RQM+ Weekly Watch #11

RQM+ Recap

RQM+ news, content recently published, and upcoming online events.

News

• RQM+ Launches Fern.ai Smart Authoring Module for MedTech | Press Release, LinkedIn

Technical Briefs

• Polymer Failure Analysis with Jordi Labs, an RQM+ Company

Video/Audio

• RQM+ Launches Fern.ai Smart Authoring Module for MedTech (Walkthrough Video) | LinkedIn

Upcoming Online Events

• [THREAD Live] 22 May – Modernizing MedTech Research via Hybrid Study Approaches to Enhance Your Patient Recruitment, featuring RQM+ Clinical Trials Chief Operating Officer, David Novotny

• [Webinar] 23 May – We Need to Talk About Risk: The Critical Role of Communication in Risk Management, presented by Edward Ball

• [RQM+ Live! #79] 6 June panel and Q&A – FDA's Wound Care Shakeup: Ensuring Your Products Make the Cut, featuring Allison Komiyama, PhD, RAC, Mark DuVal, J.D. FRAPS, Jonathan Gimbel, and Erin Gontang.

Europe

• The HPRA updated their guidance on conducting clinical investigations in Ireland.
• BVMed have issued a press release to remind device manufacturers of the upcoming deadline of 26th May 2024 whilst also reiterating their concerns about the MDR implementation. “The extended transition period buys time, but it does not change the fundamental problems of the MDR. We now have to further develop the MDR structurally and improve it in a big step, otherwise this will continue to be at the expense of patient care and Europe as a MedTech location,” said BVMed managing director and board member Dr. Marc Pierre M?ll.
• BVMed also published a summary of facts and figures about the MDR.?
• BSI published a report summarizing their capacity and lead times for MDR & IVDR applications and conformity assessments.
• Team-NB published their updated sector-survey data along with a press release.?
• The Commission released updated data from the notified bodies survey on certifications and applications (MDR/IVDR): Survey results of the 8th NB survey with data status 29 February 2024 (small and medium dataset)
• The European Commission released a report on the progress of the COMBINE project. The COMBINE project was initiated in response to the growing number of challenges identified when conducting combined studies in Europe. The initial phase explored the interface ?between clinical trials (CT) of investigational medicinal products (IMP), performance studies (PS) of In-Vitro Diagnostic Medical Devices ?(IVDs) and clinical investigations (CI) of medical devices (MDs). Combined studies are studies in which medicinal products are assessed together with medical devices or in vitro diagnostics. With patients as the ultimate beneficiaries, the COMBINE project is an EU initiative addressing combined studies. The purpose of the project is simple: to streamline regulatory processes and cut the time needed to get innovative and personalized treatments to patients.?
• MedTech Europe co-signed a statement regarding proposals for compulsory licensing during significant health situations: Joint business statement on the EU Proposal on Compulsory Licensing.
• MDCG released four templates for the preliminary assessment and re-assessments under MDR and IVDR: MDCG 2024-6, MDCG 2024-7, MDCG 2024-8, MDCG 2024-9.?
• The UK government announced a package of up to ￡85 million to support the international community in tackling the growing threat of antimicrobial resistance (AMR), a global issue that makes infections difficult or impossible to treat. In addition, the MHRA is to establish a dedicated team to provide regulatory scientific support for innovators creating novel antimicrobials and diagnostics as part of a program led by the Department of Health and Social Care (DHSC) to support the international community in tackling the growing threat of antimicrobial resistance (AMR).

United States and Canada

• The FDA have updated their list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices with 191 additions. With this update, the FDA has authorized 882 AI/ML-enabled medical devices. Of those newly added to the list, 151 are devices with final decision dates between August 1, 2023, and March 31, 2024.
• The FDA have added the following tool to their list of qualified medical device development tools for the assessment of clinical outcomes of intraocular lenses: Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) instrument. The tool is intended to assess the frequency and bother of ocular symptoms in certain patients after receiving bilateral intraocular lens implants.

Rest of World

• The WHO released its updated Bacterial Priority Pathogens List (BPPL) 2024, featuring 15 families of antibiotic-resistant bacteria grouped into critical, high and medium categories for prioritization. The list provides guidance on the development of new and necessary treatments to stop the spread of antimicrobial resistance (AMR).

