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  3. Saturday, 23 February 2002
POST 00429E : NEEDLE-FREE INJECTORS FOR MASS IMMUNIZATION CAMPAIGNS Follow up on Posts 00405E, 00408E, 00411E, 00147E, 00420E and 00426E 23 February 2002 _______________________________________________________________________ Mary Catlin of the Young Women's Research Center, University of Arizona Cancer Center comments on the topic and also offers some help in securing grants if anyone needs such support for evaluating the device. _______________________________________________________________________ I believe that needle-free injectors are of such great potential global importance that an objective quantification of their risks is merited prior to their introduction. WHO/PAHO/FDA recently published A Model Regulatory Program for Medical Devices: an International Guide. Essential Drugs and Technology Program, Division of Health Systems and Services Development. PAHO 2001. (Authors contact info: John Stigi at FDA mailto:jfs@cdrh.fda.gov, and Antonio Hernandez at PAHO, mailto:1hernana@paho.org.) They posted a list of relevant questions for the reuse of medical devices that need to be answered. Here are questions that I've extracted from their list for our purposes somewhat. Is there adequate information to determine the safety and clinical effectiveness of specific reusable devices? Are there established methods for reprocessing (cleaning, decontamination, disinfections and re-sterilizing) prior to re-use and for validating the integrity of devices reprocessed for use? Note : we need to be concerned both with the sterility of the fluid paths as well as the risk of blood-borne transmission. What level of sterility and assurance of sterility is desired or acceptable? Is information available to exclude specific devices from being used? Is proficiency training necessary for devices to be safely used? Are there specific requirements of the health care setting that are necessary for these devices to be safely used in their settings of intended use (supplies, trained user, repair, accompaniment of syringes for back-up, vial sizes, supervision, water etc)? What level of surveillance is necessary to avoid product failure and detect system related errors in use? If there is a demonstrable level of risk in their use, should health care providers be encouraged or compelled to obtain patient informed consent prior to medical treatment involving reused devices? We need to understand the risks when used as directed under ideal conditions, and the risks when used in the settings of intended use. If things go wrong with comparatively simple devices such as disposable syringes, things will go wrong with devices of moderate complexity such as mass injectors. If we identify critical point in advance, we can modify the device, restrict their use to systems able to use them safely, or train users. We can ameliorate the risks. So I believe part of the assessment needs to incorporate - to use FDA lingo - Human Factors Analysis. A useful reference can be found at http://www.fda.gov.chrh/humfac/1497.html , Medical device Use-Safety: Incorporating Human Factors Engineering in Risk Management. issued July 18, 2000. If I could be of assistance, after March 31, I would be happy to help write grants to fund a rigorous evaluation of these devices if available funding is part of the problem.... Mary Catlin ----------------------------------------------------------------------------- CONTRIBUTIONS: Contributions to: or use your reply button! The TechNet21 e-Forum welcomes new subscribers who are involved in immunization services. SUBCRIBE: To subscribe, send an e-mail to: Leave the SUBJECT area BLANK, do not type anything. In the body text, just write: Subscribe TECHNET21E Surname Name Do not use any accents in your name and surname. 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