USFDA CDRH MEDICAL DEVICES WEBINARS : Download CDRH Industry Basics Workshop (All Day Webinars) – November 4, 2014

Date: 5th Nov 2014

Webinar: CDRH Industry Basics Workshop

Summary: This workshop (presented by webinar) will provide information on the fundamental concepts of medical device regulations.

The workshop will feature five sessions, each of which will consist of a presentation followed by a question and answer session with a panel of experts. Participants will be able to email or call us with your questions during each session.

Participants can choose to participate in any and/or all of the sessions. Each session will begin precisely at the scheduled time. Click link to view.download printable slides of respective webinar

• 10:00-11:00 am: Investigational Device Exemption (IDE) Program
• 11:00-12:00 noon: 510(k) Program
• 12:00-1:00 pm: De Novo Program
• 2:00-3:00 pm: Corrective and Preventive Actions (CAPA) Basics
• 3:00-4:00 pm: Electronic Medical Device Reporting (eMDR) 21 CFR Part 803

Target Audience included experts and professionals from Medical Device Industry, Medical Device Developers, Medical Device Industry Associations.

USFDA CDRH Webinar on Distinguishing Medical Device Recalls from Medical Device Enhancements conducted on 5th Nov 2014..

Webinar: Distinguishing Medical Device Recalls from Medical Device Enhancements – Final Guidance

Summary: The guidance clarifies for manufacturers how to determine when changes to a device constitute a recall and when they are considered a product enhancement.

The guidance contains clear definitions and practical examples to help manufacturers distinguish a recall from an enhancement. Correctly identifying a change to a device as a recall reduces the time between identification of a device defect/failure and public notification.

Clarifying when a change to a device represents a recall or an enhancement will help manufacturers better understand when reporting device changes to the FDA is required.

View/Download Printable Slides of the Webinar CLICK HERE

USFDA Medical Device Recall Alert : Richard-Allan Scientific, 10% Neutral Buffered Formalin - May Contain Incorrect Concentration of Formalin

Recall Class: Class I

Date Recall Initiated: September 17, 2014

Products: 10% Neutral Buffered Formalin.

All other lots not included the table below, or similar products manufactured by Richard-Allan Scientific, are not affected by this recall.

Manufacturing Date: July 18, 2014, Distribution Dates: July 18 - September 17, 2014

Use: 10% neutral buffered Formalin is a liquid chemical used to preserve human tissue samples. These tissues are later examined for changes that could be caused by specific conditions or diseases, including cancer. The primary users of this solution are doctors’ offices, clinics, hospital emergency departments, and operating rooms.

Recalling Firm: 

Richard-Allan Scientific, subsidiary of Thermo Fisher Scientific

4481 Campus Drive

Kalamazoo, Michigan 49008

Reason for Recall: Richard-Allan Scientific discovered that the defective products returned from several customers were found to have from 0% to 3% Formalin content instead of the required 10%.  A too-low or too high concentration of Formalin will not properly preserve or can damage tissues.

Use of this defective Formalin may prevent or delay diagnoses and treatment decisions. The long-range health impact can include death or disability from a disease, such as cancer, that was not correctly diagnosed or treated, or an injury from using a treatment that may not have been needed.

Johnson & Johnson Slapped With Injunction In Covidien Patent Case...

A federal district court granted a preliminary injunction sought by Covidien against a subsidiary of Johnson & Johnson related to the alleged infringement of three surgical device patents held by Covidien.

The decision by the U.S. District Court in Connecticut prevents J&J’s unit Ethicon Endo-Surgery Inc. from making, marketing, and selling the ultrasonic surgical tool Harmonic ACE+7 Shears.

 “Covidien operates within a highly competitive global health care environment. We are pleased that the court has recognized the value of our intellectual property. As demonstrated by our actions, we will vigorously protect our innovative products, solutions and intellectual property,” Chris Barry, president, Advanced Surgical, Covidien said.

J&J said it would appeal the court’s decision, and pointed out that the suit does not involve Harmonic ACE+7’s adaptive tissue technology, which the company says is the product’s innovative feature, according to the WSJ report.

In the suit filed against Ethicon in June, Covidien alleged that the J&J subsidiary’s Harmonic ACE+7 infringed on three U.S. patents, namely 6,063,050, 6,468,286, and 6,682,544. Covidien said that the same court had earlier ruled that the patents were infringed by other Ethicon surgical ultrasonic devices.

