Overview
Custom Procedure Tray (CPT) is a customized solution for specific hospital procedures. It contains a bundle of disposable products, which would be required for a particular procedure. Procedure trays meet the surgical user’s needs for single-use components in one sterile pack and provide a convenient way of managing surgical interventions. Since a number of components are added to a pack, they are sourced from a wide and diverse supplier base, tailored to meet individual needs including delivery options that will meet the users operating requirements. The provision of all the single-use components in one pack helps save the time involved in setting up, reduces packaging waste and benefits the environment, reducing inventory and associated costs.
The kits consist of dressing material, operating room (OR) drapes and various disposable products for the daily OR requirements like syringes, cannulae, suture material and others. Disposable products such as patient drapes, surgical staff clothing and surgical dressings account for approximately 20 to 30 per cent of the contents in a normal tray. The remaining products include instruments, sutures, tubes, bowls and various other single-use products are sourced from different suppliers.
The largest component by value in a typical CPT, is drapes and gowns constituting around half the value of the CPT market. Other components include swabs, syringes and suction tubes, but a large number of surgical products may be included in CPTs. In view of the lack of demand side substitutability, various sub-segments of CPTs may constitute relevant product markets depending on the surgery they are intended for (general surgery, heart surgery, orthopaedics, and so on). The OR market covers all surgical procedures performed in the operating room.
The European CPT market is growing at a fast pace. The idea of ‘customization’ means offering customers whatever they want. Hospitals often have special requirements for procedure kits. Choices vary with doctors and even amongst theatre staff, posing a huge challenge for stock holding for a CPT company. Hence, it is critical for these companies to have the ability to source various products from a number of suppliers. The challenge is to segment the products in a CPT into a range of categories and develop distinct strategies for each type.
Effective and efficient management of the supply chain is essential in the CPT market. Hence, it is very important for CPT companies to closely keep track of the hospitals and their needs. It is critical to understand the importance of selecting the appropriate components for inclusion within a procedure tray. End users such as surgeons are generally highly brand conscious, and the failure to provide the desired brand may result in business failure. Hence, adequate training should be provided to the theatre staff about the benefits and usage of a company’s products.
Component Supplier Partnership
End users such as surgeons and operating room (OR) staff are highly brand conscious, and the inability of CPT vendors to provide a desired brand may result in loss of business and inability to maintain healthy customer relations. Market participants have to dedicate significant attention to purchasing and supply chain management at both strategic and operational levels. It is very important in a supply chain market to source an efficient supplier for effectively running the supply chain without hindering the cycle. It is also essential to find and develop suppliers that are competent and interested in helping their customers save costs as well. Thus, the success of the purchaser also depends on his/her skill in locating or developing suppliers, analysing supplier capabilities, selecting the appropriate supplier and collaborating with the supplier to obtain continuous process improvement to result in a win-win situation for both the purchaser and the supplier.
Usage of prepacked, sterilized kits would greatly contribute to the reduction of any nosocomial and iatrogenic infections. Usage of procedure packs reduces linen and other operating room accessories handling, thereby preventing chances of infection. Usage of disposable drapes and gowns, which contribute a major portion of the procedure pack, also decreases the spread of contamination and reduces lint in operating theatres.
The growing diversity of operating procedures and surgical preferences requires the procurement of a massive variety and volume of supporting clinical products. There is also the need to reduce stockholding space, manage costs and meet emergency requirements. The time, costs, inconvenience and stress of supplying single-use products to the operating team needs to be minimized by the most effective purchasing departments. Usage of procedure packs reduces administrative issues and minimizes the need to liaise with non-core suppliers.
It also enables inventory reduction, easier control on storage and simplified delivery schedules. Procedure kits create an opportunity to standardize contract items and control costs.
Regulatory Overview
While the MDD does not specifically define what a system or procedure pack is, it is clear from Article 12 of the MDD that it is the combination or assembly of medical devices that have CE marking approval and are proven to be compatible, considering their original intended use, for a specific medical purpose.
If such conditions are met, and the devices will be marketed together as a system or procedure pack then the following applies:
1. The natural/legal person is required to draw up a statement/declaration stating that:
• The mutual compatibility of the devices has been verified in accordance to the manufacturer’s instructions and intended use
• The system/procedure pack has been packaged with the relevant information supplied from the manufacturers to the user
• All the activity regarding combination of devices is subject to the appropriate methods on internal monitoring and control
2. For devices designed by their manufacturer to be sterilised before use:
• Follow the procedures set out in Annex II OR Annex V of the MDD. (The scope of these procedures is limited to ensuring sterility until the package is either opened or damaged).
