Medical Device Packaging Testing And Regulations
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For years, manufacturers of medical devices have marked their packages as "sterile until opened."The latest requirement is that the expiry date be marked on the package with an unsubstantiated claim that it is valid for five years or more.This puts pressure on manufacturers.It is difficult to treat the conditions of packing roughly.Packages can be stored at high, low and/or high temperatures, placed on vibration benches to simulate truck overland transport, or dropped from specified heights to cause damage.It is not a simple matter to damage a well-designed medical sterile packaging.But it is realistic to know breakage by actually following up the packaging.Testing There are a lot of tests done on medical sterilization bag.Many of these tests are meaningless.You must consider the test method, the significance of the test results, and the relationship between the test conditions and actual performance, and in particular, you must affirm the need for testing.Some societies and associations have developed standard testing procedures applicable to medical packaging.Some of these testing procedures are available from ASTM, AAMI, HIMA, TAPPJ. The above associations and societies are mainly concerned with the physical properties of packaging materials and should also pay attention to the safety evaluation of packaging materials in which certain compounds may be transferred to devices.The possible risk of poisoning must be assessed.Some of the tests mentioned above are non-destructive.The American Association of Health Industry Manufacturers proposes nine microbial test methods to evaluate packaging materials and packages.Unfortunately, all of these methods are destructive, and none of the tests is universally accepted.It is debatable whether the test conditions used are too broad or too strict, and therefore representative of what normally happens.
The sterile packaging of medical devices is subject to a wide range of government regulations.Most regulations in the United States are issued by the Food and Drug Administration.Restrictions on labels should be strictly enforced.The Government's insistence that special instructions be clearly and prominently displayed on packaging raises a range of issues that need to be addressed in different ways.Manufacturers with limited production capacity often attach pressure-sensitive or heat-sealed labels to unprinted cakes.As device production increases, pre-printed packaging is often used instead of labels.Due to the increase in complexity and the need for longer text for instructions, it is often impossible to print very long instructions on the packaging surface. It is an important advantage to be able to print on both sides of the packaging material by inserting a manual or printing part or all of the instructions on the inside of the package.Factories that produce many kinds of apparatus often put color marks on the packages.To avoid confusion of products, all packages should be printed with a distinctive color or, as appropriate, a special color on the back of the package or on the patch.Packaging operations are also subject to the FOOD and Drug Administration's Good Manufacturing Practices Act.It's a long rule, but it's simple.The panel divided the devices into three categories.The third category is the strictest, with very strict conditions attached.The first and second categories are loosely regulated.The Good Manufacturing Act was based on a 1976 revision of the Food and Drug Act.The FOOD and Drug Administration is no longer concerned with the number and type of quality control steps required.However, "good Manufacturing Practices" require manufacturers to set up specialized agencies, write written procedures and comply with them.The most important thing is to do it carefully. For example, if a manufacturer states in a written procedure that the equipment is inspected regularly, he must keep a record of the inspection.It is also important to keep archives of "public opinion".The reasons for the complaints, action taken on the findings and corrective measures, if any, must be documented.In short, "good manufacturing practices" require manufacturers to strictly control operating procedures.Both the U.S. Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA) are concerned about the sterile packaging of medical devices, especially regarding the disinfection and handling of packaging materials.