2013 seventh annual nky tbi 3/22/13 conferencebridgesnky.org/public/lawrence 2013 nky tbi conf ppt...

2013 Seventh Annual NKY TBIConference

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THERAPEUTIC TREATMENT:LEGAL ROADBLOCKS/LEGAL REMEDIES

JENNIFER L. LAWRENCE, ESQ.THE LAWRENCE FIRM, P.S.C.www.lawrencefirm.com

Product Development &Implementation

Medical Device Manufacturers

Johnson & Johnson(JNJ)

General Electric(GE)

Siemens AG (SIE)Medtronic (MDT) Baxter International

(BAX)

Cardinal Health(CAH)

Stryker Corp. (SYK)Abbott Lab. (ABT) Boston Scientific

(BSX)Olympus Corp.

(OCPNY) Bayer AG (BAYN)


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Today, the United States is the acknowledged world leader in medicaldevices and diagnostic products. With more than half of the leadingglobal medical device companies based in the United States, theindustry currently employs more than 400,000 Americans directly and 2million people indirectly. Between 2005 and 2007, the industry created80,000 new jobs, a workforce growth of 20% in just two years. Further, itconsistently devotes significant revenues to innovation; from 2007-2009,R&D investment in medical devices increased by 9%. Not only is theindustry a source of life-enhancing and life-sustaining treatments andcures, but it is also an important manufacturing industry and a driver ofcurrent and future U.S. economic growth. It is one of the few Americanmanufacturing industries that consistently export more than it imports(exports doubled between 1998 and 2008, to $33 billion annually).

U.S. Food & Drug Administration

“Protecting & Promoting Your Health”

FDA Regulations

Federal Law

21 CFR Subchapter H,Parts 800 - 898http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/overview/default.htm#ide


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The FDA Approval Process Register Devices 510K Process Investigational

Device Exemption(IDE)

Quality Systems Labeling

FDA


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510K Applications –Different Manufacturers

HOME SEARCH COMPANIES PRODUCT CODES DEVICE NAMES CONTACTS APPLICATIONS DECISIONS

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FDA 510(k) Applications for Medical Device Product Code "HDB"(Extractor, Vacuum, Fetal)FDA 510(k)Number Applicant Address City / Country State /

ProvincePostalCode

K881306 CHALLENGE MFG., INC. P.O. BOX 5877 BEND OR 97708



K981260 CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOODST.

MURRAY UT 84107

K915763 COLUMBIA MEDICAL & SURGICAL, INC. P.O. BOX 5877 BEND OR 97708

K942725 COLUMBIA MEDICAL & SURGICAL, INC. P.O. BOX 1530 REDMOND OR 97756

K771558 DOW CORNING CORP. HEALTHCARE INDUSTRIESMATERIALS

K021193 FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANGVILLAGESAN-CHIH HSIANG

TAIPEI HSIEN

K911326 GESCO INTL., INC. 5714 EPSILON DR. SAN ANTONIO TX 78249

K891465 GO MEDICAL INDUSTRIES PTY. LTD. 200 CHURCHILL AVE. SUBIACO, PERTH

K840008 GOMEDICAL INDUSTRIES PTY LTD.

K895700 HOLLISTER, INC. C/OBURDIT,RADZIUS,CHARTERED333 W.WACKER DR.

CHICAGO IL 60606

K980976 HOLLISTER, INC. 2000 HOLLISTER DR. LIBERTYVILLE IL 60048

K041579 MEDELA AG LAETTICHSTRASSE 4B BAAR, ZUG

K830012 MEDELA, INC.

K841492 MEDELA, INC.

K043614 MEDEVCO, INC. 2300 MCDERMOTT RD.#200-207

PLANO TX 75025

K890307 NEWARD ENTERPRISES, INC. P.O. BOX 7259251 ARCHIBALD AVENUE

CUCAMONGA CA 91730


CUCAMONGA CA 91730


CUCAMONGA CA 91730

K943938 NEWARD ENTERPRISES, INC. 9251 ARCHIBALD AVE.P.O. BOX 725

RANCHOCUCAMONGA

CA 917290725

K960549 NEWARD ENTERPRISES, INC. P.O. BOX 725 CUCAMONGA CA 91730

K011532 PRISM ENTERPRISES, INC. 555 THIRTEENTH ST. N.W. WASHINGTON DC 200045600

K020447 PRISM ENTERPRISES, INC. 555 THIRTEENTH ST. N.W. WASHINGTON DC 200045600

K980212 PRISM TECHNOLOGIES, INC. 555 THIRTEENTH STREET,N.W.

