RQM+ Weekly Watch #3

This newsletter contains information published through the previous Friday.

RQM+ Recap

RQM+ content published last week and upcoming events.

Technical Briefs

• Brought to You by the Letter M: Operational Considerations for Transitioning From the QSR to the QMSR

Video/Audio

• Fern.ai human-in-the-loop approach to full-text data extraction | LinkedIn
• Excellence Spotlight: Noel Keegan, Sr. Director, Data Operations (Clinical Trials) | LinkedIn, Apple Podcasts, Spotify

Upcoming

• [This Thursday] 28 March RQM+ Live! #77 presentation and panel – Get Ahead of the Crisis: How Your Quality System Can Prevent Negative Impacts on Customers, Patients, and Reputation
• 16 April presentation and Q&A – Aligning Your QMS with the FDA's QMSR Updates
• 25 April RQM+ Live! #78 – Behind the Scenes with BSI Head of IVD Notified Body, Alex Laan

Europe

• Further to last week's news post…the presentation of the most recent Notified Body survey on applications and certifications was revised on 11 March 2024, with minor adjustments in some of the charts. Figure 1 below summarizes the survey data in the context of the conformity assessment process.

• The Italian Medicines Agency (AIFA) published their GUIDELINE FOR CONSULTATION OF THE AIFA BY A NOTIFIED BODY ON AN ANCILLARY MEDICINAL SUBSTANCE TO BE USED IN A CLASS III MEDICAL DEVICE.?
• The EU's Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) have been busy this week, with a draft update to the benefit risk assessment for the use of phthalates in medical devices and a notification that they will be reporting on the risks associated with the use of brain stimulators with no intended medical purpose:
• — Mandate on risks for the health associated to the use of brain stimulators not having an intended medical purpose described in the group 6 of Regulation (EU) 2017/745
• — Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) “UPDATE of the GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties”
• The MHRA have updated their guidance on how to notify the MHRA about a clinical investigation for a medical device, with the addition of Electrical guidance for clinical investigations (i.e. guidance on content specific for electrical medical equipment).
• The MDCG have released their updated plans for MDCG guidance. It outlines what we can expect to see in 2024 and beyond. Items of note are:

• — Another Device-Specific Vigilance Guidance
• — Three more Common Specifications for IVDs
• — Updates to all things PMS (guidance and form templates)
• — More IVDR related guidance

United States and Canada

• The FDA updated their Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list. From launch of the Breakthrough Devices Program through December 31, 2023, in total, the FDA:
• — granted 933 Breakthrough Devices designations, and
• — authorized 95 Breakthrough Devices for marketing
• The transcript and summary minutes are available from the FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting from 13th February 2024.
• BSI published a blog on the US FDA recognition of Vaporized Hydrogen Peroxide sterilization as Established Category A method.

Rest of World

• ISO 17665:2024 Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices has just been published. The EN and national versions should be along shortly. This new version replaces ISO 17665-1:2006, ISO/TS 17665-2:2009 and ISO/TS 17665-3:2013 which have all been withdrawn at ISO level and the associated national versions will all be in the process of being withdrawn.

Recalls, FSCAs & Alerts

Class I recall (US)

• Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks
• Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing Defect That Can Lead to Injury or Death
• Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist

FDA Safety Communications

• FDA Provides Update on Plastic Syringes Made in China, Issues Warning Letters Related to Violative Products
• UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

European FSCAs / Safety notices:

• Guardian? 4 Sensor. Priority 2 – Warning (via the HPRA)
• Class 4 Medicines Notification: Fresenius Kabi Limited, Sodium Chloride Intravenous Infusion 0.9% Freeflex, EL (24)A/10 (via the MHRA)
• FSNs published in the UK

Warning Letters (United States)

• Medline Industries, LPMARCS-CMS 677545 — MARCH 18, 2024: Adulterated devices (Change control, design control, regulatory clearance)
• Jiangsu Shenli Medical Production Co., Ltd. MARCS-CMS 677753 — MARCH 18, 2024 Adulterated devices (Change control, design control, regulatory clearance)
• Sol-Millennium Medical, Inc. MARCS-CMS 677524 — MARCH 18, 2024 Adulterated devices (Change control, design control, regulatory clearance) ?

Approvals and Clearances

• Consumer Information:?Belotero Balance? (+)?-?P090016/S050?(Merz North America, Inc.)

Articles We Read?

Europe Related

• All articles we read in this category this week were behind a paywall (we exclude these).

United States Related

• FDA warns consumers against using plastic syringes made in China (RAPS)
• FDA sends 3 warning letters in probe of plastic syringes made in China
• FDA Premarket Cybersecurity Guidance Gets New Draft Guidance (AAMI)
• Biden Signs Sweeping Executive Order To Advance Women’s Health?
• As FDA’s LDT rule looms, experts warn patients may lose access to critical tests
• EPA final rule limits EtO emissions for medical device sterilizers
• Abiomed’s latest Impella recall linked to 129 injury, 49 death reports
• Fresenius Kabi receives FDA warning letter over issues at ex-Ivenix site
• Medtronic claims win in Axonics patent row, pushes for jury trial
• Could the Supreme Court Blindside the FDA on the First Amendment?
• Another Potentially Bubbly Battle Over Hydrogen Peroxide Fizzles Out
• Deka’s automated insulin delivery system, powered by patient-led app, gets FDA clearance
• 6 ways the FDA can improve medical device recalls
• A Thorny PMA Preemption Decision from Rhode Island
• Feeling the Heat (or Cold) – New Draft Guidance Addresses Requirements for Devices that Produce Thermal Effects
• Another Weird Alabama Decision
• Abbott recalls Heartmate LVAD communication system
• US hospitals predict uptick in procedures as staffing pressures ease
• Bad Labs! Bad Labs? Whatcha Gonna Do??

General Industry News

• Women have been ‘left out of medical devices’, say experts amid bias concerns
• As A Young Woman Marissa Fayer ‘Fell’ Into Medtech. Now, As An Industry Leader, She’s Focused On Leveling The Field
• Technology must tackle bias in medical devices
• Reliance: How not if (GMDN Blog)
• Stryker’s next head of joint replacement talks about new revision, robotics products
• Medtech layoffs continue in 2024
• Thermo Fisher, Bayer partner to develop companion diagnostics
• BD’s CTO Beth McCombs Discusses Key Initiatives – AI/Gen AI; DE&I Strategy; Succession Planning
• Siemens Healthineers to close fast track diagnostics unit, lay off about 90 workers
• Better Therapeutics lays off staff, considers winding down business
• QuidelOrtho to lay off employees after firing CEO ?

Stay Connected

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