MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • MassDevice Today
    • Cardiovascular
    • Clinical Trials
    • Legal News
    • Orthopedics
    • Regulatory/Compliance
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • More MedTech
    • Cosmetic/Aesthetic
    • Diabetes
    • Dialysis
    • Distribution
    • Imaging
    • Otolaryngology Ear, Nose & Throat
    • Pharma
    • Respiratory
    • Wound Care
  • Blog
  • DeviceTalks Podcasts
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • Videos
    • White Papers
  • DeviceTalks
Home » UPDATE: Medtronic traces surgical kit possibly contaminated with fatal brain disease

UPDATE: Medtronic traces surgical kit possibly contaminated with fatal brain disease

September 6, 2013 By Sony Salzman Leave a Comment

Share
UPDATE: Medtronic confirms sequence of contamination in deadly brain disease infection warning

Medtronic (NYSE:MDT) is working with New England hospitals and government health officials to track the movement of surgical medical equipment involved in several cases of possible patient exposure to Creutzfeldt-Jakob disease, a rare and fatal relative to the more commonly known "mad cow" disease.

This morning a spokesperson confirmed that Medtronic tools were involved in 7 out of the suspected 13 total cases of patient exposure to the deadly brain disease.

"Medtronic was recently notified by Catholic Medical Center in New Hampshire that our surgical instruments had been used on a patient who may have had sporadic CJD at the time of surgery," according to a company statement. "Upon notification that our instruments had been used in this case, we followed procedures to quickly track that specific set of instruments and have confirmed they were used in 7 additional cases."

Medtronic equipment was also confirmed in the 1st documented case at Catholic Medical Center in N.H., in which a patient who underwent a procedure with the rented tools later died. Autopsy reports have yet to confirm whether that patient carried the rare and fatal Creutzfeldt-Jakob disease, health officials said.

After Catholic Medical informed the Minn.-based medical device giant about the in-hospital exposure, the company used its own databases to track the contaminated tools, which had already been used on patients at Cape Cod Hospital. All instruments in question are currently being quarantined, and health officials will fully confirm the Creutzfeldt-Jakob diagnosis when autopsy reports from the deceased patient come in.

An autopsy is 1 of the only ways to confirm Creutzfeldt-Jakob, a rare but deadly disease that attacks the brain. Only 4 known cases of  Creutzfeldt-Jakob contamination from medical instruments have taken place in the last 40 years, none in the U.S.

Hospitals frequently rent medical equipment directly from the manufacturer, and each time the equipment changes hands it goes through a sterilization procedure. By the time the equipment arrived at Cape Cod Hospital it had undergone 4 different sterilization processes, Dr. Donald Guadagnoli, the hospital’s chief medical officer, told The Boston Globe.

Creutzfeldt-Jakob disease disease attacks the brain through protein-like structures called prions, which are more difficult to completely eradicated during standard hospital sterilization.

Health officials said the risk of further infection is very low because of the number of times the equipment has been sterilized, and because exposed patients underwent spine, not brain surgery. In Mass., the low-risk exposure "is limited to 5 Cape Cod Hospital patients who received procedures between June and August using the same device that was used on the New Hampshire patient," a Mass. health department notice said.

Filed Under: News Well Tagged With: Diseases, Minnesota, Personal Injury

In case you missed it

  • Affluent Medical touts results of endovascular aneurysm repair study
  • NeoTract’s UroLift system gains expanded insurance coverage
  • Innovasive rebrands as Amplify Surgical
  • Report: FDA panel wants more extensive data, quality of life outcomes for vaginal mesh products
  • These medtech companies raised the most VC in 2018
  • IEEE publishes safety standards draft for medtech interoperability
  • Senseonics partners to provide veterans with Eversense CGM
  • FDA goes after California stem cell doc for unapproved breast implant device
  • FTC wants more details on $4B Boston Scientific-BTG tie-up
  • Tandem wins interoperable claim for insulin pump from FDA
  • Nevro files patent infringement suit against Stimwave
  • A record year for device innovation
  • Soterix Medical launches tDCS trial for cocaine addiction
  • Corindus asks FDA for expanded neurosurgery indication for CorPath GRX
  • FDA green-lights early feasibility trial for Foldax’s Tria biopolymer heart valve
  • Wisc. Dem seeks co-sponsors for bill to repeal medical device tax
  • Titan Medical hopeful for Q4 FDA IDE trial launch for Sport robotic platform