WASHINGTON DC 20004

K970170 RICHARD G. LINDSAY 6824 ELK CANYON RD. OKLAHOMA CITY OK 73162

K013460 SWIFT DELIVERY PRODUCTS 6824 ELK CANYON RD. OKLAHOMA CITY OK 73162



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Medical Suction RegulatorContinuous - Intermittent -Surgical High Vac - Pediatric - Best Price!

www.wtfarley.com/suctionregs

In the FlowSiemens Green+ Hospital concept for

hospitals' sustainable success.siemens.com/answers/green-hospitals

Multiple Applications SameManufacturer

HOME SEARCH COMPANIES PRODUCT CODES DEVICE NAMES CONTACTS APPLICATIONS DECISIONS

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FDA 510(k) Applications Submitted by NEWARD ENTERPRISES, INC.Home | Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact

FDA 510(k) Number Submission Date Device Name Applicant

K840403 01/31/1984 VENA * BRIDGE NEWARD ENTERPRISES, INC.

K960549 02/08/1996 MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE NEWARD ENTERPRISES, INC.

K890307 01/23/1989 MITYVAC "M" STYLE VACUUM EXTRACTOR, DISPOSABLE NEWARD ENTERPRISES, INC.

K910815 02/26/1991 CR SPIRAL ELECTRODE NEWARD ENTERPRISES, INC.

K943938 08/12/1994 MITYVAC SUPER "M" STYLE VACUM EXTRACTOR, DISPOSABLE NEWARD ENTERPRISES, INC.

K925572 11/03/1992 MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE NEWARD ENTERPRISES, INC.

K913324 07/25/1991 MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT NEWARD ENTERPRISES, INC.

K934011 08/17/1993 MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE NEWARD ENTERPRISES, INC.

Associates in Ob-Gyn, IncNormal & High Risk Pregnancy 4D Sonogram $75 (Save 50%)

www.associnobgyn.com

510k


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End of the RoadFDA Approval

Devices

483sDrugsDrug PatentsDevicesFDA EmployeesFDA MAUDEStoreBlog

K943938: MITYVAC SUPER "M" STYLEVACUM EXTRACTOR, DISPOSABLEby NEWARD ENTERPRISES, INC.

510(k) K943938Device Name MITYVAC SUPER "M" STYLE VACUM EXTRACTOR, DISPOSABLEApplicant NEWARD ENTERPRISES, INC.

Contact

ALLYSON C CARMARK9251 ARCHIBALD AVE.P.O. BOX 725RANCHO CUCAMONGACA91729 0725

Product Code HDBDate Received Aug 12, 1994Decision Date May 03, 1995Decision SEClassification AdvisoryCommittee OB

Summary StatementType TraditionalReviewd by 3rd Party NExpedited Reviewsource fda.gov

X-FDA ConsultingcGMP's, FDA 483, Mock Audits FDA Interactions/Meetings

www.xfdainvestigators.com


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FDA APPROVED

DIFFERENT WAYS IN WHICHINJURIES OCCUR

INJURIES FROM OPERATIVE DEVICES SUCHAS FORCEPS AND VACUUM EXTRACTORS


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Stations of Fetal Head

Into Stream of Commerce Post market

surveillanceMedical Device

ReportsMedwatch Reports RecallsModifying 510Ks

MANDATORYREPORTING

• Hospitals

• Other user facilities

• Manufacturers

ADVERSE EVENTS• Deaths• Serious Illnesses• And Injuriesassociated with theuse of medicaldevices.


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FDA Public Health Advisory: Need for CAUTION When Using Vacuum Assisted Delivery DevicesThis is an archived document and is no longer current information.

May 21, 1998

To: Obstetricians, Birthing Centers, Nurse Mid-Wives,Pediatricians, Ultrasonographers, ObGyn Nurses,Family Practitioners, Radiologists, Hospital Risk Managers,Hospital ObGyn Departments

PURPOSEThis is to advise you that vacuum assisted delivery devices may cause serious or fatal complications, and toprovide guidance to minimize the risk. While no instrumented delivery is risk free, we are concerned that somehealth care professionals who use vacuum assisted delivery devices, or those who care for these infants followingdelivery, may not be aware that the device may produce life-threatening complications (see attached list forsample of references). We are also concerned that if health care professionals responsible for the care ofneonates are not alerted when a vacuum assisted delivery device has been used on a particular infant, they maynot adequately monitor for the signs and symptoms of device-related injuries.

BACKGROUNDOver the past four years, FDA has received reports of 12 deaths and nine serious injuries among newborns onwhom vacuum assisted delivery devices were used, an average of five events per year. In contrast, during thepreceding 11 years there were four deaths and five serious injuries reported to us, fewer than one event peryear. Part, but probably not all, of this five-fold increase can be explained by an increase in usage – based upondata from 1989-1995, it is estimated that use of vacuum assisted delivery devices increased from 3.5 percent ofall deliveries to 5.9 percent.The total number of serious complications reported to FDA from vacuum assisted delivery devices remains smallin relation to the total number of births per year in which these devices are used – 228,354 in 1995, as reportedto the National Center for Health Statistics. Nonetheless, we are concerned that at least some of thesecomplications might be avoidable. This is why we are providing the recommendations below.At this point, FDA does not have complete information on how use patterns, the clinical environment or otherspecific circumstances might relate to adverse outcomes from vacuum assisted delivery devices. We will continueto investigate the possible causes of these complications.

TYPES OF COMPLICATIONSAlthough all infants exposed to vacuum assisted delivery devices will have a caput succedaneum, care providersneed to be aware that two major life-threatening complications following use of vacuum assisted devices havebeen reported to us:

Subgaleal hematoma (Subaponeurotic hematoma)

This occurs when emissary veins are damaged and blood accumulates in the potential space between the galeaaponeurotica (epicranial aponeurosis) and the periosteum of the skull (pericraniaum). Since the subaponeuroticspace has no containing membranes nor boundaries, the subgaleal hematoma may extend from the orbital ridgesto the nape of the neck. This condition is dangerous because of the large potential space for blood accumulationand the possibility of life-threatening hemorrhage.Signs: diffuse swelling of the head and signs of hypovolemic shock (e.g., pallor, hypotension, tachycardia andincreased respiration rate). The signs may be present at delivery or may not become clinically apparent untilseveral hours or up to a few days following delivery. The swelling is usually diffuse, shifts dependently when theinfant’s head is repositioned and indents easily on palpation. However, in some cases the swelling is difficult to

Medical Devices

Home Medical Devices Medical Device Safety Safety Communications

FDA Public Health Advisory: Need for CAUTION When Using Vacuum Assisted Delivery DevicesThis is an archived document and is no longer current information.

May 21, 1998

To: Obstetricians, Birthing Centers, Nurse Mid-Wives,Pediatricians, Ultrasonographers, ObGyn Nurses,Family Practitioners, Radiologists, Hospital Risk Managers,Hospital ObGyn Departments

PURPOSEThis is to advise you that vacuum assisted delivery devices may cause serious or fatal complications, and toprovide guidance to minimize the risk. While no instrumented delivery is risk free, we are concerned that somehealth care professionals who use vacuum assisted delivery devices, or those who care for these infants followingdelivery, may not be aware that the device may produce life-threatening complications (see attached list forsample of references). We are also concerned that if health care professionals responsible for the care ofneonates are not alerted when a vacuum assisted delivery device has been used on a particular infant, they maynot adequately monitor for the signs and symptoms of device-related injuries.

BACKGROUNDOver the past four years, FDA has received reports of 12 deaths and nine serious injuries among newborns onwhom vacuum assisted delivery devices were used, an average of five events per year. In contrast, during thepreceding 11 years there were four deaths and five serious injuries reported to us, fewer than one event peryear. Part, but probably not all, of this five-fold increase can be explained by an increase in usage – based upondata from 1989-1995, it is estimated that use of vacuum assisted delivery devices increased from 3.5 percent ofall deliveries to 5.9 percent.The total number of serious complications reported to FDA from vacuum assisted delivery devices remains smallin relation to the total number of births per year in which these devices are used – 228,354 in 1995, as reportedto the National Center for Health Statistics. Nonetheless, we are concerned that at least some of thesecomplications might be avoidable. This is why we are providing the recommendations below.At this point, FDA does not have complete information on how use patterns, the clinical environment or otherspecific circumstances might relate to adverse outcomes from vacuum assisted delivery devices. We will continueto investigate the possible causes of these complications.

TYPES OF COMPLICATIONSAlthough all infants exposed to vacuum assisted delivery devices will have a caput succedaneum, care providersneed to be aware that two major life-threatening complications following use of vacuum assisted devices havebeen reported to us:

Subgaleal hematoma (Subaponeurotic hematoma)

This occurs when emissary veins are damaged and blood accumulates in the potential space between the galeaaponeurotica (epicranial aponeurosis) and the periosteum of the skull (pericraniaum). Since the subaponeuroticspace has no containing membranes nor boundaries, the subgaleal hematoma may extend from the orbital ridgesto the nape of the neck. This condition is dangerous because of the large potential space for blood accumulationand the possibility of life-threatening hemorrhage.Signs: diffuse swelling of the head and signs of hypovolemic shock (e.g., pallor, hypotension, tachycardia andincreased respiration rate). The signs may be present at delivery or may not become clinically apparent untilseveral hours or up to a few days following delivery. The swelling is usually diffuse, shifts dependently when theinfant’s head is repositioned and indents easily on palpation. However, in some cases the swelling is difficult to

Medical Devices

Home Medical Devices Medical Device Safety Safety Communications


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VACUUM EXTRACTION

Vacuum Extractor Injuries:Subgaleal hematoma

Subgaleal hematoma


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510 K Process Continues….

FETAL PULSE OXIMETRY


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HOSPITAL POLICY & PROCEDURE


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DOCTOR ON USEOF FETAL PULSE OX

DEPOSITION TESTIMONY


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INJURIES TO BABYHYPOXIADecrease in oxygen supplyto brain even though thereis adequate blood flow

INJURIES CAN BE BOTH

KNOWN AS “HIE”

ISCHEMICInadequate blood flow tobrain

HYPOXIC & ISCHEMIC

HYPOXIC ISCHEMICENCEPATHOLOPATHY


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LoginUnited States

Tuesday, March 19, 2013 RSS E-mail Newsletters Put PRWeb on your site

Of the 13 neonates with HIEthat we have treated withtherapeutic hypothermia, the 12surviving patients achievedneurological outcomes that arebetter than expected thus far. Wewill need to follow these childrenfor several years to fully assessthe results of this promisingtherapy.

Cincinnati, OH (PRWEB) July 25, 2008

Cincinnati Sub-Zero (CSZ) Medical, a division of CSZProducts, Inc. and the leader in the design anddevelopment of advanced patient temperaturemanagement solutions, today announced its inclusionin the implementation of a neonatal therapeutichypothermia protocol by Children's Hospital Boston.The hospital was the first to offer the treatment in NewEngland.

Approximately one in every 1,000 babies suffers fromhypoxic-ischemic encephalopathy (HIE), a loss ofoxygen at birth. Clinical studies indicate therapeutichypothermia, including whole-body cooling begunwithin six hours after birth, reduces brain injuryassociated with the hypoxic- ischemic exposure,minimizing or avoiding consequences that mightotherwise include cerebral palsy or severe cognitiveand visual impairments. Depending on the severity of hypoxia-ischemia, up to 50% of babies may sustainneurological damage or death without the therapy.

Following nationwide trials involving 500 infants, the American Academy of Pediatrics (AAP) concluded in 2005 thatnot using therapeutic hypothermia for treating HIE resulted in greater neurological damage. Physicians at Children'sHospital Boston instituted a protocol beginning in July 2007. Using the CSZ Blanketrol® II Hypo-HyperthermiaSystem with CSZ cooling/warming blankets, physicians cool an infant's body to 33.5C (92.3F) for72 hours before rewarming to normal temperature.

Children's Hospital Boston Neonatal Intensive Care Unit (NICU) Medical Director and Harvard Medical SchoolAssistant Professor of Pediatrics Anne Hansen, MD, MPH, helped establish the treatment protocol. Says Dr. Hansen,"We have been offering therapeutic hypothermia to treat HIE for the past year with encouraging results. We hope ourexperience will help lead the way in therapy implementation and effectiveness."

Dr. Hansen's colleague in developing the protocol, Neonatal Neurology Program Associate Director and HarvardMedical School Assistant Professor of Neurology Janet Soul, MD, CM, said, "Of the 13 neonates with HIE that wehave treated with therapeutic hypothermia, the 12 surviving patients achieved neurological outcomes that are betterthan expected thus far. We will need to follow these children for several years to fully assess the results of thispromising therapy."

A news story about neonatal therapeutic hypothermia at Children's Hospital Boston aired yesterday, July 24, 2008, onBoston ABC affiliate, WCVB-TV, Channel 5. The media story aims to inform the medical community and generalpublic about the benefits of the treatment.

CSZ Vice President and CSZ Medical General Manager Mark Beran said, "Hypoxic-ischemic encephalopathy is a life-altering, potentially life-threatening, event for a newborn infant. We understand the vital contribution our products canmake in the lives of these babies and their families. Just knowing there is one more positive outcome as a result ofapplying a cooling solution, whether it's ours or not, is what matters."

