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Medical Device Regulation: Reprocessing of Single-Use Devices

The final draft of the Medical Device Regulation (MDR) clarifies what will be legally expected of health institutions, or by external parties on their behalf, who opt for the reprocessing of single-use devices.

A single-use device, as is implied by its name, is a device which is intended to be used on a single patient for a single procedure. This means that such a device should not be used again on the same patient, and is not intended to be reprocessed. The current symbol being used to indicate a single-use device is shown below. Tighter healthcare budgets and resource restrictions may lead some institutions to reprocess such single-use devices. Increasing regulation on these processes reduces the risks involved.

The MDR states that further use and reprocessing of single-use devices must be performed only where permitted by national law and only when such a process complies with the requirements set out in the Regulation. Furthermore, the reprocessor will be considered to be the manufacturer of the reprocessed device and will assume the obligations under the Regulation.

However, Member States will have the power to decide that the obligations of a health institution or its external reprocessor may differ from the obligations set out for manufacturers in the Regulation. Such divergence from the Regulation shall only be permitted when the health institution or external reprocessor complies with the relevant common specifications, or in their absence, with harmonised standards and national provisions.

If a Member State decides that a health institution or its reprocessor shall not meet the obligations set out for manufacturers in the Regulation, they must ensure that a detailed risk management, validation of the processes involved, performance testing, quality management system, incident reporting, and traceability of reprocessed devices are in performed. Some Member States may also demand health institutions to provide patients with information on the use of reprocessed devices with which they are treated with. On the other hand, Member States may decide to further restrict, or event prohibit the use of reprocessed single-use devices in their territory.

The Regulation will also demand that the reprocessing of any device should have the same level of safety and performance as the original device. This ensures that such devices will be able to be re-used in a safe manner. Only reprocessing procedures which have been deemed safe by recent scientific evaluation may be carried out.

The term reprocessing is now defined as the

process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device. [Article 2(39) of the MDR]

All reprocessed devices must be issued with an indication that they are reprocessed devices, how many reprocessing cycles have taken place, as well as the reprocessing cycle limit.

We’ll keep you informed on any changes which may occur.

Reusable Surgical Instruments

This article has been updated! Please visit the following link:

http://www.advenamedical.com/news/5935/reusable-surgical-instruments-in-eu-regulation-7452017/

 

The upcoming EU Medical Device Regulation brings with it several new device classification and one specifically involves Class I Reusable Surgical Instruments. Which are defined as:

“an instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which are intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out” – Article VII Part I 2.3

It should be noted that only devices without any connection to an active medical device can be defined is this manner, otherwise they will be given a higher classification. Examples of this class include:

  • Scalpels and scalpel handles
  • Reamers
  • Drill bits
  • Saws, that not intended for connection to an active device
  • Retractors, forceps, excavators, and chisels
  • Sternum retractors for transient use

Under the current Medical Device Directive, such devices would have fallen under the Class I classification, with no Notified Body (NB) involvement. On the other hand, the new Regulation gives specific conformity routes for these devices:

Conformity assessment based on a quality management system and on assessment of the technical documentation – Annex VIII, excluding Chapter II
OR
Conformity assessment based on product conformity verification – Annex X, Part A

In all cases, the NB involvement will be limited to the aspects of reuse, in particular:

  • Cleaning
  • Disinfection
  • Sterilisation
  • Maintenance and functional testing
  • Related instructions for use

Therefore, a vital part of conformance with the Regulation will be to provide detailed procedures for the processes involved in allowing the reuse of the device. This Information for Reuse will include the validated method of re-sterilisation appropriate to the Member State in which the device is placed on the market.

Furthermore, the information provided should also indicate the limitations of reuse such that the device remains safe to use. A maximum allowable number of reuses, could be provided to the user who would need to keep track of how many times that particular device has been used. Alternatively, the user can look out for signs of material degradation which could indicate that the device is no longer safe to use.

It is also required that any traceable, or safety information present on the device should remain legible after every preparation for reuse.

The Unique Device Identifier (UDI) will be required to be present on the device itself. In the case that the technology to include the UDI on the device is too expensive, does not exist, or if marking adversely affects safety or performance, the DI may be omitted. However, the UDI must be present on the label, and higher levels of packaging.

Lithium batteries and Medical Devices in the EU

The safety of battery operated devices is attracting increasingly stringent scrutiny and it has been determined that, as from 1 May 2012, all lithium-ion batteries must be tested and certified to the standard IEC 62133. The exceptions are for information technology equipment (standard IEC 60950-1 applies) and audio/video devices where IEC 60065 applies.

This includes all batteries and battery packs intended for use in conjunction with medical products which must be evaluated and certified accordingly. (This would normally be undertaken and certified by the battery manufacturer / supplier.)

A supplier’s pre-certification to IEC 62133 will assist to assure that the legally required and applicable Medical Device Directive essential requirements may be answered , in particular essential requirement 9.3:

9.3 Devices must be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention must be paid to devices whose intended use includes exposure to flammable substances or to substances which could cause combustion.

This will then relate to the way the a medical device manufacturer may demonstrate that hazards from using such batteries in their device(s) have been risk assessed to the EU harmonised and essential standard EN ISO 14771; 2012. By undertaking such a risk study, as part of the Technical File, it should be demonstrated that the device is:

  1. Inherent safety by design
  2. Protective measures in the actual medical device and/or manufacturing process
  3. Information for safety, such as labeling and instructions for use

If the battery is incorporated within a device then the whole device, including the actual battery and charging circuits, should conform to EN ISO 60601-1 which covers basic safety and essential performance for all Medical Electrical Equipment.

With the spread of wireless and mobile technology, electromagnetic disturbances arise which can affect medical equipment and prevent it from working in the way it was intended to. Therefore it is also essential that such medical equipment is not oversensitive to radio frequency interference and in addition electromagnetic emissions from it should not interfere with other equipment and systems. Essentially this means testing and certifying to

BS EN 60601-1-2:2015 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

Before any electrically powered device will be accepted in a clinical or hospitals environment it would be expect it to be certified accordingly before they would purchase.

Meet Advena at MEDICA 2016

medica_logoTwo members of our team will be attending MEDICA 2016 in Düsseldorf on Monday 14th and Tuesday 15th November.

We are available to meet both new and existing clients – please email in advance to arrange an appointment at a convenient time.

 

Anthony Kirby
Business Manager
anthony.kirby@advenamedical.com
Zennia Paniwynk
Quality/Regulatory Administrator
zennia@advenamedical.com

Prepared for Brexit: Advena in the news

The Business Desk West Midlands

“Warwick firm adopts Maltese registration to improve EU trading”

http://www.thebusinessdesk.com/westmidlands/news/739349-warwick-firm-adopts-maltese-registration-to-improve-eu-trading.html

Coventry Telegraph

“Advena Limited is based in Warwick and will retain all of its operations in the UK, but has set-up an office in Malta where the business is now registered as a subsidiary.”

http://www.coventrytelegraph.net/news/business/brexit-forces-warwickshire-business-move-11832211

Advena are prepared, by active leadership from our dual locations, to assist medical device and cosmetics manufacturers wherever they are to practically and efficiently work through any political eventuality that the UK’s vote to leave the EU may inspire. For further details please see our Brexit Information Portal >

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