MHRA Issues Guidance on Re-manufacturing Single-use Medical Devices
The Medicines & Healthcare products Regulatory Agency (MHRA) recently released a new guidance document titled “Single-use medical devices: UK guidance on re-manufacturing” published on July 5, 2016 for the purpose of making a clear distinction between re-manufactured single-use devices (SUDs) and devices that are reprocessed or fully refurbished.
The document outlines recommendations for some requirements such as technical documentation, bioburden assessment, labeling, risk management, and post-market surveillance that re-manufacturers need to comply in order to put re-manufactured SUDs on the UK market or into service. Aside from the re-manufacturers’ responsibilities, the document also specifies responsibilities for healthcare institutions/facilities.
Re-manufacturing and reprocessing are both processes applied to used devices. The reprocessing and reuse of single-use medical devices is a long-standing practice, although the MHRA advises against this as outlined in guidance document: “Single-use medical devices: implications and consequences of reuse” published on December 1, 2013. The key difference between the reprocessing and re-manufacturing is that re-manufacturing SUDs requires the re-manufacturer to meet all appropriate criteria relevant to the medical devices directives and place a CE Mark to declare conformity with the relevant Directive. A change of the initial intended use is not allowed. A re-manufactured SUD may not necessarily have components changed in all re-manufacturing conditions. However, prior to placing on the market or putting into service, the device will be cleaned, disinfected and sterilized and be tested against the re-manufacturer’s specifications to ensure the SUD continues to operate safely and as intended.
The re-manufacturer should prepare and maintain full technical documentation of the re-manufactured SUD. This documentation must include clinical evidence that may come from the re-manufacturer’s own clinical trial or through detailed information on equivalence to the original manufacturer’s device. Notified Bodies must examine the re-manufactured device’s design and compliance with relevant Directive in cases of re-manufactured SUDs belonging to Class III, Class IIa and IIb.
Furthermore, MHRA considers that Class I products should not be re-manufactured for CE Mark compliance; this is not required as specified in the current Medical Device Directive (MDD). However, the new European Union (EU) Medical Device Regulation is expected to repeal the current Medical Device Directive. When implemented, the MHRA will review and update the guidance document.
Managing bioburden assessments
As part of the bioburden assessment, the re-manufacturer should have validated SUD decontamination, cleaning and sterility processes in place. These validations include the evaluation of the removal of substances that may have a negative effect upon the patient or user safety (e.g., toxic substances, endotoxins, prion/TSE, etc.). Packaging and instructions for use should clearly state that the SUD is a re-manufactured version of the original and must have the symbol below, which means do not reuse/use only once/single-use only.
ISO 14971 compliance
The re-manufacturer must ensure good quality systems by complying with the standard EN ISO 14971: Medical Devices – Application of Risk Management to Medical Devices. As part of its post-market surveillance activities, the re-manufacturer should have a continuous monitoring process to identify problems associated with the re-manufactured devices as well as changes the original equipment manufacturer (OEM) makes to components, materials or specifications. Also, the re-manufacturer is responsible for managing product safety issues associated with their re-manufactured product and any product safety notification or recall that the OEM has implemented and that has an impact on a re-manufactured device.
The guidance further recommends healthcare facilities that use re-manufactured SUDs have a contract with a re-manufacturer or different manufacturers for different SUDs. The contract must indicate that the healthcare facility must always return the used SUD to the same re-manufacturer prohibiting sale or donation to any other third party. Also an internal reprocessing should not be performed.
Conclusion: Demonstrable conformity required
In conclusion, anyone who intends to re-manufacture SUDs must take on the full legal obligations of a manufacturer as specified in the relevant directives, as the medical devices do not explicitly permit re-manufacturing or reprocessing of SUD’s. Thus, re-manufactured SUDs must demonstrate conformity. Thus, to declare conformity with the directives, the re-manufacturer must place a CE mark on the product as applicable to the device classification.
Guenter Fiedler is Senior Customer Solutions Consultant at UL.