22nd June 2022.
Summary
The webinar, chaired by Ian Lindsley, Secretary of the European Biosafety, was well-attended with over 50 attendees and strong engagement from participants. After welcoming attendees, Mr Lindsley talked through the agenda of the webinar and set out the context of the ISO 23908 standard on safety mechanisms and the prevention of sharps injuries.
The first presentation of the webinar gave an introduction to the MDR/IVDR standardisation request on ISO 23908 and interpretation of 11.1 and 22.2 of Annex I of the MDR. Mario Gabrielli Cossellu,Policy and Legal Officer, Medical Devices, DG SANTE, gave attendees the history behind harmonised standards in support of the EU Regulations on medical devices and discussed the next steps of the process. The full presentation can be accessed here.
The second presentation of the webinar was given by Robert Nesbitt, chair of TC84 and Director of Abbvie. Mr Nesbitt spoke about the scope of ISO Technical Committee 84 and how sharps protection fits in the broader context of TC84’s work. The presentation focussed on what kinds of devices are covered by TC84 and the number of ISO/IEC Standards impact Delivery Systems and which relate to Post-Use Sharps Protection. The full presentation can be accessed here.
Francois Thomassin, convenor of WG8 and Health, hygiene and medical devices, ISOPERM, followed with a presentation which provided attendees with an overview of progress with the Working Group 8 of TC84 to revise ISO 23908. Mr Thomassin explained that Working Group 8 has experience in testing methods for preventing the risk of unintended cuts and pricks, body fluid exposures and microbial contamination. He talked through the working dynamic of the group, the new scope and the potential milestones to be met en route to the publication of the final standard. The full presentation can be accessed here.
The penultimate presentation of the webinar was given by Dr Philip Bickford Smith, project leader of WG8 and medical device consultant. It covered the current state of play with the technical work of Working Group 8 and interestingly highlighted that fully-automatic (passive) safety mechanisms are least likely to result in a needlestick injury. Dr Bickford Smith explained that a draft was still being developed and praised the work of the group to date, especially in regard to the draft of Annex ZA. The full presentation can be accessed here.
Dr Jose Luis Cobos, Vice Secretary General of the Spanish General Council of Nursing, concluded the presentations by providing interpretation guidance on Annex I, Points 11.1 and 22.2 of the MDR. Dr Cobos referenced Spanish General Council of Nursing guidance which was published to ensure consistency in the implementation and the interpretation of the MDR across Notified Bodies, Member States and manufacturers regarding the requirements defined in Annex 1, points 11.1 and 22.2. The full presentation can be accessed here.
Following on from the presentations, Dr Bickford Smith asked Robert Nesbitt if it would be worthwhile focussing on the most commonly used needle configurations first given the large number of devices. Mr Nesbitt agreed with the point made and highlighted that the scope in the draft document addresses this directly and drove previous revisions. The working group will have to decide at what point the scope becomes too broad.
