Dr. Andreas Ostrowicki, managing director of BGS Beta-Gamma-Service in Germany, looks at the necessary considerations for companies considering a second source for the sterilisation of medical devices.
Due to the outbreak of the coronavirus pandemic, the reliable and consistent provision of medical consumables is faltering. The lesson learned from the crisis is that not only in Europe, but worldwide, supply chains and the dealing with critical suppliers are being re-evaluated. In particular, sterilisation processes and capacities are in the focus. Owing to special technology as well as expenses for plant operations, these sterilisation processes are often outsourced to specialised providers. As a rule, each product is validated for only one sterilisation procedure, sometimes only for one plant. If longer downtimes occur, whether through plant shutdowns or disrupted supply chains, this may result in massive financial losses for the manufacturer, but also considerable supply gaps in the market. Based on the regulatory effort needed to establish a second supplier, a quick solution cannot be expected in such cases. It is all the more important therefore for manufacturers of medical devices to look into and evaluate existing production and supply chains in good time. Due to the present experience, many manufacturers are focusing on setting up a second source for their sterilisation processes in the context of their risk assessment.
Second source for sterilisation of medical devices: Central issues
Dr. Andreas Ostrowicki, managing director of BGS Beta-Gamma-Service, Germany
Those considering a second source need to look into a number of strategic issues. Can the device be qualified for a second plant at the existing provider? Will the partnership with a further sterilisation service provider optimally reduce the existing downtime risks or does it make sense to qualify for another sterilisation method? Furthermore, it is necessary to check the sterilisation and plant capacities of the selected provider as well as the provision of internal resources. For without employees, who have the necessary expertise, and without an appropriate budget, the process will very soon encounter its limits.
Change in sterilisation procedure, provider, or the plant: Overview of validation steps
One of the most common methods of sterilising medical devices is using Ethylene Oxide (EO) and beta or gamma rays. Both methods have their advantages, and to a degree, they complement one another. If a change in the sterilisation method is under discussion, it first has to be assessed whether the relevant medical device is suitable. The assessment includes important factors such as material, packaging and the packing scheme of the device. EO is able to penetrate numerous layers of air-permeable packaging and is optimally suited, e.g. for the sterilisation of complex instruments already assembled or devices with integrated electronics. Thermolabile and powdery substances, products that cannot get wet, or are gas-proof packed, are not suited for this type of sterilisation.
In these cases, radiation sterilisation is used. This is the preferred method when complex geometries or large surfaces are involved. A further advantage of radiation sterilisation is that following treatment, the devices are ready for use immediately. Compared to EO sterilisation, no final degassing of the treated devices is necessary. For medical devices containing electronic components, this sterilisation method is not suited as a rule, just as little as for devices containing polymers such as PTFE and POM.
After checking and selecting the desired method and finding an appropriate sterilisation service provider, the next step is drawing up a validation plan together. This requires a close exchange of expertise between the manufacturer and service provider. Depending on the planned change, costs will vary.
If the manufacturer plans to maintain the chosen method of sterilisation and qualify its product for a second plant or supplier, the microbiological and application-related validation will retain its validity. In this case, it is important to validate the new plant and register the service provider - a process, which, by comparison, requires the least effort. The most expensive case, e.g. changing from one established sterilisation procedure to another, requires registering the new service provider and the new plant, as well as a microbiological and application-related validation.
Single versus second source: Effort and expense worthwhile
In view of the numerous legal requirements that apply to marketing of sterile medical devices, establishment of a second source appears to be more complex at first glance in this area than in other sectors. Undoubtedly, the process is complex and is further complicated by current development of the Medical Device Regulation and the availability of the notified body. Strategically, it is nonetheless a topic which each manufacturer should deal with critically and which cannot be started early enough due to the long lead times. This overview also shows that a procedure validation to qualify a device in another plant is possible with manageable investments. Sterilisation service providers can offer their expertise here.