MAUDE Database Research Articles

Enteral nutrition access devices

The ASGE Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but, in many cases, data from randomized, controlled trials are lacking. In such situations, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the ASGE Governing Board. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through August 2009 for articles related to endoscopy in patients requiring enteral feeding access by using the keywords "endoscopy," "percutaneous," "gastrostomy," "jejunostomy," "nasogastric," "nasoenteric," "nasojejunal," "transnasal," "feeding tube," "enteric," and "button." Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

Minimizing occupational hazards in endoscopy: personal protective equipment, radiation safety, and ergonomics

The ASGE Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, by using a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through August 2009 for articles related to personal protection equipment by using the key words "personal protection equipment" (exp Protective Clothing/ or exp Protective Devices/ or exp Masks/ or exp Occupational Exposure/'') "infection control" paired with "Endoscopy." For the radiation section, the following key words were used: "radiation and endoscopy," "radiation and ERCP," and "radiation safety." For the ergonomics section, the following key words were used: "ergonomics of endoscopy," "endoscopist injury," "medical ergonomics," "endoscopy and musculoskeletal strain," "musculoskeletal injury and endoscopists," "occupational diseases and endoscopy," "cumulative trauma disorder and endoscopy," "repetitive strain injury and endoscopy." Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

The role of the U.S. Food and Drug Administration in device evaluation and monitoring

The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through October 2009 for articles and references related to devices and the U.S. Food and Drug Administration by using the keywords "FDA" and "devices." In addition, the Web was searched using the same keywords. The U.S. Food and Drug Administration website was also thoroughly reviewed. Practitioners should continue to monitor the medical literature for subsequent data about these issues. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

Interventional EUS

The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of new or emerging endoscopic technologies that have the potential to have an impact on the practice of GI endoscopy. Evidence-based methodology is used by performing a MEDLINE literature search to identify pertinent preclinical and clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but, in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. For this review, the MEDLINE database was searched through August 2009 by using the keywords "interventional endoscopic ultrasound," "EUS," and "interventional endoscopy." Reports on Emerging Technologies are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. These reports are scientific reviews provided solely for educational and informational purposes. Reports on Emerging Technologies are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

Complications Associated with Hysteroscopic Sterilization; a Critical Review of the Literature and Review of the MAUDE Database

Complications Associated with Hysteroscopic Sterilization; a Critical Review of the Literature and Review of the MAUDE Database

84: Adverse Events From Endometrial Ablation Devices: Update of the MAUDE Database 2003-2006

84: Adverse Events From Endometrial Ablation Devices: Update of the MAUDE Database 2003-2006

Reported Failures of the Polymer Self-Locking (Hem-O-Lok) Clip: Review of Data from the Food and Drug Administration

New technology has played an important role in the proliferation of laparoscopy within urology. A central issue remains meticulous hemostasis, particularly for larger vessels (e.g., renal artery and vein). This paper presents available information regarding failure of the widely utilized nonabsorbable polymer Hem-o-lok clip (Weck Closure Systems, Research Triangle Park, NC), introduced in 1999. The Food and Drug Administration Center for Devices and Radiological Health maintains a compendium of reports of adverse events involving medical devices (MAUDE). We performed multiple searches of MAUDE using a variety of key words, including Weck, Hem-o-lok, laparoscopy, nephrectomy, and clip. Within the MAUDE database, we identified 27 reports of problems with the Hem-o-lok clip until July 6, 2005. Of these events, only 1 (4%) involved application during open surgery, with the remainder occurring during laparoscopy. Minimal morbidity resulted from applicator difficulty during laparoscopic cholecystectomy (N = 7; 26%), with one case of open conversion. Forty-eight percent (N = 13) of the failures occurred during urologic laparoscopy; of these, bleeding was the primary problem in 77%. Delayed exploration, immediate open conversion, and death resulted in 38% (N = 5), 8% (N = 1), and 15% (N = 2), respectively. No clear etiology for the events could be found, although in all situations, multiple clips had been applied with apparent initial vessel control intraoperatively. Reported difficulty with the Hem-o-lok clip occurs primarily during laparoscopic surgery. Cases of failure after laparoscopic nephrectomy require urgent exploration, although it is unclear whether device or user error is the underlying cause. Regardless, care must be taken in securing the renal vessels, surgeons must be educated regarding proper use and techniques, and consideration should be given to using transfixing techniques.

Complications Associated With Global Endometrial Ablation: The Utility of the MAUDE Database

Complications Associated With Global Endometrial Ablation: The Utility of the MAUDE Database

Endovascular Stents: Market Vigilance and Risk Factors

With the aim of enhancing the safety and reliability level of coronary stents, we analyzed data collected from accident reports drawn from the MAUDE database (Manufacturer and User Facility Device Experience Database) of the FDA from 1996 to 2000. This analysis allowed us to highlight problems related to the use of coronary stents by means of the analysis of these reports at different levels, beginning from the causes that can lead to a certain type of accident up to the possible complication related to that event. Moreover we analyzed the procedure outcomes in terms of stent position inside the patient's body and the possible therapies adopted to solve the problems. The results showed that the most probable event that can lead to an accident is the stent separation from the balloon which, alone, turns up in a number of cases equal to the sum of all the others. This result highlights the importance of the technical skill of the operators accomplished by special training and of the importance of clarity and completeness in the instructions for the use of the device. Another critical point is the reliability of the device which must guarantee an adequate safety level when it is used according to the instructions.

Complications associated with non-resectoscopic endometrial ablation: The utility of the MAUDE database

Complications associated with non-resectoscopic endometrial ablation: The utility of the MAUDE database