The federal court in Connecticut has previously recognized the value of Covidien’s intellectual property in this area and, with this new lawsuit, we will continue to vigorously protect both our innovations and intellectual property,” Lawrence Weiss, vice president and general counsel, Surgical Solutions, Covidien, said.

USFDA CDRH Medical Device Safety and Recalls: Covidien, Medi-Trace Cadence and Kendall Defibrillation Electrodes...

A recall has been issued for the Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes because the electrodes will not work with Philips FR3 and FRx Automated External Defibrillators.  

Philips made changes to the design of their connectors for the FR3 and FRx AEDs, and because of these changes, the Covidien defibrillation electrodes will not work with these AEDs.  Use of these electrodes could cause a delay in delivering electrical therapy that is needed to revive patients. Additionally, their use could lead to severe health problems such as stroke, organ failure, or death if alternative defibrillator electrodes are not readily available. Covidien received two reports of injuries. There was a delay in resuscitating one patient which may have contributed to the subsequent death of the patient.  

For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm419565.htm

MHRA Medical Device Alert : Babytherm infant warmers and open infant care units for newborns manufactured by Draeger Medical...

Babytherm infant warmers and open infant care units for newborns.

Manufactured by Draeger Medical.

Model numbers: 8004, 8010 and 8000WB.

This device is an open care unit for warming premature babies, neonates and infants with a body weight of up to 8 kg.

Risk of baby falling out of the device.

Failure to follow the instructions for use for inserting the inner safety panels and locking the outer safety side panels may result in them opening unexpectedly.

Draeger sent a Field Safety Notice to its customers in August 2014 but hasn’t had enough replies to know if users have received and acted upon this information.

• Identify affected devices.

• Ensure users read the important information in the Field Safety Notice (FSN) and follow the instructions (see appendix) to ensure that the inner safety panels are in place and the outer side panels are securely locked into position.

• If the locking mechanism is not functioning, contact Draeger.

• Complete the acknowledgement sheet you received with the FSN and return it to Draeger.

Action by

All those who use these devices.

MHRA Medical Device Alert : Neonatal and paediatric support devices: Gel-E Donut and Squishon 2 manufactured by Philips Healthcare (Children’s Medical Ventures)

Neonatal and paediatric support devices

Gel-E Donut, part numbers: 
92025-A, 92025-B, 92025-C

Squishon 2, part number: 
91033-2
All batches

Manufactured by Philips Healthcare (Children’s Medical Ventures)

 These are gel-filled products used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body.

For detailed information on recall alert CLICK HERE

USFDA CDER Guidance Document : Custom Device Exemption...

A guidance document has been posted regarding the Custom Device Exemption. 

The Food and Drug Administration (FDA) has developed this document to provide guidance to industry and FDA staff about implementation of the custom device exemption contained in Section 520(b) the Food, Drug and Cosmetic Act (FD&C Act). 

The guidance provides definitions of terms used in the custom device exemption, explains how FDA interprets the “5 units per year of a particular device type” language contained in section 520(b)(2)(B) of the FD&C Act, describes what information should be submitted in a Custom Device Annual Report (“annual report”), and provides recommendations on how to submit an annual report for devices distributed under the custom device exemption.  

To view/download the guidance, please CLICK HERE

MHRA Medical Device Recall Alert : Portex® endotracheal tube holder (2.5mm and 3.0mm) manufactured by Smiths Medical

Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits.

Manufactured by Smiths Medical.

Specific product codes and lot numbers.

PROBLEM:

Risk of extubation or delay to therapy as there may be difficulty passing a suction catheter through the endotracheal tube when the holder is locked. There may also be difficulty locking the holder.
This is due to a manufacturing problem, which means the holder might compress the endotracheal tube.
Smiths Medical has issued a Field Safety Notice (FSN) recalling affected devices but hasn’t had sufficient confirmation that customers have received it and acted on it.

For detailed information on recall alert CLICK HERE

MHRA Medical Device Recall Alert: Ellipse™ VR/DR implantable cardioverter defibrillators manufactured by St Jude Medical...

CAS deadlines
Action underway: 23 September 2014, action complete: 17 November 2014
 
EllipseTM VR/DR implantable cardioverter defibrillators (ICDs).

Model numbers CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C and -36QC suffixes). All serial numbers distributed before the field action.

Manufactured by St Jude Medical.

PROBLEM:  
Potential for delayed or insufficient energy defibrillation therapy due to a capacitor fault.

