DPI's technical representatives and experienced team of engineers work closely with customers, assisting them with design for manufacturing and other value-added services.

William R. Drummond Jr., MBA Biocompatibility Engineer & Material Scientist

How did I end up working with medical devices? Reflecting on my career, it's been diverse. Three years ago, I was working on protein structure in research labs. I never thought I'd be in the world of quality later on!

The analysis of extractables and leachables and subsequent risk assessment is an important aspect of the determination of biocompatibility for many medical devices. Leachable chemicals have the potential to pose a toxicological risk to patients, and therefore it is required that they be adequately characterized and assessed for potential safety concerns. One important consideration in the assessment of leachables is the choice of a suitable simulating solvent intended to replicate the use condition for the device and its biological environment. This aspect of study design is especially difficult for blood-contacting medical devices due to the complexity of simulating the biological matrix. This publication reports a comparison of the extracting power of different binary solvent mixtures and saline in comparison with whole blood for a bloodline tubing set connected to a hemodialyzer. Ten different known extractables, spanning a range of physicochemical properties and molecular weights, were quantified. The results indicated that for low-molecular-weight analytes, a suitable exaggeration for whole blood can be obtained using a low-concentration ethanol/water mixture (20%), and in general, extracted quantity increases with the concentration of alcohol cosolvent. For polyvinylpyrrolidone, the opposite trend was observed, as solubility of the polymer was found to decrease with increasing alcohol concentration, resulting in lower extracted quantities at high alcohol concentrations. Analysis of ethanol/water concentrations in the extract solutions post extraction indicated no change in solvent composition.

The centrally sponsored scheme for strengthening of medical devices industry (SMDI), launched by the Central government last week, was widely welcomed by the medical devices industry in the country.

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading

The Health Ministry has notified the Medical Devices Rule, 2017 in which manufacturers of medical devices will be required to meet risk proportionate regulatory requirements.

The government's new Rs 500 crore scheme for the medical device industry will not only boost domestic manufacturing but also reduce reliance on import, said medtech leaders on Saturday.

The group said the move puts at risk patient safety and undermines the domestic med-tech sector. It said that refurbished machines are not subject to stringent quality checks applicable to new devices.

Sponsored Conversation by Abbott Laboratories. A conversation with Abbott Laboratories' Lisa Earnhardt.

The South Africa medical device market will register a 9.1% CAGR between 2017-2018 according to a recent Fitch Solutions report. This significant growth will raise the market to USD 1.27 bn by 2018.

Medical devices comprising an anti-connexin agent suitable for introduction into a subject.

Implantable devices and related systems utilize power management features in conjunction with a recharge circuit that includes a coil and capacitance. The reactance such as the capacitance and/or inductance may be variable such that in the event of an overcharge condition, the reactance may be varied to change the resonant frequency of the circuit of the coil from the recharge frequency to another frequency to reduce the power being received. Other power management features may additionally or alternatively be employed. For instance, the device may send an uplink telemetry signal to an external device to request that recharge power be decreased. The device may switch additional resistance into the circuit of the coil to reduce the Q of the circuit. As another example, the device may clamp the circuit of the coil to ground.

A medical device, comprising first and second components coupled via a first wireless link; and a third component coupled to the first device via a second wireless link. The device implements a communication scheme in which transmissions via the second wireless link occur during a time period that is interleaved between periods including transmissions via the first link.

A hermetic terminal for an active implantable medical device (AIMD), includes an RF distance telemetry pin antenna, a capacitor conductively coupled between the antenna and a ground for the AIMD, and an inductor electrically disposed in parallel with the capacitor and conductively coupled between the antenna and a ground for the AIMD. The capacitor and the inductor form a band pass filter for attenuating electromagnetic signals through the antenna except at a selected frequency band. Values of capacitance and inductance are selected such that the band pass filter is resonant at the selected frequency band. In an alternative form, the band pass filter is coupled in series with the telemetry pin antenna for attenuating MRI signals of a selected frequency band.

