DOTmed Industry Sector Report: Medical Disposables Sales and Service
August 04, 2008
Various single-use
medical devices
medical devices
by Joan Trombetti
This article is from in the July 2008 issue of DOTmed Business News. A list of registered users that provide sales & service can be found at the end.
As the cost of medical supplies and devices continues to skyrocket, hospitals and medical treatment facilities are forever on the lookout to find ways to cut corners when it comes to saving money and reducing losses. Hence, the reprocessing and reuse of medical devices labeled "single-use" or "disposable" has become a popular, albeit controversial worldwide practice.
The facts
The U.S. Government Accountability Office (GAO) issued a report in January 2008
addressing the SUD reprocessing industry, the number of reprocessing establishments, the types of devices reprocessed, and the extent to which hospitals use reprocessed SUDs. The report also reviewed the steps the FDA has taken to strengthen oversight of reprocessed SUDs - on its own and in response to legislative requirements, as well as the safety of reprocessed SUDs compared with other types of medical devices. The GAO report concluded that FDA oversight has increased since 2000, and available information does not indicate that the use of SUDs presents an elevated health risk.
New measures by the FDA
In essence, the FDA has regulated the reprocessing of SUDs since 2000, calling for all SUDs to be cleaned, checked for functional integrity and sterilized according to the requirements applicable to OEMs. The FDA added new points of governance in 2006, including an order for any reprocessor to add its name to the reprocessed device. The only exception to that regulation is when the original device, or an attachment to it, does not prominently and conspicuously identify the name of the OEM.
Through the FDA Medical Device Reporting (MDR) system and the MedWatch reporting system, healthcare professionals submit voluntary reports. And, under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the MedWatch report form was revised, adding a question to enhance the agency's ability to identify and investigate reports of problems that are linked to reprocessed SUDs.
The FDA has implemented the following procedures to further ensure that SUDs are safe for public health: an addition of two new rules to ensure that reprocessors submit cleaning, sterilization and functional performance data to show that their device is more than equivalent to the predicate device; established work groups to keep scientists abreast of evolving literature and new consensus standards relevant to the reprocessing of SUDs; submitted reprocessor inspection requests to the Office of Regulatory Affairs; provided regular updates to its 'reuse web page' to keep healthcare facilities and providers informed; updated guidances to industry and FDA reviewers on validation data requirements for reprocessed SUDs; updated lists of reprocessed SUDs subject to the additional pre-market requirements imposed by MDUFMA; conducted research to develop/establish "acceptable" SUD cleaning criteria and are collaborating with two healthcare facilities monitoring changes in the design of some SUDs and identifying new SUDs being reprocessed.
This article is from in the July 2008 issue of DOTmed Business News. A list of registered users that provide sales & service can be found at the end.
As the cost of medical supplies and devices continues to skyrocket, hospitals and medical treatment facilities are forever on the lookout to find ways to cut corners when it comes to saving money and reducing losses. Hence, the reprocessing and reuse of medical devices labeled "single-use" or "disposable" has become a popular, albeit controversial worldwide practice.
The facts
The U.S. Government Accountability Office (GAO) issued a report in January 2008
addressing the SUD reprocessing industry, the number of reprocessing establishments, the types of devices reprocessed, and the extent to which hospitals use reprocessed SUDs. The report also reviewed the steps the FDA has taken to strengthen oversight of reprocessed SUDs - on its own and in response to legislative requirements, as well as the safety of reprocessed SUDs compared with other types of medical devices. The GAO report concluded that FDA oversight has increased since 2000, and available information does not indicate that the use of SUDs presents an elevated health risk.
New measures by the FDA
In essence, the FDA has regulated the reprocessing of SUDs since 2000, calling for all SUDs to be cleaned, checked for functional integrity and sterilized according to the requirements applicable to OEMs. The FDA added new points of governance in 2006, including an order for any reprocessor to add its name to the reprocessed device. The only exception to that regulation is when the original device, or an attachment to it, does not prominently and conspicuously identify the name of the OEM.
Through the FDA Medical Device Reporting (MDR) system and the MedWatch reporting system, healthcare professionals submit voluntary reports. And, under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the MedWatch report form was revised, adding a question to enhance the agency's ability to identify and investigate reports of problems that are linked to reprocessed SUDs.
The FDA has implemented the following procedures to further ensure that SUDs are safe for public health: an addition of two new rules to ensure that reprocessors submit cleaning, sterilization and functional performance data to show that their device is more than equivalent to the predicate device; established work groups to keep scientists abreast of evolving literature and new consensus standards relevant to the reprocessing of SUDs; submitted reprocessor inspection requests to the Office of Regulatory Affairs; provided regular updates to its 'reuse web page' to keep healthcare facilities and providers informed; updated guidances to industry and FDA reviewers on validation data requirements for reprocessed SUDs; updated lists of reprocessed SUDs subject to the additional pre-market requirements imposed by MDUFMA; conducted research to develop/establish "acceptable" SUD cleaning criteria and are collaborating with two healthcare facilities monitoring changes in the design of some SUDs and identifying new SUDs being reprocessed.