St Jude Medical issued a FSN dated 19 August 2014, describing a potential failure mode which can delay or reduce the therapy that can be delivered by the ICD. The problem has been traced to an ICD capacitor defect, accompanied in some returned devices with evidence of arcing between the capacitor anode and cathode. Analysis so far indicates that it is not possible to predict which ICDs will suffer this failure or when it may occur, so despite a low failure rate of 0.42%, all patients and clinicians will need to be vigilant.

All affected ICDs will exhibit extended charge times, evident not only during device testing / maintenance but also when preparing to deliver therapy. To date all potential failures reported to St Jude Medical have been identified through timeout warnings triggered by automated capacitor maintenance or during in-clinic testing, rather than being associated with serious adverse events.

The manufacturer has confirmed that all affected ICDs should now have been retrieved from hospital supplies and they are currently replacing them with newly designed product not expected to be susceptible to this failure mode. Replacement product can be identified according to the serial numbers detailed at the end of the FSN, and by the green label fixed to the ICD packaging.

For Detailed Information on Recall CLICK HERE
 

USFDA CDRH Medical Device Class I Recall Alert - Cook CloverSnare 4-Loop Vascular Retrieval Snare

Product:  CloverSnare 4-Loop Vascular Retrieval Snare

• Model Number VRS-6.0-90
• Manufacturing Dates: August 2012 – August 2013
• Distribution Dates: March 8, 2013 – July 1, 2014
• Complete Listing of Affected Lot Numbers
• 671 devices have been distributed nationwide

Use: The CloverSnare 4-Loop Vascular Retrieval Snare is used to manipulate and retrieve items in the cardiovascular system, such as temporary implanted devices. This includes inferior vena cava filters or broken devices (e.g., guidewires, coils, balloons, and catheters).

Recalling Firm: 
Cook Inc. 
750 N Daniels Way
Bloomington, Indiana 47404-9120

Reason for Recall: There is a potential for the snare loop to separate from the shaft.  If this occurs, the snare loop may travel through the vascular system and block blood vessels or become stuck in other organs, such as the heart and lungs. Additional intervention may be necessary to retrieve the separated snare loop from the patient.  This failure will also cause the device to stop working.  Four injuries have been reported.

The use of the affected product may cause serious adverse health consequences, including death.

On July 17, 2014, Cook Medical sent customers an Urgent Medical Device Recall letter informing them of the product, problem and actions to be taken.  The firm requested customers:

• Separate any affected unused products from inventory. 
• Collect and return all unused products to Cook Medical as soon as possible for credit.
• Complete and return the Recalled Product Reply Form to Cook Medical, separately or when returning the product.

About Class I Recalls

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Guidance for Industry: CDRH - Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices

A guidance document titled, "Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices" has recently been posted.  

This document recommends studies for establishing the performance characteristics of HMMDs. 

FDA considers these recommended studies to be relevant for premarket notifications (e.g., 510(k) or de novo) that may be required for a particular device.  

To view the guidance, please CLICK HERE

MHRA: Medical Device Alert

This medical device alert is being issued due to the risk of some of the devices within the highlighted product codes having small cracks or holes. This could compromise the sterile field.

Medical Device Alert: Basin/bowl liner or equipment cover (drape) manufactured by Microtek Medical (MDA/2014/034)

USFDA Medical Device Class I Recall Alert: DePuy Synthes Craniomaxillofacial Distraction System - May Reverse Directions After Surgery...

Recall Class: Class I

Date Recall Initiated: April 16, 2014

Product: The DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies). Also called an External Mandibular Fixator And/Or Distractor and a Bone Plate.

Manufacturing Dates: April 20, 2009 through April 15, 2011

Distribution Dates: November 3, 2009 to April 14, 2014

See the Recall Notice or the Firm Customer Notice for a complete listing of affected products with part and lot numbers.

Use: The DePuy Synthes Craniomaxillofacial (CMF) Distraction System is an implant used to lengthen and/or stabilize the lower jawbone (mandibular body) and the side of the lower jaw (ramus). This device is used in pediatric and adult patients to correct birth (congenital) or post-traumatic defects of the jaw by gradually lengthening the bone (distraction).

Recalling Firm: 
Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380

Reason for Recall: DePuy Synthes is recalling certain lots of the Craniomaxillofacial Distraction System because the device may reverse direction and lose the desired distraction distance after surgery.

• Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.
• Children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.
• In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.

There have been 15 reports of injury associated with the use of this device.

Public Contact: Customers who have questions about this recall may contact DePuy Synthes Customer Support at 1-800- 479-6328, Monday – Friday, 9:00 a.m. to 8:00 p.m. Eastern Time or the sales consultant.

