2013 Seventh Annual NKY TBI Conference 3/22/13 1 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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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).
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.
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.
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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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
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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,