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Meet Advena at Arab Health 2017

Advena will be located in Za’abeel Hall 4, Stand Z4 E40 at this important show in Dubai from 30th January to 2nd February 2017.

We will be available to meet clients old and new during this trade show and have access to meeting room facilities at the ABHI UK Pavilion. We advise those who would like to meet one of our team to contact Anthony Kirby (Anthony.kirby@advenamedical.com) well in advance as the meeting room needs to be booked for any extended conversations or product reviews.

Further details about Arab Health 2017 may be found at http://www.arabhealthonline.com/

Anthony Kirby
Business Manager
Kenneth Shaw
Regulatory Associate

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.

Client Satisfaction Survey 2016 – Results

advenateam16_400x220Across three key areas, the results of Advena’s Client Satisfaction Survey for 2016 are testament to our policy of continuous improvement right across our service provision:

1. Value
We asked clients if they thought Advena provided an extremely competitively priced service – none of the respondents disagreed.

2. Efficiency
98% of respondents agreed that Advena are always very responsive to questions, queries and requests for information.

3. Effectiveness
96% of respondents said they relied on the regulatory advice provided by Advena, using it as an important part of their decision-making processes.

Our 2016 survey also saw a surge in recognition of our free regulatory newsletter as an “important service”. Respondents regard it as an invaluable means to keep up-to-date with the ever-changing regulations and standards, including the landmark decision for the UK to leave the European Union – referred to as ‘Brexit’ by the media.

We would like to thank all who participated in our 2016 survey and reaffirm our commitment to continuously improve our consultancy services, whilst maintaining competitive cost-effective rates.

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
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