Biomedical Market Newsletter articles from July 2001

Biomedical Market Newsletter archives from July 2001

Is FDA Backing Down On Regulating Reuse Of Medical Devices? Reuse trade association needles FDA officials.(Brief Article)
July 1, 2001... On Aug. 16, 2001, the Association of Disposable Device Manufacturers (AMDM; Washington DC) publicily charged that the FDA is choosing expediency over patient safety, by again delaying enforcement of controversial new regulations on reprocessing...

Medical Equipment Supplier Compliance With Medicare Standards Has Improved.(Brief Article)
July 1, 2001... AUGUST 20, 2001-- WASHINGTON DC -- Medical equipment suppliers are required to comply with standards set out by CMS, in order to receive a billing number. The US DHHS Office of the Inspector General (OIG) 1997 inspection uncovered compliance...

Text of Remarks by President Bush on Stem Cell Research.(Transcript)
July 1, 2001... CRAWFORD, TEXAS, THE BUSH RANCH -- AUGUST 9, 2001 -- Good evening. I appreciate you giving me a few minutes of your time tonight so I can discuss with you a complex and difficult issue, an issue that is one of the most profound of our time. ...

Fact Sheet On Embryonic Stem Cell Research Released By The White House.(Brief Article)
July 1, 2001... WASHINGTON DC -- AUG. 9, 2001 -- Federal funding of research using existing embryonic stem cell lines is consistent with the President's belief in the fundamental value and sanctity of human life. The President's decision reflects his...

Are There Way Too Many Medical Meetings?(Brief Article)
July 1, 2001... With at least 5,000 medical meetings, seminars, symposia, conferences, trade shows, exhibitions, congresses and courses held annually worldwide, associations and meeting organizers are scrambling to fill vacant seats at their events. ...

Study Challenges Previous Medical Errors Assertions.(Brief Article)
July 1, 2001... CHICAGO IL -- JULY 24, 2001 -- Nearly one-fourth of hospital patient deaths reviewed by trained physician reviewers were rated at least possibly preventable, if medical care had been optimal. But the probability that medical error actually...

Upcoming Reuse Events.(Brief Article)
July 1, 2001... * Sept. 11, 2001--Central New York Healthcare Central Service Professionals, Verona, New York, FDA Speaker: Sharon Kalokerinos. For more info call Peg Galluppi at 315-338-7323 * Oct. 4-5, 2001--Texas Society of Infection Control...

Recalls & Safety Alerts For Pacemakers & Implantable Defibrillators Are Rising : Number of patients affected by advisories may increase as frequency of device implantation rises.
July 1, 2001... American Medical Association Chicago IL USA Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillators (ICDs) occur often. They also appear to be increasing, costing millions of dollars annually, according to...

Major Depression Is Common In Hospitalized Congestive Heart Failure Patients.(Brief Article)(Statistical Data Included)
July 1, 2001... American Medical Association Chicago IL USA Major depression may play a role in an increased risk of death and hospital readmissions for patients with congestive heart failure, according to an article in the Aug. 13/27, 2001 issue of the...

Changes Needed In The System Of Development, Implementation & Monitoring For Pacemakers & ICDs.(Brief Article)
July 1, 2001... In an accompanying editorial in the August 15, 2001 issue of JAMA, Kim A Eagle MD of the Div of Cardiovascular Disease, Univ of Michigan Medical Ctr, Ann Arbor, states, "The article by Maisel et al establishes that safety recalls are occurring...

Medtronic Responds To JAMA Article On Pacemaker & ICD Safety.(Brief Article)
July 1, 2001... MINNEAPOLIS MN -- Aug. 14, 2001 -- Medtronic, Inc. (NYSE:MDT) today issued the following statement in response to an article appearing in the most recent issue of the Journal of the American Medical Association (JAMA) regarding pacemaker and...

Adverse Events & Deaths From Lab Errors At Pennsylvania Hospital Reported.(Brief Article)
July 1, 2001... Office of the Director Div of Healthcare Quality Promotion National Center for Infectious Diseases US Centers for Disease Control & Prevention Atlanta GA ATLANTA GA USA -- AUGUST 24, 2001 -- On August 3, 2001, the US Centers for...

Women & Elderly Under-Represented In Cardiovascular Research Trials.(Brief Article)(Statistical Data Included)
July 1, 2001... American Medical Association Chicago IL USA CHICAGO IL -- AUG. 8, 2001 -- The proportion of women and elderly patients enrolled in cardiovascular research clinical trials is well below the representation of these patients among all patients...

Establishment Registration & Medical Device Listing.
July 1, 2001... On August 14, 2000, the US FDA released a guidance document, "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties & Hospitals" (http://www.fda.gov/cdrh/reuse/1168.html). In the guidance, the FDA stated that it...

Applying The Quality System Regulation To Hospitals That Reprocess Single-Use Devices.(Brief Article)
July 1, 2001... A hospital that reprocesses a single-use device (SUD) for reuse must meet the current Quality System (QS) regulation for medical devices (Title 21 of the Code of Federal Regulations (CFR) Part 820), unless the device is exempt from the Good...