FDA District: Philadelphia District Office

More Information about this Recall: 

On April 16, 2014, DePuy Synthes sent an Urgent Notice to their customers. The notice identified the problem, affected products and tells customer to:

• Review their inventory and remove affected lots from stock.
• Call DePuy Synthes at 1-800-479-6329 for a return authorization number
• Complete and return the verification in the letter included with the notice.

USFDA Recall Alert: Sterile Convenience Surgical Packs by Customed, Inc. - Potential Loss of Sterility

Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility

ISSUE: Customed, Inc. initiated a recall of sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion. The defect could result in loss of product sterility and lead to infection. No serious injuries or deaths have been reported as of August 21, 2014. Affected products were manufactured from January 9, 2009 to May 19, 2014, and distributed January 2009 to May 2014.

See the firm Press Release for a listing of recalled product catalog and lot numbers.

BACKGROUND: Products were distributed within the domestic (Puerto Rico Commonwealth, Florida State, New York State, US Virgin Islands); and international market (Geographical Area Central America-Costa Rica & Panama; and South America-Colombia).

RECOMMENDATION: Customers who have products should stop using the product lots included in the recall. Customed, Inc. is notifying its distributors by mail and arranging for the products return. Customed is requiring distributors to notify any customers who received the product through redistribution. Customers with questions about this recall may contact Ms. Wanda Cotto, Recall Coordinator, at 1-787-801-0100 Ext. 7540, Monday through Friday, 8:00 a.m. – 5:00 p.m., Eastern Time.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm411461.htm

USFDA Medical Device Approval of Low-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.)

The FDA has approved the Low-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.) to be marketed.  The LVIS Device is a stent and delivery system used to treat certain brain aneurysms. The stent is a self-expanding, nickel-titanium (nitinol) single wire braid. The delivery system consists of an introducer and delivery wire and is used to deliver the stent to the aneurysm. The stent keeps the soft platinum coils that are put into the aneurysm from slipping back into the main blood vessel.  

For more information, please see:http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm411207.htm

MHRA: Medical Device Alert

This medical device alert is being issued due to the risk of infection as the balloon gastrostomy kit may contain out-of-date devices. In addition, the safety and performance of these devices has not been properly evaluated and so the CE marking is invalid.

Medical Device Alert: Gastrostomy devices manufactured by Medicina Ltd (MDA/2014/032)

USFDA: Recall: CloverSnare™ 4-Loop Vascular Retrieval Snare Recall

On July 10, 2014, Cook Medical initiated a recall of 696 of its CloverSnare™ 4-Loop Vascular Retrieval Snare devices. The device was recalled because of a potential for the loop to separate from the shaft, resulting in loss of device function, potential for embolization of snare fragments and the potential need for intervention to retrieve the separated snare. 

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click CloverSnare™ 4-Loop Vascular Retrieval Snare Recall

MHRA : Medical Device Alert

This MDA is being issued due to affected devices unable to deliver fewer than 7 units of insulin. In addition, the safety and performance of these devices has not been properly evaluated and so the CE marking of all of these devices is invalid.

Medical Device Alert: Insulin syringe 1ml safety syringe 27G (for professional use) manufactured by Medicina Ltd (MDA/2014/033)

FDA issues Guidance on the Unique Device Identification System: Frequently Asked Questions, Vol. 1

Today the Food and Drug Administration is making available Unique Device Identification System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff. FDA is issuing this document as level 2 guidance consistent with FDA’s good guidance practices regulation. While Level 2 guidance documents are posted for immediate implementation, comments on any guidance document may be submitted by following the instructions in theregulation. This guidance represents the FDA's current thinking on this topic.

Specifically, this guidance is intended to summarize key aspects of the UDI final rule, as identified through inquiries frequently submitted to the FDA UDI Help Desk. It addresses UDI basics, UDI placement, the Global Unique Device Identifier Database (GUDID), and direct marking, as well as exceptions, alternatives and exemptions.

At its most basic, the Unique Device Identification System requires device labelers (usually manufacturers) to include a unique device identifier (UDI) on the labels and packages of medical devices distributed in the United States, unless the FDA grants an exception or alternative. The UDI must be displayed in both easily readable plain-text and Automatic Identification and Data Capture (AIDC) technology – companies frequently have chosen to use a bar code. The UDI Rule also requires labelers to submit specified product information to FDA’s GUDID. Implementation of the rule will be phased in over seven years. For information on the benefits of the Unique Device Identification System please see the UDI website.

We hope you find this guidance useful and if you have any questions related to the implementation of the UDI rule please contact the FDA’s UDI Help Desk.