The present disclosure relates to an apparatus and process for forming medical devices from an injectable composition. The apparatus includes a supply assembly configured to maintain and selective dispense a first precursor and a second precursor, a mixing assembly configured to mix the first and second precursors, and at least one catalyzing element including a transition metal ion to aid in the polymerization of the first and second precursors. The process includes dispensing a volume of the first precursor and a volume of the second precursor into a mixing assembly and mixing the first and second precursors. The first and second precursors each possess a core and at least one functional group known to have click reactivity with each other. The mixed precursors are contacted with a transition metal catalyst to produce a flowable composition for use as a medical device.

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

Methods of reclaiming plastic from plastic medical waste containers containing medical waste and manufacturing recycled medical devices are described. Recycled medical devices made from plastic medical waste containers containing medical waste are also described.

A light-based medical diagnostic system includes a plurality of semiconductor diodes with pump beams and a multiplexer capable of combining the pump beams and generating at least a multiplexed pump beam comprising one or more wavelengths. A first waveguide structure is configured to receive at least a portion of the one or more wavelengths and outputs a first optical beam. A second waveguide structure is configured to receive at least a portion of the first optical beam and to communicate at least the portion of the first optical beam to an output end of the second waveguide structure to form an output beam. A lens system is configured to receive at least a portion of the output beam and to communicate at least the portion of the output beam onto a part of a patient's body, such as a patient's blood.

Medical devices, methods and kits are described. An exemplary medical device comprises a catheter that has a catheter wall and defines a catheter lumen, a bend, and a coil disposed distal to the bend. The catheter defines one or more apertures that extend through the catheter wall and are in communication with the catheter lumen.

Pressure sensing guidewires are disclosed. The pressure sensing guidewires may include a tubular member having a proximal portion and a distal portion. The distal portion may have a plurality of slots formed therein. The distal portion may have a first wall thickness along a first region and a second wall thickness smaller than the first wall thickness along a second region. A pressure sensor may be disposed within the distal portion of the tubular member and housed within the second region. An anti-thrombogenic coating may be disposed on an inner surface, an outer surface, or both of the second region of the distal portion of the tubular member.

Karen gives an update on the advocacy of software freedom for medical devices, while Bradley continually takes the show off-topic.

Show Notes:

• Bradley mentioned Jimmy Fallon's … And We're Back script.
• Barnaby Jack showed lethal attacks exist on wireless devices. (06:25)
• Karen previously gave a talk about her heart condition on the show. (07:13)
• Hugo Campos, who also works on this issue. (26:08)
• Bradley mentioned the Therac-25 software-related disaster. (29:30)

Send feedback and comments on the cast to <oggcast@faif.us>. You can keep in touch with Free as in Freedom on our IRC channel, #faif on irc.freenode.net, and by following Conservancy on on Twitter and and FaiF on Twitter.

Free as in Freedom is produced by Dan Lynch of danlynch.org. Theme music written and performed by Mike Tarantino with Charlie Paxson on drums.

The content of this audcast, and the accompanying show notes and music are licensed under the Creative Commons Attribution-Share-Alike 4.0 license (CC BY-SA 4.0).

While medical professionals everywhere around the globe are working as hard as they can, both them as well as consumers are trying to get protective products to remain healthy and, where possible, prevent being contaminated. It is clear that in seve...

“The Department of Justice will be vigilant in pursuing cases against medical device companies that break the law and defraud taxpayers,” said Tony West, Assistant Attorney General for the Justice Department’s Civil Division.

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading

UC Davis researchers have designed a plug-in interface which will usher in the new generation of compact medical devices. "We think there is a huge

It will amend Drugs & Cosmetics Rules to ensure availability of low-cost drugs & promote generics

State government is planning production of devices and equipment for healthcare sector on a large scale with the active participation of public sector institutions to fight Covid-19 pandemic and meet Kerala’s long-term requirements.

Hayden Library - TA459.A5171 1990 v.23

IEEE Computer Society

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