FDA Labeling & Tracking Requirements.(Brief Article)
July 1, 2001... As manufacturers, hospital reprocessors of single-use devices (SUDs) also must comply with the regulatory requirements of device labeling and device tracking. LABELING Reprocessed SUDs must be labeled according to the requirements of the...

FDA Medical Device Reporting Requirements.(Brief Article)
July 1, 2001... Adverse event reports submitted under the Medical Device Reporting (MDR) regulation (Title 21 of the Code of Federal Regulations (CFR) Part 803), provide the FDA with information about the post-market experience of medical devices. ...

Reports Of Corrections & Removals.(Brief Article)
July 1, 2001... Hospitals and third-parties that reprocess devices labeled for single use are subject to Part 806 (Reports of Corrections and Removals) of Title 21 of the Code of Federal Regulations (CFR) (http://www.fda.gov/...

AdvaMed Members Ask Congress To Help Enforce Japanese Trade Agreements.(Brief Article)
July 1, 2001... BLOOMINGTON MN -- MAY 14, 2001 -- Chief executive officers from two leading US medical technology companies today testified before Congress about the many global health and US economic benefits of maintaining and expanding overseas trade. ...

6th Annual Small Business Survival Index Ranks the States According to How Friendly Their Policies Are For Entrepreneurs.(Brief Article)(Statistical Data Included)
July 1, 2001... On August 12, 2001 -- The Small Business Survival Committee (SBSC) has released its sixth annual rankings of the states according to their respective policy climates for small business and entrepreneurship in the "Small Business Survival Index...

FDA-CDRH MDR Pilot Program Meeting.(Brief Article)
July 1, 2001... A meeting with representatives of CDRH's Office of Surveillance & Biometrics (OSB) will be held on a new concept for alternate MDR program, based on risk analysis, on Sept. 10, 2001, from 1:30 - 4:00 PM at Allergan, 2525 Dupont Dr, Irvine CA....

CLIA Regulation of Unestablished Lab Tests.(Brief Article)
July 1, 2001... WASHINGTON DC -- AUGUST 2, 2001 -- A new report released today by the DHHS Office of the Inspector General (OIG) examines the regulation of unestablished lab tests--i.e., tests that are not generally accepted by those involved in traditional...

Medicare Complaint Process Found Lacking.(Brief Article)
July 1, 2001... AUGUST 13, 2001-- WASHINGTON DC -- A new DHHS Office of the Inspector General (OIG) inspection (OEI-01-00-00060) examines the effectiveness of the beneficiary complaint process administered by Medicare's peer review organizations (PROs), and...

Controversial Practices of the Tissue Bank Industry : Testimony Before the Permanent Subcommittee on Investigations Committee on Governmental Affairs US Senate.
July 1, 2001... Testimony of George Grob Deputy Inspector General for Evaluations &Inspections US DHHS Office of Inspector General May 24, 2001 Human tissue is an important source of medical treatment, benefitting thousands of Americans every...

Latest Available Health & Medical Statistics Collected By The US DHHS National Center for Health Statistics.(Statistical Data Included)
July 1, 2001... Compiled as of Late August 2001 Asthma (All figures are for US) There were 5,438 deaths from Asthma (1998) Source: National Vital Statistics Reports, Vol. 48, No. 11 Nearly 14.5 mln Americans have Asthma (1996) 10.5 mln of these...

Problems Finding Relevant & Complete Health/Medical Info On The Internet : Deficiencies in information have a negative influence on consumer health decisions, including whether to seek care.(Brief Article)
July 1, 2001... American Medical Association Chicago IL CHICAGO IL -- MAY 21 2001 -- Accessing health information using Internet search engines and simple search terms is not efficient. In addition, coverage of key information on English-and...

$5 Bln Market For Gastroesophageal Reflux Disease (GERD) Treatments.(Brief Article)
July 1, 2001... However, 10 year follow-up study suggests anti-reflux surgery should not be advised with the expectation that patients will no longer need to take medications American Medical Association Chicago IL CHICAGO IL -- MAY 3 2001 -- Nearly...

Reconsidering Surgical Therapy For Reflux Disease.(Brief Article)
July 1, 2001... In an accompanying editorial, Peter J. Kahrilas, M.D., of Northwestern Univ Medical School, Chicago IL, writes that the findings of Spechler and colleagues make it easier for physicians to offer patients with GERD reasons not to have...

Hip Fracture Market : Risk Factors Predict Patient Survival & Ability To Function After Incidents.(Brief Article)
July 1, 2001... Study suggests need for greater attention to patient factors & hospital performance to improve outcomes after hip fracture American Medical Association Chicago IL CHICAGO IL -- JUNE 5 2001 -- Risk factors, including age and residency...

2001 Guide To Biotechnology : Excerpted, Condensed & Edited Version.(Statistical Data Included)
July 1, 2001... Biotechnology Industry Organization Washington DC The modern era of genetic engineering began in 1973 with the first successful experiment to recombine DNA from one organism with that of another by Drs. Herbert Boyer and Stanley Cohen....