Description of Event or Problem · 1
AS AN ENGINEERING MANAGER RPTR ROUTINELY TESTS NEW PEAK FLOW METERS THAT ARE INTRODUCED TO THE MARKET. DURING RECENT TESTING, RPTR FOUND WHAT SHE BELIEVES TO BE A SAFETY PROBLEM. IN 7/93, MFR INTRODUCED THIS PEAK FLOW METER. SINCE THAT INTRODUCTION, THE PRODUCT HAS BEEN MODIFIED TO INCLUDE A SMALL PLASTIC SLEEVE WITHIN THE MAIN BODY OF THE UNIT. THE INSTRUCTIONS FOR THE PRODUCT STATE THAT TO RESET THE METER, THE UNIT IS TO BE SHAKEN DOWN AS ONE WOULD A THERMOMETER. UPON SHAKING THE UNIT THE INTERNAL SLEEVE BECAME DISLODGED, MAKING THE PRODUCT UNUSABLE. THE CALIBRATION OF THE PRODUCT IS CHANGED DEPENDING UPON THE POSITION OF THIS SLEEVE. AS PREVIOUSLY STATED, THE METER MUST BE SHAKEN DOWN IN ORDER TO BE RESET. THIS IS NOT A SIGNIFICANT PROBLEM WHEN THE METER IS USED IN THE PRIVACY OF ONE'S HOME. HOWEVER, WHEN THE METER IS USED IN A PUBLIC SETTING SUCH AS IN A HOSP OR CLINIC, THE SHAKING ACTION ALLOWS SPUTUM TO BE DISPERSED IN THE IMMEDIATE ENVIRONS. IT IS IRRELEVANT THAT THE PRODUCT IS INDICATED FOR SINGLE PT USE SINCE EVEN A SINGLE USER SHARES HIS ENVIRONMENT WITH HEALTH CARE PROFESSIONALS AND OTHER PTS. AS A FINAL POINT, RPTR WOULD APPRECIATE CLARIFICATION OF AN ISSUE PERTAINING TO PEAK FLOW METER PRESCRIPTION STATUS. SHE UNDERSTOOD DEVICES THAT INCLUDED ZONE MANAGEMENT SYSTEMS WERE TO BE SOLD BY PRESCRIPTION ONLY. DEVICE DETAILS SETTING UP AN ASTHMA PLAN USING THE ZONE "TAPES" INCLUDED WITH THE UNIT. WHY WOULDN'T THE INCLUSION OF THESE TAPES AS PART OF THE PACKAGING OF THIS PRODUCT REQUIRE IT TO HAVE PRESCRIPTION STATUS?