• The natural/legal person must draw up a statement/declaration that serialisation was done in accordance to the manufacturer’s instructions
3. Systems/procedure packs do not require an additional CE mark, however they do require:
• Information supplied by the manufacturer as per Annex I (13) of the MDD
• The statement/declaration referred to above to be kept at the disposal of the competent authorities for 5 years
In the case that the conditions are not fulfilled then Article 11 applies instead, this can be due to:
a. One or more of the devices in the system/procedure pack is NOT CE marked
b. One or more of the devices in the system/procedure pack IS CE marked but not for the intended use of the system/procedure pack
Article 11 requires the system/procedure pack to be treated as a device in its own right and must obtain its own CE mark. All components will require documentation that proves compliance with Annex I (Essential requirements) and the conformity assessment procedure would be determined by the device which has the highest classification in accordance with Annex IX (classification criteria)
The new MDR defines systems and procedure packs in Article 2 (Definitions) as follows:
“(10) ‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose; “
“(11) ‘system’ means a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose;”
The new MDR has a clear definition of what a procedure pack or system is, this was absent in the MDD. Every procedure pack is considered to be a system, but not every system is necessarily a procedure pack.
1. As with the MDD, the MDR requires the natural/legal person to draw up a statement/declaration stating that:
• the mutual compatibility of the devices has been verified in accordance to the manufacturer’s instructions and intended use
• the system/procedure pack has been packaged with the relevant information supplied from the manufacturers to the users
• all the activity regarding combination of devices is subject to the appropriate methods on internal monitoring and control (MDR adds emphasis on the validation and verification of these activities)
• One addition to the MDR is that it specifies the types of devices that would be part of a system/procedure pack.
These are:
– Other CE marked devices
– In-Vitro Diagnostic devices (governed by the IVDR 2017/746)
– Other products that conform to their relevant legislation only when they are used as part of the medical or procedure or their inclusion in the system/procedure pack is justified.
While this was also generally true for the MDD it was not specified in such a way.
2. For devices designed by their manufacturer to be sterilised before use:
• Follow the procedures set out in Annex IX OR Part A of Annex XI. (The scope of these procedures is limited to ensuring sterility until the package is either opened or damaged).
The natural/legal person must draw up a statement/declaration that serialisation was done in accordance to the manufacturer’s instructions.
3. Also, like the MDD the MDR states that systems/procedure packs do not require and additional CE mark, however they do require:
– The registered trade name/trade mark of the natural/legal person and their contact address.
– The correct labelling and information for use as per Annex I (23)
– The declaration referred to above to be kept at the disposal of the competent authorities for a period of 10 to 15 years depending on the type of devices involved as per Article 10 (8)
The key differences between the MDR and MDD here are related to any changes regarding labelling and information for use (see Annex I, chapter III (23)) and the period of keeping the declaration/statements which has increased from 5 to 10 years and up to 15 years in the case of implantable devices. An important addition to the MDR is that in the case where a system/procedure pack contains devices without CE marking or the combination of devices are not compatible according to original intended purpose or where sterilisation was not done according to the manufacturer’s instructions then such systems/procedure packs will be considered as a device in their own right and subject to the relevant procedures set out in Article 52. In such cases the natural/legal person assumes the obligations of the manufacturer.
Classification of medical device systems and procedure packs under the MDD According to MEDDEV 2.4/1 rev 9:
“3.1.6 Procedure packs Procedure packs per Article 12 of Directive 93/42/EEC normally do not require classification as each device in the procedure pack keeps its own CE marking and classification. However, in cases where:
• the procedure pack incorporates devices which do not bear a CE marking,
• or where the chosen combination of devices is not compatible in view of their original intended use, the system or procedure pack shall be treated as a device in its own right and as such be subjected to the relevant procedure pursuant to Article 11 of Directive 93/42/EEC (and classification rules based on Annex IX).
For a procedure pack that is a device in its own right, the classification is normally determined by the intended use. In those cases where the intended use of the procedure pack is not specific enough to determine the classification, the classification of the pack is at the level of the highest classified device included in the pack, where applicable taking into account the new intended use of the device.”
Classification of medical device systems and procedure packs under the MDR Based on Article 22 (4): “
4. Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer’s instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers.”
It can be inferred that the same process for the classification of procedure packs under the MDD can be applied to procedure packs under the MDR, where each device within the pack has its own classification and CE mark and thus the procedure does not need to be classified in itself. However, when devices without a CE marking are included in the pack or there is an incompatibility between the devices in view of their intended use then the pack should be treated as a device in its own right and should be subject to the conformity assessment procedures set out in Article 52 and classification rules set out in Annex VIII. Such a classification would be based on the pack’s intended use. In cases where the intended use of the pack is not specific enough for classification then the classification of the pack should be the same as the highest classified device included in it.