Key insight around neonatal therapeutic hypothermia will disseminate in the months ahead. Educational tracks willoccur at the October 2008 Therapeutic Temperature Management (TTM) Congress and the APA National Meeting.And, a nearly 400-patient study in the United Kingdom, the 'TOBY' study, will present results in November 2008.

More information about the Children's Hospital Boston therapeutic hypothermia protocol can be found athttp://www.childrenshospital.org/views/feb08/new_induced_hypothermia.html. A replay of the WCVB-TV news story isavailable at http://www.thebostonchannel.com/health/16979736/detail.html. More about the TTM Congress and theAPA meeting are at http://www.ttmcongress2008.com and http://www.aapexperience.org. More about the TOBYstudy is at http://www.npeu.ox.ac.uk/toby.

About Cincinnati Sub-Zero and CSZ Medical

Cincinnati Sub-Zero (CSZ) is a leading manufacturer of temperature management products for medical and industrialmarkets. CSZ also manages a portfolio of industrial environmental simulation testing chambers, and a first-class, on-

Children's Hospital Boston Minimizing NeurologicalDamage from Infant At-Birth Trauma with ModerateWhole-Body CoolingCincinnati Sub-Zero therapeutic hypothermia products in use in protocolimplantation of neonatal hypoxic-ischemic encephalopathy treatment

Karl LagodzkiCincinnati Sub-Zero Medical(513) 772-8810Email

Ellen Hassette-sagacity

Email

Contact

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CRITERIA FOR COOLING• 36 weeks GA or greater and at least one

of the following:

*Apgar score 5 or less at 10 min.*Continued need for resuscitation at 10 min.*Acidosis with cord pH or any arterial pHwithin 60 min. of birth of less than 7.00*Base Deficit greater than or equal to 16

COOLING


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COOLING

BACKGROUND:

OBJECTIVES:

SEARCH METHODS:

SELECTION CRITERIA:

DATA COLLECTION AND ANALYSIS:

MAIN RESULTS:

Cochrane Database Syst Rev. 2013 Jan 31;1:CD003311. doi: 10.1002/14651858.CD003311.pub3.

Cooling for newborns with hypoxic ischaemic encephalopathy.Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG.Neonatal Services, Royal Women’s Hospital, Parkville, Melbourne, Australia. [email protected]

AbstractNewborn animal studies and pilot studies in humans suggest that mild hypothermia

following peripartum hypoxia-ischaemia in newborn infants may reduce neurological sequelaewithout adverse effects.

To determine the effect of therapeutic hypothermia in encephalopathic asphyxiatednewborn infants on mortality, long-term neurodevelopmental disability and clinically important sideeffects.

We used the standard search strategy of the Cochrane Neonatal ReviewGroup as outlined in The Cochrane Library (Issue 2, 2007). Randomised controlled trials evaluatingtherapeutic hypothermia in term and late preterm newborns with hypoxic ischaemic encephalopathywere identified by searching the Oxford Database of Perinatal Trials, the Cochrane Central Registerof Controlled Trials (CENTRAL, The Cochrane Library, 2007, Issue 2), MEDLINE (1966 to June2007), previous reviews including cross-references, abstracts, conferences, symposia proceedings,expert informants and journal handsearching. We updated this search in May 2012.

We included randomised controlled trials comparing the use of therapeutichypothermia with standard care in encephalopathic term or late preterm infants with evidence ofperipartum asphyxia and without recognisable major congenital anomalies. The primary outcomemeasure was death or long-term major neurodevelopmental disability. Other outcomes includedadverse effects of cooling and 'early' indicators of neurodevelopmental outcome.

Four review authors independently selected, assessed thequality of and extracted data from the included studies. Study authors were contacted for furtherinformation. Meta-analyses were performed using risk ratios (RR) and risk differences (RD) fordichotomous data, and weighted mean difference for continuous data with 95% confidence intervals(CI).

We included 11 randomised controlled trials in this updated review, comprising1505 term and late preterm infants with moderate/severe encephalopathy and evidence ofintrapartum asphyxia. Therapeutic hypothermia resulted in a statistically significant and clinicallyimportant reduction in the combined outcome of mortality or major neurodevelopmental disability to18 months of age (typical RR 0.75 (95% CI 0.68 to 0.83); typical RD -0.15, 95% CI -0.20 to -0.10);number needed to treat for an additional beneficial outcome (NNTB) 7 (95% CI 5 to 10) (8 studies,

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2013 seventh annual nky tbi 3/22/13 conferencebridgesnky.org/public/lawrence 2013 nky tbi conf ppt...

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