A number of ISO standards have been published (either for the first time, or in an additional language):

• ISO 10394:2023 Dentistry — Designation system for supernumerary teeth?
• ISO 23402-3:2024 Dentistry — Portable dental equipment for use in non‐permanent healthcare environment — Part 3: Portable suction equipment
• ISO 5832-1:2024 Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
• ISO 5832-4:2024 Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy
• ISO 5832-7:2024 Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenumiron alloy
• ISO 8637-2:2024 Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
• ISO 23500-3:2024 Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
• ISO 23500-4:2024 Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
• ISO 23500-5:2024 Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
• ISO 7151:2024 Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods
• ISO 16840- 2:2018/Amd 1:2024 Wheelchair seating — Part 2: Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity — Amendment 1: Updates and addition of new Annex covering alternatively sized cushions
• ISO 16840- 10:2021/Amd 1:2024 Wheelchair seating — Part 10: Resistance to ignition of postural support devices — Requirements and test method — Amendment 1: Amended with additional Annexes and test method
• ISO/TS 16840-15:2024 Wheelchair seating — Part 15: Selection, placement and fixation of flexible postural support devices in seating
• ISO 16021:2024 Absorbent incontinence products for urine and/or faeces — Basic principles for evaluation of single-use adult products from the perspective of users and caregivers
• ISO 21860:2020 Health Informatics — Reference standards portfolio (RSP) — Clinical imaging
• ISO 5363:2024 Robotics — Test methods for exoskeleton-type walking RACA robot

Recalls, FSCAs & Alerts

Class I Recall (US)

• Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff?
• Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power (Updated)
• Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction

FDA Safety Communications

• UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication (Updated)
• Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication

Other FSCAs / Safety Notices

• Ireland: CU Medical Systems, Inc. iPAD CU-SP1, iPAD CU-SP1 AUTO AEDs
• FSNs published in the UK: Field Safety Notices: 6 to 10 May 2024

In the News

• Getinge to limit US sales of heart devices after FDA safety warning
• FDA issues import alerts against 2 more plastic syringe manufacturers
• Boston Scientific recalls more than 1M angiographic catheters
• Abbott recalls Heartmate pump after 70 injuries, 2 deaths reported
• GE Healthcare warns of cybersecurity risks in ultrasound devices, software
• FDA advises against using Cue Health COVID-19 tests, sends warning letter
• Route 92 catheter recall tied to 2 injuries, 1 death
• J&J’s Megadyne discontinues pediatric electrode pad after burn reports

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Warning Letters (US)

• Cue Health, Inc. MARCS-CMS 675673 — MAY 09, 2024 [Breach of Emergency Use Authorisation; Change Management; Acceptance Activities]

Approvals and clearances

• None to report.

In the news:

• BD wins FDA approval for cervical cancer screening self-collection kit

Articles We Read

Europe Related

• Euro Convergence: Experts discuss supply chain challenges, potential solutions (RAPS)
• EU report examines barriers to combined studies of drugs, IVDs, and devices (RAPS)
• Euro Convergence: Experts concerned about incompatibilities between AI Act and MDR (RAPS)
• Euro Convergence: Stakeholders seek more product-specific, technical dossier-related guidance (RAPS)
• Euro Roundup: MHRA launches AI Airlock (RAPS)

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United States Related

• FDA said it "never" inspected dental lab that made controversial AGGA device
• FDA targets health inequality by improving at-home devices
• Groups tell Congress FDA does not need a new regulatory framework for AI devices (RAPS)
• Stakeholders request tweaks to FDA’s device cybersecurity guidance (RAPS)
• WDNC Dismisses Bone Graft Material Warranty Claims (Drug & Device Law Blog)
• When Worlds Collide: The Theory of Real-World Evidence Meets Reality (FDA Law Blog)

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General Industry News

• Medical registries and MDR: striking a delicate balance?
• AAMI News: In conversation - Standardizing AI on a Global Stage: About IEC's SNAIG

Stay In the Know

• Subscribe to the RQM+ Device Advice podcast (Apple, Spotify, Google)
• Visit the RQM+ Knowledge Center for upcoming and on-demand content
• Follow RQM+ on LinkedIn for regular updates