of hospital reprocessing single-use devices whereas regulated commercial remanufacturing can demonstrate measurable value when assessing current device purchasing patterns versus purchasing a mix of new and remanufactured equipment.

➤ A 2008 study showing that hospital reprocessed angiography catheters were actually more expensive than the cost of new devices versus studies of commercially remanufactured devices underscoring measurable cost-savings.[1]

3) Ethical and Legal Concerns

➤ Are patients being properly and fully informed about the seriousness of the risks they are being exposed to? Would patients be happy with a reused catheter designed for single-use if they knew about it?  CE marked, remanufactured devices, however, are not investigated or experimental and present no new patient safety risks and thus informed consent is not necessary.

➤ How are healthcare providers deciding which patients are treated with a hospital reprocessed device or a new single-use device?  CE marked, remanufactured devices, however, offer the same safety and efficacy standards as original equipment, thus offering all patients the same degree of safety.

➤ Do healthcare providers in the theatre even know that an in-house reprocessed device is being used?  This is in contrast to regulated, remanufactured devices which must be packaged and marked as such and individually tracked and traced to identify the remanufacturer

➤ There is a clear case that the very serious risks and lack of informed consent associated with hospital reuse of SUDs are unacceptable when a regulated alternative exists.

Summary / Going forward:

In order to allow for the reprocessing of SUDs, each EU Member State must affirmatively allow so in law or regulation (17.1) and report such to the European Commission.

Member States may “opt-in” to the EU MDR’s requirements that any reused SUDs placed on their markets, must meet full manufacturer requirements and obtain a CE mark, like any other device (17.2).

Member States may also elect to allow hospitals or hospital service providers to reprocess single-use devices, but to do so, these reprocessors must be in compliance with the European Commission’s forthcoming “Common Specifications” and have such reprocessed audited by a Notified Body (17.3-5).  To date, EAASM is unaware of any Notified Bodies accredited to certify such hospital reuse.

EAASM supports proper remanufacturing of SUDs, demonstrating the devices meet the same safety and efficacy standards as if being brand new.  EAASM, therefore, urges the Member States to take action to stop inappropriate device reuse, and opt into 17.2, confirming that hospital reuse of SUDs is not allowed and the legal and safe pathway to reuse SUDs is by only accepting CE marked remanufactured devices.

Historical Background

➤ Historically, the vast majority of medical devices were designed to be reusable. Their design, shape and size, as well as the construction materials used – glass, metal and rubber – lent themselves to relatively straightforward cleaning and sterilisation.5

➤ However, as public awareness grew of the risk of transmission of serious blood-borne diseases such as hepatitis and HIV, the desire for single-use medical devices to reduce the risk of infection escalated.4

➤ The development of these single-use devices offered opportunities to use different materials and more complex designs. They did not have to: – withstand the rigours of reprocessing, such as steam sterilisation and exposure to chemical cleaning – some of these devices were impossible to clean or sterilise effectively in the hospital setting, so they were labelled for ‘single-use’.4

➤ Since 2010  the European Union’s Medical Devices Directive made a clear distinction between those medical devices that were intended by the manufacturer to be reused and those intended only for single use: – manufacturers subsequently had to label their products accordingly – in the case of a reusable device, this meant including instructions on how to prepare for reuse and any restrictions on the number of times it may be recycled – those devices intended for single-use needed to have this clearly indicated on the label4

➤ An industry has grown up to remanufacture single-use devices: – a practice that was previously carried out by institutions, such as hospitals, but now regulated companies have emerged to help hospitals extend the life cycle of existing medical device and therefore save money and reduce cost.  With the passage of the EU MDR, these companies and their devices are now held to the same standards as all other medical device makers and devices and liability is shifted to the commercial reprocessors, who have an excellent track record of safety.  Some of these companies are subsidiaries of large respected medical device companies like Arjo, Cardinal, Medline and Stryker while others remain independent, including European-based Vanguard AG

[1] See, Bruno de Sosa Martinis, Reprocessing of Single-Use Medical Devices: Clinical and Financial Results, Portuguese Journal of Public Health, February 2019.  See also, Lisa WM Leung, Banu Evranos, Alexander Grimster, Anthonly Li, Abhay Bajpai, Zia Zuberi, Mana Sohal and Mark M. Gallagher, Remanufactured Circular Mapping Catheters: Safety, Effectiveness and Cost, Journal of Interventional Cardiac Electrophysiology, December 2019.

[2] Health First Europe facts and figures on patient safety: http://www.healthfirsteurope.org/index.php?pid=82

[3]  Larmuseau David, Siok Swan Tan. The impact of reprocessing single-use devices in Belgium – An economic study, Erasmus MC University Medical Center, Institute for Medical Technology Assessment, Rotterdam, Netherlands, 2008.