RSS From Medical Design & Outsourcing

  • FDA clears Safe Medical Design’s urethral catheter
    Safe Medical Design (San Francisco) said that FDA has cleared its Signal Catheter for commercialization in the United States. The 100% silicone foley catheter features a novel hub design allowing the catheter to reduce excessive balloon pressure in the event the catheter is improperly placed. Each year in the United States there are as many as 500,000… […]
  • These medtech companies raised the most VC in 2018
    Venture capital firms invested more than $2.9 billion in medical device companies in 2018 — a slight increase from the $2.8 billion raised in 2017, according to a MoneyTree report from PricewaterhouseCoopers (PwC) and CB Insights. Both the first and second quarters of 2018 saw an increase in investments, totaling nearly $778 million and $786 million… […]
  • ODU touts Medi-Snap Advanced plastic circular connector for medical applications
    ODU (Camarillo, Calif.) recently announced that it is introducing its Medi-Snap Advanced plastic circular connector to the North American market. ODU describes the Medi-Snap as lightweight and cost-efficient. It’s a plastic circular connector with high chemical resistance ideal for medical, industrial and test and measurement applications, according to the company. The autoclavable connector is IEC 60601-1 compliant and… […]
  • Regulatory software company Complion raises $7M
    Complion (Cleveland) — a maker of regulatory software for clinical research sites — recently announced that it has raised $7 million in its latest funding round. Beringea led the Series B round, the company announced on Feb. 12. The round ended up being oversubscribed, thanks to interest from existing investors including the Ohio Innovation Fund, JumpStart… […]
  • These new titanium strip grades could enable better neuromodulation devices
    Officials at Ametek Specialty Metal Products (Collegeville, Pa.) think their new titanium strip grades for medical applications could enable more innovation in the fast-growing neuromodulation device sector. Ametek’s Hamilton Precision Metals and SMP Wallingford businesses have proprietary production processes for the new titanium grades — grades 9 and 23. They manufacture thin strips of the titanium through cold… […]
  • CoorsTek Bioceramics touts composite ceramic material
    CoorsTek Bioceramics officials think testing and clinical feedback since 2011 has shown their CeraSurf-p alumina matrix composite ceramic material to be a state-of-the-art ceramic bearing material for total hip arthroplasty. CoorsTek’s CeraSurf-p is an implant grade alumina matrix composite ceramic material that falls under the ISO 6474-2 Type X (extra high strength) material standard. The proprietary material… […]
  • Life Spine launches sacroiliac screw study
    Life Spine (Huntley, Ill.) said it has begun a study of sacroiliac joint fixation outcomes using its SImpact screw. SImpact is a cannulated and fenestrated screw, intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis through a lateral approach. It incorporates the proprietary surface technology Osseo-Loc, and is available in… […]
  • Olympus named 2019 Edison Awards finalist
    Olympus recently announced that its EndoEye Flex 3D and its FlexDex Needle Driver have been named a finalist in this year’s Edison Awards. The Edison Awards recognize innovation, creativity and ingenuity in today’s global economy. “Olympus is creating value by offering a cost alternative to robotic surgery through its innovative combination of EndoEye Flex 3D… […]
  • Tegra Medical appoints new general manager
    Tegra Medical has appointed Hal Blenkhorn as its general manager at Tegra’s Franklin, Mass. location. Blenkhorn will report to president and CEO J. Mark King and will be responsible for its local management team and plant operations. He originally joined the company in 2006 as a manufacturing engineer and was later promoted to manufacturing engineering director… […]
  • FDA approves BD’s arteriovenous fistula system
    Becton Dickinson & Co. (NYSE:BDX) said that FDA has cleared its WavelinQ 4 French (4F) endovascular arteriovenous fistula (endoAVF) system for people with end-stage renal disease (ESRD). The 4F endoAVF will allow for the creation of a  fistula in either the ulnar artery and ulnar vein or the radial artery and radial vein, providing a minimally… […]
  • How facial skin wounds could be healed with 3D-bioprinted masks
    Scientists at Wake Forest Institute for Regenerative Medicine (WFIRM) have created a 3D-bioprinted BioMask that could treat facial wounds or burns with tissue regenerated from the mask. The BioMask was developed using a customized, bioengineered skin substitute in combination with a wound dressing layer that can snugly fit onto a facial wound to regenerate skin,… […]

Leave a Reply Cancel reply

You must be logged in to post a comment.

Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us
Privacy
Add us on FacebookMassDevice Network
Follow us on Twitter@MassDevice
Connect with us on LinkedInLinkedIn
Follow us on YouTube YouTube

Copyright © 2019 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS