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Association Of Indian Medical Device
Industry (AIMED) : International Regulatory Update
SAFETY OF REPROCESSED MEDICAL DEVICES MARKETED FOR SINGLE-USE
- ADOPTION OF SCIENTIFIC OPINION
The European Commission's independent Scientific Committee on
Emerging and Newly Identified Health Risks (SCENIHR) has recently published its
opinion on the safety of reprocessed medical devices marketed for single-use.
They say; A single-use medical device (SUD) is a device intended to be used once
only for a single patient. Examples of SUDs are single-use syringes and needles,
catheters and breathing tubes.
The Directive (93/42/EEC) regulating the placing of medical
devices on the EU-market distinguishes between devices that are intended for
reuse and those intended for single-use only. However, the practice of
reprocessing SUDs is not regulated at EU-level and legislation in Member States
differs. A few countries allow the reprocessing of SUDs, others prohibit the
practice and some have no specific legislation.
The Commission asked the Scientific Committee on Emerging and
Newly Identified Health Risks (SCENIHR) to assess whether the reprocessing of
SUDs may constitute a hazard for human health.
Although clinical data is limited, the SCENIHR opinion
identifies several potential hazards of re-using SUDs that may lead to a risk
for patients. The opinion concludes that certain design features make a SUD
unsuitable for reprocessing. Major hazards can arise from inadequate cleaning,
disinfection and/or sterilization, resulting in contamination and possibly
causing toxic reactions or infections. Chemicals used for disinfection may also
affect the performance of the device. Areas of particular concern are the
potential contamination with agents that cause transmissible spongiform
encephalopathies (TSEs) and the risk of using reprocessed SUDs in invasive
medical procedures. Other hazards mentioned in the opinion include poor
traceability of a reprocessed SUD and loss of documentation such as the
instructions for use.
The Commission will now finalize the report on the issue of
the reprocessing of medical devices in light of the SCENIHR opinion and will
submit it to the European Parliament and the Council in accordance with
Directive 93/42/EEC.
Courtsey : Forum Co-ordinator
Association Of Indian Medical Device Industry, ( AIMED ).
GL-3 , Ashoka Estate, 24 , Barakhamba Road, New Delhi – 110 001
J&J Sees Fast-Growing Device Market :
Plans 80 Regulatory Submissions For New Devices
*Plans 80 regulatory submissions for new devices
Johnson & Johnson (JNJ.N) sees itself competing in a
faster-growing segment of the medical device market and plans about 80
"significant" regulatory submissions for its largest unit in the next two years.
J&J outlined its plans for the medical device business -- its
top product category with annual sales of about $25 billion -- as it tries to
overcome a manufacturing crisis at its consumer unit that makes Tylenol and
other products.
Many analysts gathered at company headquarters in New
Brunswick, New Jersey, on Thursday also hoped for an update about J&J's series
of recalls of Children's Tylenol and dozens of other over-the-counter
medications.
Management declined to discuss the recalls, which the U.S.
Food and Drug Administration are investigating.
The company handled the recalls "sloppily," said Andrew
Busser, portfolio manager at Symphony Capital in New York.
"Their execution and communication has not been crisp, but I
don't think this will be meaningful long term," he said.
BDR analyst Matt Duffy said he was looking for signs that J&J
is keeping its edge in devices and diagnostics against the likes of Abbott
Laboratories Inc (ABT.N).
"There are a lot of questions about devices and diagnostics,"
Duffy said. "The stent business has been unbelievably competitive with
(Abbott's) Xience taking over the world."
J&J said it has received more than a dozen regulatory
approvals in 2010. Additional submissions will be rolled out across its seven
franchises, including its DePuy orthopedics unit, Cordis cardiovascular business
and Ethicon, which makes surgical instruments.
The maker of Band-Aids and Motrin told analysts it expects
sales of the types of medical devices that it sells to grow by an average of 6
percent per year between 2009 and 2014. That would outpace growth of the wider
medical device industry, which it forecast at 5 percent annually. J&J did not
provide a forecast for its own medical device sales.
Total sales were $61.9 billion in 2009.
Shares of J&J were down less than 1 percent to $59.71 in
afternoon trading on the New York Stock Exchange.
http://www.reuters.com/article/idUSN0325435620100603?
type=marketsNews |
